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

Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

• Препарат HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA
  Choice of F/TDF, F/TAF, or CAB-LA for HIV prevention
• Препарат STI PEP - Doxycycline as Doxy-PEP
  Doxycycline as doxy-PEP for STI prevention
• Поведенческое 3P mHealth package
  Suite of mHealth tools (MyPrEP, PrEPmate, PrEPsmart) to assist with HIV PrEP uptake and adherence decision making
• Поведенческое Handout about HIV PrEP options available at the site
  Handout about HIV PrEP options available at the site
• Поведенческое Standard-of-care HIV PrEP counseling from qualified study staff
  Standard-of-care HIV PrEP counseling from qualified study staff

Первичные конечные точки

• To determine the efficacy of the 3P mHealth package on PrEP uptake among participants [Срок оценки: 52 weeks]
• To determine the efficacy of the 3P mHealth package on PrEP adherence among participants [Срок оценки: Weeks 20, 36, and 52]
• To assess doxycycline PEP uptake and associated factors [Срок оценки: Week 52]
• To assess doxycycline PEP use and associated factors [Срок оценки: Weeks 20, 36, and 52]
• To assess doxycycline PEP acceptability and associated factors [Срок оценки: Week 52]
• To assess the incidence of HIV infections among participants choosing to use CAB-LA [Срок оценки: Week 52]

Вторичные конечные точки (4)

• To determine the acceptability and use of the 3P mHealth package in the intervention arm by site [Срок оценки: Week 52]
• To compare the frequency, directionality, and reasons for PrEP regimen choice and switching, between arms [Срок оценки: Week 52]
• To evaluate demographic, behavioral, and attitudinal factors associated with choice of PrEP regimen [Срок оценки: Week 52]
• To determine the efficacy of the 3P mHealth package on prevention-effective adherence [Срок оценки: Weeks 20, 36, and 52]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• UCLA Vine Street Clinic — Los Angeles
• Bronx Prevention Research Center CRS — The Bronx

Аргентина · 1 центр

• Fundacion Huesped CRS — Buenos Aires

Бразилия · 1 центр

• Instituto de Pesquisa Clinicaq Evandro Chagas CRS — Manguinhos

Перу · 1 центр

• San Miguel CRS — Lima

Идентификаторы

NCT: NCT07658976 · HPTN 113 · UM1AI068619

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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