Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- To determine the efficacy of the 3P mHealth package on PrEP uptake among participants
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men ages 18 - 29 years
- •Men who are in communities most affected by the HIV epidemic
- •Willing and able to provide informed consent
- •Reports having anal sex with men in the last 6 months
- •Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:
- •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
- •Reporting 2 or more male partners, regardless of condom use
- •Reporting gonorrhea, chlamydia, or syphilis diagnosis
- •Any stimulant use (e.g., cocaine, amphetamines)
- •Not on PrEP within the past 3 months due to participant choice
- •Interested in learning more about PrEP or starting PrEP
- •No evidence of HIV infection at Screening and Enrollment, based on the HIV testing algorithm
- •Owns an iOS or Android mobile phone and able to successfully download mobile apps and send and receive text messages
- •Must not share the mobile phone used for their participation in the study
- •Able to read and write
排除标准
- •Participated in HPTN 113-01
- •Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083
- •Plans to move away from the study area within the next year
- •Currently on doxycycline for STI PEP
- •Has ever used CAB-LA or other long-acting PrEP agent
- •Tetracycline allergy
- •Prior diagnosis of HIV infection
- •Reactive HIV rapid test at Screening or reactive HIV Ag/Ab rapid test at Enrollment, regardless of subsequent HIV test results
- •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
研究组 & 干预措施
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
干预措施: HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA (Drug)
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
干预措施: STI PEP - Doxycycline as Doxy-PEP (Drug)
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
干预措施: 3P mHealth package (Behavioral)
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
干预措施: Handout about HIV PrEP options available at the site (Behavioral)
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
干预措施: Standard-of-care HIV PrEP counseling from qualified study staff (Behavioral)
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
干预措施: HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA (Drug)
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
干预措施: STI PEP - Doxycycline as Doxy-PEP (Drug)
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
干预措施: Handout about HIV PrEP options available at the site (Behavioral)
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
干预措施: Standard-of-care HIV PrEP counseling from qualified study staff (Behavioral)
结局指标
主要结局
To determine the efficacy of the 3P mHealth package on PrEP uptake among participants
时间窗: 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.
To determine the efficacy of the 3P mHealth package on PrEP adherence among participants
时间窗: 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.
To assess doxycycline PEP uptake and associated factors
时间窗: 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.
To assess doxycycline PEP use and associated factors
时间窗: 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.
To assess doxycycline PEP acceptability and associated factors
时间窗: 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.
To assess the incidence of HIV infections among participants choosing to use CAB-LA
时间窗: 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.
次要结局
- To determine 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(Week 52)
- To evaluate demographic, behavioral, and attitudinal factors associated with choice of PrEP regimen(Week 52)
- To determine the efficacy of the 3P mHealth package on prevention-effective adherence(Weeks 20, 36, and 52)