提高 MSM 中 PrEP 持久性的简单干预措施,以改善决策
从医疗保健提供者和患者的角度(男男性行为者)认知偏差在请求、提供、接受和继续 PrEP 的决定中的作用
Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality that requires individuals to take a daily tablet to prevent themselves acquiring HIV. In South Africa while this is freely available in the public sector, persistence (that is continuation after initiation) is low amongst vulnerable populations, including men who have sex with men (MSM).
This study is a feasibility and acceptability study of a behavioral economics informed intervention to improve persistence amongst MSM newly initiating PrEP in South Africa. The goal of this study is to show that this approach is possible in a routine setting and gather the necessary data for a fully powered effectiveness trial.
Study participants will complete a baseline questionnaire and then be randomized to either receive standard of care (control) or to receive the intervention. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. The intervention package aims to address present bias, optimism bias and salience. The intervention is delivered and the enrollment visit and then through mobile phone reminders / text messages. There is no further in person interaction after the initial interaction. Participants may be contacted for a telephonic enplane questionnaire. Outcome data is obtained from passive followup through routine medical record review with the primary end point being persistence at 3 months.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
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:
- Not currently on pre exposure prophylaxis (PrEP); no PrEP within the last 12 months
- Initiating PrEP on the date of enrolment
- Access to a mobile phone
- Willing and able to provide written informed consent in English
Exclusion Criteria:
- PrEP status unknown
- Previous PrEP experience within the last year (12 months from enrolment)
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Intervention group
Participants randomized into this group will receive a behavioral economics informed intervention to improve persistence among amongst high risk men newly initiating PrEP in South Africa. |
A light touch, once off, low cost. lay counsellor led intervention, designed to focus decision making around HIV prevention addressing present bias, salience and over optimism. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. |
|
无干预:Control group
Usual care for high risk men newly initiating PrEP in South Africa. |
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 |
|---|---|---|
|
Target population recruitment (feasibility)
大体时间:5 months
|
The percent of participants enrolled from those that meet eligibility criteria and are offered will be assessed from screening log. |
5 months
|
|
Fidelity to intervention
大体时间:5 months
|
Percent of intervention interactions that are delivered in the first 3 months (Max interactions in 3 months = 2 visit reminders and 24 text messages (2 per week) = 26 total interactions). |
5 months
|
|
Acceptability by intervention participants
大体时间:5 months
|
The percent of participants that accept to participate in the intervention (set reminders/receive text messages) after being randomized to the intervention arm. |
5 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PrEP persistence at 3 months
大体时间:4 months
|
PrEP persistence is defined as having at least a specific number of months of PrEP dispensed after study enrolment. The outcome is determined at the subsequent month to allow for variable timing around return visits. For example persistence at 3 months is defined as having at least 90 days of PrEP dispensed by 4 months. |
4 months
|
合作者和调查者
调查人员
- 首席研究员:Lawrence C Long, PhD MCom、Boston University School of Public Health,Global Health
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
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.