Implementation of STTR Strategies Among People Who Inject Drugs in Malaysia

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03987282
• Other study ID #: 2000023790
• Secondary ID: 1R01DA047789-01
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: Marek C Chawarski, PhD
• Phone: 2039747602
• Email: marek.chawarski[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: August 30, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• HIV Seropositivity
• Opioid-Related Disorders
• Opioid-use Disorder

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

Locations

Country	Name	City	State
Malaysia	Universiti Sains Malalysia	Gelugor	Penang

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA), Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Opioid use	Illicit opioid use measured by rates of opioid negative urine toxicology results and self-report	24 weeks
Secondary	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
Secondary	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
Secondary	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