Clinical trial NCT03987282: Implementation of STTR Strategies Among People Who Inject Drugs in Malaysia
Official title: Implementation of Seek, Test, Treat & Retain Strategies Among People Who Inject Drugs in Malaysia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: HIV Seropositivity
Opioid-use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Universiti Sains Malaysia
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-06-17
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pre- versus post-implementation evaluation
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Virologic suppression
timeFrame: 24 weeks
Secondary outcomes:
measure: ART adherence, proportion of days when medication is taken as prescribed
timeFrame: 24 weeks
measure: Opioid use
timeFrame: 24 weeks
measure: Depression scores
timeFrame: 24 weeks
measure: Psychiatric symptoms
timeFrame: 24 weeks
measure: Changes in the quality of life index
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Gelugor
country: Malaysia
facility: Universiti Sains Malalysia
state: Penang
Study officials:
affiliation: Yale University
name: Marek C Chawarski, PhD
role: PRINCIPAL_INVESTIGATOR
References: