Implementation of STTR Strategies Among People Who Inject Drugs in Malaysia

NCT ID: NCT03987282

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2026-03-31

Brief Summary

This pragmatic, multisite, implementation and effectiveness research evaluates a strategy to improve HIV treatment outcomes (increased rates of patients on ART with virological suppression, improved treatment retention and ART adherence) for people living with HIV (PLWH) with opioid use disorder (OUD). Engaging 4 large regional HIV/AIDS treatment centers in Malaysia, the study will evaluate barriers and facilitators for implementation of improved care model and will evaluate the comparative effectiveness of the model in a clinical trial. The research will provide critically important evidence for implementation of effective Seek-Test-Treat, and Retain models for PLWH and OUD throughout Malaysia and inform healthcare policy in other low to middle income countries and regions with limited healthcare resources.

Detailed Description

At each of the study locations, individuals testing HIV positive who also have OUD (n=4x70) will receive concurrent anti-retroviral therapy (ART) and methadone maintenance treatment (MMT) based on the usual care standards. Their patient level outcomes will be compared with individuals meeting the same inclusion criteria (n=4x70) and treated under the proposed improved model (post implementation evaluation). The usual care standard will consist of provision of ART and medical care for HIV and other medical HIV co-morbidities provided at the HIV/AIDS treatment center with an expedited and facilitated referral to a methadone maintenance treatment (MMT). The improved care model will include the usual care supplemented by continuing education and coaching of medical staff at HIV/AIDS and MMT clinics and by provision of additional peer-based counseling intervention focused on behavioral skills and strategies that patients can learn and master to achieve uninterrupted, long-term ART treatment participation while continuing OUD recovery through MMT. The primary outcome measure, rates of patients with virologic suppression (< 20 copies/mL) in the two care models will be assessed at 24 weeks. The secondary outcomes, also followed for 24 weeks, will include ART adherence measured by objective measures (tenofovir dried blood spots, clinic records) and self-report; decreased illicit opioid use measured by rates of opioid negative urine toxicology results and self-report; and improvements on other health-related and functional status outcomes.

Aim 1: To evaluate comparative effectiveness of fully implemented seek, test, treat and retain strategy (FI-STTR) the study will compare clinical, patient level, outcomes between enhanced usual care (EUC) and FI-STTR across the four study sites.

Hypothesis: The investigators hypothesize a statistically significant effect on the primary outcome favoring the FI-STTR over EUC. It is also hypothesized that FI-STTR will be superior over EUC on all secondary outcomes.

Concurrently at each study location, using implementation science mixed methods research tools and engaging key local stakeholders (treatment providers, patients, their families, and community activists), and evaluating clinical and healthcare data, the study will assess existing barriers (organizational, personnel, and community level factors) and uncover available resources and facilitators for a successful implementation of the improved care model.

Aim 2: To assess existing barriers; organizational, personnel, community level factors; and available resources and potentially facilitating factors for successful implementation of the FI-STTR at HIV/AIDS clinics. There are no hypotheses specified a priori for Aim 2 of the proposed study.

Conditions

HIV Seropositivity; Opioid-use Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enhanced usual care (EUC)

The EUC consists of provision of ART and medical care for HIV and other medical HIV co-morbidities provided at the HIV/AIDS treatment center with an expedited and facilitated referral to a methadone maintenance treatment (MMT).

Group Type: ACTIVE_COMPARATOR

Enhanced usual care (EUC)

Intervention Type: OTHER

Provision of ART and medical care for HIV and other medical HIV co-morbidities provided at the HIV/AIDS treatment center with an expedited and facilitated referral to a methadone maintenance treatment (MMT).

Fully Implemented Seek-Test-Treat-Retain (FI-STTR) model

The FI-STTR care model will include the usual care supplemented by continuing education and coaching of medical staff at HIV/AIDS and MMT clinics and by provision of additional peer-based counseling intervention

Group Type: EXPERIMENTAL

Enhanced usual care (EUC)

Intervention Type: OTHER

Provision of ART and medical care for HIV and other medical HIV co-morbidities provided at the HIV/AIDS treatment center with an expedited and facilitated referral to a methadone maintenance treatment (MMT).

Peer-based counseling

Intervention Type: BEHAVIORAL

Peer-based counseling intervention focused on behavioral skills and strategies that patients can learn and master to achieve uninterrupted, long-term ART treatment participation while continuing OUD recovery through MMT

Interventions

Enhanced usual care (EUC)

Provision of ART and medical care for HIV and other medical HIV co-morbidities provided at the HIV/AIDS treatment center with an expedited and facilitated referral to a methadone maintenance treatment (MMT).

Intervention Type: OTHER

Peer-based counseling

Peer-based counseling intervention focused on behavioral skills and strategies that patients can learn and master to achieve uninterrupted, long-term ART treatment participation while continuing OUD recovery through MMT

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

• potential participants must meet the inclusion criteria for ART and MMT and begin receiving these treatments

Exclusion Criteria:

• ART and MMT exclusion criteria include: liver enzymes greater than 5 times the upper limit of normal (ULN); liver failure (Childs Pugh Turcot Grade B or C).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marek C Chawarski, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Universiti Sains Malalysia

Tasek Gelugor, Pulau Pinang, Malaysia

Countries

Malaysia

Other Identifiers

1R01DA047789-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000023790

Identifier Type: -

Identifier Source: org_study_id