Evaluation of Safer Sex Intervention (SSI)

Teen Pregnancy Prevention Clinical Trial

Official title:

Evaluation of Safer Sex Intervention (SSI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544841
• Other study ID #: 5 TP1AH000003-02-00 SSI
• Status: Completed
• Phase: N/A
• First received: September 4, 2015
• Last updated: November 7, 2016
• Start date: February 2012
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: The Policy & Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 of treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: August 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Teen Pregnancy Prevention

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Policy & Research Group	Department of Health and Human Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	6 months after end of intervention	No
Secondary	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.	6 months after end of intervention	No