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临床试验/NCT06949774
NCT06949774招募中不适用

INcentives and ReMINDers to Improve Long-term Medication Adherence

RAND2 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2025年4月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
RAND
入组人数
550
试验地点
2
主要终点
Electronically measured mean medication adherence

研究概览

简要总结

Low medication adherence when initiating antiretroviral treatment (ART) is a key barrier to HIV virologic suppression, resulting in avoidable cases of drug resistance, death, and viral transmission. Routinized pill-taking can lead to successful long-term ART adherence, and short-term behavioral economics-based supports are a novel way to overcome the limited success of existing routinization interventions. This study proposes to test this combined approach for promoting long-term ART adherence using a Stage III Sequential, Multiple Assignment, Randomized Trial (SMART) design in one of the largest HIV clinics in Uganda to identify the most cost-effective adaptive intervention that if found effective is generalizable to other settings and other chronic diseases.

详细描述

Building on a previous R34 study, the investigators will adapt and deliver the INMIND approach to 550 ART initiators at Mildmay. Participants will initially be randomized to receive either usual care (Control, n=275) or daily text messages (Messages, n=275) to support adherence routines. At months 1 and 2, participants may revise their adherence plans. Those showing <80% adherence in month 3 will be re-randomized to receive either monthly or monthly escalated prize incentives for the next three months. Adherence will be monitored for an additional 12 months (total follow-up: 18 months) to assess long-term routine maintenance and recovery after interruptions. The SMART design will help identify the most cost-effective intervention sequencing. A cost-effectiveness analysis and stakeholder dissemination will support future scale-up. The investigators hypothesize that Messages will be more effective than Control as a first-stage treatment; that monthly escalated prizes will be more effective than monthly prizes as a second-stage treatment; and that the mechanisms of lack of Salience and Present Bias will mediate the effect of INMIND on our primary and secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female clients age 18 and older.
  • Started ART at Mildmay or another clinic within the preceding 2 months
  • Able to speak and understand either English or Luganda.
  • Have their own cell phone or have consistent access to someone else's phone.
  • Willing to receive daily text messages for the 6 months of intervention duration.
  • Willing and able to use the WisePill device distributed for adherence verification for the duration of the study.

排除标准

  • Not mentally fit to consent.
  • Language other than Luganda or English.
  • Not willing to consistently use the Wisepill device for adherence measurement.

研究组 & 干预措施

Phase B Stage 1: Control

No Intervention

This arm will receive care as usual, including the adherence support mechanisms that are part of usual care practices. At recruitment participant will be explained the importance of pill-taking. All participants (including in the control group) will receive a leaflet containing detailed information on how to establish healthy pill-taking routines. Finally, clinic staff will counsel participants on how to select an already existing routine behavior that occurs at roughly the same time each day that forms the basis of their implementation plan.

Phase B Stage 1: Intervention group receiving messages (Messages group)

Experimental

The Messages group will receive the same brief information session as the Control group but also receive daily text messages reinforcing the information provided at the recruitment visit and reminders of their personalized routinization strategy.

干预措施: Daily Text Messages (Behavioral)

Phase B Stage 2: Intervention group receiving messages and incentives (Monthly prize draws)

Experimental

First-stage non-responders will be re-randomized to the monthly prize draw group, where they may become eligible for a small prize each month for three months of the intervention if they take their ART pills within one hour of the time, they carry out their existing routine as stated in their anchoring plan for at least 80% of the days in that month. The prizes at each monthly drawing will be worth 1,000; 5,000; or 10,000 Uganda Shillings. Participants who were receiving messages will continue to receive messages as before.

干预措施: Daily Text Messages (Behavioral)

Phase B Stage 2: Intervention group receiving messages and incentives (Monthly prize draws)

Experimental

First-stage non-responders will be re-randomized to the monthly prize draw group, where they may become eligible for a small prize each month for three months of the intervention if they take their ART pills within one hour of the time, they carry out their existing routine as stated in their anchoring plan for at least 80% of the days in that month. The prizes at each monthly drawing will be worth 1,000; 5,000; or 10,000 Uganda Shillings. Participants who were receiving messages will continue to receive messages as before.

干预措施: Incentivization based on timely ART adherence (Behavioral)

Phase B Stage 2: Intervention group receiving messages and incentives (Monthly escalated Prizes)

Experimental

First-stage non-responders will be re-randomized to the monthly escalating prizes group, where they may become eligible for a small prize each month for three months of the intervention if they take their ART pills for at least 80% of the days in that month. In the first month, the prize will be worth 1,000 Uganda Shillings. If they are consistent, the prize amount will increase to 5,000 Uganda Shillings in the second month and 10,000 Uganda Shillings in the third month. However, if they do not achieve the 80% adherence level, they will be reset to only receive 1,000 Uganda Shillings in that month. Participants in this group who have been receiving messages will continue to receive messages as before.

干预措施: Incentivization based on timely ART adherence (Behavioral)

Phase B Stage 2: Intervention group receiving messages and incentives (Monthly escalated Prizes)

Experimental

First-stage non-responders will be re-randomized to the monthly escalating prizes group, where they may become eligible for a small prize each month for three months of the intervention if they take their ART pills for at least 80% of the days in that month. In the first month, the prize will be worth 1,000 Uganda Shillings. If they are consistent, the prize amount will increase to 5,000 Uganda Shillings in the second month and 10,000 Uganda Shillings in the third month. However, if they do not achieve the 80% adherence level, they will be reset to only receive 1,000 Uganda Shillings in that month. Participants in this group who have been receiving messages will continue to receive messages as before.

干预措施: Daily Text Messages (Behavioral)

结局指标

主要结局

Electronically measured mean medication adherence

时间窗: 24 months

We will collect Wisepill data continuously over the 24-month study period to calculate the primary outcome variable of mean adherence (# of actual bottle openings /# of prescribed bottle openings)

次要结局

  • Retention in Care.(24 months)
  • Viral Suppression(24 months)
  • Routinization of ART adherence(24 months)

研究者

发起方
RAND
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastian Linnemayr

Senior Economist; Professor, RAND Pardee Graduate School

RAND

研究点 (2)

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