Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Changes in HIV Medication Adherence Throughout Intervention Phase
研究概览
简要总结
The purpose of this study is to test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors using a task sharing model in local HIV clinics. The behavioral intervention will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as described in study endpoint section below).
详细描述
The HIV epidemic in South Africa (SA) is among the highest in the world. SA has a large antiretroviral therapy (ART) program, but some individuals exhibit poor ART adherence, which increases the likelihood of developing drug resistance and failing the only available first and second line ART regimens in SA. ART nonadherence contributes to greater morbidity, mortality, and higher likelihood of sexual HIV transmission when virus is detectable. At the same time, alcohol and other drug use is prevalent among HIV-infected individuals in SA and associated with worse ART adherence, lower rates of viral suppression, and HIV transmission risk behavior. Yet, despite the impact of untreated substance use on poor HIV treatment outcomes and continued HIV transmission, there is little if any integration of substance use and HIV care services in SA, which creates a fragmented and incomplete system of care. This study had three phases, first being formative, qualitative work which led to a systematic treatment adaptation phase. This third phase, the clinical trial, is based on this formative work and other empirical support using behavioral interventions to improve ART adherence and reduce substance use in resource-limited settings, including SA. This study is a Type 1 hybrid effectiveness-implementation trial of a lay counselor-delivered behavioral intervention for adherence and substance use integrated into the HIV primary care setting in SA. To ensure that those who need this intervention most will receive it, participants will be patients with HIV who are struggling with adherence (as defined in the investigator's inclusion criteria) and who have an elevated substance use risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positive and on ART
- •18-65 years of age
- •Elevated substance use risk (ASSIST score greater than or equal to 4 for drugs or greater than or equal to 11 for alcohol)
- •Have at least one of the following:
- •Not attained viral suppression from first line ART (VL>400 copies/mL)
- •On second-line ART treatment
- •Reinitiated first-line treatment within the past three months
- •Had a pharmacy non-refill at least once in the past 3 months
排除标准
- •Inability to provide informed consent or complete procedures in English or isiXhosa
- •Severe risk/likely dependence for opiates (ASSIST score >26) because opiate substitution therapy may not be available
- •Severe alcohol dependence symptoms that may warrant medical management of potential withdrawal symptoms
- •Active, untreated, major mental illness (with untreated psychosis or mania) that would interfere with the paraprofessional adapted intervention
结局指标
主要结局
Changes in HIV Medication Adherence Throughout Intervention Phase
时间窗: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device
Changes in Self-reported Substance Use
时间窗: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST). It is a measure used to assess substance use risk for alcohol, cannabis, cocaine, opiates, and amphetamines, hallucinogens, and other drugs. Standardized cutoff scores are used to categorize risk levels: low risk (0-3 for illicit drugs/0-10 for alcohol), moderate risk (4-26 for illicit drugs/11-26 for alcohol), or high risk (\> 26) for substance use-related problems.
Biological Measure of Substance Use
时间窗: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Substance use measured with urinalysis.
次要结局
- Changes in Self-reported Substance Use(Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment))
- Intervention Acceptability(Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment))
- Intervention Feasibility(Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment))
- Intervention Fidelity(Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment))
- Intervention Uptake(Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment))
- Biological Measure of Substance Use(Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment))
研究者
Jessica Magidson
Assistant Professor
University of Maryland, College Park