Teen Pregnancy PreventionNCT02544841
Evaluation of Safer Sex Intervention (SSI)
A study testing Safer Sex Intervention (SSI) and Female Sexual Health in people with Teen Pregnancy Prevention, run by The Policy & Research Group.
Trial summary
The purpose of the study is to determine the impact of the offer to participate in Safer Sex Intervention (SSI) (treatment) relative to the offer to participate in Female Sexual Health (control) on three self-reported sexual behaviors (condom use, other contraceptive use, and frequency of sex) six months after the end… Read more about this study
- Who is it for?
- Ages 14 to 19 years, women only
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- Safer Sex Intervention (SSI) and Female Sexual Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Aug 2016
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 14-19 Had engaged in sex with a male in the three months prior to enrollment Provide parental consent (if under age 18) and participant assent to participate in the study.
Who cannot join
- Not have previously participated in any of the following pregnancy/HIV prevention programs:
- 4 Real Health
- Becoming a Responsible Teen (BART)
- Healthy Living
- Staying Mature and Responsible Towards Sex (SMARTS)
- Sisters Informing Healthy Living and Empowering (SIHLE)
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- Project AIM
- Making Proud Choices
- Be Proud Be Responsible
- Focus on Your Future
About this study
The purpose of the study is to determine the impact of the offer to participate in Safer Sex Intervention (SSI) (treatment) relative to the offer to participate in Female Sexual Health (control) on three self-reported sexual behaviors (condom use, other contraceptive use, and frequency of sex) six months after the end of treatment.
Read the detailed description
The Policy \& Research Group (PRG) will be evaluating the Safer Sex Intervention (SSI). The Safer Sex Intervention is based in Social Cognitive Theory, the Transtheoretical Model of Behavior Change, and motivational interviewing. Coupled with skill-building exercises, the intervention is intended to increase knowledge related to risk and safe-sex behaviors, to increase awareness of risk and need for behavior change, to help build self-efficacy to engage in safe-sex behaviors, and, ultimately, to motivate participants to engage in and maintain safe sex practices. The intervention is meant to be delivered in four, one-on-one sessions over the course of six months. Each session is to be conducted in a private setting by a female health educator trained in motivational interviewing and Safer Sex Intervention. The initial or primary intervention session should take approximately 30 to 50 minutes. Subsequent "booster sessions" delivered 1, 3, and 6 months following the initial session are to take 10 to 30 minutes. Booster sessions are intended to sustain any resulting behavior change. The control (counterfactual) condition, Female Sexual Health, was developed specifically for use in this study; it consists of a 30-minute PowerPoint presentation, intended to be delivered in one face-to-face session that provides information about reproductive anatomy and STIs. After the presentation, participants receive free condoms. This is the only session for the control condition; there are no booster sessions. Though there were some variations in consent requirements across sites, there were no differences in the recruitment process between the treatment and control groups. All eligible individuals who provided the proper consent to participate were randomized and enrolled into the study at the time they attended their first scheduled study session. Data were collected via self-administered questionnaires that were scheduled at baseline and six months post treatment (12 months after baseline). The study took place in New Orleans, Louisiana, at five clinics that served young women between the ages of 14 and 19.
- Conditions
- Teen Pregnancy Prevention
- Being tested
- Safer Sex Intervention (SSI), Female Sexual Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safer Sex Intervention (SSI)Behavioural
Safer Sex Intervention (SSI) is an in-person, individual-level, clinic-based intervention implemented by a female health educator trained in the intervention. It is intended to be implemented in one initial session lasting 30-50 minutes and three booster sessions lasting 10-30 minutes at one, three, and six month intervals.
Female Sexual HealthBehavioural
Female Sexual Health is a knowledge-based intervention that intends to provide information on how STIs are contracted, the consequences of contracting STIs, and how to prevent them. Female Sexual Health includes the information-only component of the first session of SSI and baseline exposure to a health educator but does not include booster sessions.
| Study group | Role | What they receive |
|---|---|---|
| Safer Sex Intervention (SSI) | Experimental | Safer Sex Intervention (SSI) is the treatment condition. SSI is an in-person, individual-level, clinic-based intervention that aims to reduce risky sexual behaviors among sexually active adolescent females. Receives: Behavioral: Safer Sex Intervention (SSI) |
| Female Sexual Health | Active comparator | Female Sexual Health is the control counterfactual condition. It is an individual-level, information-only sex education program that aims to increase participants' knowledge on various topics related to STIs. Receives: Behavioral: Female Sexual Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two questionnaire items measuring consistency of condom use
The risk outcome is operationalized as the proportion of times in the past three months a person reports having any type of sex without using a condom. The measure is calculated from the following items on the Outcome Questionnaire administered 6 months after the program ends:
- In total, how many times have you had any type of sex in the past 3 months?
- Now, think about the number of times that you had any type of sex in the past 3 months. How many of those times did you use condoms? The resulting variable is a continuous proportion with values that range from 0 to 1, where 0 indicates that a person has not engaged in sex without a condom in the past three months, and 1 indicates that the person has engaged in sex without a condom 100% of the times they had sex in the past three months.
Measured: 6 months after the end of intervention
Secondary outcomes (2)
Two questionnaire items measuring consistency of contraceptive use
The risk outcome is operationalized as the proportion of times a person reports having sexual intercourse without using any form of birth control (including condoms). The measure is calculated from the following items:
- In total, how many times have you had sexual intercourse in the past 3 months?
- In the past 3 months, how many times have you had sexual intercourse without using any of these methods of birth control (options listed)?
The measure is calculated by dividing the total number of times a person reported having sexual intercourse without using any contraception by the total number of times she reported having sexual intercourse.
Measured: 6 months after end of intervention
One questionnaire item measuring frequency of sexual activity
The risk outcome is operationalized as the number of times in the past three months a person reports having any type of sex.
The measure is taken directly from the following item:
- In total, how many times have you had any type of sex in the past 3 months?
The variable is continuous, with values ranging from 0 to k, where 0= no sexual activity reported in past 3 months and k = number of times sex reported.
Measured: 6 months after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startFeb 2012
- Primary completionOct 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen Pregnancy PreventionStudies 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
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Policy & Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Eric Jenner, PhD, Principal investigator, The Policy & Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544841
- Sponsor's protocol ID
- 5 TP1AH000003-02-00 SSI
- Status last verified
- Nov 2016
- First submitted
- 4 Sep 2015
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safer Sex Intervention (SSI)
- ClinicalTrials.gov ID
- NCT02544841
- Acronym / sponsor ID
- 5 TP1AH000003-02-00 SSI
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- The Policy & Research GroupUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Feb 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Sep 2015 (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.
The purpose of the study is to determine the impact of the offer to participate in Safer Sex Intervention (SSI) (treatment) relative to the offer to participate in Female Sexual Health (control) on three self-reported sexual behaviors (condom use, other contraceptive use, and frequency of sex) six months after the end of treatment.
Detailed description
The Policy \& Research Group (PRG) will be evaluating the Safer Sex Intervention (SSI). The Safer Sex Intervention is based in Social Cognitive Theory, the Transtheoretical Model of Behavior Change, and motivational interviewing. Coupled with skill-building exercises, the intervention is intended to increase knowledge related to risk and safe-sex behaviors, to increase awareness of risk and need for behavior change, to help build self-efficacy to engage in safe-sex behaviors, and, ultimately, to motivate participants to engage in and maintain safe sex practices. The intervention is meant to be delivered in four, one-on-one sessions over the course of six months. Each session is to be conducted in a private setting by a female health educator trained in motivational interviewing and Safer Sex Intervention. The initial or primary intervention session should take approximately 30 to 50 minutes. Subsequent "booster sessions" delivered 1, 3, and 6 months following the initial session are to take 10 to 30 minutes. Booster sessions are intended to sustain any resulting behavior change. The control (counterfactual) condition, Female Sexual Health, was developed specifically for use in this study; it consists of a 30-minute PowerPoint presentation, intended to be delivered in one face-to-face session that provides information about reproductive anatomy and STIs. After the presentation, participants receive free condoms. This is the only session for the control condition; there are no booster sessions. Though there were some variations in consent requirements across sites, there were no differences in the recruitment process between the treatment and control groups. All eligible individuals who provided the proper consent to participate were randomized and enrolled into the study at the time they attended their first scheduled study session. Data were collected via self-administered questionnaires that were scheduled at baseline and six months post treatment (12 months after baseline). The study took place in New Orleans, Louisiana, at five clinics that served young women between the ages of 14 and 19.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safer Sex Intervention (SSI) | Experimental | Behavioral: Safer Sex Intervention (SSI)Safer Sex Intervention (SSI) is the treatment condition. SSI is an in-person, individual-level, clinic-based intervention that aims to reduce risky sexual behaviors among sexually active adolescent females. |
| Female Sexual Health | Active comparator | Behavioral: Female Sexual HealthFemale Sexual Health is the control counterfactual condition. It is an individual-level, information-only sex education program that aims to increase participants' knowledge on various topics related to STIs. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Between the ages of 14-19 Had engaged in sex with a male in the three months prior to enrollment Provide parental consent (if under age 18) and participant assent to participate in the study.
Key exclusion criteria (10 listed)
- Not have previously participated in any of the following pregnancy/HIV prevention programs:
- 4 Real Health
- Becoming a Responsible Teen (BART)
- Healthy Living
- Staying Mature and Responsible Towards Sex (SMARTS)
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 |
|---|---|---|
| Safer Sex Intervention (SSI)Safer Sex Intervention (SSI) is an in-person, individual-level, clinic-based intervention implemented by a female health educator trained in the intervention. It is intended to be implemented in one initial session lasting 30-50 minutes and three booster sessions lasting 10-30 minutes at one, three, and six month intervals. | Behavioural | Safer Sex Intervention (SSI) |
| Female Sexual HealthFemale Sexual Health is a knowledge-based intervention that intends to provide information on how STIs are contracted, the consequences of contracting STIs, and how to prevent them. Female Sexual Health includes the information-only component of the first session of SSI and baseline exposure to a health educator but does not include booster sessions. | Behavioural | Female Sexual Health |
Primary outcome
Two questionnaire items measuring consistency of condom use
Time frame: 6 months after the end of intervention
The risk outcome is operationalized as the proportion of times in the past three months a person reports having any type of sex without using a condom. The measure is calculated from the following items on the Outcome Questionnaire administered 6 months after the program ends: * In total, how many times have you had any type of sex in the past 3 months? * Now, think about the number of times that you had any type of sex in the past 3 months. How many of those times did you use condoms? The resulting variable is a continuous proportion with values that range from 0 to 1, where 0 indicates that a person has not engaged in sex without a condom in the past three months, and 1 indicates that the person has engaged in sex without a condom 100% of the times they had sex in the past three months.
2 secondary outcomes
Two questionnaire items measuring consistency of contraceptive use
Time frame: 6 months after end of intervention
One questionnaire item measuring frequency of sexual activity
Time frame: 6 months after end of intervention
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 8 Nov 2016.
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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.
Eric Jenner, PhD principal investigator
The Policy & Research Group
Questions about this trial
What is this clinical trial studying?
A study testing Safer Sex Intervention (SSI) and Female Sexual Health in people with Teen Pregnancy Prevention, run by The Policy & Research Group.
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 1 inclusion and 10 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Two questionnaire items measuring consistency of condom use (time frame: 6 months after the end of intervention). 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 8 Nov 2016.