Multilevel Strategies & Tailored HIV Prevention and Care for Young Couples Who Use Alcohol and Other Drugs Across Cape Town: Couples Health CoOp Plus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 962
- 试验地点
- 2
- 主要终点
- Antiretroviral Therapy (ART) Initiation [individual and couple-level]
研究概览
简要总结
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), received either a stigma awareness and education workshop or no workshop with repeated measures. Within clinic catchment areas, 481 couples (young women and their primary male sex partners both aged 18 to 30) were recruited. These couples received HIV testing services (HTS) and/or the Couples Health CoOp Plus (CHC+), depending on their intervention arm.
The overarching aim of these interventions is to prevent new cases of HIV. It is hypothesized that communities that are assigned to the stigma awareness and education workshop will demonstrate higher levels of social acceptance and fewer cases of enacted/experienced stigma at the community level. Additionally, it is expected couples assigned to the Couples Health CoOp Plus (CHC+) intervention will have greater antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) initiation and adherence, lower alcohol and other drug (AOD) use, less sexual risk, less violence, and more positive relationship norms and communication.
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 who use AODs and other people seeking HIV services (testing/ART/PrEP) and other health services 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 violence, and enhance positive relationship norms and communication relative to HIV testing services (HTS) (secondary outcomes).
Aim 4: Examine through mixed methods the interaction of a stigma awareness and education workshop and the Couples Health CoOp Plus (CHC+) on increased antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) and initiation, retention, and adherence among young women and their primary partners.
详细描述
The Couples Health CoOp Plus (CHC+) was adapted from the Couples Health CoOp (CHC)-an empowerment-based intervention developed for South African couples that addresses the syndemic of alcohol and other drug (AOD) use, violence, and HIV risk. It is grounded in Social Cognitive Theory and promoted prevention strategies that addressed the relational context of equality in which sexual risk takes place. The Couples Health CoOp (CHC) has demonstrated efficacy in increasing condom use, improving relationship norms, decreasing heavy alcohol use among men, and decreasing HIV incidence among women. Long-term benefits of the Couples Health CoOp (CHC) have been explored including women reporting less fighting with their partner and men reporting being more faithful and loving. As part of this current study (Aim 1), the behavioral Couples Health CoOp (CHC) was adapted to include biomedical HIV strategies antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) and updated materials. Formative qualitative work with a Community Collaborative Board (CCB) and a Peer Advisory Board (PAB) guided the adaptation and updating of the Couples Health CoOp Plus (CHC+) intervention. The Couples Health CoOp Plus (CHC+) is a 2-module workshop delivered over two days and contains didactic and experiential lessons on alcohol and other drug (AOD) use, a status-neutral approach to the prevention and management of HIV, sexual and reproductive health (SRH), relationship norms, violence, and tools to improve communication.
Formative findings regarding clinic-level stigma and discrimination showed that stigma reduction training provided in communities surrounding healthcare clinics may reduce stigmatizing behaviors and attitudes that are enacted by family, friends, and other community members toward those seeking healthcare. The stigma reduction survey and workshop were developed and adapted as part of Aim 1 formative activities.
The study enrolled approximately 20 couples in each of the 24 communities in and around Cape Town, South Africa. Communities surrounding healthcare clinics were paired according to community demographic and socioeconomic factors and randomized to one of four arms:
- stigma awareness and education workshop (community) and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) (couple);
- stigma awareness and education workshop (community), and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) with Couples Health CoOp Plus (CHC+) (couple);
- no stigma awareness and education workshop (community) and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) (couple);
- no stigma awareness and education workshop (community), and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) with Couples Health CoOp Plus (CHC+) (couple).
As noted, couples in communities that were not assigned to receive the CHC+ intervention received HIV testing services (HTS), including provision of antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) as part of standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Antiretroviral Therapy (ART) Initiation [individual and couple-level]
时间窗: 6-month follow-up
ART initiation will be measured using initiation information recorded in the participant's clinic medical record.
Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level]
时间窗: 6-month follow-up
Pre-exposure prophylaxis (PrEP) initiation will be measured using initiation information recorded in the participant's clinic medical record.
Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level]
时间窗: 6-month follow-up
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).
Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level]
时间窗: 6-month follow-up
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+).
Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]
时间窗: 6-month follow-up
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).
Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]
时间窗: 6-month follow-up
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+).
Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level]
时间窗: 6-month follow-up
Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records.
Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level]
时间窗: 6-month follow-up
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+).
Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level
时间窗: 6-month follow-up
Number of pre-exposure prophylaxis (PrEP) refills since initiation as recorded clinic medical records.
Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level]
时间窗: 6-month follow-up
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+).
Data Extraction: Antiretroviral therapy (ART) Retention
时间窗: 6-month follow-up
Antiretroviral therapy (ART) retention in care will be measured as attendance to follow-up visits as recorded in clinic medical records.
Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level]
时间窗: 6-month follow-up
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+).
次要结局
- Community Stigma [structural level](8-month follow-up)
- Biological: Drug use [individual level](6-month follow-up)
- Biological: Alcohol use [individual level](6-month follow-up)
- Self-Report: Violence [individual and couple-level](6-month follow-up)
- Self-Report: Sexual Risk [individual and couple-level](6-month follow-up)
- Self-Report: Relationship Norms [individual and couple-level](6-month follow-up)
- Self-Report: Communication [individual and couple-level](6-month follow-up)
- Self-Report: Observed or Knowledge of Stigma [individual and couple-level](6-month follow-up)
- Community Stigma [structural level](8-month follow-up)
- Biological: Drug use [individual level](6-month follow-up)
- Biological: Alcohol use [individual level](6-month follow-up)
- Self-Report: Violence [individual and couple-level](6-month follow-up)
- Self-Report: Sexual Risk [individual and couple-level](6-month follow-up)
- Self-Report: Relationship Norms [individual and couple-level](6-month follow-up)
- Self-Report: Communication [individual and couple-level](6-month follow-up)
- Self-Report: Observed or Knowledge of Stigma [individual and couple-level](6-month follow-up)
研究者
Felicia A. Browne, ScD, MPH
Senior Research Social Epidemiologist
RTI International