Principle Investigator(s):
Funder: National Institute on Drug Abuse
Project period: 09/01/2018 - 07/31/2023
Grant Type: Research
Further Detail
Abstract Text:
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.
