An interventional study of HIV Connect and Project ECHO for HIV Prevention in Hiv, sponsored by University of Delaware. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by University of Delaware · Not applicable, Interventional, and Screening
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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 78 is below the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Exclusion Criteria:
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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
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
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
online education and clinical skills
education and clinical skills
education, clinical skills and contact
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 9 Assessment
HIV Prevention Procedures: HIV Testing
Measured with weekly diary of HIV tests performed. Number of HIV tests will be summed over duration of intervention.
Time frame: 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.
Time frame: Cumulative over 9 month intervention
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.
| Milestone | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction |
|---|---|---|---|
| Started | 26 | 26 | 26 |
| Completed | 26 | 26 | 25 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
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.
| score on a scale | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction |
|---|---|---|---|
| Acceptability of Intervention | 4.22 ± 0.44 | 4.72 ± 0.39 | 4.45 ± 0.48 |
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.
| score on a scale | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction |
|---|---|---|---|
| Feasibility of Intervention | 4.22 ± 0.44 | 4.62 ± 0.45 | 4.32 ± 0.60 |
Measured with Feelings Thermometers. Positive/Negative affect is measured on 0-100 point scale, with higher scores indicating more prejudice.
| score on a scale | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction |
|---|---|---|---|
| Stigma Reduction: Prejudice | 29.13 ± 18.84 | 23.28 ± 20.50 | 32.07 ± 15.36 |
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.
| score on a scale | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction |
|---|---|---|---|
| Stigma Reduction: Stereotypes | 2.55 ± 0.50 | 2.01 ± 0.59 | 2.32 ± 0.69 |
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.
| score on a scale | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction |
|---|---|---|---|
| Stigma Reduction: Discrimination | 4.44 ± 0.50 | 4.67 ± 0.85 | 4.64 ± 0.42 |
Measured with weekly diary of HIV tests performed. Number of HIV tests will be summed over duration of intervention.
| number of HIV tests | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction |
|---|---|---|---|
| HIV Prevention Procedures: HIV Testing | 21.54 ± 45.14 | 2.65 ± 6.17 | 10.46 ± 46.24 |
Measured with weekly diary of PrEP prescriptions. Number of PrEP prescriptions will be summed over duration of intervention.
| number of PrEP prescriptions | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction |
|---|---|---|---|
| HIV Prevention Procedures: PrEP Prescriptions | 2.04 ± 8.80 | 0.07 ± 0.27 | 0.11 ± 0.43 |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HIV Connect | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Project ECHO for HIV Prevention | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Project ECHO for HIV Prevention + Stigma Reduction | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
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.
| Age, Continuous(years) | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction | Total |
|---|---|---|---|---|
| Mean | 37.42 ± 6.37 | 36.50 ± 4.05 | 38.23 ± 7.28 | 37.38 ± 6.02 |
| Sex: Female, Male(Participants) | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction | Total |
|---|---|---|---|---|
| Female | 13 | 9 | 10 | 32 |
| Male | 13 | 17 | 16 | 46 |
| Race/Ethnicity, Customized(Participants) | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction | Total |
|---|---|---|---|---|
| Malay | 4 | 14 | 10 | 28 |
| Chinese | 16 | 6 | 13 | 35 |
| Indian | 5 | 6 | 13 | 24 |
| Other | 1 | 0 | 0 | 1 |
| Region of Enrollment(participants) | HIV Connect | Project ECHO for HIV Prevention | Project ECHO for HIV Prevention + Stigma Reduction | Total |
|---|---|---|---|---|
| Malaysia | 26 | 26 | 26 | 78 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Ran from Jul 2022 to primary completion in Mar 2023, 8 months.
Results were first posted in Dec 2024, 1 year 8 months after primary completion.
Of 497 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 47. This study's 8 months is below that.
Counting every sponsor, half of 500 studies reached it within 31 months; a quarter within 18 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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