Reducing Stigma in People Who Inject Drugs (PWID) With HIV Using a Rapid Start Antiretroviral Therapy Intervention (ART)

Официальное название

Reducing Stigma in People Who Inject Drugs With HIV Using a Rapid Start Antiretroviral Therapy Intervention (RS-ART)

Обзор

This study seeks to develop an RS-ART implementation strategy by utilizing the Delphi method and interviewing experts and PWID regarding their experiences with ART. This strategy will then be pilot tested in a randomized controlled trial (Aim 3). The research will not impact the type of medication and dose prescribed, but rather, how soon providers are able to prescribe ART after diagnosis. The focus of this registration is Aim 3.

Подробное описание

Investigators will use a prospective, longitudinal design to pilot test a newly developed RS-ART protocol for PWID with both participants and their HIV clinicians. PWID with HIV will be initiated into the protocol as part of routine care. Aim 3 will be further divided into into aims 3a (general population) and 3b (prisoner population). Aim 3a will not be opened until informed by data collected from Aim 1 and 2. Aim 3b: Will not open until the project is certified by OHRP.

Systematic reviews and cohort studies confirm rapid-start ART (RS-ART) significantly increases ART initiation and viral suppression (VS), central tenets for HIV treatment as prevention (TasP). It focuses on ART initiation within 7 days of diagnosis. Despite recommendations by international agencies and Malaysia's Ministry of Health (MoH) to widely implement RS-ART immediately after diagnosis, it is rarely implemented in Malaysia in key-affected populations (KAPs). Because RS-ART redesigns HIV care by focusing on clinical indicators rather than exploring a patient's worthiness (i.e., stereotypes) for treatment, it has the potential to reduce stigma, though it has not been tested empirically as a stigma reduction strategy in MSM.

Stigma is a well-documented global barrier to health-seeking behavior, engagement in care, and adherence to treatment across a range of health conditions.Stigma emerges when a label associated with a negative stereotype (e.g., MSM, etc.), causing such persons to be seen as separate from and lower in status than others and thus, as legitimate targets of discrimination.

RS-ART, may potentially reduce stigma as a behavioral design intervention (BDI), which can be especially effective where stigma is deeply embedded and difficult to change. BDIs, unlike most extant stigma reduction interventions, use choice architecture, framing and nudging to guide individuals to make specific choices (e.g., immediate ART) or guide behaviors.

Вмешательства

• Поведенческое Rapid-Start ART (RS-ART)
  ART initiation within 7 days of HIV diagnosis. (RS-ART intervention to be informed and developed in Aims 1 and 2.) RS-ART is a strategy that focuses on clinical decision-making generally based solely on clinical criteria, and later organizing support for mental health, adherence, and management of comorbid conditions only after the patient has initiated ART.

Первичные конечные точки

• HIV Stigma Framework Scale [Срок оценки: Baseline and 6 months]
• Substance Use Mechanism Scale [Срок оценки: Baseline and 6 months]

Вторичные конечные точки (1)

• Viral Load [Срок оценки: 6 months]

Критерии участия

Критерии включения

PWID in general population:

• Be a PWID from the general population enrolling into ART services at one of the study's HIV clinics. PWID can include patients injecting opioids, amphetamines, or other combinations of injectable drugs. Some of these patients may be diagnosed with Opioid Use Disorder (OUD).
• Provide informed consent.
• HIV clinicians prescribing ART

• Be the HIV clinician who prescribes ART for a PWID in one of the selected clinics.
• Be willing to use the RS-ART protocol.
• Be at least 18 years old. No minors below age 18 will be enrolled in the study.
• Provide informed consent.

PWID in prison population:

• Be a PWID enrolling into ART services at Kajang prison. PWID can include patients injecting opioids, amphetamines, or other combinations of injectable drugs. Some of these patients may be diagnosed with Opioid Use Disorder (OUD).
• Provide informed consent.

Критерии исключения

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Малайзия · 3 центра

• Kajang Prison — Kajang
• Centre of Excellence for Research in AIDS (CERiA) - University of Malaya — Kuala Lumpur
• Primary Healthcare Centers — Kuala Lumpur

Идентификаторы

NCT: NCT06541028 · 2000035076 · 1F32MH138253-01 · 1R01TW012674-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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