Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Yale University

Collaborating Sponsors:

National Institute of Mental Health (NIMH)

Fogarty International Center of the National Institute of Health

Conditions:

Hiv

Drug Use

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 te...

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...

Eligibility Criteria

Inclusion

  • 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

  • \-

Key Trial Info

Start Date :

November 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

135 Patients enrolled

Trial Details

Trial ID

NCT06541028

Start Date

November 1 2025

End Date

August 1 2026

Last Update

October 17 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Kajang Prison

Kajang, Malaysia, 43000

2

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

Kuala Lumpur, Malaysia, 50450

3

Primary Healthcare Centers

Kuala Lumpur, Malaysia, 50450

4

SSPs

Kuala Lumpur, Malaysia, 50450