- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01554423
Four-Arm Randomized Control Trial of Brief MI Versus Couples-Based HIV/STI Prevention in South Africa (SA R01)
July 18, 2017 updated by: Dr. William Latimer, The City College of New York
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
464
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gauteng
-
Pretoria, Gauteng, South Africa, 0002
- Louis Pasteur Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Outcome measure will be assessed up to 18 months after enrollment.
|
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.
|
Outcome measure will be assessed up to 18 months after enrollment.
|
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.
|
Outcome measure will be assessed up to 18 months after enrollment.
|
Intimate partner violence
Time Frame: Outcome measure will be assessed up to 18 months after enrollment.
|
Psychological, physical, and sexual violence.
|
Outcome measure will be assessed up to 18 months after enrollment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: William W Latimer, Ph.D., University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
January 31, 2017
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
March 12, 2012
First Posted (Estimate)
March 15, 2012
Study Record Updates
Last Update Posted (Actual)
July 19, 2017
Last Update Submitted That Met QC Criteria
July 18, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01DA029894 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Prevention
-
Prof Mags BeksinskaCompletedHIV Prevention | Pregnancy PreventionSouth Africa
-
Yale UniversityCompletedHIV Prevention | STI PreventionUnited States
-
Centers for Disease Control and PreventionUniversity of Minnesota; The Fenway Institute; AIDS Action Committee of Massachusetts and other collaboratorsCompletedHIV Prevention | STD PreventionUnited States
-
International Partnership for Microbicides, Inc.CompletedHIV PreventionSouth Africa, Uganda
-
Microbicide Trials NetworkNational Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy... and other collaboratorsCompleted
-
Fenway Community HealthCompleted
-
University of California, Los AngelesUniversity of California, San Diego; California HIV/AIDS Research Program; Los... and other collaboratorsCompletedHIV PreventionUnited States
-
Microbicide Trials NetworkNational Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy... and other collaboratorsCompletedHIV PreventionUganda, South Africa, Zimbabwe
-
Massachusetts General HospitalMbarara University of Science and TechnologyCompleted
-
Orion Biotechnology Polska Sp. z o.o.Scope International AGCompleted
Clinical Trials on Testing and Counseling
-
Emory UniversityNational Institute of Mental Health (NIMH)Completed
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV InfectionsSouth Africa
-
National Development and Research Institutes, Inc.National Institute on Drug Abuse (NIDA)Completed
-
Hunter College of City University of New YorkNational Institute on Drug Abuse (NIDA); University of MichiganEnrolling by invitationHIV InfectionsUnited States
-
University of California, Los AngelesEmory University; BroadReach Healthcare; USAID, South Africa; South African Department...CompletedHIV Infections | HIV Seropositivity | ARTSouth Africa
-
University of WashingtonCompletedPregnancy | HIV Counseling and Testing | Home Based | Male PartnerKenya
-
M.D. Anderson Cancer CenterRecruitingBreast Cancer | Gynecologic Cancer | Pancreatic Cancer | Lynch Syndrome | Endometrial Cancer | Colon Cancer | Hereditary Breast and Ovarian Cancer Syndrome | Uterus Cancer | Ovary CancerUnited States
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletedHuman Immunodeficiency Virus (HIV) | Acquired Immune Deficiency Syndrome (AIDS)Lesotho
-
Medical College of WisconsinNational Institute of Mental Health (NIMH)Enrolling by invitation
-
M.D. Anderson Cancer CenterRecruitingBreast Cancer | Colorectal CancerUnited States