HIV PreventionSA R01NCT01554423
Four-Arm Randomized Control Trial of Brief MI Versus Couples-Based HIV/STI Prevention in South Africa
A study testing Testing and Counseling, Brief Motivational Interview (BMI) and Integrated Family and Cognitive Behavioral Therapy in people with HIV Prevention, run by The City College of New York at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Testing and Counseling, Brief Motivational Interview (BMI) and Integrated Family and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jul 2010to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Acute suicidality/homicidality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- HIV Prevention
- Being tested
- Testing and Counseling, Brief Motivational Interview (BMI), Integrated Family and Cognitive Behavioral Therapy
- Keywords
- HIV Prevention Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing and CounselingOther
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)Behavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Testing and Counseling | Active comparator | 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. Receives: Other: Testing and Counseling |
| Brief Motivational Interview (BMI) | Experimental | 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. Receives: Behavioral: Brief Motivational Interview (BMI) |
| Integrated Family and Cognitive Behavioral Therapy | Experimental | 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. Receives: Behavioral: Integrated Family and Cognitive Behavioral Therapy |
| BMI + IFCBT | Experimental | Participants assigned to this experimental arm will receive Brief Motivational Interviewing combined with Integrated Family and Cognitive Behavioral Therapy. Receives: Behavioral: Brief Motivational Interview (BMI); Behavioral: Integrated Family and Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biologically confirmed infectious disease status
Biologically confirmed infectious disease (HIV, Chlamydia, gonorrhea, and trichomoniasis)
Measured: Outcome measure will be assessed up to 18 months after enrollment.
Condom use and sexual risk behavior
Condom use during last sexual intercourse, proportion of unprotected sex episodes; number of partners.
Measured: Outcome measure will be assessed up to 18 months after enrollment.
Drug taking risk behavior
Hazardous alcohol use, and positive urinalysis for marijuana, cocaine, heroin.
Measured: Outcome measure will be assessed up to 18 months after enrollment.
Intimate partner violence
Psychological, physical, and sexual violence.
Measured: Outcome measure will be assessed up to 18 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startJul 2010
- Primary completion31 Jan 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- The City College of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Dr. William Latimer, The City College of New York
- Investigators
- William W Latimer, Ph.D., Study director, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554423
- Sponsor's protocol ID
- R01DA029894
- Other IDs
- R01DA029894
- Acronym
- SA R01
- Status last verified
- Jul 2017
- First submitted
- 7 Feb 2012
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four-Arm RCT of Brief MI vs. Couples-Based HIV/STI Prevention in South Africa
- ClinicalTrials.gov ID
- NCT01554423
- Acronym / sponsor ID
- SA R01 / R01DA029894
- Conditions
- HIV Prevention
- Keywords
- HIV Prevention Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- The City College of New YorkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2010
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Testing and Counseling | Active comparator | Other: Testing and CounselingOne 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. |
| Brief Motivational Interview (BMI) | Experimental | 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. 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. |
| Integrated Family and Cognitive Behavioral Therapy | Experimental | Behavioral: Integrated Family and Cognitive Behavioral TherapyThe 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. |
| BMI + IFCBT | Experimental | Behavioral: Brief Motivational Interview (BMI), Behavioral: Integrated Family and Cognitive Behavioral TherapyParticipants assigned to this experimental arm will receive Brief Motivational Interviewing combined with Integrated Family and Cognitive Behavioral Therapy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Acute suicidality/homicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing and CounselingCouples will receive information on the transmission and prevention of HIV and STIs, the meaning of test results, and health consequences. | Other | Testing and Counseling |
| 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. | Behavioural | BMI + IFCBT, Brief Motivational Interview (BMI) |
| Integrated Family and Cognitive Behavioral TherapyThe 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. | Behavioural | BMI + IFCBT, Integrated Family and Cognitive Behavioral Therapy |
Primary outcome
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)
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.
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.
Intimate partner violence
Time frame: Outcome measure will be assessed up to 18 months after enrollment.
Psychological, physical, and sexual violence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William W Latimer, Ph.D. study director
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing and Counseling, Brief Motivational Interview (BMI) and Integrated Family and Cognitive Behavioral Therapy in people with HIV Prevention, run by The City College of New York at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biologically confirmed infectious disease status (time frame: Outcome measure will be assessed up to 18 months after enrollment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.