PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study

Обзор

The US opioid overdose epidemic has been accompanied by an increase in human immunodeficiency (HIV) among persons who inject drugs. HIV pre-exposure prophylaxis (PrEP) is an FDA approved medication taken daily orally by individuals who are HIV negative, but who are at increased risk for HIV. In order to obtain PrEP, a prescription is needed. Before being prescribed HIV PrEP, it is recommended by the Centers for Disease Control and Prevention (CDC) to obtain an HIV test first. Although home HIV self-test kits are recommended by the CDC and are locally available, uptake remains low. CHORUS+ (Comprehensive HIV, Hepatitis C, and Opioid Use Disorder Response to the Unaddressed Syndemic +) is a theory-based, peer-delivered, mobile phone-supported intervention focused on enhancing uptake and adherence to HIV PrEP (primary outcome), and continuation of MOUD (secondary outcome) among persons who inject opioids. At recruitment, the intervention will include HIV self-testing, rapid initiation of PrEP and MOUD, and 6-month peer recovery coaching (PRC) to support adherence to these medications. This research study seeks to determine the efficacy of a novel intervention to increase the uptake of evidence-based measures to prevent HIV and treat opioid use disorder. The efficacy of this multi-site, two-arm randomized control trial of CHORUS+ and usual care \[passive referral\]. This study is not testing the efficacy of PrEP or HIV home testing which is already known. In addition the investigators will determine the influence of HIV self-testing on PrEP uptake and adherence. In the CHORUS+/ intervention arm, there will be a baseline in-person session with the participant to encourage uptake of PrEP and MOUD using motivational interviewing (MI).

Вмешательства

• Поведенческое CHORUS+
  The CHORUS+ intervention will include a baseline interview with a peer recovery coach to encourage uptake of HIV PrEP (pre-exposure prophylaxis) and medications for opioid use disorder (MOUD) through motivational interviewing (MI). Participants will also be offered HIV self-testing on the day of recruitment, HIV PrEP (if they are HIV negative) and MOUD. Participants will then receive peer coaching for 6 months to increase adherence to PrEP and or MOUD.
• Другое Standard of care
  Normal protocols for care of participants who inject opioids will be followed.

Первичные конечные точки

• Adherence to HIV PrEP at 6 months Adherence to HIV PrEP [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Adherence to PrEP at 3 and 12 months [Срок оценки: 3 months. 12 months]
• Receipt of medication for opioid use disorder (MOUD) [Срок оценки: 3 months, 6 months, and 12 months]
• Test results for gonorrhea [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• Test results for chlamydia [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
• Test results for syphilis [Срок оценки: Baseline, 3 months, 6 months, and 12 months]

Критерии участия

Критерии включения

• Injected opioids within the past 6 months (by self-report)
• Willingness to provide contact information for two family members or friends
• Willingness to sign medical records release forms
• Ability to speak English
• Plans to reside in Boston area for the next 6 months
• Are medically cleared to take PrEP and MOUD (normal renal and PrEP-related labs)

Критерии исключения

• Persons with previous HIV diagnosis (by self-report; confirmed via HIV test result)
• Express desire to harm themselves or others
• Individuals who are pregnant at baseline
• Individuals who are already enrolled in an interventional study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Boston Medical Center Faster Paths Bridge Clinic — Boston
• Victory Programs Mobile Prevention Services Van and Navigation Center — Boston

Публикации

• Miller SE, Dukes KA, Damato-MacPherson C, Psaros C, Scott NA, Taylor JL, Muroff J, Winter MR, Skiba LE, Lugo H, Cruz R, Ruiz-Mercado G, Crawford ND, Mayer KH, Assoumou SA. Pre-exposure prophylaxis (PrEP) and medications for opioid use disorder for persons who inject drugs: the CHORUS + randomized controlled trial study protocol. Addict Sci Clin Pract. 2025 Dec 25;21(1):17. doi: 10.1186/s13722-025- PMID 41449454

Идентификаторы

NCT: NCT05769218 · H-43487 · R01DA058367

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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