Four-Arm Randomized Control Trial of Brief MI Versus Couples-Based HIV/STI Prevention in South Africa (SA R01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01554423
First received: February 7, 2012
Last updated: March 24, 2014
Last verified: March 2014

February 7, 2012
March 24, 2014
July 2010
March 2015   (final data collection date for primary outcome measure)
  • Biologically confirmed infectious disease status [ Time Frame: Outcome measure will be assessed up to 18 months after enrollment. ] [ Designated as safety issue: No ]
    Biologically confirmed infectious disease (HIV, Chlamydia, gonorrhea, and trichomoniasis)
  • Condom use and sexual risk behavior [ Time Frame: Outcome measure will be assessed up to 18 months after enrollment. ] [ Designated as safety issue: No ]
    Condom use during last sexual intercourse, proportion of unprotected sex episodes; number of partners.
  • Drug taking risk behavior [ Time Frame: Outcome measure will be assessed up to 18 months after enrollment. ] [ Designated as safety issue: No ]
    Hazardous alcohol use, and positive urinalysis for marijuana, cocaine, heroin.
  • Intimate partner violence [ Time Frame: Outcome measure will be assessed up to 18 months after enrollment. ] [ Designated as safety issue: No ]
    Psychological, physical, and sexual violence.
Same as current
Complete list of historical versions of study NCT01554423 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Prevention
  • 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.
  • Active Comparator: 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.
    Intervention: Other: Testing and Counseling
  • Experimental: 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.
    Intervention: Behavioral: Brief Motivational Interview (BMI)
  • Experimental: 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.
    Intervention: Behavioral: Integrated Family and Cognitive Behavioral Therapy
  • Experimental: BMI + IFCBT
    Participants assigned to this experimental arm will receive Brief Motivational Interviewing combined with Integrated Family and Cognitive Behavioral Therapy.
    Interventions:
    • Behavioral: Brief Motivational Interview (BMI)
    • Behavioral: Integrated Family and Cognitive Behavioral Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
720
June 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact: Anne Gloria Moleko, Ph.D. 12-420-2930 Anne.Moleko@up.ac.za
South Africa
 
NCT01554423
R01DA029894
Yes
University of Florida
University of Florida
National Institute on Drug Abuse (NIDA)
Study Director: William W Latimer, Ph.D. University of Florida
University of Florida
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP