- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05597787
HIV-Related Stigma Intervention for Malaysian Clinicians
November 15, 2024 updated by: University of Delaware
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kuala Lumpur, Malaysia
- University of Malaya
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- practicing general practitioner or family medicine specialist in Malaysia
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
online education and clinical skills
|
|
Active Comparator: 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.
|
education and clinical skills
|
|
Experimental: 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.
|
education, clinical skills and contact
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Month 9 Assessment
|
|
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.
|
Month 9 Assessment
|
|
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.
|
Month 9 Assessment
|
|
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.
|
Month 9 Assessment
|
|
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.
|
Month 9 Assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HIV Prevention Procedures: HIV Testing
Time Frame: Cumulative over 9 month intervention
|
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
Time Frame: Cumulative over 9 month intervention
|
Measured with weekly diary of PrEP prescriptions.
Number of PrEP prescriptions will be summed over duration of intervention.
|
Cumulative over 9 month intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 26, 2022
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
May 11, 2023
Study Registration Dates
First Submitted
July 25, 2022
First Submitted That Met QC Criteria
October 24, 2022
First Posted (Actual)
October 28, 2022
Study Record Updates
Last Update Posted (Estimated)
December 11, 2024
Last Update Submitted That Met QC Criteria
November 15, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- R34MH124390 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hiv
-
Duke UniversityGilead SciencesRecruitingHIV Prevention | HIV Pre-exposure Prophylaxis | HIV Prevention Program | HIV Prevention and Care | HIV Pre-exposure Prophylaxis UseUnited States
-
Federal University of São PauloGilead SciencesCompleted
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecruitingHIV | HIV Testing | HIV Linkage to Care | HIV TreatmentUnited States
-
University of Alabama at BirminghamNational Institute of Mental Health (NIMH)RecruitingPrEP | HIV | HIV Prevention | PrEP UptakeUnited States
-
Institute of HIV Research and Innovation Foundation...National Institutes of Health (NIH)RecruitingHIV Prevention | PrEP Adherence | HIV Related StigmaThailand
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationCompletedPartner HIV Testing | Couple HIV Counseling | Couple Communication | HIV IncidenceCameroon, Dominican Republic, Georgia, India
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)RecruitingFeasibility | HIV Prevention | PrEP Uptake | Acceptability | HIV Self-testing | Male Partners of HIV-negative Postpartum WomenSouth Africa
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement and other collaboratorsUnknownHIV | HIV-uninfected Children | Children Exposed to HIVCameroon
-
University of PennsylvaniaNational Institute of Mental Health (NIMH); University of BotswanaRecruitingPregnancy | HIV | Post-partum | HIV Antiretroviral Therapy (ART) AdherenceBotswana
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
Clinical Trials on HIV Connect
-
Minnesota Department of HealthCompleted
-
Columbia UniversityNational Institute of Mental Health (NIMH)Completed
-
New York UniversityHofstra UniversityNot yet recruitingChildhood Apraxia of Speech
-
George Washington UniversityBill and Melinda Gates Foundation; Save the Children; Save the Children International...CompletedContraceptive UsageBangladesh
-
University of South CarolinaNational Institute of Nursing Research (NINR)RecruitingConnect Through PLAY: A Staff-based Physical Activity Intervention for Middle School Youth (Connect)Physical Activity | Obesity PreventionUnited States
-
George Washington UniversityBill and Melinda Gates Foundation; Save the Children; Save the Children International...CompletedContraceptive UsageTanzania
-
RANDNational Institute of Mental Health (NIMH); University of Stellenbosch; Western...Completed
-
University of PittsburghNational Cancer Institute (NCI)CompletedAdvanced CancerUnited States
-
University Health Network, TorontoNot yet recruitingLung Cancer Non-Small Cell Cancer (NSCLC) | Lung Cancer Small Cell Lung Cancer (SCLC) | Patient NavigationCanada
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH); Columbia University; Indiana University... and other collaboratorsActive, not recruiting