Rapid-start HIV treatment to reduce stigma for people who inject drugs

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

This project will test whether starting HIV treatment quickly (within 7 days) reduces stigma and improves care for people who inject drugs, including those in prison.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 3 sites (Kajang and 2 other locations)
• Trial ID: NCT06541028 on ClinicalTrials.gov

What this trial studies

Researchers will use the Delphi method and interviews with experts and people who inject drugs to develop a rapid-start antiretroviral therapy (RS-ART) protocol, then pilot test it in a randomized, prospective, longitudinal trial. The intervention focuses on offering ART within 7 days of diagnosis and changing how quickly clinicians prescribe, without altering medication types or doses. Aim 3 includes a general-population pilot and a separate prison-population pilot at Kajang prison, with enrollment at participating Malaysian clinics and prison health services. The study will enroll PWID initiating ART and their HIV clinicians and measure outcomes such as ART initiation timing, viral suppression, and experiences of stigma.

Who should consider this trial

Good fit: Ideal candidates are adults who inject drugs with HIV who are initiating ART at participating Malaysian clinics or at Kajang prison, and HIV clinicians who prescribe ART and consent to use the RS-ART protocol.

Not a fit: People who are already on ART, are not PWID, are under 18, or who do not receive care at the participating clinics or Kajang prison are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the approach could speed treatment starts, reduce stigma associated with seeking care, and increase viral suppression among people who inject drugs.

How similar studies have performed: Previous systematic reviews and cohort studies show rapid-start ART reliably increases treatment initiation and viral suppression, but using RS-ART specifically as a stigma-reduction strategy among PWID remains untested.

Eligibility criteria

Inclusion Criteria:

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

  1. Be the HIV clinician who prescribes ART for a PWID in one of the selected clinics.
  2. Be willing to use the RS-ART protocol.
  3. Be at least 18 years old. No minors below age 18 will be enrolled in the study.
  4. 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 Criteria:

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Where this trial is running

Kajang and 2 other locations

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

Study contacts

• Principal investigator: Frederick L Altice, MD — Professor of Medicine (Infectious Diseases) and of Epidemiology (Microbial Diseases)
• Study coordinator: David Oliveros Gómez, MPH

Conditions Hiv; Drug Use