跳至主要内容
临床试验/NCT06476847
NCT06476847进行中(未招募)不适用

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)

Boston University3 个研究点 分布在 2 个国家目标入组 106 人开始时间: 2025年1月23日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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