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

Yale University

Status: Not yet enrolling

Conditions: Hiv; Drug Use

Treatments: Behavioral: Rapid-Start ART (RS-ART)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06541028

1R01TW012674-01 (U.S. NIH Grant/Contract)

2000035076

1F32MH138253-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

135 participants in 2 patient groups

PWID in Malaysia- General Population

Experimental group

Description:

Participants will receive the RS-START strategy (RS-START strategy will be informed and developed in Aims 1 and 2) from prescribing physicians. Participants will complete a survey to assess their experiences with stigma, health behaviors, and other related constructs at baseline, month 1, month 3 and month 6. Data from viral load that are obtained as part of participants' standard of care will be obtained through medical record review.

Treatment:

Behavioral: Rapid-Start ART (RS-ART)

PWID in Malaysia- Prisoners

Experimental group

Description:

Participants will receive the RS-START strategy (RS-START strategy will be informed and developed in Aims 1 and 2). Participants will complete a survey to assess their experiences with stigma, health behaviors, and other related constructs at baseline, month 1, month 3 and month 6. Data from viral load that are obtained as part of participants' standard of care will be obtained through medical record review.

Treatment:

Behavioral: Rapid-Start ART (RS-ART)