Supporting Adolescents to Adhere - an Intervention Using Airtime Rewards Allocated by a Prize Drawing (SATA)
This study is an extension of Reminding Adolescents to Adhere (RATA) (Unique protocol ID: 1R01HD074925-01). Participants for SATA will be recruited during the RATA month 24 exit survey.
Participants will be randomized 1:1:1 into either one of two intervention group (receiving the weekly messages and a chance to draw a prize at each clinic visit based on either a fixed adherence level of 90% or a self-chosen one of at least 80% as further detailed below) or the control group that receives the existing RATA intervention consisting of weekly motivational messages and the chance to get mobile airtime rewards conditional on responding. Doing so will allow the investigators to cleanly evaluate the impact of these additional adherence-based lotteries, and guarantees that those who have been in the control group receiving standard of care in the first 24 months of the RATA intervention will also receive an intervention for reasons of fairness.
研究概览
详细说明
- For Group 1 (lottery reward with fixed target): Study coordinators check participant's MEMS extraction for last month's adherence. Study coordinators then tell participants of the participants' adherence in the last month. Participants are also informed that during the next clinic visit, if they adhere at least 90 percent they have a chance to enter into a game where they have a chance of winning mobile airtime, by drawing into a bag and picking a card associated with their airtime winnings. If they do not have 90% adherence, they will not receive the airtime award game, but there will be another chance the next time they come for their scheduled clinic visit during the study period.
- For Group 2 (lottery award with own target): Study coordinators check participant's MEMS extraction for last month's adherence. They inform participants of their adherence in the last month. In order to be eligible for an airtime reward game, during their next clinic visit they must reach their own target goal. The target adherence goal must be greater than 80%. Participants may, for example, choose 80%, 85%, 90%, 95%, or 100%. Again, if they meet or exceed this target they have a chance to draw into a bag to win mobile airtime. If they do not have meet this self-imposed target adherence, they will not be eligible to play the airtime award game, but there will be another chance the next time they come for their scheduled clinic visit during the study period.
During each clinic visit, participants will have their MEMS extracted and study coordinators will check for average adherence between that day and the last clinic visit. For those who have met the target, coordinators will initiate the lottery, complete the drawing procedure, or send them the airtime reward without drawing (depending on which group).
Every Sunday, study investigators will send treatment participants a motivational message to remind them about the reward. Within each of the two intervention groups, study investigators will randomly send the message either in a loss-frame or a gain-frame, i.e. an intervention participant (in either group) will some weeks receive a message telling them to keep up motivation (as a code-word for adherence) to win a prize, and some weeks telling them to make sure not to lose their chance to win a prize.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Kampala、乌干达
- Mildmay Uganda
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- have been in HIV care at the clinic for at least three months
- are currently taking HIV-related medication (ART or co-trimoxazole)
- either own a phone or have regular access to one
- intend to stay at the clinic for the study period
- are not in boarding school (where phones are forbidden)
Exclusion Criteria:
- does not speak or understand either English or Luganda
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Own Adherence Group
Participant chooses their adherence level to be reached at next clinic visit (at least 80%, but can be higher).
If they reach that percentage measured using the MEMS cap, they can participate in a lottery for an airtime reward of none, a small amount, and a larger amount.
Participants also receive a weekly motivational message reminding them of their incentive to adhere.
If they respond to the message they will receive airtime top-up.
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Participant chooses their adherence level to be reached at next clinic visit (at least 80%, but can be higher).
If they reach that percentage measured using the MEMS cap, they can participate in a lottery for an airtime reward of none, a small amount, and a larger amount.
Participants also receive a weekly motivational message reminding them of their incentive to adhere.
If they respond to the message they will receive airtime top-up.
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实验性的：Fixed Adherence Group
Participant is told to meet a pre-determined target of 90%.
If they reach that percentage measured using the MEMS cap, they can participate in a lottery for an airtime reward of none, a small amount, and a larger amount.
Participants also receive a weekly motivational message reminding them of their incentive to adhere.
If they respond to the message they will receive airtime top-up.
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Participant is told to meet a pre-determined target of 90%.
If they reach that percentage measured using the MEMS cap, they can participate in a lottery for an airtime reward of none, a small amount, and a larger amount.
Participants also receive a weekly motivational message reminding them of their incentive to adhere.
If they respond to the message they will receive airtime top-up.
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有源比较器：Control Group
Participants do not receive a lottery incentive conditional on adherence.
Participants will however, continue to receive weekly messaging with airtime top-up contingent on response.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Medication adherence rates using electronically monitored adherence (MEMS cap) data
大体时间：9 months after enrollment
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Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 9-month study period allowing the study investigators to investigate daily adherence and its timing.
MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the primary outcome variable of adherence (# of actual bottle openings / # of prescribed bottle openings).
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9 months after enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Fraction of clients displaying adherence of 90% or more
大体时间：9 months after enrollment
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MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the secondary outcome measures of fraction of clients displaying adherence of 90% or more.
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9 months after enrollment
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Indicator for treatment interruptions of more than 48 hours
大体时间：9 months after enrollment
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MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the secondary outcome measures of an indicator for treatment interruptions of more than 48 hours.
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9 months after enrollment
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Viral load assays
大体时间：9 months after enrollment
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9 months after enrollment
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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