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

Not Applicable

Completed

• Conditions: HIV Prevention

• Registration Number: NCT01554423
• Lead Sponsor: The City College of New York

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-15
• Primary Completion: 2017-01-31
• Study Completion: 2017-06-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

• Live in the Pretoria, South Africa region
• 18-40 Years of Age
• In a steady, intimate relationship for 6 months or longer
• Used illicit drugs in the past 6 months

Exclusion Criteria

• Acute suicidality/homicidality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Drug taking risk behavior	Outcome measure will be assessed up to 18 months after enrollment.	Hazardous alcohol use, and positive urinalysis for marijuana, cocaine, heroin.
Biologically confirmed infectious disease status	Outcome measure will be assessed up to 18 months after enrollment.	Biologically confirmed infectious disease (HIV, Chlamydia, gonorrhea, and trichomoniasis)
Intimate partner violence	Outcome measure will be assessed up to 18 months after enrollment.	Psychological, physical, and sexual violence.
Condom use and sexual risk behavior	Outcome measure will be assessed up to 18 months after enrollment.	Condom use during last sexual intercourse, proportion of unprotected sex episodes; number of partners.

Trial Locations

Locations (1)

Louis Pasteur Medical Centre; 🇿🇦 Pretoria, Gauteng, South Africa