Clinical trial NCT06541028: Reducing Stigma in People Who Inject Drugs (PWID) With HIV Using a Rapid Start Antiretroviral Therapy Intervention (ART)
Official title: Reducing Stigma in People Who Inject Drugs With HIV Using a Rapid Start Antiretroviral Therapy Intervention (RS-ART)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Drug Use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Fogarty International Center of the National Institute of Health
First posted: 2024-08-07
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Investigators will use a prospective, longitudinal design to pilot test a newly developed RS-ART protocol for PWID with both participants and their HIV clinicians. PWID with HIV will be initiated into the protocol as part of routine care. Aim 3 will be further divided into into aims 3a (general population) and 3b (prisoner population). Aim 3a will not be opened until informed by data collected from Aim 1 and 2. Aim 3b: Will not open until the project is certified by OHRP.

Systematic reviews and cohort studies confirm rapid-start ART (RS-ART) significantly increases ART initiation and viral suppression (VS), central tenets for HIV treatment as prevention (TasP). It focuses on ART initiation within 7 days of diagnosis. Despite recommendations by international agencies and Malaysia's Ministry of Health (MoH) to widely implement RS-ART immediately after diagnosis, it is rarely implemented in Malaysia in key-affected populations (KAPs). Because RS-ART redesigns HIV care by focusing on clinical indicators rather than exploring a patient's worthiness (i.e., stereotypes) for treatment, it has the potential to reduce stigma, though it has not been tested empirically as a stigma reduction strategy in MSM.

Stigma is a well-documented global barrier to health-seeking behavior, engagement in care, and adherence to treatment across a range of health conditions.Stigma emerges when a label associated with a negative stereotype (e.g., MSM, etc.), causing such persons to be seen as separate from and lower in status than others and thus, as legitimate targets of discrimination.

RS-ART, may potentially reduce stigma as a behavioral design intervention (BDI), which can be especially effective where stigma is deeply embedded and difficult to change. BDIs, unlike most extant stigma reduction interventions, use choice architecture, framing and nudging to guide individuals to make specific choices (e.g., immediate ART) or guide behaviors.

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:

-

Primary outcomes:
measure: HIV Stigma Framework Scale
timeFrame: Baseline and 6 months
measure: Substance Use Mechanism Scale
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Viral Load
timeFrame: 6 months
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Kajang Prison
city: Kuala Lumpur
country: Malaysia
facility: Centre of Excellence for Research in AIDS (CERiA) - University of Malaya
city: Kuala Lumpur
country: Malaysia
facility: Primary Healthcare Centers
city: Kuala Lumpur
country: Malaysia
facility: SSPs
Study officials:
affiliation: Professor of Medicine (Infectious Diseases) and of Epidemiology (Microbial Diseases)
name: Frederick L Altice, MD
role: PRINCIPAL_INVESTIGATOR
References: