Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 914
- 试验地点
- 1
- 主要终点
- Medication possession ratio (MPR) at least 95%, 6 month window
研究概览
简要总结
This study will explore whether financial incentives, reminders, information about HIV/AIDS and its treatment and anti-stigma counseling help improve anti-retroviral therapy (ART) adherence among HIV infected individuals in a resource-limited environment. The interventions will be randomized in the study population in a cross-cutting design, with a control group, a financial incentive treatment group, a reminders treatment group, a treatment group that receives both the financial incentive and reminder interventions. In addition, there will be an information treatment group, a stigma-relieving treatment group and a group that receives both information and stigma-relieving interventions. The primary outcomes of interest for this study will be the adherence to ART, measured by attendance rates at clinic appointments and refill collection rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infected with HIV;
- •Have not start ART, or started ART less than 90 days before;
- •Have a phone number on which can discuss private health matters.
排除标准
- •Not infected with HIV;
- •On ART for more than 90 days;
- •Do not have a private phone.
研究组 & 干预措施
Information and Stigma-relieving Group
干预措施: Information and Stigma-relieving (Behavioral)
Financial Incentive Group
干预措施: Financial Incentive (Behavioral)
Reminders Group
干预措施: Reminders (Behavioral)
Financial Incentive and Reminders Group
干预措施: Financial Incentive and Reminders (Behavioral)
Control Group
Information Group
干预措施: Information (Behavioral)
Stigma-relieving Group
干预措施: Stigma-relieving (Behavioral)
结局指标
主要结局
Medication possession ratio (MPR) at least 95%, 6 month window
时间窗: 0-6 month interval from date of study enrollment
Fraction of participants for whom MPR is greater than or equal to 95%. MPR is proportion of days that a respondent is in possession of at least one ART dose. MPR is computed from pharmacy dispensing records. Measurement window truncated to last visit date for patients who transfer clinics, opt out of future study participation, or die.
次要结局
- Test Referral, 1-month window(1 month interval from date of study enrollment)
- Lost to follow-up (LTFU)(0-6 month interval from date of study enrollment)
- Medication possession ratio (MPR) at least 95%, 3 month window(0-3 month interval from date of study enrollment)
- Appointment attendance rate (AAR)(0-6 month interval from date of study enrollment)
- Medication possession ratio (MPR) at least 80%, 6 month window(0-6 month interval from date of study enrollment)
- Medication possession ratio (MPR) at least 80%, 3 month window(0-3 month interval from date of study enrollment)
研究者
James Riddell
Clinical Professor
University of Michigan