Online Cohort of Sexual and Gender Minorities: Evaluating Digital Interventions to Improve HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment Uptake and Adherence
Online Cohort of Sexual and Gender Minorities: Evaluating the Effect of Digital Interventions on the Uptake and Adherence to HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment
This study will create and follow an online cohort of sexual and gender minorities in Brazil to better understand the use of HIV prevention and treatment strategies, particularly pre-exposure prophylaxis (PrEP) and antiretroviral treatment (ART). Participants will complete online questionnaires at the beginning of the study and every three months for one year to provide information about medication use and adherence, sexual behaviors, HIV prevention and testing, sexually transmitted infections, mental health, and experiences of discrimination in health services.
Participants who are using PrEP or ART and agree to take part in the intervention will be randomly assigned to receive either a digital intervention or no digital intervention. The digital intervention will consist of weekly WhatsApp messages for six months, including reminders and information intended to support adherence to PrEP or ART.
The main question of the study is whether weekly WhatsApp messages can improve adherence to PrEP or ART among sexual and gender minorities in Brazil. The study hypothesis is that participants who receive the digital intervention will have higher adherence to PrEP or ART than participants who do not receive the intervention.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Thiago S Torres, PhD
- 电话号码：+55 2138659128
- 邮箱：ttorres79@gmail.com
学习地点
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Rio de Janeiro
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Rio de Janeiro、Rio de Janeiro、巴西、21040-360
- 招聘中
- Instituto Nacional de Infectologia Evandro Chagas
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接触：
- Thiago S Torres, PhD
- 电话号码：+55 2138659128
- 邮箱：ttorres79@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
male sex assigned at birth and identifying as a man, travesti, transgender person, or non-binary person; age ≥18 years; residing in Brazil; access to the internet; and self-reporting sex with a man in the past 12 months.
Exclusion Criteria:
incorrectly answering the attention-check questions; and incomplete responses, defined as not reaching the end of the screening questionnaire
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 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 |
|---|---|
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实验性的：Weekly WhatsApp Messages
Participants receiving weekly WhatsApp messages for 6 months to support adherence to PrEP or ART, including medication reminders and brief standardized HIV prevention and treatment information.
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Participants randomized to the intervention arm will receive weekly WhatsApp messages for 6 months designed to support adherence to pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART).
Messages will include medication reminders and brief, standardized information related to HIV prevention and treatment.
Messages will be delivered through a scheduled automated system.
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无干预：No Weekly Messages
Participants will receive the standard study follow-up procedures without the weekly WhatsApp adherence messages.
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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 to PrEP or ART
大体时间：Baseline and Months 3, 6, 9, and 12
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Medication adherence will be assessed using a visual analog scale in which participants report the percentage of prescribed PrEP or ART doses taken during the previous 30 days, from 0% to 100%.
Participants reporting adherence greater than 95% will be classified as adherent.
The primary analysis will compare the proportion of participants classified as adherent between the weekly WhatsApp intervention and control groups over follow-up.
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Baseline and Months 3, 6, 9, and 12
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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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Medication Adherence to PrEP
大体时间：Baseline and Months 3, 6, 9, and 12
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Self-reported adherence to PrEP during the previous 30 days, measured using a 0% to 100% visual analog scale.
Participants reporting adherence greater than 95% will be classified as adherent.
Adherence will be evaluated over follow-up and compared between intervention and control groups among participants using PrEP.
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Baseline and Months 3, 6, 9, and 12
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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.