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| Name | Class |
|---|---|
| University of Malaya | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV Connect | Behavioral | online education and clinical skills |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Month 9 Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Prevention Procedures: HIV Testing | Measured with weekly diary of HIV tests performed. Number of HIV tests will be summed over duration of intervention. | Cumulative over 9 month intervention |
| HIV Prevention Procedures: PrEP Prescriptions |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya | Kuala Lumpur | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40736373 | Derived | 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. | |
| 40691430 | Derived | Chong 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. |
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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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n=411 individuals accessed the registration link. Of these, n=257 were excluded because they declined to participate in the study, were withdrawn because they provided incomplete registration data or their identity could not be verified, or were waitlisted. Of the remaining individuals, n=26 were allocated to an intervention condition. Individuals who did not receive an intervention withdrew, became non-responsive to communication from the project coordinator, or were waitlisted.
Advertisements were posted to Malaysian medical groups (i.e., Family Medicine Association, Malaysian Medicine Association, Malaysian Primary Care Network, Doctors Only Bulletin Board System) between May and July 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV Connect | 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. HIV Connect: online education and clinical skills |
| FG001 | Project ECHO for HIV Prevention | 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. Project ECHO for HIV Prevention: education and clinical skills |
| FG002 | Project ECHO for HIV Prevention + Stigma Reduction | 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. Project ECHO for HIV Prevention and Stigma Reduction: education, clinical skills and contact |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The participant who withdrew from the Project ECHO for HIV Prevention and Stigma Reduction condition completed follow-up surveys, and so is included in analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV Connect | 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. HIV Connect: online education and clinical skills |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Two participants in the Project ECHO for HIV Prevention Condition did not complete the month 9 survey | Posted | Mean | Standard Deviation | score on a scale | Month 9 Assessment |
|
9 months
The definition of adverse event and/or serious adverse event did not differ from the clinicaltrials.gov definitions for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV Connect | 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. HIV Connect: online education and clinical skills |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Earnshaw | University of Delaware | (302) 831-6500 | earnshaw@udel.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2022 | Oct 9, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2022 | Oct 9, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Project ECHO for HIV Prevention |
| Behavioral |
education and clinical skills |
|
| Project ECHO for HIV Prevention and Stigma Reduction | Behavioral | education, clinical skills and contact |
|
Measured with weekly diary of PrEP prescriptions. Number of PrEP prescriptions will be summed over duration of intervention.
| Cumulative over 9 month intervention |
| BG001 | Project ECHO for HIV Prevention | 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. Project ECHO for HIV Prevention: education and clinical skills |
| BG002 | Project ECHO for HIV Prevention + Stigma Reduction | 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. Project ECHO for HIV Prevention and Stigma Reduction: education, clinical skills and contact |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Project ECHO for HIV Prevention | 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. Project ECHO for HIV Prevention: education and clinical skills |
| OG002 | Project ECHO for HIV Prevention + Stigma Reduction | 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. Project ECHO for HIV Prevention and Stigma Reduction: education, clinical skills and contact |
|
|
| Primary | 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. | Two participants in the Project ECHO for HIV Prevention Condition did not complete the final survey. | Posted | Mean | Standard Deviation | score on a scale | Month 9 Assessment |
|
|
|
| Primary | Stigma Reduction: Prejudice | Measured with Feelings Thermometers. Positive/Negative affect is measured on 0-100 point scale, with higher scores indicating more prejudice. | Two participants in the Project ECHO for HIV Prevention condition did not complete the final survey. | Posted | Mean | Standard Deviation | score on a scale | Month 9 Assessment |
|
|
|
| Primary | 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. | Two participants in the Project ECHO for HIV Prevention condition did not complete the final survey. | Posted | Mean | Standard Deviation | score on a scale | Month 9 Assessment |
|
|
|
| Primary | 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. | Two participants in the Project ECHO for HIV Prevention condition did not complete the final survey. | Posted | Mean | Standard Deviation | score on a scale | Month 9 Assessment |
|
|
|
| Secondary | HIV Prevention Procedures: HIV Testing | Measured with weekly diary of HIV tests performed. Number of HIV tests will be summed over duration of intervention. | Submission of procedures data was inconsistent, with many participants missing submissions in each condition. | Posted | Mean | Standard Deviation | number of HIV tests | Cumulative over 9 month intervention |
|
|
|
| Secondary | HIV Prevention Procedures: PrEP Prescriptions | Measured with weekly diary of PrEP prescriptions. Number of PrEP prescriptions will be summed over duration of intervention. | Submission of procedures data was inconsistent, with many participants missing submissions in each condition. | Posted | Mean | Standard Deviation | number of PrEP prescriptions | Cumulative over 9 month intervention |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Project ECHO for HIV Prevention | 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. Project ECHO for HIV Prevention: education and clinical skills | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Project ECHO for HIV Prevention + Stigma Reduction | 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. Project ECHO for HIV Prevention and Stigma Reduction: education, clinical skills and contact | 0 | 26 | 0 | 26 | 0 | 26 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |