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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kajang Prison
  Kajang, Malaysia Recruiting
• Primary Healthcare Centers
  Kuala Lumpur, Malaysia Recruiting
• Centre of Excellence for Research in AIDS (CERiA) - University of Malaya
  Kuala Lumpur, Malaysia Active not 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
• Email: david.oliveros@yale.edu
• Phone: 202-805-8118

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.