Trial Outcomes & Findings for HIV-Related Stigma Intervention for Malaysian Clinicians (NCT NCT05597787)

NCT ID: NCT05597787

Last Updated: 2024-12-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

Month 9 Assessment

Results posted on

2024-12-11

Participant Flow

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.

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 Of these, n=257 were excluded because they declined to participate in the study, were withdrawn because they provided incomplete registration data or their identity could not be verified, or were waitlisted.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.

Participant milestones

Participant milestones
Measure
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
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
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
Overall Study
STARTED
26
26
26
Overall Study
COMPLETED
26
26
25
Overall Study
NOT COMPLETED
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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
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
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
Overall Study
Withdrawal by Subject
0
0
1

Baseline Characteristics

HIV-Related Stigma Intervention for Malaysian Clinicians

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
HIV Connect
n=26 Participants
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
Project ECHO for HIV Prevention
n=26 Participants
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
Project ECHO for HIV Prevention + Stigma Reduction
n=26 Participants
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
Total
n=78 Participants
Total of all reporting groups
Age, Continuous
37.42 years
STANDARD_DEVIATION 6.37 • n=5 Participants
36.50 years
STANDARD_DEVIATION 4.05 • n=7 Participants
38.23 years
STANDARD_DEVIATION 7.28 • n=5 Participants
37.38 years
STANDARD_DEVIATION 6.02 • n=4 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
9 Participants
n=7 Participants
10 Participants
n=5 Participants
32 Participants
n=4 Participants
Sex: Female, Male
Male
13 Participants
n=5 Participants
17 Participants
n=7 Participants
16 Participants
n=5 Participants
46 Participants
n=4 Participants
Race/Ethnicity, Customized
Malay
4 Participants
n=5 Participants
14 Participants
n=7 Participants
10 Participants
n=5 Participants
28 Participants
n=4 Participants
Race/Ethnicity, Customized
Chinese
16 Participants
n=5 Participants
6 Participants
n=7 Participants
13 Participants
n=5 Participants
35 Participants
n=4 Participants
Race/Ethnicity, Customized
Indian
5 Participants
n=5 Participants
6 Participants
n=7 Participants
13 Participants
n=5 Participants
24 Participants
n=4 Participants
Race/Ethnicity, Customized
Other
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Region of Enrollment
Malaysia
26 participants
n=5 Participants
26 participants
n=7 Participants
26 participants
n=5 Participants
78 participants
n=4 Participants

PRIMARY outcome

Timeframe: Month 9 Assessment

Population: Two participants in the Project ECHO for HIV Prevention Condition did not complete the month 9 survey

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.

Outcome measures

Outcome measures
Measure
HIV Connect
n=26 Participants
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
Project ECHO for HIV Prevention
n=24 Participants
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
Project ECHO for HIV Prevention + Stigma Reduction
n=26 Participants
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
Acceptability of Intervention
4.22 score on a scale
Standard Deviation 0.44
4.72 score on a scale
Standard Deviation 0.39
4.45 score on a scale
Standard Deviation 0.48

PRIMARY outcome

Timeframe: Month 9 Assessment

Population: Two participants in the Project ECHO for HIV Prevention Condition did not complete the final survey.

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.

Outcome measures

Outcome measures
Measure
HIV Connect
n=26 Participants
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
Project ECHO for HIV Prevention
n=24 Participants
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
Project ECHO for HIV Prevention + Stigma Reduction
n=26 Participants
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
Feasibility of Intervention
4.22 score on a scale
Standard Deviation 0.44
4.62 score on a scale
Standard Deviation 0.45
4.32 score on a scale
Standard Deviation 0.60

PRIMARY outcome

Timeframe: Month 9 Assessment

Population: Two participants in the Project ECHO for HIV Prevention condition did not complete the final survey.

Measured with Feelings Thermometers. Positive/Negative affect is measured on 0-100 point scale, with higher scores indicating more prejudice.

Outcome measures

Outcome measures
Measure
HIV Connect
n=26 Participants
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
Project ECHO for HIV Prevention
n=24 Participants
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
Project ECHO for HIV Prevention + Stigma Reduction
n=26 Participants
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
Stigma Reduction: Prejudice
29.13 score on a scale
Standard Deviation 18.84
23.28 score on a scale
Standard Deviation 20.50
32.07 score on a scale
Standard Deviation 15.36

PRIMARY outcome

Timeframe: Month 9 Assessment

Population: Two participants in the Project ECHO for HIV Prevention condition did not complete the final survey.

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.

Outcome measures

Outcome measures
Measure
HIV Connect
n=26 Participants
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
Project ECHO for HIV Prevention
n=24 Participants
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
Project ECHO for HIV Prevention + Stigma Reduction
n=26 Participants
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
Stigma Reduction: Stereotypes
2.55 score on a scale
Standard Deviation 0.50
2.01 score on a scale
Standard Deviation 0.59
2.32 score on a scale
Standard Deviation 0.69

PRIMARY outcome

Timeframe: Month 9 Assessment

Population: Two participants in the Project ECHO for HIV Prevention condition did not complete the final survey.

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.

Outcome measures

Outcome measures
Measure
HIV Connect
n=26 Participants
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
Project ECHO for HIV Prevention
n=24 Participants
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
Project ECHO for HIV Prevention + Stigma Reduction
n=26 Participants
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
Stigma Reduction: Discrimination
4.44 score on a scale
Standard Deviation 0.50
4.67 score on a scale
Standard Deviation 0.85
4.64 score on a scale
Standard Deviation 0.42

SECONDARY outcome

Timeframe: Cumulative over 9 month intervention

Population: Submission of procedures data was inconsistent, with many participants missing submissions in each condition.

Measured with weekly diary of HIV tests performed. Number of HIV tests will be summed over duration of intervention.

Outcome measures

Outcome measures
Measure
HIV Connect
n=19 Participants
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
Project ECHO for HIV Prevention
n=15 Participants
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
Project ECHO for HIV Prevention + Stigma Reduction
n=18 Participants
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
HIV Prevention Procedures: HIV Testing
21.54 number of HIV tests
Standard Deviation 45.14
2.65 number of HIV tests
Standard Deviation 6.17
10.46 number of HIV tests
Standard Deviation 46.24

SECONDARY outcome

Timeframe: Cumulative over 9 month intervention

Population: Submission of procedures data was inconsistent, with many participants missing submissions in each condition.

Measured with weekly diary of PrEP prescriptions. Number of PrEP prescriptions will be summed over duration of intervention.

Outcome measures

Outcome measures
Measure
HIV Connect
n=19 Participants
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
Project ECHO for HIV Prevention
n=15 Participants
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
Project ECHO for HIV Prevention + Stigma Reduction
n=18 Participants
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
HIV Prevention Procedures: PrEP Prescriptions
2.04 number of PrEP prescriptions
Standard Deviation 8.80
0.07 number of PrEP prescriptions
Standard Deviation 0.27
0.11 number of PrEP prescriptions
Standard Deviation 0.43

Adverse Events

HIV Connect

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Project ECHO for HIV Prevention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Project ECHO for HIV Prevention + Stigma Reduction

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Valerie Earnshaw

University of Delaware

Phone: (302) 831-6500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place