Evaluation of Safer Sex Intervention (SSI)
Condition: Teen Pregnancy Prevention
Study type: Interventional

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.
    

Intervention name(s): Safer Sex Intervention (SSI); Female Sexual Health
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention