Implementation of STTR Strategies Among People Who Inject Drugs in Malaysia

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Seropositivity; Opioid-use Disorder
• Intervention / Treatment: Other: Enhanced usual care (EUC); Behavioral: Peer-based counseling

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.

• Study Type: Interventional
• Enrollment (Estimated): 560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marek C Chawarski, PhD; Phone Number: 2039747602; Email: marek.chawarski@yale.edu

Study Locations

• Malaysia
  • Penang
    • Gelugor, Penang, Malaysia, 11800
      • Recruiting
      • Universiti Sains Malalysia
      • Contact: Vicknasingam Kasinather, PhD; Phone Number: 604 6532140; Email: vickna@usm.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: 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).
Experimental: 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	Other: 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).; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Virologic suppression	The rates of patients with virologic suppression (< 20 copies/mL) in the two care models will be assessed at 24 weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ART adherence, proportion of days when medication is taken as prescribed	ART adherence will be assessed by self-report using a timeline follow back (TLFB) methodology	24 weeks
Opioid use	Illicit opioid use measured by rates of opioid negative urine toxicology results and self-report	24 weeks
Depression scores	Center for Epidemiological Studies Depression Scale (CES-D) total score. The scale range is from 0 to 60; higher scores indicate more depression symptoms.	24 weeks
Psychiatric symptoms	Brief Symptom Inventory (BSI) a 53-item self-report inventory in which participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. The BSI has nine subscales designed to assess individual symptom groups: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. Higher scores indicate higher severity of symptoms.	24 weeks
Changes in the quality of life index	Short version of the World Health Organization Quality of Life (WHOQOL-BREF). The WHOQOL-BREF contains a total of 26 questions. In addition, two items from the Overall quality of Life and General Health facet are included. Four domains are assessed: Physical, Psychological, Social Relationship, and Environment.	24 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); Universiti Sains Malaysia
• Investigators: Principal Investigator: Marek C Chawarski, PhD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Narcotic-Related Disorders; HIV Infections; Urogenital Diseases; Genital Diseases; HIV Seropositivity; Opioid-Related Disorders
• Other Study ID Numbers: 2000023790; 1R01DA047789-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No