跳至主要内容
临床试验/NCT02503072
NCT02503072已完成不适用

Variable Rewards Incentives for ART Adherence in Uganda

RAND1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
157
试验地点
1
主要终点
Medication Event Monitoring System (MEMS) cap measured adherence

研究概览

简要总结

The goal of this study is to identify ways for implementing small prizes allocated by a drawing to improve adherence to antiretroviral medication in an HIV clinic in Kampala, Uganda. The study is called Rewarding Adherence Program (RAP).

详细描述

The proposed 3-year study will develop and test RAP for incentivizing ART clients to remain engaged in care and highly adherent to their medication. Phase 1 of the project will consist of focus groups with patients, clinic providers and directors, and community leaders and will elicit information on barriers and facilitators of long-term retention and adherence maintenance, how to best implement the intervention to ensure acceptability and feasibility, and perceptions of the transportability of the planned intervention. Parameters of the intervention that will be probed include the frequency, type, and value of the prizes, and award presentation. Phase 2 will build on Phase 1 to develop and pilot test the RAP in a 20 months long randomized controlled trial (RCT) among clients who have been on ART for at least 2 years and have problems with missed clinic appointments or ART doses. Primary assessments will be administered at screening and months 4, 8, 14 and 20. In Phase 3 some adjustments to the intervention will be made after reviewing Phase 2 data, if needed, and then the intervention will be administered to the control group for 6 months to assess effects on adherence in this group (the original intervention group will not participate in this phase). Finally, the investigators will conduct focus groups with providers, implementers, and study participants to learn about implementation difficulties and areas for future improvement. Study findings will directly inform the design parameters of a larger, more rigorous evaluation in an R01 application that will focus on the cost-effectiveness and sustainability of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • •patient at Mildmay Kampala clinic
  • •on antiretroviral medication (ARV) for at least two years
  • •shows recent adherence problems (missing a clinic visit or pharmacy refill in the last six months)

排除标准

  • •not able to understand study procedures and/or provide informed consent
  • •not fluent in either English or Luganda (the two main languages spoken around Kampala)

研究组 & 干预措施

Prizes conditional on adherence

Active Comparator

Participants in this group are eligible for a prize drawing if they come on their scheduled clinic day. They receive the intervention 'Behavioral: Small lottery prizes based on adherence'.

干预措施: Small lottery prizes based on adherence (Behavioral)

Prizes conditional on clinic visits

Active Comparator

Participants in this group are eligible for a prize drawing if they show 95% adherence or higher based on their MEMS-cap measured adherence. They receive the intervention 'Behavioral: Small lottery prizes based on timely clinic visits'.

干预措施: Small lottery prizes based on timely clinic visits (Behavioral)

结局指标

主要结局

Medication Event Monitoring System (MEMS) cap measured adherence

时间窗: 9 months

Change in adherence over the first nine months of the study as an interim outcome

Medication Event Monitoring System (MEMS) cap measured adherence

时间窗: 20 months

Change in adherence over the course of the study

次要结局

  • Timely clinic visits(20 months)
  • Self-reported adherence(20 months)

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (1)

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