About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Rapid-Start ART (RS-ART)
BehavioralART 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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.
Secondary outcomes
Viral Load
Mean HIV viral load (in copies/mL) will be obtained through medical record review. A viral load of 200 copies/mL or less is considered 'undetectable' with no risk of HIV transmission.
Sponsors and contacts
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Yale University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Fogarty International Center of the National Institute of Health
Collaborator