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

NCT ID: NCT01554423

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 464 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2017-06-30

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.

Conditions

HIV Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Testing and Counseling

One of the four RCT arms will be comprised of couples randomly assigned to testing and counseling on HIV and associated STI co-infections based on revised procedures developed by the CDC. Couples will receive information on the transmission and prevention of HIV and STIs, the meaning of test results, and health consequences. Randomized trial studies of behavioral interventions have incorporated testing and counseling as a comparison condition and studies in the US and SSA countries have shown that testing and counseling on its own can help to reduce HIV/STI risk behaviors.

Group Type: ACTIVE_COMPARATOR

Testing and Counseling

Intervention Type: 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)

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. Each module is delivered by the clinician using a two-sided laminated card that includes scripted questions and visual aids. Consistent with brief intervention models, the BMI intervention is delivered during one 45 minute session with advice giving as a primary characteristic. Motivational interviewing is also incorporated within the BMI intervention by using a client-centered method of communication to foster behavior change through five techniques of expressing empathy, developing discrepancy, avoiding argumentation, supporting self-efficacy, and motivational rules.

Group Type: EXPERIMENTAL

Brief Motivational Interview (BMI)

Intervention Type: 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

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. The six IFCBT sessions are delivered during a 2-week period with two group couples' sessions and one individual couples' session each week.

Group Type: EXPERIMENTAL

Integrated Family and Cognitive Behavioral Therapy

Intervention Type: 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.

BMI + IFCBT

Participants assigned to this experimental arm will receive Brief Motivational Interviewing combined with Integrated Family and Cognitive Behavioral Therapy.

Group Type: EXPERIMENTAL

Brief Motivational Interview (BMI)

Intervention Type: 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

Intervention Type: 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.

Interventions

Testing and Counseling

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

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

The City College of New York

OTHER

Sponsor Role: lead

Responsible Party

Dr. William Latimer

Professor and Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William W Latimer, Ph.D.

Role: STUDY_DIRECTOR

University of Florida

Locations

Louis Pasteur Medical Centre

Pretoria, Gauteng, South Africa

Countries

South Africa

Other Identifiers

R01DA029894

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA029894

Identifier Type: NIH

Identifier Source: org_study_id

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