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

NCT06541028 NA RECRUITING

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.

Details

Lead sponsor	Yale University
Phase	NA
Status	RECRUITING
Enrolment	135
Start date	2025-11-04
Completion	2028-05

Conditions

• Hiv
• Drug Use

Interventions

• Rapid-Start ART (RS-ART)

Primary outcomes

• HIV Stigma Framework Scale — Baseline and 6 months
  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).
• Substance Use Mechanism Scale — Baseline and 6 months
  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.

Countries

Malaysia