HIV SeropositivityNCT03987282
Implementation of STTR Strategies Among People Who Inject Drugs in Malaysia
A study testing Peer-based counseling in people with HIV Seropositivity and Opioid-use Disorder, run by Yale University at 1 site in Malaysia.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Seropositivity, Opioid-use Disorder
- What is being tested?
- Peer-based counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteMalaysia
- Study dates
- 26 Apr 2022to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- potential participants must meet the inclusion criteria for ART and MMT and begin receiving these treatments
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Seropositivity, Opioid-use Disorder
- Being tested
- Enhanced usual care (EUC), Peer-based counseling
- Medical subject headings
- HIV Seropositivity, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Peer-based counselingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Other: Enhanced usual care (EUC); Behavioral: Peer-based counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic suppression
The rates of patients with virologic suppression (< 20 copies/mL) in the two care models will be assessed at 24 weeks
Measured: 24 weeks
Secondary outcomes (5)
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
Measured: 24 weeks
Opioid use
Illicit opioid use measured by rates of opioid negative urine toxicology results and self-report
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start26 Apr 2022
- Primary completion31 May 2026
- Study completion31 May 2026
Why it stopped: lack of eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pre- versus post-implementation evaluation
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Malaysia, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Marek C Chawarski, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987282
- Sponsor's protocol ID
- 2000023790
- Other IDs
- 1R01DA047789-01
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2019
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Seek, Test, Treat & Retain Strategies Among People Who Inject Drugs in Malaysia
- ClinicalTrials.gov ID
- NCT03987282
- Acronym / sponsor ID
- 2000023790
- Conditions
- HIV Seropositivity, Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of eligible participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Universiti Sains Malaysia, National Institute on Drug Abuse (NIDA)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre- versus post-implementation evaluation
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care (EUC) | Active comparator | Other: 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). |
| Fully Implemented Seek-Test-Treat-Retain (FI-STTR) model | Experimental | Other: Enhanced usual care (EUC), Behavioral: Peer-based counselingThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- potential participants must meet the inclusion criteria for ART and MMT and begin receiving these treatments
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Enhanced usual care (EUC), Fully Implemented Seek-Test-Treat-Retain (FI-STTR) model |
| Peer-based counselingPeer-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 | Behavioural | Fully Implemented Seek-Test-Treat-Retain (FI-STTR) model |
Primary outcome
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
5 secondary outcomes
ART adherence, proportion of days when medication is taken as prescribed
Time frame: 24 weeks
Opioid use
Time frame: 24 weeks
Depression scores
Time frame: 24 weeks
Psychiatric symptoms
Time frame: 24 weeks
Changes in the quality of life index
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: lack of eligible participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek C Chawarski, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-based counseling in people with HIV Seropositivity and Opioid-use Disorder, run by Yale University at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of eligible participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic suppression (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.