Sexually Transmitted InfectionsNCT04661566
Optimizing a Multi-Modal Intervention to Reduce Health-Risking Sexual Behaviors: Component Selection
A study testing Basic Education ("Education"), Narrative Videos ("Narratives") and Skills Building Videos ("Skills") in people with Sexually Transmitted Infections and Pregnancy, Unplanned, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial summary
The goal of this project is to evaluate the components of the app-based intervention Mission Wellness to reduce health-risking sexual behaviors (HRSBs; e.g., condom non-use, multiple sexual partners) in active-duty members of the US Military to improve their sexual and reproductive health (SRH) and readiness to serve. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections, Pregnancy, Unplanned, Military Personnel
- What is being tested?
- Basic Education ("Education"), Narrative Videos ("Narratives") and Skills Building Videos ("Skills")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 549 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to 9 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 17 or older,
- currently serving as active duty in the US military, and
- willing to participate in all study activities if eligible and enrolled
Who cannot join
- Does not meet eligibility criteria,
- unable to read, speak, or comprehend English, or
- unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814
About this study
The goal of this project is to evaluate the components of the app-based intervention Mission Wellness to reduce health-risking sexual behaviors (HRSBs; e.g., condom non-use, multiple sexual partners) in active-duty members of the US Military to improve their sexual and reproductive health (SRH) and readiness to serve. Following the multiphase optimization strategy (MOST) framework, factorial component selection experiments (CSEs) will be conducted to evaluate which five experimental intervention components (i.e., Narratives, Skills, Scenarios, Future, and Risk) elicit the greatest improvements in the outcomes of interest given key constraints.
Read the detailed description
Negative SRH outcomes (e.g., sexually transmitted infections [STIs], unintended pregnancy, STI-related cancers) reduce human performance and undermine military readiness. Service members face unique challenges to maintaining SRH during their military service. HRSBs (e.g., multiple sexual partners, unprotected sexual behavior) offer potential intervention targets to improve SRH. Electronic-health interventions are cost-effective and dynamic, and have the potential to reach millions of users as part of an overall strategy for individual behavior and systems change. In civilian populations, e-health interventions have demonstrated success in reducing HRSBs. However, effective HRSB-prevention interventions must consider the specific values, mission, and context of military populations and settings. The MOST framework is used to develop highly effective, efficient, and economic behavioral interventions that is particularly well suited to be used in this context.
This project aims to address this problem by delivering an optimized app-based prevention intervention package ready for evaluation via a subsequent randomized controlled trial (RCT). The specific purpose of this project is to determine which component(s) should be included in the packaged app-based intervention Mission Wellness for US service members based on their effects on the outcomes of interest (i.e., improved knowledge, motivation, and behavior skills related to SRH and reduced HRSBs) in no more than 25 minutes of content. The components tested in the factorial CSEs include: Narratives; Skills; Scenarios; Future; and Risk. Each component has two levels: "on" (included) or "off" (not included). Main and interaction effects of components will be measured to determine the components constituting the packaged intervention.
- Being tested
- Basic Education ("Education"), Narrative Videos ("Narratives"), Skills Building Videos ("Skills"), Interactive Scenarios ("Scenarios"), Future Life Planning Tool ("Future")
- Keywords
- Women's Health, Sexual and Reproductive Health, Military, Multiphase Optimization Strategy
- Medical subject headings
- Sexually Transmitted Diseases, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Education ("Education")Behavioural
All participants will receive the basic educational component in the Mission Wellness app. This component will contain text and media (e.g., images, videos) to teach basic SRH topics. The exact information in this component will be determined by an assessment of baseline SRH knowledge at the start of the intervention.
Narrative Videos ("Narratives")Behavioural
The narrative video component is a motivation-based component that includes stories of individuals engaging in positive and negative SRH behaviors that lead to either positive or negative outcomes, respectively, in a video format.
Skills Building Videos ("Skills")Behavioural
The skills-building videos component is a component rooted in behavioral skills that involves the provision of information on how to perform or engage positive SRH behaviors (e.g., correctly using a condom, what to expect when having a Pap smear) via instructional videos.
Interactive Scenarios ("Scenarios")Behavioural
The interactive scenarios are a behavioral skills-building component that walks through conversations surrounding SRH with select individuals (e.g., partner, healthcare provider), providing suggestions on how to have these conversations and why these conversations are important to have.
Future Life Planning Tool ("Future")Behavioural
The future life planning tool is a motivation-based component contains a series of questions to help users plan future goals to put current decision making related to SRH into perspective and provide suggestions on how to stay healthy now to be able to achieve those goals later.
Epidemiological Risk Scenario ("Risk")Behavioural
The risk component is an information- and motivation-based component with tailored epidemiological risk information about relative risk of contracting a specific STI and/or having an unintended pregnancy. Relative risk information will be determined by adjusting variables within the component (e.g., number of partners within the last month, percent of time using condoms).
| Study group | Role | What they receive |
|---|---|---|
| Education+Narratives+Skills+Scenarios+Future+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives, Skills, Scenarios, Future, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Narratives+Skills+Scenarios+Future | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives, Skills, Scenarios, and Future Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future") |
| Education+Narratives+Skills+Scenarios+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives, Skills, Scenarios, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Narratives+Skills+Scenarios | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives, Skills, and Scenarios Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios") |
| Education+Narratives+Skills+Future+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives, Skills, Future, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Narratives+Skills+Future | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives, Skills, and Future Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Future Life Planning Tool ("Future") |
| Education+Narratives+Skills+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives, Skills, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Narratives+Skills | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives and Skills Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Skills Building Videos ("Skills") |
| Education+Narratives+Scenarios+Future+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives. Scenarios, Future, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Narratives+Scenarios+Future | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives, Scenarios, and Future Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future") |
| Education+Narratives+Scenarios+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives, Scenarios, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Narratives+Scenarios | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives and Scenarios Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Interactive Scenarios ("Scenarios") |
| Education+Narratives+Future+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives, Future, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Narratives+Future | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives and Future Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Future Life Planning Tool ("Future") |
| Education+Narratives+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Narratives | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Narratives Receives: Behavioral: Basic Education ("Education"); Behavioral: Narrative Videos ("Narratives") |
| Education+Skills+Scenarios+Future+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Skills, Scenarios, Future, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Skills+Scenarios+Future | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Skills, Scenarios, and Future Receives: Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future") |
| Education+Skills+Scenarios+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Skills, Scenarios, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Skills+Scenarios | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Skills and Scenarios Receives: Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Interactive Scenarios ("Scenarios") |
| Education+Skills+Future+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Skills, Future, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Skills+Future | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Skills Future Receives: Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Future Life Planning Tool ("Future") |
| Education+Skills+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Skills and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Skills | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Skills Receives: Behavioral: Basic Education ("Education"); Behavioral: Skills Building Videos ("Skills") |
| Education+Scenarios+Future+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Scenarios, Future, and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Scenarios+Future | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Scenarios and Future Receives: Behavioral: Basic Education ("Education"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Future Life Planning Tool ("Future") |
| Education+Scenarios+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Scenarios and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Interactive Scenarios ("Scenarios"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Scenarios | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Scenarios Receives: Behavioral: Basic Education ("Education"); Behavioral: Interactive Scenarios ("Scenarios") |
| Education+Future+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Future and Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Future Life Planning Tool ("Future"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education+Future | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Future Receives: Behavioral: Basic Education ("Education"); Behavioral: Future Life Planning Tool ("Future") |
| Education+Risk | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components:
Risk Receives: Behavioral: Basic Education ("Education"); Behavioral: Epidemiological Risk Scenario ("Risk") |
| Education | Experimental | Participants will receive a version of the Mission Wellness app (intervention) that only includes the static educational component. Receives: Behavioral: Basic Education ("Education") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SRH knowledge as assessed by measures of STI Knowledge
Change in SRH knowledge as assessed by STI Knowledge (Outcome 1) and Pregnancy and Birth Control Knowledge (Outcome 2).
STI knowledge is measured on a dichotomous (true/false [outcome varies by item]) scale adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in SRH knowledge as assessed by measures of Pregnancy and Birth Control Knowledge
Change in SRH knowledge as assessed by STI Knowledge (Outcome 1) and Pregnancy and Birth Control Knowledge (Outcome 2).
Pregnancy and Birth Control is measured on a dichotomous (true/false [outcome varies by item]) scale adapted from measures used in Frost's et al (2012) Young Adults' Contraceptive Knowledge, Norms, and Attitudes: Associations with Risk of Unintended Pregnancy and Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in perceived risk of having a negative SRH outcome as assessed by measures of Perceived Risk
Change in perceived risk of having a negative SRH outcome assessed by Perceived Risk on an 5-point ordinal scale (from "no risk" [better outcome] to "very high risk" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in attitudes about SRH as assessed by measures of Condom Attitudes on a likert scale
Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8).
Condom Attitudes is a composite score of Outcome 5 and a 7-point likert scale (from "strongly disagree" [1] to "strongly agree" [7; outcome varies by item]) adapted from Crosby's et al (2008) Correct Condom Use Self-Efficacy Scale (CCUSS) and Helweg-Larson and Collins' (1994) UCLA Multidimensional Condom Attitudes Scale (MCAS).
Measured: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in attitudes about SRH as assessed by measures of Condom Attitudes on an ordinal item
Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8).
Condom Attitudes is a composite score of Outcome 4 and a 5-point ordinal item (from "very positive" [better outcome] to "very negative" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in attitudes about SRH as assessed by measures of Birth Control Attitudes on a likert-type scale
Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8).
Birth Control Attitudes is a composite score of Outcome 7 and a 5-point likert-type scale (from "very positive" [better outcome] to "very negative" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in attitudes about SRH as assessed by measures of Birth Control Attitudes on a likert scale
Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8).
Birth Control Attitudes is a composite score of Outcome 6 and a 5-point likert scale (from "strongly agree" [1; worse outcome] to "strongly disagree" [5; better outcome]) adapted from measures used in Guzza and Hayford's (2018) Adolescent Reproductive and Contraceptive Knowledge and Attitudes and Adult Contraceptive Behavior.
Measured: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in attitudes about SRH as assessed by measures of Norms
Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8).
Change in attitudes about SRH assessed by Norms on a 5-point likert scale (from "strongly agree" to "strongly disagree" [no better/worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in self-efficacy about SRH as assessed by measures of Condom/Birth Control Use
Change in self-efficacy about SRH assessed by Condom/Birth Control Use (Outcome 9) and Partner Communication/Negotiation (Outcome 10).
Change in self-efficacy about SRH assessed by Condom/Birth Control Use on 5-point likert-type scales (from "not at all confident" [1; worse outcome] to "extremely confident" [5; better outcome]) adapted from Crosby's et al (2008) Correct Condom Use Self-Efficacy Scale (CCUSS) and Marin's et al (1997) Condom Self-Efficacy.
Measured: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in self-efficacy about SRH as assessed by measures of Partner Communication/Negotiation
Change in self-efficacy about SRH assessed by Condom/Birth Control Use (Outcome 9) and Partner Communication/Negotiation (Outcome 10).
Change in self-efficacy about SRH assessed by Partner Communication/Negotiation on a 4-point likert-type scale (from "very difficult" [1; worse outcome] to "very easy" [4; better outcome]) adapted from Noar's et al (2002) Condom Influence Strategy Questionnaire and Quinn-Nilas' et al (2016) Sexual Communication Self-Efficacy Scale.
Measured: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on ordinal items
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16).
Sexual Behavior is a composite score of Outcomes 12-16 and ordinal (from "never" [worse outcome] to "all the time" [better outcome]) items adapted from measures used in Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Baseline and 30-to-90 days post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on yes/no/dont-know items
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16).
Sexual Behavior is a composite score of Outcomes 11 and 13-16, and yes/no/dont-know (nominal; outcome varies by item) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Baseline and 30-to-90 days post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on no/yes,previously/yes,currently items
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16).
Sexual Behavior is a composite score of Outcomes 11-12 and 14-16 and no/yes,previously/yes,currently (nominal; no better/worse outcome) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Baseline and 30-to-90 days post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on dichotomous items
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16).
Sexual Behavior is a composite score of Outcomes 11-13 and 15-16 and dichotomous (yes/no [outcome varies by item]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Baseline and 30-to-90 days post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on open response (number input) items
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16).
Sexual Behavior is a composite score of Outcomes 11-14 and 16 and open response (number input) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Baseline and 30-to-90 days post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on nominal items
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16).
Sexual Behavior is a composite score of Outcomes 11-15 and nominal items (main/casual other [no better/worse outcome]) adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Baseline and 30-to-90 days post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on ordinal items
Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21).
Sexual Behavior Intentions is a composite score of Outcomes 18-21 and 5-point ordinal (from "never" [worse outcome] to "all of the time" [better outcome]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Within 3 weeks post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on yes/no/dont-know items
Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21).
Sexual Behavior Intentions is a composite score of Outcomes 17 and 19-21 and nominal (yes/no/dont-know [outcome varies by item]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Within 3 weeks post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on dichotomous items
Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21).
Sexual Behavior Intentions is a composite score of Outcomes 17-18 and 20-21 and dichotomous (yes/no [outcome varies by item]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Within 3 weeks post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on open response (number input) items
Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21).
Sexual Behavior Intentions is a composite score of Outcomes 17-19 and 21 and open response (number input) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Within 3 weeks post-intervention
Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions
Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21).
Sexual Behavior Intentions is a composite score of Outcomes 17-20 and a 7-point likert-type (from "definitely" [better outcome] to "not likely at all" [worse outcome]) scale adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Measured: Within 3 weeks post-intervention
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "very helpful" to "not helpful at all")
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27).
Health Care is a composite score of Outcomes 23-27 and on 5-point ordinal or likert-type (from "very helpful" [better outcome] to "not helpful at all" [worse outcome]) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "strongly agree" to "strongly disagree")
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27).
Health Care is a composite score of Outcomes 22 and 24-27 and on 5-point ordinal or likert-type (from "strongly agree" [better outcome] to "strongly disagree" [worse outcome]) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "to much" to "some to little")
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27).
Health Care is a composite score of Outcomes 22-23 and 25-27 and on 5-point ordinal or likert-type (from "too much" to "some too little" [no better/worse outcome]) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on yes/no/dont-know nominal items
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27).
Health Care is a composite score of Outcomes 22-24 and 26-27 and yes/no/dont-know (no better/worse outcome) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on no/yes,recent/yes,not-recent nominal items
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27).
Health Care is a composite score of Outcomes 22-25 and 27 and no/yes,recent/yes,not-recent (no better/worse outcome) nominal items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on a cumulative scale
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27).
Health Care is a composite score of Outcomes 22 and 24-26 and a cumulative (outcome varies by item) scales adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Measured: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare provider interactions as assessed by measures of Patient-Provider Communication
Quality and satisfaction of healthcare provider interactions as assessed by Patient-Provider Communication on a 5-point likert-type scale (from "I do not agree" [worse outcome] to "I fully agree" [better outcome]) adapted from Bieber's et al (2010) Questionnaire on the Quality of Physician-Patient Interaction (QQPPI)
Measured: Baseline
Change in self-reported mental health as assessed by Depression (PHQ-2)
Change in mental health assessed by Depression on the Patient Health Questionnaire-2 (PHQ-2) (from "not at all" [better outcome] to "nearly every day" [worse outcome])
Measured: Baseline and 30-to-90 days post-intervention
Change in self-reported mental health as assessed by Anxiety (HAI)
Change in mental health assessed by the Anxiety on the Health Anxiety Inventory (HAI)
Measured: Baseline and 30-to-90 days post-intervention
Intervention acceptability as assessed by measures on Acceptability
Acceptability of the intervention assessed by composite measures on Acceptability (Outcomes 31-33).
Acceptability is a composite score of Outcome 32-33 and a 5-point ordinal or likert-type scale (from "do not agree at all" [worse outcome] to "agree completely" [better outcome]) adapted from Stoyanov's et al (2015) Mobile App Rating Scale and measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Kelley's et al (2005) An Evaluation of a Sexual Assault Prevention and Advocacy Program for US Navy Personnel.
Measured: Within 3 weeks post-intervention
Intervention acceptability as assessed by measures on Acceptability as open-ended items
Acceptability of the intervention assessed by composite measures on Acceptability (Outcomes 31-33).
Acceptability is a composite score of Outcome 31 and 33 and open-ended items adapted from Stoyanov's et al (2015) Mobile App Rating Scale and measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Kelley's et al (2005) An Evaluation of a Sexual Assault Prevention and Advocacy Program for US Navy Personnel.
Measured: Within 3 weeks post-intervention
Intervention acceptability as assessed by measures on Acceptability on a rating scale
Acceptability of the intervention assessed by composite measures on Acceptability (Outcomes 31-33).
Acceptability is a composite score of Outcome 31-32 and a rating scale (from 1 ["not at all likely"; worse outcome] to 10 ["extremely likely"; better outcome]) adapted from Stoyanov's et al (2015) Mobile App Rating Scale and measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Kelley's et al (2005) An Evaluation of a Sexual Assault Prevention and Advocacy Program for US Navy Personnel.
Measured: Within 3 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start2 Sep 2021
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The MOST framework will be used. This study follows the optimization phase of the MOST framework where component selection experiments are conducted to experimentally evaluate the effectiveness of individual intervention components. Using a factorial design in this phase allows the effect of each intervention component to be evaluated and for observation of interaction effects while maximizing statistical power using a smaller sample size compared to an randomized controlled trial (RCT) powered similarly to explore individual components of an intervention. The optimization phase then allows for time and resources to be saved by ensuring only optimized components are retained after the RCT in the final intervention package.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- The Miriam Hospital
- Responsible party
- Sponsor
- Investigators
- Ryan R Landoll, PhD, Principal investigator, Uniformed Services University of the Health SciencesSara E Vargas, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661566
- Sponsor's protocol ID
- USUHS.2020-055
- Status last verified
- May 2025
- First submitted
- 23 Oct 2020
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Multi-Modal Intervention to Reduce Health-Risking Sexual Behaviors: Component Selection
- ClinicalTrials.gov ID
- NCT04661566
- Acronym / sponsor ID
- USUHS.2020-055
- Keywords
- Women's Health, Sexual and Reproductive Health, Military, Multiphase Optimization Strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- The Miriam Hospital
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to evaluate the components of the app-based intervention Mission Wellness to reduce health-risking sexual behaviors (HRSBs; e.g., condom non-use, multiple sexual partners) in active-duty members of the US Military to improve their sexual and reproductive health (SRH) and readiness to serve. Following the multiphase optimization strategy (MOST) framework, factorial component selection experiments (CSEs) will be conducted to evaluate which five experimental intervention components (i.e., Narratives, Skills, Scenarios, Future, and Risk) elicit the greatest improvements in the outcomes of interest given key constraints.
Detailed description
Negative SRH outcomes (e.g., sexually transmitted infections [STIs], unintended pregnancy, STI-related cancers) reduce human performance and undermine military readiness. Service members face unique challenges to maintaining SRH during their military service. HRSBs (e.g., multiple sexual partners, unprotected sexual behavior) offer potential intervention targets to improve SRH. Electronic-health interventions are cost-effective and dynamic, and have the potential to reach millions of users as part of an overall strategy for individual behavior and systems change. In civilian populations, e-health interventions have demonstrated success in reducing HRSBs. However, effective HRSB-prevention interventions must consider the specific values, mission, and context of military populations and settings. The MOST framework is used to develop highly effective, efficient, and economic behavioral interventions that is particularly well suited to be used in this context.
This project aims to address this problem by delivering an optimized app-based prevention intervention package ready for evaluation via a subsequent randomized controlled trial (RCT). The specific purpose of this project is to determine which component(s) should be included in the packaged app-based intervention Mission Wellness for US service members based on their effects on the outcomes of interest (i.e., improved knowledge, motivation, and behavior skills related to SRH and reduced HRSBs) in no more than 25 minutes of content. The components tested in the factorial CSEs include: Narratives; Skills; Scenarios; Future; and Risk. Each component has two levels: "on" (included) or "off" (not included). Main and interaction effects of components will be measured to determine the components constituting the packaged intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 32
- Model description
- The MOST framework will be used. This study follows the optimization phase of the MOST framework where component selection experiments are conducted to experimentally evaluate the effectiveness of individual intervention components. Using a factorial design in this phase allows the effect of each intervention component to be evaluated and for observation of interaction effects while maximizing statistical power using a smaller sample size compared to an randomized controlled trial (RCT) powered similarly to explore individual components of an intervention. The optimization phase then allows for time and resources to be saved by ensuring only optimized components are retained after the RCT in the final intervention package.
| Arm | Type | Receives |
|---|---|---|
| Education+Narratives+Skills+Scenarios+Future+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Future Life Planning Tool ("Future"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, Scenarios, Future, and Risk |
| Education+Narratives+Skills+Scenarios+Future | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Future Life Planning Tool ("Future")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, Scenarios, and Future |
| Education+Narratives+Skills+Scenarios+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, Scenarios, and Risk |
| Education+Narratives+Skills+Scenarios | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Interactive Scenarios ("Scenarios")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, and Scenarios |
| Education+Narratives+Skills+Future+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Future Life Planning Tool ("Future"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, Future, and Risk |
| Education+Narratives+Skills+Future | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Future Life Planning Tool ("Future")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, and Future |
| Education+Narratives+Skills+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Skills, and Risk |
| Education+Narratives+Skills | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Skills Building Videos ("Skills")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives and Skills |
| Education+Narratives+Scenarios+Future+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Future Life Planning Tool ("Future"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives. Scenarios, Future, and Risk |
| Education+Narratives+Scenarios+Future | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Future Life Planning Tool ("Future")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Scenarios, and Future |
| Education+Narratives+Scenarios+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Scenarios, and Risk |
| Education+Narratives+Scenarios | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Interactive Scenarios ("Scenarios")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives and Scenarios |
| Education+Narratives+Future+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Future Life Planning Tool ("Future"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives, Future, and Risk |
| Education+Narratives+Future | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Future Life Planning Tool ("Future")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives and Future |
| Education+Narratives+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives and Risk |
| Education+Narratives | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Narrative Videos ("Narratives")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Narratives |
| Education+Skills+Scenarios+Future+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Future Life Planning Tool ("Future"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills, Scenarios, Future, and Risk |
| Education+Skills+Scenarios+Future | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Future Life Planning Tool ("Future")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills, Scenarios, and Future |
| Education+Skills+Scenarios+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills, Scenarios, and Risk |
| Education+Skills+Scenarios | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Interactive Scenarios ("Scenarios")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills and Scenarios |
| Education+Skills+Future+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Future Life Planning Tool ("Future"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills, Future, and Risk |
| Education+Skills+Future | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Future Life Planning Tool ("Future")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills Future |
| Education+Skills+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Skills Building Videos ("Skills"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills and Risk |
| Education+Skills | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Skills Building Videos ("Skills")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Skills |
| Education+Scenarios+Future+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Future Life Planning Tool ("Future"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Scenarios, Future, and Risk |
| Education+Scenarios+Future | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Future Life Planning Tool ("Future")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Scenarios and Future |
| Education+Scenarios+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Interactive Scenarios ("Scenarios"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Scenarios and Risk |
| Education+Scenarios | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Interactive Scenarios ("Scenarios")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Scenarios |
| Education+Future+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Future Life Planning Tool ("Future"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Future and Risk |
| Education+Future | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Future Life Planning Tool ("Future")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Future |
| Education+Risk | Experimental | Behavioral: Basic Education ("Education"), Behavioral: Epidemiological Risk Scenario ("Risk")Participants will receive a version of the Mission Wellness app (intervention) that includes the static educational component and the following components: Risk |
| Education | Experimental | Behavioral: Basic Education ("Education")Participants will receive a version of the Mission Wellness app (intervention) that only includes the static educational component. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 17 or older,
- currently serving as active duty in the US military, and
- willing to participate in all study activities if eligible and enrolled
Key exclusion criteria (3 listed)
- Does not meet eligibility criteria,
- unable to read, speak, or comprehend English, or
- unable or unwilling to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Education ("Education")All participants will receive the basic educational component in the Mission Wellness app. This component will contain text and media (e.g., images, videos) to teach basic SRH topics. The exact information in this component will be determined by an assessment of baseline SRH knowledge at the start of the intervention. | Behavioural | Education, Education+Future, Education+Future+Risk, Education+Narratives, Education+Narratives+Future, Education+Narratives+Future+Risk, Education+Narratives+Risk, Education+Narratives+Scenarios, Education+Narratives+Scenarios+Future, Education+Narratives+Scenarios+Future+Risk, Education+Narratives+Scenarios+Risk, Education+Narratives+Skills, Education+Narratives+Skills+Future, Education+Narratives+Skills+Future+Risk, Education+Narratives+Skills+Risk, Education+Narratives+Skills+Scenarios, Education+Narratives+Skills+Scenarios+Future, Education+Narratives+Skills+Scenarios+Future+Risk, Education+Narratives+Skills+Scenarios+Risk, Education+Risk, Education+Scenarios, Education+Scenarios+Future, Education+Scenarios+Future+Risk, Education+Scenarios+Risk, Education+Skills, Education+Skills+Future, Education+Skills+Future+Risk, Education+Skills+Risk, Education+Skills+Scenarios, Education+Skills+Scenarios+Future, Education+Skills+Scenarios+Future+Risk, Education+Skills+Scenarios+Risk |
| Narrative Videos ("Narratives")The narrative video component is a motivation-based component that includes stories of individuals engaging in positive and negative SRH behaviors that lead to either positive or negative outcomes, respectively, in a video format. | Behavioural | Education+Narratives, Education+Narratives+Future, Education+Narratives+Future+Risk, Education+Narratives+Risk, Education+Narratives+Scenarios, Education+Narratives+Scenarios+Future, Education+Narratives+Scenarios+Future+Risk, Education+Narratives+Scenarios+Risk, Education+Narratives+Skills, Education+Narratives+Skills+Future, Education+Narratives+Skills+Future+Risk, Education+Narratives+Skills+Risk, Education+Narratives+Skills+Scenarios, Education+Narratives+Skills+Scenarios+Future, Education+Narratives+Skills+Scenarios+Future+Risk, Education+Narratives+Skills+Scenarios+Risk |
| Skills Building Videos ("Skills")The skills-building videos component is a component rooted in behavioral skills that involves the provision of information on how to perform or engage positive SRH behaviors (e.g., correctly using a condom, what to expect when having a Pap smear) via instructional videos. | Behavioural | Education+Narratives+Skills, Education+Narratives+Skills+Future, Education+Narratives+Skills+Future+Risk, Education+Narratives+Skills+Risk, Education+Narratives+Skills+Scenarios, Education+Narratives+Skills+Scenarios+Future, Education+Narratives+Skills+Scenarios+Future+Risk, Education+Narratives+Skills+Scenarios+Risk, Education+Skills, Education+Skills+Future, Education+Skills+Future+Risk, Education+Skills+Risk, Education+Skills+Scenarios, Education+Skills+Scenarios+Future, Education+Skills+Scenarios+Future+Risk, Education+Skills+Scenarios+Risk |
| Interactive Scenarios ("Scenarios")The interactive scenarios are a behavioral skills-building component that walks through conversations surrounding SRH with select individuals (e.g., partner, healthcare provider), providing suggestions on how to have these conversations and why these conversations are important to have. | Behavioural | Education+Narratives+Scenarios, Education+Narratives+Scenarios+Future, Education+Narratives+Scenarios+Future+Risk, Education+Narratives+Scenarios+Risk, Education+Narratives+Skills+Scenarios, Education+Narratives+Skills+Scenarios+Future, Education+Narratives+Skills+Scenarios+Future+Risk, Education+Narratives+Skills+Scenarios+Risk, Education+Scenarios, Education+Scenarios+Future, Education+Scenarios+Future+Risk, Education+Scenarios+Risk, Education+Skills+Scenarios, Education+Skills+Scenarios+Future, Education+Skills+Scenarios+Future+Risk, Education+Skills+Scenarios+Risk |
| Future Life Planning Tool ("Future")The future life planning tool is a motivation-based component contains a series of questions to help users plan future goals to put current decision making related to SRH into perspective and provide suggestions on how to stay healthy now to be able to achieve those goals later. | Behavioural | Education+Future, Education+Future+Risk, Education+Narratives+Future, Education+Narratives+Future+Risk, Education+Narratives+Scenarios+Future, Education+Narratives+Scenarios+Future+Risk, Education+Narratives+Skills+Future, Education+Narratives+Skills+Future+Risk, Education+Narratives+Skills+Scenarios+Future, Education+Narratives+Skills+Scenarios+Future+Risk, Education+Scenarios+Future, Education+Scenarios+Future+Risk, Education+Skills+Future, Education+Skills+Future+Risk, Education+Skills+Scenarios+Future, Education+Skills+Scenarios+Future+Risk |
| Epidemiological Risk Scenario ("Risk")The risk component is an information- and motivation-based component with tailored epidemiological risk information about relative risk of contracting a specific STI and/or having an unintended pregnancy. Relative risk information will be determined by adjusting variables within the component (e.g., number of partners within the last month, percent of time using condoms). | Behavioural | Education+Future+Risk, Education+Narratives+Future+Risk, Education+Narratives+Risk, Education+Narratives+Scenarios+Future+Risk, Education+Narratives+Scenarios+Risk, Education+Narratives+Skills+Future+Risk, Education+Narratives+Skills+Risk, Education+Narratives+Skills+Scenarios+Future+Risk, Education+Narratives+Skills+Scenarios+Risk, Education+Risk, Education+Scenarios+Future+Risk, Education+Scenarios+Risk, Education+Skills+Future+Risk, Education+Skills+Risk, Education+Skills+Scenarios+Future+Risk, Education+Skills+Scenarios+Risk |
Primary outcome
Change in SRH knowledge as assessed by measures of STI Knowledge
Time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in SRH knowledge as assessed by STI Knowledge (Outcome 1) and Pregnancy and Birth Control Knowledge (Outcome 2). STI knowledge is measured on a dichotomous (true/false [outcome varies by item]) scale adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Change in SRH knowledge as assessed by measures of Pregnancy and Birth Control Knowledge
Time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in SRH knowledge as assessed by STI Knowledge (Outcome 1) and Pregnancy and Birth Control Knowledge (Outcome 2). Pregnancy and Birth Control is measured on a dichotomous (true/false [outcome varies by item]) scale adapted from measures used in Frost's et al (2012) Young Adults' Contraceptive Knowledge, Norms, and Attitudes: Associations with Risk of Unintended Pregnancy and Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Change in perceived risk of having a negative SRH outcome as assessed by measures of Perceived Risk
Time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in perceived risk of having a negative SRH outcome assessed by Perceived Risk on an 5-point ordinal scale (from "no risk" [better outcome] to "very high risk" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Change in attitudes about SRH as assessed by measures of Condom Attitudes on a likert scale
Time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Condom Attitudes is a composite score of Outcome 5 and a 7-point likert scale (from "strongly disagree" [1] to "strongly agree" [7; outcome varies by item]) adapted from Crosby's et al (2008) Correct Condom Use Self-Efficacy Scale (CCUSS) and Helweg-Larson and Collins' (1994) UCLA Multidimensional Condom Attitudes Scale (MCAS).
Change in attitudes about SRH as assessed by measures of Condom Attitudes on an ordinal item
Time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Condom Attitudes is a composite score of Outcome 4 and a 5-point ordinal item (from "very positive" [better outcome] to "very negative" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Change in attitudes about SRH as assessed by measures of Birth Control Attitudes on a likert-type scale
Time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Birth Control Attitudes is a composite score of Outcome 7 and a 5-point likert-type scale (from "very positive" [better outcome] to "very negative" [worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Change in attitudes about SRH as assessed by measures of Birth Control Attitudes on a likert scale
Time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Birth Control Attitudes is a composite score of Outcome 6 and a 5-point likert scale (from "strongly agree" [1; worse outcome] to "strongly disagree" [5; better outcome]) adapted from measures used in Guzza and Hayford's (2018) Adolescent Reproductive and Contraceptive Knowledge and Attitudes and Adult Contraceptive Behavior.
Change in attitudes about SRH as assessed by measures of Norms
Time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in attitudes about SRH assessed by the composite Condom Attitudes (Outcome 4 and Outcome 5), composite Birth Control Attitudes (Outcome 6 and Outcome 7), and Norms (Outcome 8). Change in attitudes about SRH assessed by Norms on a 5-point likert scale (from "strongly agree" to "strongly disagree" [no better/worse outcome]) adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Change in self-efficacy about SRH as assessed by measures of Condom/Birth Control Use
Time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in self-efficacy about SRH assessed by Condom/Birth Control Use (Outcome 9) and Partner Communication/Negotiation (Outcome 10). Change in self-efficacy about SRH assessed by Condom/Birth Control Use on 5-point likert-type scales (from "not at all confident" [1; worse outcome] to "extremely confident" [5; better outcome]) adapted from Crosby's et al (2008) Correct Condom Use Self-Efficacy Scale (CCUSS) and Marin's et al (1997) Condom Self-Efficacy.
Change in self-efficacy about SRH as assessed by measures of Partner Communication/Negotiation
Time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention
Change in self-efficacy about SRH assessed by Condom/Birth Control Use (Outcome 9) and Partner Communication/Negotiation (Outcome 10). Change in self-efficacy about SRH assessed by Partner Communication/Negotiation on a 4-point likert-type scale (from "very difficult" [1; worse outcome] to "very easy" [4; better outcome]) adapted from Noar's et al (2002) Condom Influence Strategy Questionnaire and Quinn-Nilas' et al (2016) Sexual Communication Self-Efficacy Scale.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on ordinal items
Time frame: Baseline and 30-to-90 days post-intervention
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 12-16 and ordinal (from "never" [worse outcome] to "all the time" [better outcome]) items adapted from measures used in Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on yes/no/dont-know items
Time frame: Baseline and 30-to-90 days post-intervention
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 11 and 13-16, and yes/no/dont-know (nominal; outcome varies by item) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on no/yes,previously/yes,currently items
Time frame: Baseline and 30-to-90 days post-intervention
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 11-12 and 14-16 and no/yes,previously/yes,currently (nominal; no better/worse outcome) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on dichotomous items
Time frame: Baseline and 30-to-90 days post-intervention
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 11-13 and 15-16 and dichotomous (yes/no [outcome varies by item]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on open response (number input) items
Time frame: Baseline and 30-to-90 days post-intervention
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 11-14 and 16 and open response (number input) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavior on nominal items
Time frame: Baseline and 30-to-90 days post-intervention
Change in sexual behavior assessed by composite Sexual Behavior score (Outcomes 11-16). Sexual Behavior is a composite score of Outcomes 11-15 and nominal items (main/casual other [no better/worse outcome]) adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on ordinal items
Time frame: Within 3 weeks post-intervention
Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21). Sexual Behavior Intentions is a composite score of Outcomes 18-21 and 5-point ordinal (from "never" [worse outcome] to "all of the time" [better outcome]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on yes/no/dont-know items
Time frame: Within 3 weeks post-intervention
Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21). Sexual Behavior Intentions is a composite score of Outcomes 17 and 19-21 and nominal (yes/no/dont-know [outcome varies by item]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on dichotomous items
Time frame: Within 3 weeks post-intervention
Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21). Sexual Behavior Intentions is a composite score of Outcomes 17-18 and 20-21 and dichotomous (yes/no [outcome varies by item]) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions on open response (number input) items
Time frame: Within 3 weeks post-intervention
Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21). Sexual Behavior Intentions is a composite score of Outcomes 17-19 and 21 and open response (number input) items adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Change in self-reported sexual behavior as assessed by measures of Sexual Behavioral Intentions
Time frame: Within 3 weeks post-intervention
Change in sexual behavior assessed by composite Sexual Behavioral Intentions (Outcomes 17-21). Sexual Behavior Intentions is a composite score of Outcomes 17-20 and a 7-point likert-type (from "definitely" [better outcome] to "not likely at all" [worse outcome]) scale adapted from measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits, Hwang's et al (2007) Sexual Behaviors After Universal Screening of Sexually Transmitted Infections in Healthy Young Women, and Booth-Kewley's et al (2001) One-Year Follow-Up Evaluation of the Sexually Transmitted Disease/Human Immunodeficiency Virus Intervention Program in a Marine Corps sample.
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "very helpful" to "not helpful at all")
Time frame: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 23-27 and on 5-point ordinal or likert-type (from "very helpful" [better outcome] to "not helpful at all" [worse outcome]) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "strongly agree" to "strongly disagree")
Time frame: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 22 and 24-27 and on 5-point ordinal or likert-type (from "strongly agree" [better outcome] to "strongly disagree" [worse outcome]) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on ordinal items (from "to much" to "some to little")
Time frame: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 22-23 and 25-27 and on 5-point ordinal or likert-type (from "too much" to "some too little" [no better/worse outcome]) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on yes/no/dont-know nominal items
Time frame: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 22-24 and 26-27 and yes/no/dont-know (no better/worse outcome) items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on no/yes,recent/yes,not-recent nominal items
Time frame: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 22-25 and 27 and no/yes,recent/yes,not-recent (no better/worse outcome) nominal items adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Quality and satisfaction of healthcare experiences as assessed by measures of Health Care on a cumulative scale
Time frame: Baseline and 30-to-90 days post-intervention
Quality and satisfaction of healthcare experiences assessed by composite Health Care (Outcomes 22-27). Health Care is a composite score of Outcomes 22 and 24-26 and a cumulative (outcome varies by item) scales adapted from measures used in Gold's (1997) CD-ROM Technology to Increase Appropriate Self-Care and Preventive Behaviors among Army and Navy Women.
Quality and satisfaction of healthcare provider interactions as assessed by measures of Patient-Provider Communication
Time frame: Baseline
Quality and satisfaction of healthcare provider interactions as assessed by Patient-Provider Communication on a 5-point likert-type scale (from "I do not agree" [worse outcome] to "I fully agree" [better outcome]) adapted from Bieber's et al (2010) Questionnaire on the Quality of Physician-Patient Interaction (QQPPI)
Change in self-reported mental health as assessed by Depression (PHQ-2)
Time frame: Baseline and 30-to-90 days post-intervention
Change in mental health assessed by Depression on the Patient Health Questionnaire-2 (PHQ-2) (from "not at all" [better outcome] to "nearly every day" [worse outcome])
Change in self-reported mental health as assessed by Anxiety (HAI)
Time frame: Baseline and 30-to-90 days post-intervention
Change in mental health assessed by the Anxiety on the Health Anxiety Inventory (HAI)
Intervention acceptability as assessed by measures on Acceptability
Time frame: Within 3 weeks post-intervention
Acceptability of the intervention assessed by composite measures on Acceptability (Outcomes 31-33). Acceptability is a composite score of Outcome 32-33 and a 5-point ordinal or likert-type scale (from "do not agree at all" [worse outcome] to "agree completely" [better outcome]) adapted from Stoyanov's et al (2015) Mobile App Rating Scale and measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Kelley's et al (2005) An Evaluation of a Sexual Assault Prevention and Advocacy Program for US Navy Personnel.
Intervention acceptability as assessed by measures on Acceptability as open-ended items
Time frame: Within 3 weeks post-intervention
Acceptability of the intervention assessed by composite measures on Acceptability (Outcomes 31-33). Acceptability is a composite score of Outcome 31 and 33 and open-ended items adapted from Stoyanov's et al (2015) Mobile App Rating Scale and measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Kelley's et al (2005) An Evaluation of a Sexual Assault Prevention and Advocacy Program for US Navy Personnel.
Intervention acceptability as assessed by measures on Acceptability on a rating scale
Time frame: Within 3 weeks post-intervention
Acceptability of the intervention assessed by composite measures on Acceptability (Outcomes 31-33). Acceptability is a composite score of Outcome 31-32 and a rating scale (from 1 ["not at all likely"; worse outcome] to 10 ["extremely likely"; better outcome]) adapted from Stoyanov's et al (2015) Mobile App Rating Scale and measures used in Acari's et al (2004) Feasibility and Short-Term Impact of Linked Education and Urine Screening Interventions for Chlamydia and Gonorrhea in Male Army Recruits and Kelley's et al (2005) An Evaluation of a Sexual Assault Prevention and Advocacy Program for US Navy Personnel.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan R Landoll, PhD principal investigator
Uniformed Services University of the Health Sciences
Sara E Vargas, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Education ("Education"), Narrative Videos ("Narratives") and Skills Building Videos ("Skills") in people with Sexually Transmitted Infections and Pregnancy, Unplanned, run by Uniformed Services University of the Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SRH knowledge as assessed by measures of STI Knowledge (time frame: Baseline, within 3 weeks post-intervention, and 30-to-90 days post-intervention). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.