Evaluation of Safer Sex Intervention (SSI)

NCT02544841 | Completed

• 1 other identifier: 5 TP1AH000003-02-00 SSI
• Study Type: interventional
• Target: 319
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Teen Pregnancy Prevention

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after the end of intervention

Secondary Outcomes (2)

• Two questionnaire items measuring consistency of contraceptive use

  6 months after end of intervention

• One questionnaire item measuring frequency of sexual activity

  6 months after end of intervention

Study Arms (2)

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.

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.

Behavioral: Female Sexual Health

Interventions

Safer Sex Intervention (SSI) BEHAVIORAL

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.

Safer Sex Intervention (SSI)

Female Sexual Health BEHAVIORAL

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.

Female Sexual Health

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Not have previously participated in any of the following pregnancy/HIV prevention programs:
• 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

Sponsors & Collaborators

• The Policy & Research Group: lead
• Department of Health and Human Services: collaborator

Study Officials

• Eric Jenner, PhD

  The Policy & Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 9, 2015
• Study Start: February 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: August 1, 2016
• Last Updated: November 8, 2016

Record last verified: 2016-11