Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202205640398485 Date of Approval: 09/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Couples Health CoOp Plus ( CHC+ )
Official scientific title Multilevel Strategies & Tailored HIV Prevention and Care for Young Couples Who Use Alcohol and Other Drugs Across Cape Town: Couples Health CoOp Plus
Brief summary describing the background and objectives of the trial This study addresses HIV prevention and treatment for young couples living in Cape Town, South Africa, through a comprehensive biobehavioral multilevel approach- the Couples Health CoOp Plus (CHC+). Through a cluster randomized trial with a modified factorial design, 24 Cape Town communities consisting of catchment areas for clinics that provide antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP), will receive either a stigma awareness education workshops or no workshop with repeated measures. Within clinic catchment areas, 480 couples (young women and their primary male sex partners both aged 18 to 30) will be recruited. These couples will receive HIV testing services (HTS) and/or the Couples Health CoOp Plus (CHC+), depending on intervention arm. Specifically, the study aims to: Aim 1: Modify the Couples Health CoOp (CHC) intervention to include antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) in a formative phase and with review from the Community Collaborative Board (CCB) and Peer Advisory Board (PAB). Aim 2: Evaluate the impact of a stigma awareness and education workshop on community members' attitudes and behaviors toward young women and men wh ouse AODs and others seeking HIV services (testing/ART/PrEP) and other health services in their local clinics at 4- and 8-month follow-up. Aim 3: Test the efficacy of the Couples Health CoOp Plus (CHC+) to increase both partners’ antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) initiation and adherence (primary outcome) and reduce alcohol and other drug (AOD) use, sexual risk and gender-based violence (GBV), and enhance positive gender norms and communication relative to HIV testing services (HTS) (secondary outcomes). Aim 4: Examine through mixed methods the interaction of stigma awareness and education workshops and the CHC+ on increased antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) and initiation, retention and adherence among young women and their primary partners
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial biobehavioural interventions
Anticipated trial start date 06/05/2022
Actual trial start date 07/07/2022
Anticipated date of last follow up 29/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 3288
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group community stigma awareness and education workskhop One 3 hours Key aspects of the training include community stigma awareness and education of people living with HIV, use of antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) for prevention of HIV and attitudes towards people who use alcohol and drugs. Selected modules will be modified from the existing clinic-based training to fit community stigma awareness and attitudes, as needed, to focus on aspects of stigma specific only to young women and men who engage in syndemic-related behaviours who live in their communities. This intervention has been adapted from implementation in clinics in Pretoria for use in a community setting in Cape Town. The stigma workshops will be delivered in communities randomized to receive this training (N=12 communities; estimated N=1164 participants at three time periods). 1164
Experimental Group community stigma awareness and education workshop and CHC Plus Community Stigma Awareness and Education Workshop: one workshop CHC+: two workshops Community Stigma Education and Awareness Workshop: three hours per workshop CHC+: three hours per workshop Behavioral: Community Stigma Awareness and Education Workshop Key aspects of the training include community stigma awareness and education workshop of people living with HIV, use of antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) for prevention of HIV and attitudes towards people who use alcohol and drugs. Selected modules will be modified from the existing clinic-based training to fit community stigma awareness and attitudes, as needed, to focus on aspects of stigma specific only to young women and men who engage in syndemic-related behaviours who live in their communities. This intervention has been adapted from implementation in clinics in Pretoria for use in a community setting in Cape Town. The stigma reduction awareness and education workshop will be delivered in communities randomized to receive this training (N=12 communities; estimated N=1164 participants). Behavioral: Couples Health CoOp Plus (CHC+) The Couples Health CoOp Plus (CHC+) was adapted from the initial Couples Health CoOp (CHC)—an empowerment-based intervention developed for South African couples that addresses the syndemic of alcohol and other drug (AOD) use, gender-based violence (GBV), and HIV risk. It is grounded in Social Cognitive Theory and promotes prevention strategies that address the relational context of equality in which sexual risk takes place. The adapted Couples Health CoOp Plus (CHC+) incorporates antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) for a biobehavioral approach with an emphasis on uptake and good adherence (N=12 communities; estimated N=240 couples at baseline (480 individuals). 1644
Control Group No intervention No intervention No intervention No Intervention: No Community Stigma Reduction Training and HTS/ART/PrEP Only Participants in the communities/catchment areas randomized to this arm will complete the community stigma assessments but will not receive the stigma reduction training workshops. Couples will have access to standard HIV testing services (HTS) with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) but not the Couples Health CoOp Plus (CHC+) intervention. 0 Active-Treatment of Control Group
Experimental Group Couples Health CoOp Plus Two workshops Three hours per workshop Behavioral: Couples Health CoOp Plus (CHC+) The Couples Health CoOp Plus (CHC+) was adapted from the initial Couples Health CoOp (CHC)—an empowerment-based intervention developed for South African couples that addresses the syndemic of alcohol and other drug (AOD) use, gender-based violence (GBV), and HIV risk. It is grounded in Social Cognitive Theory and promotes prevention strategies that address the relational context of equality in which sexual risk takes place. The adapted Couples Health CoOp Plus (CHC+) incorporates antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) for a biobehavioral approach with an emphasis on uptake and good adherence (N=12 communities; estimated N=240 couples (480 individuals). 480
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Is in a relationship with a primary partner • Had recent condomless sex with their primary partner • Has not taken PrEP or ART in the past 90 days • Has drunk alcohol and/or used drugs at least once a week over the past 90 days • Not currently pregnant (for women) • Not currently being treated for drug-resistant tuberculosis (TB) Adult: 19 Year-44 Year 18 Year(s) 30 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/09/2020 South African Medical Research Council
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Tygerberg 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/01/2022 South African Medical Research Council
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Tygerberg 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/03/2022 City of Cape Town
Ethics Committee Address
Street address City Postal code Country
Hertzog Boulevard Cape Town 8000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/09/2022 South African Medical Research Council
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Tygerberg 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/09/2023 South African Medical Research Council
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Tygerberg 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Antiretroviral Therapy (ART) Initiation [individual and couple-level] ART initiation will be measured using initiation information recorded in the participant’s clinic medical record. 3-month and 6-month follow-up
Primary Outcome Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level] Pre-exposure prophylaxis (PrEP) initiation will be measured using initiation information recorded in the participant’s clinic medical record. 3-month and 6-month follow-up
Primary Outcome Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level] ART adherence will be measured using viral load or cluster of differentiation 4 (CD4) count measures recorded in the participant’s medical record. Threshold for adherence will be cluster of differentiation 4 (CD4) count (more than 200) and HIV viral load (less than 50 copies per ml). 3-month and 6-month follow-up
Primary Outcome Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level] Self-report past 30-day use, missed doses and patterns of use of antiretroviral therapy (ART) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+). 3-month and 6-month follow-up
Primary Outcome Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level] Tenofovir Diphosphate (TFV-DP) and FTC Triphosphate (FTC-TP) concentrations in dried blood spots (DBS) with drug concentrations of greater than 700 femtomoles (fmol)/liters(L) will be considered adherent to pre-exposure prophylaxis (PrEP). 3-month and 6-month follow-up
Primary Outcome Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level] Self-report past 30-day use, missed doses and patterns of use of pre-exposure prophylaxis (PrEP) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+). 3-month and 6-month follow-up
Primary Outcome Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level] Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records. 3-month and 6-month follow-up
Primary Outcome Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level] Self-reported time in months on antiretroviral therapy (ART) since initiation will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+). 3-month and 6-month follow-up
Primary Outcome Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level Number of pre-exposure prophylaxis (PrEP) refills since initiation as recorded clinic medical records. 3-month and 6-month follow-up
Primary Outcome Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level] Self-reported time in months on pre-exposure prophylaxis (PrEP) since initiation on pre-exposure prophylaxis (PrEP) will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+). 3-month and 6-month follow-up
Primary Outcome Data Extraction: Antiretroviral therapy (ART) Retention Antiretroviral therapy (ART) retention in care will be measured as attendance to follow-up visits as recorded in clinic medical records. 3-month and 6-month follow-up
Primary Outcome Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level] Self-report pre-exposure prophylaxis (PrEP) retention in care will be measured as attendance to follow-up visits using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+). 3-month and 6-month follow-ups
Secondary Outcome Community Stigma [structural level] Surveys will be used to measure stigmatizing attitudes and perceptions towards people who use alcohol and other drugs (AODs), living with HIV and seeking and antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) services for prevention. Greater values indicate higher levels of community-level stigma and discrimination. Baseline, 4-month follow-up and 8-month follow-up
Secondary Outcome Biological: Drug use [individual level] Recent drug use (amphetamine, cocaine, methamphetamine, marijuana [THC], opiates and/or Mandrax) will be measured using a rapid urine-based drug screening test panel. Baseline, 3-month and 6-month follow-up
Secondary Outcome Biological: Alcohol use [individual level] Recent alcohol (last 10 days) use will be measured by the presence of ethyl glucuronide (EtG), a breakdown product of ethanol, using an ethyl glucuronide (EtG) urine test. Baseline, 3-month and 6-month follow-up
Secondary Outcome Self-Report: Gender-Based Violence (GBV) [individual and couple-level] Self-report emotional, physical, and sexual abuse, recent victimization, and family violence & experience of physical & sexual abuse will be measured using the World Health Organization (WHO) assessment of emotional, physical, & sexual abuse and the Revised Risk Behavior Assessment (RRBA). Baseline, 3-month and 6-month follow-up
Secondary Outcome Self-Report: Sexual Risk [individual and couple-level] Self-reported frequency of condom use at last sex over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+). Baseline, 3-month and 6-month follow-up
Secondary Outcome Self-Report: Sexual Risk [individual and couple-level] Self-reported frequency of alcohol and other drug (AOD) use prior to sex in the last 3 months as measured by the Pretoria Risk Behavior Assessment (PRBA+). Baseline, 3-month and 6-month follow-up
Secondary Outcome Self-Report: Sexual Risk [individual and couple-level] Self-reported number of sex partners, concurrent sexual partners and sex trading partners over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+). Baseline, 3-month and 6-month follow-up
Secondary Outcome Self-Report: Sexual Risk [individual and couple-level] Self-report responses on the single item measured by the Pretoria Risk Behavior Assessment (PRBA+) will be used to assess use of contraception and types of contraception. Baseline, 3-month and 6-month follow-up
Secondary Outcome Self-Report: Sexual Risk [individual and couple-level] Self-report responses on single-item questions will be used to assess the extent to which participants perceive themselves as at risk for HIV infection measured by the Pretoria Risk Behavior Assessment (PRBA+). Higher levels indicate greater perceived HIV risk. Baseline, 3-month and 6-month follow-up
Secondary Outcome Self-Report: Gender Norms [individual and couple-level] Self-reported attitudes about traditional gender roles, empowerment, and assertiveness will be measured by the Gender ideology Scale (GIS) and the Pretoria Risk Behavior Assessment (PRBA+). Baseline, 3-month and 6-month follow-up
Secondary Outcome Self-Report: Communication [individual and couple-level] Self-reported communication between partners regarding testing, HIV and sexually transmitted infection (STI) status, other partners, sexual negotiation, and condom use as measured by the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+). Baseline, 3-month and 6-month follow-up
Secondary Outcome Self-Report: Observed or Knowledge of Stigma [individual and couple-level] Observations or knowledge of stigma perpetrated by others in the community will be measured by the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+). Baseline, 3-month and 6-month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
South African Medical Research Council Brentwood Park, Hindle Road Delft 7100 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute on Drug Abuse NIDA 3WFN MSC 6024, 301 North Stonestreet Ave Bethesda MD 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor RTI International 3040 East Cornwallis Road Research Triangle Park North Carolina 277092194 United States of America Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tara Carney tara.carney@mrc.ac.za +279380326 Francie van Zyl Drive
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa specialist scientist
Role Name Email Phone Street address
Public Enquiries Belinda Chamberlain belinda.chamberlain@mrc.ac.za 279380947 Francie van Zyl Drive
City Postal code Country Position/Affiliation
Tygerberg South Africa senior administrator
Role Name Email Phone Street address
Scientific Enquiries Wendee Wechsberg wmw@rti.org +27714344659 3040 East Cornwallis Road
City Postal code Country Position/Affiliation
Research Triangle Park North Carolina 27709-219 United States of America Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The proposed data sharing plan will allow for multiple uses of the data from the beginning of the project by carefully planning what constructs are measured, how each construct is measured, and how the analytic files are prepared, including the de-identification of data files. This approach will ensure that the data can be shared easily and used by others. This is a study funded by the National Institute on Drug Abuse-funded studies have participated in an international data harmonization effort and the writing of joint papers. A major focus of the data harmonization effort is to encourage researchers to collect standardized data that can be shared, combined, and analyzed by other researchers across multiple sites. The proposed project will follow that same model to ensure that our data are consistent with data harmonization standards so that the data can be analyzed individually or dyadically, or combined easily with other data sets to increase statistical power for examining rare events. Privacy and Data Sharing Agreements Analytic data sets will be prepared in accordance with the “Privacy Rule” of the Health Insurance Portability and Accountability Act (HIPAA; http://www.hhs.gov/ocr/) as “limited data sets” in which names and other personal health identifiers are removed, birthdays have been converted to age at intake, and other dates have been changed to be days before or after the date of intake. Because there are fewer than 20,000 people in the data set, HIPAA indicates that we cannot ensure that it is completely de-identified; HIPAA requires that we treat it a “limited data set” and that we have a data sharing agreement (DSA) in place before giving anyone access to the client-level data. Note- that this does not limit the questions someone can ask, but does require them to respect the terms of the informed consent and not to attempt to re-identify the respondents. Study Protocol After the main findings are published, we will welcome other researchers who want to analyze the data in other ways. Prior to this time, however, we anticipate establishing a publication plan that involves other researchers and institutions, especially given the international and collaborative nature of the proposed project. During the project and post project, we will welcome and actively recruit other researchers to publish secondary analyses of the data on other topics. Analytic files will be prepared in SAS on the SAS Grid, with online codebooks giving the variable name, label, type, format, positions, consistency codes, and, if applicable, values and value labels. Requesting access to data will involve drafting an abstract, checking the feasibility relative to the available data, and then seeking the permission of Dr. Wechsberg and the team for review, if appropriate. The data sets will be ready for use in SAS and/or they can be converted to other analytic tools, such as Excel, SPSS, and Stata. For the qualitative data, the Microsoft Word documents will be transcribed and analyzed in ATLAS.ti.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information