The Role of Cognitive Biases in the Decision to Request, Offer, Accept and Continue on PrEP From a Health Care Provider and Patient Perspective (Men Who Have Sex With Men)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- Target population recruitment (feasibility)
研究概览
简要总结
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
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •PrEP status unknown
- •Previous PrEP experience within the last year (12 months from enrolment)
结局指标
主要结局
Target population recruitment (feasibility)
时间窗: 18 months
The percent of participants enrolled from those that meet eligibility criteria and are offered will be assessed from screening log.
Fidelity to intervention (feasibility)
时间窗: 18 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).
Acceptability by intervention participants
时间窗: 18 months
The percent of participants that accept to participate in the intervention (set reminders/receive text messages) after being randomized to the intervention arm.
次要结局
- PrEP persistence at 3 months, 6 months, and 12 months(4 months, 7 months, 13 months)
