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Implementation of STTR Strategies Among People Who Inject Drugs in Malaysia

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ClinicalTrials.gov Identifier: NCT03987282
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
University of Science Malaysia
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
HIV Seropositivity Opioid-use Disorder Other: Enhanced usual care (EUC) Behavioral: Peer-based counseling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Pre- versus post-implementation evaluation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of Seek, Test, Treat & Retain Strategies Among People Who Inject Drugs in Malaysia
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. Virologic suppression [ Time Frame: 24 weeks ]
    The rates of patients with virologic suppression (< 20 copies/mL) in the two care models will be assessed at 24 weeks


Secondary Outcome Measures :
  1. ART adherence, proportion of days when medication is taken as prescribed [ Time Frame: 24 weeks ]
    ART adherence will be assessed by self-report using a timeline follow back (TLFB) methodology

  2. Opioid use [ Time Frame: 24 weeks ]
    Illicit opioid use measured by rates of opioid negative urine toxicology results and self-report

  3. Depression scores [ Time Frame: 24 weeks ]
    Center for Epidemiological Studies Depression Scale (CES-D) total score. The scale range is from 0 to 60; higher scores indicate more depression symptoms.

  4. Psychiatric symptoms [ Time Frame: 24 weeks ]
    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.

  5. Changes in the quality of life index [ Time Frame: 24 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987282


Contacts
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Contact: Marek C Chawarski, PhD 2039747602 marek.chawarski@yale.edu

Locations
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Malaysia
Universiti Sains Malalysia Not yet recruiting
Gelugor, Penang, Malaysia, 11800
Contact: Vicknasingam Kasinather, PhD    604 6532140    vickna@usm.my   
Sponsors and Collaborators
Yale University
University of Science Malaysia
Investigators
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Principal Investigator: Marek C Chawarski, PhD Yale School of Medicine

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03987282     History of Changes
Other Study ID Numbers: 2000023790
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases