Pregnancy2GetherNCT02291224
Development and Testing of a Clinic-Based Intervention to Increase Dual Protection Against Unintended Pregnancy and Sexually Transmitted Diseases (STDs) Among High Risk Female Teens
A study testing Interactive multimedia platform and Intervention arm counseling in people with Pregnancy and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
This trial will evaluate a multi-component, clinic-based intervention aimed at increasing dual protection strategy selection and adherence among young African American females at an urban family planning clinic. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Sexually Transmitted Diseases
- What is being tested?
- Interactive multimedia platform and Intervention arm counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 709 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Aug 2018
- 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 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- female,
- self-identify as African American,
- 14-19 years of age,
- present to clinic on date of potential enrollment for clinical care,
- has had vaginal sex with a male partner at least once in the past 6 months,
- HIV-negative by self-report,
Show all 12Show fewer
- not currently pregnant (verified by urine pregnancy test),
- desire to avoid pregnancy for at least 12 months,
- plan to be in the Atlanta area for the next 12 months,
- competent to participate in consenting or assenting process per recruiter evaluation,
- willing to provide contact information, and
- not previously enrolled in the pilot study of this intervention.
Who cannot join
- pregnant
- HIV positive
Trial locations and contacts
1 site in 1 country.
United States1 site
Grady Health System Teen Services Clinic
Atlanta, Georgia, 30303
About this study
This trial will evaluate a multi-component, clinic-based intervention aimed at increasing dual protection strategy selection and adherence among young African American females at an urban family planning clinic. Dual protection is the use of contraceptive strategies to prevent both unintended pregnancy (UIP) and sexually transmitted infections (STIs). This is an unblinded randomized controlled trial; participants will either get the interactive multimedia platform focused on DP strategies with intervention arm counseling or the standard of care arm counseling.
The study will recruit 710 African American females aged 14-19 who are attending the Grady Health System (GHS) Teen Services Clinic (TSC) in Atlanta, Georgia, for reproductive health care.
Read more
The trial will recruit and enroll 710 young women presenting to the clinic for clinical care who have the following characteristics:
- self-identify as African American,
- 14-19 years of age,
- have had vaginal sex with a male partner in the past 6 months,
- HIV-negative by self-report,
- not pregnant,verified by urine pregnancy test,
- no desire to be pregnant in next 12 months,
- plan to stay in the Atlanta area for the next year,
- are willing to provide contact information, and
- were not previously enrolled in the pilot study of this intervention.
Those enrolled will be in the study for 12 months. Young women who are eligible and give written consent or assent for study participation will be enrolled. Half will be randomized to the control arm, half to the intervention arm.
- Control arm (standard of care) includes individual clinical care and standard of care counseling consistent with protocols at the TSC, with study visits for data collection at enrollment, 6 months, and 12 months, during which any medical care or counseling that they would normally get will also be provided. Control arm participants will also get telephone calls from clinic staff to update their contact information and remind them of upcoming visits at 3 weeks and 5 months after the enrollment visit, and at 3 weeks and 5 months after the 6 month visit.
- Intervention arm, consisting of the following intervention components:
- Enrollment visit
- A culturally-appropriate interactive multimedia platform focused on DP strategies and designed to prepare the individual for selection of a DP strategy.
- Individual intervention arm counseling to select the DP strategy that is best suited for the participant (by a clinic health care provider).
- Individual intervention arm counseling to build skills for correct and consistent use of the selected DP strategy (by a nurse educator (NE)).
- Booster counseling via phone at about 3 weeks and 5 months after the enrollment visit, and at about 3 weeks and 5 months after the 6 month visit (by an NE).
- 6 month visit
- An abbreviated version of the interactive multimedia platform focused on dual protection strategies and strategy adherence.
- Individual intervention arm counseling to reinforce skills for correct and consistent use of the DP strategy (by an NE).
At the final study visit at 12 months there is no difference between the counseling provided to the two groups; participants in both arms will receive the clinic standard of care.
Participants in both arms of the study will follow the same data collection procedures throughout the study:
- At all three study visits, participants in both arms will receive urine pregnancy and STI tests and complete an audio computer assisted self-interview (ACASI) questionnaire.
- At 3 and 9 months after enrollment, participants in both arms will receive a data collection call with administration of a telephone questionnaire.
Throughout the study, all participants will be encouraged to come in for evaluation if they have any concerns. Any data from pregnancy or STI testing at these interim clinic visits will be later collected via chart review. If participants seek reproductive health care at other facilities during the study period, records will be requested with participant permission, and data from pregnancy or STI testing at these outside clinic visits will be collected via review of records received.
We will examine the efficacy of the intervention arm relative to control arm across the following primary behavioral and biologic outcomes over the 12 months of follow-up:
- Self-reported dual protection strategy selection
- Self-reported dual protection strategy adherence
- Incidence of pregnancy or infection with chlamydia, gonorrhea or trichomonas (as confirmed by laboratory testing)
A small pilot study was be conducted prior to the initiation of enrollment in the main study.
- Conditions
- Pregnancy, Sexually Transmitted Diseases
- Being tested
- Interactive multimedia platform, Intervention arm counseling, Standard of care counseling
- Keywords
- dual protection, pregnancy, reproductive health, sexually transmitted diseases, condoms, contraception, adolescent health services
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive multimedia platformBehavioural
Also called MMDP
An interactive platform that includes video vignettes of young women who are choosing dual protection strategies (based on a synthesis of focus group data from members of the TSC patient population), as well as true/false questions to build knowledge about dual protection and dispel common myths about contraceptive strategies. There will also be reflection questions that encourage participants to consider values and priorities in their own lives that may influence their dual protection strategy selection.
Intervention arm counselingBehavioural
Counseling for the intervention group will follow carefully developed guides and incorporate the participants' answers to the reflection questions in the interactive multi-media component. This counseling has a set structure (set forth in separate counseling guides for health care providers and nurse educators), incorporates motivational interviewing techniques, includes multiple opportunities for role play, and is designed to be patient-centered.
Standard of care counselingBehavioural
Standard of care counseling is provided by health care providers and health educators at TSC. It incorporates extensive counseling on methods to prevent both unintended pregnancy and sexually transmitted infections, however the structure of the counseling and techniques used are dependent on the standard practice of each provider or educator. This counseling does not incorporate answers to reflection questions from the multi-media platform because control arm participants will not view this content.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | The control arm receives the clinic standard of care counseling. This includes individual clinical care and counseling consistent with protocols at the Grady Health System Teen Services Clinic, with study visits at enrollment, 6 months, and 12 months, during which any medical care or counseling included in the clinic standard of care will be provided. All control group members will see a provider on the day of enrollment. Control arm participants will get phone calls from clinic staff to update their contact information and remind them of upcoming appointments at 3 weeks and 5 months after both the enrollment visit and the 6 month visit. Participants may visit the clinic at any time and will be encouraged to come into the clinic for any concerns. If they have an interim visit during the study period, they will receive the clinic standard of care. Receives: Behavioral: Standard of care counseling |
| Intervention | Experimental | 1. Enrollment
* Interactive multimedia platform focused on DP strategies.
* Intervention arm counseling by a health care provider to select DP strategy.
* Intervention arm counseling and skill-building by a nurse educator (NE) on correct, consistent use of DP strategy.
2. Booster counseling by an NE via phone at 3 weeks and 5 months after both the enrollment visit and the 6 month visit.
3. 6 month visit
* Abbreviated version of the interactive multimedia platform on DP strategies and adherence.
* Intervention arm counseling by an NE to reinforce skills for correct, consistent use of DP strategy.
4. Interim visits: Participants may visit the clinic at any time. If intervention group members visit the clinic for STI treatment or to switch birth control method, providers and/or NEs will follow structured counseling guides. If they have an interim visit for another reason, they will receive the clinic standard of care. Receives: Behavioral: Interactive multimedia platform; Behavioral: Intervention arm counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant selection of an effective dual protection (DP) strategy
Whether or not a participant self-reports having selected an effective DP strategy. An effective DP strategy is defined as one of the following:
- Abstinence from vaginal sex;
- Effective non-barrier contraceptive method [including intrauterine device (IUD), Implant, Depo, or contraceptive pill, patch or ring] with consistent condom use;
- Consistent condom use only
Measured: 6 months
Participant report of adherence to DP strategy
By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes:
- Whether or not DP strategy was used at last sex
- Whether or not DP strategy was used consistently during last 3 month time period
- Estimated proportion of time adherent to DP strategy over last 3 months
Measured: 3 months
Time to first biologic event (pregnancy or diagnosis with STI) in participants
Measured by date of positive lab test ("biologic event" refers to a positive pregnancy test or diagnosis with chlamydia, gonorrhea or trichomonas infection).
Measured: Within 12 month period following enrollment
Incidence of pregnancy and sexually transmitted infections (STIs)
Includes the proportion of participants with a lab-confirmed diagnosis of pregnancy or lab-confirmed diagnosis with infection with chlamydia, gonorrhea or trichomonas within the 12 month follow-up period (testing either performed at study site clinic and documented at study visits and via chart review, or diagnosed by outside labs with documentation obtained via release of information procedures)
Measured: Within 12 month period following enrollment
Participant selection of an effective dual protection (DP) strategy
Whether or not a participant self-reports having selected an effective DP strategy. An effective DP strategy is defined as one of the following:
- Abstinence from vaginal sex;
- Effective non-barrier contraceptive method [including intrauterine device (IUD), Implant, Depo, or contraceptive pill, patch or ring] with consistent condom use;
- Consistent condom use only
Measured: 12 months
Participant report of adherence to DP strategy
By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes:
- Whether or not DP strategy was used at last sex
- Whether or not DP strategy was used consistently during last 3 month time period
- Estimated proportion of time adherent to DP strategy over last 3 months
Measured: 6 months
Participant report of adherence to DP strategy
By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes:
- Whether or not DP strategy was used at last sex
- Whether or not DP strategy was used consistently during last 3 month time period
- Estimated proportion of time adherent to DP strategy over last 3 months
Measured: 9 months
Participant report of adherence to DP strategy
By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes:
- Whether or not DP strategy was used at last sex
- Whether or not DP strategy was used consistently during last 3 month time period
- Estimated proportion of time adherent to DP strategy over last 3 months
Measured: 12 months
Participant selection of an effective dual protection (DP) strategy
Whether or not a participant self-reports having selected an effective DP strategy. An effective DP strategy is defined as one of the following:
- Abstinence from vaginal sex;
- Effective non-barrier contraceptive method [including intrauterine device (IUD), Implant, Depo, or contraceptive pill, patch or ring] with consistent condom use;
- Consistent condom use only
Measured: At enrollment visit
Secondary outcomes (10)
Participant level of reproductive health knowledge (percentage correct of knowledge questions)
Knowledge about contraceptives and STIs, as measured by correct answers to knowledge questions on ACASI questionnaires.
Measured: 6 months
Participant intention to use DP strategy
Whether or not participant self-reports intention to use an effective DP strategy in the future, as measured by responses on ACASI questionnaires.
Measured: 6 months
Participant reproductive health self-efficacy
Whether or not participant reported high self-efficacy for condom use, contraceptive use, and communication with partner on reproductive health topics, as measured by responses on ACASI questionnaires.
Measured: 6 months
Participant report of STI testing
Frequency of self-reported STI testing by participant and partner(s) and result-sharing with partner(s), as measured by responses to ACASI questionnaires.
Measured: 6 months
Participant report of partner communication
Self-reported frequency of communication with partner on reproductive health topics, as measured by responses on ACASI questionnaires.
Measured: 6 months
Participant level of reproductive health knowledge (percentage correct of knowledge questions)
Knowledge about contraceptives and STIs, as measured by correct answers to knowledge questions on ACASI questionnaires.
Measured: 12 months
Participant intention to use DP strategy
Whether or not participant self-reports intention to use an effective DP strategy in the future, as measured by responses on ACASI questionnaires.
Measured: 12 months
Participant report of STI testing
Frequency of self-reported STI testing by participant and partner(s) and result-sharing with partner(s), as measured by responses to ACASI questionnaires.
Measured: 12 months
Participant reproductive health self-efficacy
Whether or not participant reported high self-efficacy for condom use, contraceptive use, and communication with partner on reproductive health topics, as measured by responses on ACASI questionnaires.
Measured: 12 months
Participant report of partner communication
Self-reported frequency of communication with partner on reproductive health topics, as measured by responses on ACASI questionnaires.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 709 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Emory University, Grady Health System
- Responsible party
- Sponsor
- Investigators
- Melissa Kottke, MD MPH MBA, Principal investigator, Emory University; Grady Health SystemJessica Sales, PhD, Principal investigator, Emory UniversityAthena Kourtis, MD PhD MPH, Principal investigator, Centers for Disease Control and PreventionPeggy Goedken, MPH, Study director, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291224
- Sponsor's protocol ID
- CDC-NCCDPHP-6588
- Other IDs
- DP12-001
- Acronym
- 2Gether
- Status last verified
- Nov 2018
- First submitted
- 24 Jul 2014
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kottke MJ, Sales JM, Goedken P, Brown JL, Hatfield-Timajchy K, Koumans EH, Hardin JW, Kraft JM, Kourtis AP. 2gether: A Clinic-Based Intervention to Increase Dual Protection from Sexually Transmitted Infections and Pregnancy in Young African American Females. J Womens Health (Larchmt). 2023 Jan;32(1):29-38. doi: 10.1089/jwh.2022.0209. Epub 2022 Nov 22.
PubMed 36413049Kraft JM, Snead MC, Brown JL, Sales JM, Kottke MJ, Hatfield-Timajchy K, Goedken P. Reproductive Coercion Among African American Female Adolescents: Associations with Contraception and Sexually Transmitted Diseases. J Womens Health (Larchmt). 2021 Mar;30(3):429-437. doi: 10.1089/jwh.2019.8236. Epub 2020 Jul 13.
PubMed 32667837
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Clinic-Based Intervention to Increase Dual Protection Against Unintended Pregnancy and Sexually Transmitted Diseases (STDs) Among High Risk Female Teens
- ClinicalTrials.gov ID
- NCT02291224
- Acronym / sponsor ID
- 2Gether / CDC-NCCDPHP-6588
- Conditions
- Pregnancy, Sexually Transmitted Diseases
- Keywords
- dual protection, pregnancy, reproductive health, sexually transmitted diseases, condoms, contraception, adolescent health services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 709 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Emory University, Grady Health System
- Study start
- Mar 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 14 Nov 2014 (estimated)
- 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.
This trial will evaluate a multi-component, clinic-based intervention aimed at increasing dual protection strategy selection and adherence among young African American females at an urban family planning clinic. Dual protection is the use of contraceptive strategies to prevent both unintended pregnancy (UIP) and sexually transmitted infections (STIs). This is an unblinded randomized controlled trial; participants will either get the interactive multimedia platform focused on DP strategies with intervention arm counseling or the standard of care arm counseling.
The study will recruit 710 African American females aged 14-19 who are attending the Grady Health System (GHS) Teen Services Clinic (TSC) in Atlanta, Georgia, for reproductive health care.
The trial will recruit and enroll 710 young women presenting to the clinic for clinical care who have the following characteristics:
- self-identify as African American,
- 14-19 years of age,
- have had vaginal sex with a male partner in the past 6 months,
- HIV-negative by self-report,
- not pregnant,verified by urine pregnancy test,
- no desire to be pregnant in next 12 months,
- plan to stay in the Atlanta area for the next year,
- are willing to provide contact information, and
- were not previously enrolled in the pilot study of this intervention.
Those enrolled will be in the study for 12 months. Young women who are eligible and give written consent or assent for study participation will be enrolled. Half will be randomized to the control arm, half to the intervention arm.
- Control arm (standard of care) includes individual clinical care and standard of care counseling consistent with protocols at the TSC, with study visits for data collection at enrollment, 6 months, and 12 months, during which any medical care or counseling that they would normally get will also be provided. Control arm participants will also get telephone calls from clinic staff to update their contact information and remind them of upcoming visits at 3 weeks and 5 months after the enrollment visit, and at 3 weeks and 5 months after the 6 month visit.
- Intervention arm, consisting of the following intervention components:
- Enrollment visit
- A culturally-appropriate interactive multimedia platform focused on DP strategies and designed to prepare the individual for selection of a DP strategy.
- Individual intervention arm counseling to select the DP strategy that is best suited for the participant (by a clinic health care provider).
- Individual intervention arm counseling to build skills for correct and consistent use of the selected DP strategy (by a nurse educator (NE)).
- Booster counseling via phone at about 3 weeks and 5 months after the enrollment visit, and at about 3 weeks and 5 months after the 6 month visit (by an NE).
- 6 month visit
- An abbreviated version of the interactive multimedia platform focused on dual protection strategies and strategy adherence.
- Individual intervention arm counseling to reinforce skills for correct and consistent use of the DP strategy (by an NE).
At the final study visit at 12 months there is no difference between the counseling provided to the two groups; participants in both arms will receive the clinic standard of care.
Participants in both arms of the study will follow the same data collection procedures throughout the study:
- At all three study visits, participants in both arms will receive urine pregnancy and STI tests and complete an audio computer assisted self-interview (ACASI) questionnaire.
- At 3 and 9 months after enrollment, participants in both arms will receive a data collection call with administration of a telephone questionnaire.
Throughout the study, all participants will be encouraged to come in for evaluation if they have any concerns. Any data from pregnancy or STI testing at these interim clinic visits will be later collected via chart review. If participants seek reproductive health care at other facilities during the study period, records will be requested with participant permission, and data from pregnancy or STI testing at these outside clinic visits will be collected via review of records received.
We will examine the efficacy of the intervention arm relative to control arm across the following primary behavioral and biologic outcomes over the 12 months of follow-up:
- Self-reported dual protection strategy selection
- Self-reported dual protection strategy adherence
- Incidence of pregnancy or infection with chlamydia, gonorrhea or trichomonas (as confirmed by laboratory testing)
A small pilot study was be conducted prior to the initiation of enrollment in the main study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: Standard of care counselingThe control arm receives the clinic standard of care counseling. This includes individual clinical care and counseling consistent with protocols at the Grady Health System Teen Services Clinic, with study visits at enrollment, 6 months, and 12 months, during which any medical care or counseling included in the clinic standard of care will be provided. All control group members will see a provider on the day of enrollment. Control arm participants will get phone calls from clinic staff to update their contact information and remind them of upcoming appointments at 3 weeks and 5 months after both the enrollment visit and the 6 month visit. Participants may visit the clinic at any time and will be encouraged to come into the clinic for any concerns. If they have an interim visit during the study period, they will receive the clinic standard of care. |
| Intervention | Experimental | Behavioral: Interactive multimedia platform, Behavioral: Intervention arm counseling1. Enrollment * Interactive multimedia platform focused on DP strategies. * Intervention arm counseling by a health care provider to select DP strategy. * Intervention arm counseling and skill-building by a nurse educator (NE) on correct, consistent use of DP strategy. 2. Booster counseling by an NE via phone at 3 weeks and 5 months after both the enrollment visit and the 6 month visit. 3. 6 month visit * Abbreviated version of the interactive multimedia platform on DP strategies and adherence. * Intervention arm counseling by an NE to reinforce skills for correct, consistent use of DP strategy. 4. Interim visits: Participants may visit the clinic at any time. If intervention group members visit the clinic for STI treatment or to switch birth control method, providers and/or NEs will follow structured counseling guides. If they have an interim visit for another reason, they will receive the clinic standard of care. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- female,
- self-identify as African American,
- 14-19 years of age,
- present to clinic on date of potential enrollment for clinical care,
- has had vaginal sex with a male partner at least once in the past 6 months,
Key exclusion criteria (2 listed)
- pregnant
- HIV positive
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 |
|---|---|---|
| Interactive multimedia platformAlso: MMDPAn interactive platform that includes video vignettes of young women who are choosing dual protection strategies (based on a synthesis of focus group data from members of the TSC patient population), as well as true/false questions to build knowledge about dual protection and dispel common myths about contraceptive strategies. There will also be reflection questions that encourage participants to consider values and priorities in their own lives that may influence their dual protection strategy selection. | Behavioural | Intervention |
| Intervention arm counselingCounseling for the intervention group will follow carefully developed guides and incorporate the participants' answers to the reflection questions in the interactive multi-media component. This counseling has a set structure (set forth in separate counseling guides for health care providers and nurse educators), incorporates motivational interviewing techniques, includes multiple opportunities for role play, and is designed to be patient-centered. | Behavioural | Intervention |
| Standard of care counselingStandard of care counseling is provided by health care providers and health educators at TSC. It incorporates extensive counseling on methods to prevent both unintended pregnancy and sexually transmitted infections, however the structure of the counseling and techniques used are dependent on the standard practice of each provider or educator. This counseling does not incorporate answers to reflection questions from the multi-media platform because control arm participants will not view this content. | Behavioural | Control |
Primary outcome
Participant selection of an effective dual protection (DP) strategy
Time frame: 6 months
Whether or not a participant self-reports having selected an effective DP strategy. An effective DP strategy is defined as one of the following: * Abstinence from vaginal sex; * Effective non-barrier contraceptive method [including intrauterine device (IUD), Implant, Depo, or contraceptive pill, patch or ring] with consistent condom use; * Consistent condom use only
Participant report of adherence to DP strategy
Time frame: 3 months
By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes: * Whether or not DP strategy was used at last sex * Whether or not DP strategy was used consistently during last 3 month time period * Estimated proportion of time adherent to DP strategy over last 3 months
Time to first biologic event (pregnancy or diagnosis with STI) in participants
Time frame: Within 12 month period following enrollment
Measured by date of positive lab test ("biologic event" refers to a positive pregnancy test or diagnosis with chlamydia, gonorrhea or trichomonas infection).
Incidence of pregnancy and sexually transmitted infections (STIs)
Time frame: Within 12 month period following enrollment
Includes the proportion of participants with a lab-confirmed diagnosis of pregnancy or lab-confirmed diagnosis with infection with chlamydia, gonorrhea or trichomonas within the 12 month follow-up period (testing either performed at study site clinic and documented at study visits and via chart review, or diagnosed by outside labs with documentation obtained via release of information procedures)
Participant selection of an effective dual protection (DP) strategy
Time frame: 12 months
Whether or not a participant self-reports having selected an effective DP strategy. An effective DP strategy is defined as one of the following: * Abstinence from vaginal sex; * Effective non-barrier contraceptive method [including intrauterine device (IUD), Implant, Depo, or contraceptive pill, patch or ring] with consistent condom use; * Consistent condom use only
Participant report of adherence to DP strategy
Time frame: 6 months
By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes: * Whether or not DP strategy was used at last sex * Whether or not DP strategy was used consistently during last 3 month time period * Estimated proportion of time adherent to DP strategy over last 3 months
Participant report of adherence to DP strategy
Time frame: 9 months
By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes: * Whether or not DP strategy was used at last sex * Whether or not DP strategy was used consistently during last 3 month time period * Estimated proportion of time adherent to DP strategy over last 3 months
Participant report of adherence to DP strategy
Time frame: 12 months
By self-report from audio computer-assisted self-interviewing (ACASI) and telephone questionnaires; adherence is measured by three different outcomes: * Whether or not DP strategy was used at last sex * Whether or not DP strategy was used consistently during last 3 month time period * Estimated proportion of time adherent to DP strategy over last 3 months
Participant selection of an effective dual protection (DP) strategy
Time frame: At enrollment visit
Whether or not a participant self-reports having selected an effective DP strategy. An effective DP strategy is defined as one of the following: * Abstinence from vaginal sex; * Effective non-barrier contraceptive method [including intrauterine device (IUD), Implant, Depo, or contraceptive pill, patch or ring] with consistent condom use; * Consistent condom use only
10 secondary outcomes
Participant level of reproductive health knowledge (percentage correct of knowledge questions)
Time frame: 6 months
Participant intention to use DP strategy
Time frame: 6 months
Participant reproductive health self-efficacy
Time frame: 6 months
Participant report of STI testing
Time frame: 6 months
Participant report of partner communication
Time frame: 6 months
Participant level of reproductive health knowledge (percentage correct of knowledge questions)
Time frame: 12 months
Participant intention to use DP strategy
Time frame: 12 months
Participant report of STI testing
Time frame: 12 months
Participant reproductive health self-efficacy
Time frame: 12 months
Participant report of partner communication
Time frame: 12 months
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 27 Nov 2018.
- Derived from this study: PubMed 36413049Kottke MJ, Sales JM, Goedken P, Brown JL, Hatfield-Timajchy K, Koumans EH, Hardin JW, Kraft JM, Kourtis AP. 2gether: A Clinic-Based Intervention to Increase Dual Protection from Sexually Transmitted Infections and Pregnancy in Young African American Females. J Womens Health (Larchmt). 2023 Jan;32(1):29-38. doi: 10.1089/jwh.2022.0209. Epub 2022 Nov 22.
- Derived from this study: PubMed 32667837Kraft JM, Snead MC, Brown JL, Sales JM, Kottke MJ, Hatfield-Timajchy K, Goedken P. Reproductive Coercion Among African American Female Adolescents: Associations with Contraception and Sexually Transmitted Diseases. J Womens Health (Larchmt). 2021 Mar;30(3):429-437. doi: 10.1089/jwh.2019.8236. Epub 2020 Jul 13.
- Individual participant dataSharing planned: Undecided
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Systemic Lupus Erythematosus
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
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.
Melissa Kottke, MD MPH MBA principal investigator
Emory University; Grady Health System
Jessica Sales, PhD principal investigator
Emory University
Athena Kourtis, MD PhD MPH principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive multimedia platform and Intervention arm counseling in people with Pregnancy and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention 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 12 inclusion and 2 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 27 Nov 2018. 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?
Participant selection of an effective dual protection (DP) strategy (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291224, which also lists 2 linked publications.
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 27 Nov 2018.