RecruitingNot ApplicableNCT06541028

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)


Sponsor

Yale University

Enrollment

135 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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.

Exclusion Criteria1

  • \-

Interventions

BEHAVIORALRapid-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.


Locations(3)

Kajang Prison

Kajang, Malaysia

Centre of Excellence for Research in AIDS (CERiA) - University of Malaya

Kuala Lumpur, Malaysia

Primary Healthcare Centers

Kuala Lumpur, Malaysia

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NCT06541028


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