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

NCT06541028 | Recruiting

• 3 other identifiers: 20000350761F32MH138253-011R01TW012674-01
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Hiv; Drug Use

Outcome Measures

Primary Outcomes (2)

• HIV Stigma Framework Scale

  The scale consists of 24 statements related to the devaluation of people with HIV that are scored on a 5 point Likert-type scale, with higher scores corresponding to higher levels of HIV stigma. Total score range from 24-120. The scale also contains sub-scales for enacted (9 items, score range 9-45), anticipated, (9 items, score range 9-45) and internalized stigma (6 items, score range 6-30).

  Baseline and 6 months

• Substance Use Mechanism Scale

  All responses are given on a 5-point Likert-type scale, with higher scores indicating greater endorsement of substance use stigma. The scale contains a total of 18 items, with scores ranging from 18-90. Enacted (6 items, score range 6-30), Anticipated (6 items, score range 6-30), and Internalized (6 items, score range 6-30) sub-scales can be created by taking the average of the item responses given for each stigma mechanism respectively.

  Baseline and 6 months

Secondary Outcomes (1)

• Viral Load

  6 months

Study Arms (2)

PWID in Malaysia- General Population

EXPERIMENTAL

Participants will receive the RS-START strategy (RS-START strategy will be informed and developed in Aims 1 and 2) from prescribing physicians. Participants will complete a survey to assess their experiences with stigma, health behaviors, and other related constructs at baseline, month 1, month 3 and month 6. Data from viral load that are obtained as part of participants' standard of care will be obtained through medical record review.

Behavioral: Rapid-Start ART (RS-ART)

PWID in Malaysia- Prisoners

EXPERIMENTAL

Participants will receive the RS-START strategy (RS-START strategy will be informed and developed in Aims 1 and 2). Participants will complete a survey to assess their experiences with stigma, health behaviors, and other related constructs at baseline, month 1, month 3 and month 6. Data from viral load that are obtained as part of participants' standard of care will be obtained through medical record review.

Behavioral: Rapid-Start ART (RS-ART)

Interventions

Rapid-Start ART (RS-ART) BEHAVIORAL

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.

PWID in Malaysia- General Population; PWID in Malaysia- Prisoners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (3)

Kajang Prison

Kajang, 43000, Malaysia

RECRUITING

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

Kuala Lumpur, 50450, Malaysia

ACTIVE NOT RECRUITING

Primary Healthcare Centers

Kuala Lumpur, 50450, Malaysia

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Frederick L Altice, MD

  Professor of Medicine (Infectious Diseases) and of Epidemiology (Microbial Diseases)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Oliveros Gómez, MPH

CONTACT

202-805-8118; david.oliveros@yale.edu

Daniel J Bromberg, MS

CONTACT

781-588-3019; dan.bromberg@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: November 4, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (3)