NCT05597787

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

July 26, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 11, 2024

Completed
Last Updated

December 11, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

July 25, 2022

Results QC Date

October 9, 2024

Last Update Submit

November 15, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Secondary Outcomes (2)

  • HIV Prevention Procedures: HIV Testing

    Cumulative over 9 month intervention

  • HIV Prevention Procedures: PrEP Prescriptions

    Cumulative over 9 month intervention

Study Arms (3)

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.

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.

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.

Behavioral: Project ECHO for HIV Prevention and Stigma Reduction

Interventions

HIV ConnectBEHAVIORAL

online education and clinical skills

HIV Connect

education and clinical skills

Project ECHO for HIV Prevention

education, clinical skills and contact

Project ECHO for HIV Prevention + Stigma Reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • practicing general practitioner or family medicine specialist in Malaysia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya

Kuala Lumpur, Malaysia

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Valerie Earnshaw
Organization
University of Delaware

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2022

First Posted

October 28, 2022

Study Start

July 26, 2022

Primary Completion

March 31, 2023

Study Completion

May 11, 2023

Last Updated

December 11, 2024

Results First Posted

December 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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.

Locations