Implementation of Seek, Test, Treat & Retain Strategies among People Who Inject Drugs in Malaysia

Project Summary
Most people living with HIV (PLWH) in Malaysia also have an opioid use disorder (OUD), yet only a minority
receive ART and OUD treatment, resulting in increased mortality and HIV incidence. The proposed pragmatic,
multisite, implementation and effectiveness research will evaluate a strategy to improve HIV treatment
outcomes (increased rates of patients on ART with virological suppression, improved treatment retention and
ART adherence) for PLWH with OUD. Engaging 4 large regional HIV/AIDS treatment centers in Malaysia, with
a stepped rollout of the study protocol across the study sites, offset by one year with a random order of the
sites initiation, 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. At each of the study sites, individuals
testing HIV positive who also have OUD (n=4x70) will be enrolled to receive concurrent ART and 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. A statistically significant effect on the
primary outcome and clinically meaningful effects on secondary outcomes favoring the improved care model
are hypothesized. Concurrently at each study site, 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. 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.

Grant Number: 5R01DA047789-05
NIH Institute/Center: NIH
Principal Investigator: MAREK CHAWARSKI