NCT01554423

Four-Arm Randomized Control Trial of Brief MI Versus Couples-Based HIV/STI Prevention in South Africa

Four-Arm RCT of Brief MI vs. Couples-Based HIV/STI Prevention in South Africa

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 464 (actual)
• Sponsor: The City College of New York · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study is a Randomized Controlled Trial (RCT) of Integrated and Cognitive Behavioral Therapy for HIV Prevention in Pretoria, South Africa. The RCT will evaluate the efficacy of a brief motivational interview (BMI) and a cognitive-behavioral couples' (IFCBT) intervention alone and in combination against a comparison condition to reduce new cases of HIV and sexually transmitted infections and increase condom use and decrease sexual risk behavior, drug use, and intimate partner violence among young female drug users in Pretoria, South Africa and their primary intimate partners. In the RCT, 384 couples comprised of young female drug users who do (N = 192) and do not (N = 192) trade sex and their primary intimate heterosexual partners will be randomly assigned to one-of-four conditions: (1) testing and counseling; (2) brief motivational interview (BMI); (3) cognitive-behavioral couples' intervention (IFCBT); or (4) BMI and IFCBT combined. Eligibility criteria for couples include an HIV-negative drug using female aged 18 to 40 and their primary intimate partner or spouse who is also HIV negative. Each partner of each couple will be administered assessments with a rapid test for HIV and urine tests for Chlamydia, gonorrhea, trichomoniasis, and drug use at baseline and 3-month, 6-month, and 12-month follow-up.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
OTHER	Testing and Counseling	Couples will receive information on the transmission and prevention of HIV and STIs, the meaning of test results, and health consequences.
BEHAVIORAL	Brief Motivational Interview (BMI)	The brief motivational interview (BMI) to be tested in the RCT in Pretoria is a one-session, 45 minute intervention that will coordinate three, 15-minute modules with one module each to (1) reduce hazardous drinking; (2) reduce illicit drug use; and (3) promote condom use.
BEHAVIORAL	Integrated Family and Cognitive Behavioral Therapy	The IFCBT model is 6 sessions in length and coordinates the delivery of 4 cognitive-behavioral group couples' sessions with 2 individual couples' sessions to prevent HIV and STI co-infections among adult drug users. IFCBT targets HIV risk and protective factors that operate across multiple ecological systems. The four group couples' sessions coordinate Rational Emotive Therapy and Problem Solving Therapy strategies to reduce HIV risk behavior and promote protective behaviors. The two individual couples' sessions utilize structural and strategic approaches to promote adaptive communication and shared responsibility for condom use and gender equality and to directly address and reduce any form of abuse between partners when present.

Timeline

• Start date: 2010-07-01
• Primary completion: 2017-01-31
• Completion: 2017-06-30
• First posted: 2012-03-15
• Last updated: 2017-07-19

Locations

1 site across 1 country: South Africa