Clinical trial NCT02544841: Evaluation of Safer Sex Intervention (SSI)
Official title: Evaluation of Safer Sex Intervention (SSI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Pregnancy Prevention
Lead sponsor: The Policy & Research Group
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2015-09-09
Enrollment: 319
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Two questionnaire items measuring consistency of condom use
timeFrame: 6 months after the end of intervention
Secondary outcomes:
measure: Two questionnaire items measuring consistency of contraceptive use
timeFrame: 6 months after end of intervention
measure: One questionnaire item measuring frequency of sexual activity
timeFrame: 6 months after end of intervention
Other outcomes:
Locations:
Study officials:
affiliation: The Policy & Research Group
name: Eric Jenner, PhD
role: PRINCIPAL_INVESTIGATOR
References: