NCT06541028

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hiv
• Drug Use

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2025-11-04
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2024-08-07
• Last updated: 2026-01-29

Locations

3 sites across 1 country: Malaysia