Trial record 3 of 174 for:    HIV Prevention OR HIV Seronegativity | Open Studies | Behavioral

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
  Purpose

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.


Condition Intervention
HIV Prevention
Other: Testing and Counseling
Behavioral: Brief Motivational Interview (BMI)
Behavioral: Integrated Family and Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Four-Arm RCT of Brief MI vs. Couples-Based HIV/STI Prevention in South Africa

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 720
Study Start Date: July 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.
Experimental: BMI + IFCBT
Participants assigned to this experimental arm will receive Brief Motivational Interviewing combined with Integrated Family and Cognitive Behavioral Therapy.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554423

Contacts
Contact: Anne Gloria Moleko, Ph.D. 12-420-2930 Anne.Moleko@up.ac.za

Locations
South Africa
Louis Pasteur Medical Centre Recruiting
Pretoria, Gauteng, South Africa, 0002
Contact: Anne Gloria Moleko, Ph.D.    12-420-2930    Anne.Moleko@up.ac.za   
Principal Investigator: Anne Gloria Moleko, Ph.D.         
Sponsors and Collaborators
University of Florida
Investigators
Study Director: William W Latimer, Ph.D. University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01554423     History of Changes
Other Study ID Numbers: R01DA029894
Study First Received: February 7, 2012
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board
South Africa: Human Research Ethics Committee

Keywords provided by University of Florida:
HIV Prevention Intervention

ClinicalTrials.gov processed this record on August 28, 2014