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Completed

NCT Number: NCT01554423

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

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.

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Key information

Conditions

HIV Prevention

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Pasteur Medical Centre

Pretoria, Gauteng, 0002, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testing and Counseling

Other

Couples will receive information on the transmission and prevention of HIV and STIs, the meaning of test results, and health consequences.

Brief Motivational Interview (BMI)

Behavioral

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.

Integrated Family and Cognitive Behavioral Therapy

Behavioral

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.

Primary outcomes

  1. Biologically confirmed infectious disease status

    Time frame: Outcome measure will be assessed up to 18 months after enrollment.

    Biologically confirmed infectious disease (HIV, Chlamydia, gonorrhea, and trichomoniasis)

  2. Condom use and sexual risk behavior

    Time frame: 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.

  3. Drug taking risk behavior

    Time frame: Outcome measure will be assessed up to 18 months after enrollment.

    Hazardous alcohol use, and positive urinalysis for marijuana, cocaine, heroin.

  4. Intimate partner violence

    Time frame: Outcome measure will be assessed up to 18 months after enrollment.

    Psychological, physical, and sexual violence.

Sponsors and collaborators

Lead sponsor

The City College of New York

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: SA R01

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Mar 15, 2012
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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