NCT03987282

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
2.9 years until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

3.8 years

First QC Date

June 11, 2019

Last Update Submit

May 8, 2025

Conditions

HIV SeropositivityOpioid-use Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • ART adherence, proportion of days when medication is taken as prescribed

    24 weeks

  • Opioid use

    24 weeks

  • Depression scores

    24 weeks

  • Psychiatric symptoms

    24 weeks

  • Changes in the quality of life index

    24 weeks

Study Arms (2)

Enhanced usual care (EUC)

ACTIVE COMPARATOR

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)

Fully Implemented Seek-Test-Treat-Retain (FI-STTR) model

EXPERIMENTAL

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)Behavioral: Peer-based counseling

Interventions

Enhanced usual care (EUC)OTHER

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).

Enhanced usual care (EUC)Fully Implemented Seek-Test-Treat-Retain (FI-STTR) model
Peer-based counselingBEHAVIORAL

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

Fully Implemented Seek-Test-Treat-Retain (FI-STTR) model

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Sains Malalysia

Tasek Gelugor, Pulau Pinang, 11800, Malaysia

Location

MeSH Terms

Conditions

HIV SeropositivityOpioid-Related Disorders

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Marek C Chawarski, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Pre- versus post-implementation evaluation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2019

First Posted

June 17, 2019

Study Start

April 26, 2022

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

May 11, 2025

Record last verified: 2025-05

Locations

MY(1)