This trial has been completed.

Condition teen pregnancy prevention
Treatments safer sex intervention (ssi), female sexual health
Sponsor The Policy & Research Group
Collaborator Department of Health and Human Services
Start date February 2012
End date October 2015
Trial size 319 participants
Trial identifier NCT02544841, 5 TP1AH000003-02-00 SSI


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
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.
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.
(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.
female sexual health
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.

Primary Outcomes

Two questionnaire items measuring consistency of condom use
time frame: 6 months after the end of intervention

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

Eligibility Criteria

Female participants from 14 years up to 19 years old.

Inclusion Criteria: 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. Exclusion Criteria: 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) - Project AIM - Making Proud Choices - Be Proud Be Responsible - Focus on Your Future

Additional Information

Official title Evaluation of Safer Sex Intervention (SSI)
Principal investigator Eric Jenner, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by The Policy & Research Group.