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Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy

2026年6月15日 更新者：HIV Prevention Trials Network

Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men

Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This study will test a suite of mHealth tools to increase HIV pre-exposure prophylaxis (PrEP) uptake and adherence among young men in communities most affected by the HIV epidemic and evaluate the uptake, adherence, and acceptability of doxycycline for sexually transmitted infection (STI) post-exposure prophylaxis (doxy-PEP).

研究类型

介入性

注册 (估计的)

400

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Kailazarid Gomez-Feliciano, MPM
  • 电话号码：919-321-3486
  • 邮箱：kgomez@fhi360.org

学习地点

  • 巴西
    • Rio de Janeiro
      • Manguinhos、Rio de Janeiro、巴西、221045-900
        • Instituto de Pesquisa Clinicaq Evandro Chagas CRS
  • 秘鲁
      • Lima、秘鲁、32-15088
  • 美国
    • California
      • Los Angeles、California、美国、90095
    • New York
      • The Bronx、New York、美国、10451
        • Bronx Prevention Research Center CRS
        • 接触：
  • 阿根廷
      • Buenos Aires、阿根廷、C1427CEA

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  1. Men ages 18 - 29 years
  2. Men who are in communities most affected by the HIV epidemic
  3. Willing and able to provide informed consent
  4. Reports having anal sex with men in the last 6 months

  5. Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:

    1. Any condomless anal sex with a man; not including within a monogamous relationship with an HIV-negative partner or an HIV-positive partner who is virally suppressed
    2. Reporting 2 or more male partners, regardless of condom use
    3. Reporting gonorrhea, chlamydia, or syphilis diagnosis
    4. Any stimulant use (e.g., cocaine, amphetamines)
  6. Not on PrEP within the past 3 months due to participant choice
  7. Interested in learning more about PrEP or starting PrEP
  8. No evidence of HIV infection at Screening and Enrollment, based on the HIV testing algorithm
  9. Owns an iOS or Android mobile phone and able to successfully download mobile apps and send and receive text messages
  10. Must not share the mobile phone used for their participation in the study
  11. Able to read and write

Exclusion Criteria:

  1. Participated in HPTN 113-01
  2. Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083
  3. Plans to move away from the study area within the next year
  4. Currently on doxycycline for STI PEP
  5. Has ever used CAB-LA or other long-acting PrEP agent
  6. Tetracycline allergy
  7. Prior diagnosis of HIV infection
  8. Reactive HIV rapid test at Screening or reactive HIV Ag/Ab rapid test at Enrollment, regardless of subsequent HIV test results
  9. Any other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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
实验性的：3P mHealth package
HIV PrEP, doxy-PEP, 3P mHealth package (3P: MyPrEP + PrEPmate + PrEPsmart tools) to assist with PrEP uptake and adherence decision making, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site
药品：HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA
Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
药品：STI PEP - Doxycycline as Doxy-PEP
Doxycycline as doxy-PEP for STI prevention
行为的：3P mHealth package
Suite of mHealth tools (MyPrEP, PrEPmate, PrEPsmart) to assist with HIV PrEP uptake and adherence decision making
行为的：Handout about HIV PrEP options available at the site
Handout about HIV PrEP options available at the site
行为的：Standard-of-care HIV PrEP counseling from qualified study staff
Standard-of-care HIV PrEP counseling from qualified study staff
有源比较器：Standard-of-care services
HIV PrEP, doxy-PEP, standard-of-care PrEP adherence counseling from qualified study staff, handout about the different PrEP options available at the site
药品：HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA
Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
药品：STI PEP - Doxycycline as Doxy-PEP
Doxycycline as doxy-PEP for STI prevention
行为的：Handout about HIV PrEP options available at the site
Handout about HIV PrEP options available at the site
行为的：Standard-of-care HIV PrEP counseling from qualified study staff
Standard-of-care HIV PrEP counseling from qualified study staff

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
To determine the efficacy of the 3P mHealth package on PrEP uptake among participants
大体时间：52 weeks
PrEP uptake is defined as the proportion of enrolled participants who elect to initiate PrEP (with a documented PrEP dispensation by the site) at any time during the 52 weeks of follow-up. Participants who did not initiate PrEP before loss to follow-up will be classified as non-initiators. PrEP uptake will be assessed at Week 52 for each study arm with 95% confidence limits computed using the binomial distribution. A logistic regression model will be used to compare PrEP uptake between the study arms.
52 weeks
To determine the efficacy of the 3P mHealth package on PrEP adherence among participants
大体时间：Weeks 20, 36, and 52

PrEP adherence is assessed at Weeks 20, 36 and 52 through biomedical testing for oral PrEP regimens and documentation of CAB-LA injection for CAB-LA.

Adherence measures are described in Section 8.7. Participants on oral PrEP missing an assessment visit and with no PrEP dispensed at their most recent visit will be considered non-adherent. Also, participants who have not yet initiated PrEP at a visit will be considered non-adherent at that visit. The average PrEP adherence at a visit will be computed as the proportion of participants who are determined to be adherent at that visit by study arm. The associated 95% confidence limits will be computed using the binomial distribution. Generalized estimating equations (GEE) with a logit link function will be used to examine differences in adherence proportions between the 3P and Control arms at Weeks 20, 36 and 52, while accounting for potential correlation between PrEP adherence measures over time for each participant.
Weeks 20, 36, and 52
To assess doxycycline PEP uptake and associated factors
大体时间：Week 52
doxy-PEP uptake is defined as the proportion of participants dispensed doxy-PEP during the 52 weeks of study follow-up period. doxy-PEP uptake will be computed with 95% confidence limits at Week 52. Multivariable logistic regression models will be used to assess association between doxy-PEP uptake and factors including study group, demographic and behavioral characteristics.
Week 52
To assess doxycycline PEP use and associated factors
大体时间：Weeks 20, 36, and 52
doxy-PEP use will be assessed at Weeks 20, 36 and 52. Doxy-PEP use at an assessment visit will be computed as the proportion of participants reporting use following sex acts, reported at that visit. The corresponding 95% confidence limits will be computed based on the binomial distribution. Multivariable GEE models will be used to investigate possible associations between doxy-PEP use and factors including study group, demographic and behavioral characteristics.
Weeks 20, 36, and 52
To assess doxycycline PEP acceptability and associated factors
大体时间：Week 52
Descriptive statistics will be used to summarize doxy-PEP acceptability. Multivariable generalized linear models (with a link function that is appropriate to the scale of the measure for doxy-PEP acceptability) will be used to investigate associations between doxy-PEP acceptability and factors including study group, sociodemographic, and behavioral characteristics.
Week 52
To assess the incidence of HIV infections among participants choosing to use CAB-LA
大体时间：Week 52

Uptake of CAB-LA is defined as the proportion of participants choosing to initiate CAB-LA with a documented receipt of a CAB-LA injection during the study follow-up period. CAB-LA uptake will be computed with 95% confidence interval.

Incidence of HIV infection between the date of CAB-LA initiation and the date of switch to oral PrEP (for participants switching from CAB-LA to oral PrEP) or end of follow-up (for participants staying on CAB-LA from initiation through the end of the follow-up period) will be computed with 95% confidence interval among participants choosing to use CAB-LA.
Week 52

次要结果测量

结果测量
措施说明
大体时间
To determine the acceptability and use of the 3P mHealth package in the intervention arm by site
大体时间：Week 52
Descriptive statistics will be used to summarize the acceptability and use of the 3P mHealth package in the intervention arm by site.
Week 52
To compare the frequency, directionality, and reasons for PrEP regimen choice and switching, between arms
大体时间：Week 52
Descriptive statistics will be used to summarize the frequency, directionality, and reasons for PrEP regimen choice and switching by arm. Generalized linear models will be used to assess differences in these descriptive summaries between the study arms. Reasons for PrEP regimen choice and switching obtained from qualitative interview data will be listed by arm.
Week 52
To evaluate demographic, behavioral, and attitudinal factors associated with choice of PrEP regimen
大体时间：Week 52
Multivariable logistic regression models will be used to separately assess associations between each PrEP regimen choice and demographic, behavioral, and attitudinal factors.
Week 52
To determine the efficacy of the 3P mHealth package on prevention-effective adherence
大体时间：Weeks 20, 36, and 52
  • The proportion of enrolled participants with incident STI infection will be computed with 95% confidence limits at Weeks 20, 36 and 52 by study arm.
  • The proportion of enrolled participants with incident HIV infection will be computed at Weeks 20, 36 and 52 by study arm.
  • The proportion of enrolled participants reporting HIV risk based on self-reported sexual behavior and HIV status of sexual partner will be computed at Weeks 20, 36 and 52 by study arm.
  • The proportion of enrolled participants who are determined to be PrEP adherent and potentially at HIV risk (based on incident STI, self-reported sexual behavior and HIV status of partners) will be computed with 95% confidence limits at Weeks 20, 36 and 52 by study arm. GEE models with a logit link function will be used to compare the proportions between the study arms
Weeks 20, 36, and 52

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

HIV Prevention Trials Network

合作者

National Institute of Allergy and Infectious Diseases (NIAID)
Gilead Sciences
ViiV Healthcare

调查人员

  • 学习椅：Susan Buchbinder, MD、San Francisco Department of Public Health and University of California San Francisco
  • 学习椅：Jorge Gallardo-Cartagena, MD、Centro de Investigaciones Tecnológicas Biomédicas y Medioambientales
  • 学习椅：Thiago Torres, MD、Instituto Nacional de Infectologia Evandro Chagas

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2029年9月1日

研究完成 (估计的)

2029年9月1日

研究注册日期

首次提交

2024年10月7日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HPTN 113
  • UM1AI068619 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

For studies within two years of primary objective(s) publication, de-identified individual participant data that underlie results in a publication, will be provided upon request. For studies more than two years from the primary objective(s) publication, de-identified datasets will be available upon request (Public Use Datasets).

IPD 共享时间框架

Investigators may request de-identified datasets in order to duplicate published results, as required by specific journals. Otherwise, de-identified datasets will be made available upon request, two years following publication of the primary results manuscript.

IPD 共享访问标准

Researchers may submit a request for access to data that has informed published results, by sending an email to HPTN-Data-Access@scharp.org. To access available de-identified datasets, investigators must complete the request form on the Atlas website. Researchers of approved requests will need to sign an HIV Prevention Trials Network (HPTN) Data Use Agreement before receiving the data and agree to use the provided acknowledgement statement.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

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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