HivNCT05597787
HIV-Related Stigma Intervention for Malaysian Clinicians
A study testing HIV Connect, Project ECHO for HIV Prevention and Project ECHO for HIV Prevention and Stigma Reduction in people with Hiv, run by University of Delaware at 1 site in Malaysia.
Trial summary
Key populations at risk of HIV (including men who have sex with men, people who inject drugs, transgender women, and female sex workers) are more likely to be infected with HIV but less likely than members of the general population to know of their HIV status, receive HIV prevention counseling, or be linked to HIV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv
- What is being tested?
- HIV Connect, Project ECHO for HIV Prevention and Project ECHO for HIV Prevention and Stigma Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteMalaysia
- Study dates
- 26 Jul 2022to 11 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- practicing general practitioner or family medicine specialist in Malaysia
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Stigma Reduction Tools Via a Popular Teletraining Platform to Reduce Clinician Stigma and Disparities in HIV Testing, Prevention, and Linkage to Care in Malaysia
Key populations at risk of HIV (including men who have sex with men, people who inject drugs, transgender women, and female sex workers) are more likely to be infected with HIV but less likely than members of the general population to know of their HIV status, receive HIV prevention counseling, or be linked to HIV care services. Clinician stigma towards these groups remains a potent and persistent driver of these HIV disparities in many places of the world. The investigators propose to incorporate evidence-based stigma reduction tools into a popular teletraining platform for clinicians and pilot test the resulting intervention (Project ECHO® for HIV Prevention and Stigma Reduction) with clinicians in Malaysia, a context wherein clinician stigma and HIV disparities are substantial.
- Conditions
- Hiv
- Being tested
- HIV Connect, Project ECHO for HIV Prevention, Project ECHO for HIV Prevention and Stigma Reduction
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV ConnectBehavioural
online education and clinical skills
Project ECHO for HIV PreventionBehavioural
education and clinical skills
Project ECHO for HIV Prevention and Stigma ReductionBehavioural
education, clinical skills and contact
| Study group | Role | What they receive |
|---|---|---|
| HIV Connect | Active comparator | Participants randomized to this condition will complete HIV Connect, which is an online course developed by the Malaysian Society of HIV Medicine designed to educate primary care physicians in Malaysia about HIV. It consists of a series of modules featuring HIV infectious disease experts who instruct on topics including epidemiology and natural history of HIV, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), sexual history taking and STI testing, and others. Receives: Behavioral: HIV Connect |
| Project ECHO for HIV Prevention | Active comparator | Participants randomized to this condition will receive Project ECHO for HIV Prevention, without added evidence-based stigma reduction tools. Participants will meet with the Project ECHO Hub specialists and their learning community on a bi-weekly basis for 60 minutes over the course of 9 months. Each session will feature a didactic training incorporating standardized procedures for HIV testing, prevention, and/or linkage to care, and patient-case presentation and discussion. Receives: Behavioral: Project ECHO for HIV Prevention |
| Project ECHO for HIV Prevention + Stigma Reduction | Experimental | Participants randomized to this condition will receive the Project ECHO for HIV Prevention intervention with added evidence-based stigma reduction tools. Participants will meet with the Project ECHO Hub specialists and their learning community on a bi-weekly basis for 60 minutes over the course of 9 months. Each session will feature a didactic training incorporating standardized procedures for HIV testing, prevention, and/or linkage to care, and patient-case presentation and discussion. Receives: Behavioral: Project ECHO for HIV Prevention and Stigma Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention
Measured with Acceptability of Intervention Measure. Theoretical or possible range of scores is 1-5, and actual range was 3.50-5. Higher scores indicate greater acceptability.
Measured: Month 9 Assessment
Feasibility of Intervention
Measured with Feasibility of Intervention Measure. Theoretical or possible range of scores is 1-5, and actual range was 3.25-5. Higher scores indicate greater feasibility.
Measured: Month 9 Assessment
Stigma Reduction: Prejudice
Measured with Feelings Thermometers. Positive/Negative affect is measured on 0-100 point scale, with higher scores indicating more prejudice.
Measured: Month 9 Assessment
Stigma Reduction: Stereotypes
Measured with subscale of Multidimensional HIV-Related Stigma Scale. Theoretical or possible range of scores is 1-5, and actual range was 1-3.44. Higher scores indicate greater stereotypes.
Measured: Month 9 Assessment
Stigma Reduction: Discrimination
Measured with subscale of Multidimensional HIV-Related Stigma Scale. Theoretical or possible range of scores is 1-5, and actual range was 1-5. Higher scores indicate greater discrimination.
Measured: Month 9 Assessment
Secondary outcomes (2)
HIV Prevention Procedures: HIV Testing
Measured with weekly diary of HIV tests performed. Number of HIV tests will be summed over duration of intervention.
Measured: Cumulative over 9 month intervention
HIV Prevention Procedures: PrEP Prescriptions
Measured with weekly diary of PrEP prescriptions. Number of PrEP prescriptions will be summed over duration of intervention.
Measured: Cumulative over 9 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start26 Jul 2022
- Primary completion31 Mar 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597787
- Sponsor's protocol ID
- R34MH124390
- Status last verified
- Jan 2024
- First submitted
- 25 Jul 2022
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Because of the risks and sensitivities of this study, only completely de-identified data will be shared under a use agreement. Data-sharing agreements must provide for: (1) a commitment to using the data only for research purposes, (2) a commitment to securing the data using appropriate computer technology and (3) a commitment to destroying or returning the data after analyses are completed.
Publications
Earnshaw VA, Collier ZK, Wong PL, Saifi R, Chong N, Ng RX, Azwa I, Basri S, Hassan ABA, Mousavi M, Omar SFS, Walters S, Haddad MS, Kamarulzaman A, Altice FL. Pilot randomized controlled trial to reduce HIV-related stigma among clinicians in Malaysia via project ECHO(R). AIDS Care. 2025 Aug;37(8):1313-1331. doi: 10.1080/09540121.2025.2534539. Epub 2025 Jul 30.
PubMed 40736373Chong N, Azwa I, Hassan AA, Mousavi M, Wong PL, Ng RX, Saifi R, Basri S, Omar SFS, Walters SM, Collier ZK, Haddad MS, Altice FL, Kamarulzaman A, Earnshaw VA. Strengthening HIV Activism Among Clinicians in Malaysia: A Randomised Controlled Trial. AIDS Behav. 2025 Dec;29(12):3931-3939. doi: 10.1007/s10461-025-04829-1. Epub 2025 Jul 21.
PubMed 40691430
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Stigma Reduction Tools Via a Popular Teletraining Platform to Reduce Clinician Stigma and Disparities in HIV Testing, Prevention, and Linkage to Care in Malaysia
- ClinicalTrials.gov ID
- NCT05597787
- Acronym / sponsor ID
- R34MH124390
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- University of Malaya
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Key populations at risk of HIV (including men who have sex with men, people who inject drugs, transgender women, and female sex workers) are more likely to be infected with HIV but less likely than members of the general population to know of their HIV status, receive HIV prevention counseling, or be linked to HIV care services. Clinician stigma towards these groups remains a potent and persistent driver of these HIV disparities in many places of the world. The investigators propose to incorporate evidence-based stigma reduction tools into a popular teletraining platform for clinicians and pilot test the resulting intervention (Project ECHO® for HIV Prevention and Stigma Reduction) with clinicians in Malaysia, a context wherein clinician stigma and HIV disparities are substantial.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV Connect | Active comparator | Behavioral: HIV ConnectParticipants randomized to this condition will complete HIV Connect, which is an online course developed by the Malaysian Society of HIV Medicine designed to educate primary care physicians in Malaysia about HIV. It consists of a series of modules featuring HIV infectious disease experts who instruct on topics including epidemiology and natural history of HIV, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), sexual history taking and STI testing, and others. |
| Project ECHO for HIV Prevention | Active comparator | Behavioral: Project ECHO for HIV PreventionParticipants randomized to this condition will receive Project ECHO for HIV Prevention, without added evidence-based stigma reduction tools. Participants will meet with the Project ECHO Hub specialists and their learning community on a bi-weekly basis for 60 minutes over the course of 9 months. Each session will feature a didactic training incorporating standardized procedures for HIV testing, prevention, and/or linkage to care, and patient-case presentation and discussion. |
| Project ECHO for HIV Prevention + Stigma Reduction | Experimental | Behavioral: Project ECHO for HIV Prevention and Stigma ReductionParticipants randomized to this condition will receive the Project ECHO for HIV Prevention intervention with added evidence-based stigma reduction tools. Participants will meet with the Project ECHO Hub specialists and their learning community on a bi-weekly basis for 60 minutes over the course of 9 months. Each session will feature a didactic training incorporating standardized procedures for HIV testing, prevention, and/or linkage to care, and patient-case presentation and discussion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- practicing general practitioner or family medicine specialist in Malaysia
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| HIV Connectonline education and clinical skills | Behavioural | HIV Connect |
| Project ECHO for HIV Preventioneducation and clinical skills | Behavioural | Project ECHO for HIV Prevention |
| Project ECHO for HIV Prevention and Stigma Reductioneducation, clinical skills and contact | Behavioural | Project ECHO for HIV Prevention + Stigma Reduction |
Primary outcome
Acceptability of Intervention
Time frame: Month 9 Assessment
Measured with Acceptability of Intervention Measure. Theoretical or possible range of scores is 1-5, and actual range was 3.50-5. Higher scores indicate greater acceptability.
Feasibility of Intervention
Time frame: Month 9 Assessment
Measured with Feasibility of Intervention Measure. Theoretical or possible range of scores is 1-5, and actual range was 3.25-5. Higher scores indicate greater feasibility.
Stigma Reduction: Prejudice
Time frame: Month 9 Assessment
Measured with Feelings Thermometers. Positive/Negative affect is measured on 0-100 point scale, with higher scores indicating more prejudice.
Stigma Reduction: Stereotypes
Time frame: Month 9 Assessment
Measured with subscale of Multidimensional HIV-Related Stigma Scale. Theoretical or possible range of scores is 1-5, and actual range was 1-3.44. Higher scores indicate greater stereotypes.
Stigma Reduction: Discrimination
Time frame: Month 9 Assessment
Measured with subscale of Multidimensional HIV-Related Stigma Scale. Theoretical or possible range of scores is 1-5, and actual range was 1-5. Higher scores indicate greater discrimination.
2 secondary outcomes
HIV Prevention Procedures: HIV Testing
Time frame: Cumulative over 9 month intervention
HIV Prevention Procedures: PrEP Prescriptions
Time frame: Cumulative over 9 month intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40736373Earnshaw VA, Collier ZK, Wong PL, Saifi R, Chong N, Ng RX, Azwa I, Basri S, Hassan ABA, Mousavi M, Omar SFS, Walters S, Haddad MS, Kamarulzaman A, Altice FL. Pilot randomized controlled trial to reduce HIV-related stigma among clinicians in Malaysia via project ECHO(R). AIDS Care. 2025 Aug;37(8):1313-1331. doi: 10.1080/09540121.2025.2534539. Epub 2025 Jul 30.
- Derived from this study: PubMed 40691430Chong N, Azwa I, Hassan AA, Mousavi M, Wong PL, Ng RX, Saifi R, Basri S, Omar SFS, Walters SM, Collier ZK, Haddad MS, Altice FL, Kamarulzaman A, Earnshaw VA. Strengthening HIV Activism Among Clinicians in Malaysia: A Randomised Controlled Trial. AIDS Behav. 2025 Dec;29(12):3931-3939. doi: 10.1007/s10461-025-04829-1. Epub 2025 Jul 21.
- Individual participant dataSharing planned: Yes. Because of the risks and sensitivities of this study, only completely de-identified data will be shared under a use agreement. Data-sharing agreements must provide for: (1) a commitment to using the data only for research purposes, (2) a commitment to securing the data using appropriate computer technology and (3) a commitment to destroying or returning the data after analyses are completed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Connect, Project ECHO for HIV Prevention and Project ECHO for HIV Prevention and Stigma Reduction in people with Hiv, run by University of Delaware 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: finished, as of the sponsor's last update on 11 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptability of Intervention (time frame: Month 9 Assessment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597787, which also lists 2 linked publications.
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 11 Dec 2024.