HIV Prevention
Conditions
Keywords
HIV Prevention Intervention
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.
Interventions
OTHERTesting and Counseling
Couples will receive information on the transmission and prevention of HIV and STIs, the meaning of test results, and health consequences.
BEHAVIORALBrief 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.
BEHAVIORALIntegrated 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.
Sponsors
National Institute on Drug Abuse (NIDA)
The City College of New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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. |
| Intimate partner violence | Outcome measure will be assessed up to 18 months after enrollment. | Psychological, physical, and sexual violence. |
Countries
South Africa
Outcome results
None listed