Entre Herman@s Program for HIV Prevention

Overseen By Petra Duran, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Charles Drew University of Medicine and Science

Disqualifiers: Non-Latino, Over 40, HIV-positive, others

Compensation: Varies

Number of Visits: Unknown

288 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to reduce HIV rates in Latino men who have sex with men by training their siblings to discuss PrEP, a medication that prevents HIV. PrEP is a medication that helps prevent HIV. The study looks at how discussing PrEP compares to discussing other health topics. By promoting PrEP through family support, the trial hopes to increase its use and lower HIV incidence.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should have either never used PrEP or stopped using it at least 90 days ago.

What data supports the effectiveness of the Entre Herman@s treatment for HIV prevention?

The effectiveness of the Entre Herman@s treatment for HIV prevention is supported by research showing that case management interventions, which are part of the treatment, help improve health outcomes, link patients to care, and reduce risky behaviors. These interventions have been shown to decrease mortality and improve engagement in care for people living with or at risk of HIV. ^{1 2 3 4 5}

Is the Entre Herman@s Program for HIV Prevention safe for humans?

The safety data from studies on pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) for HIV prevention suggest that these methods are generally safe for humans, with adverse events being rare. However, it's important to have medical monitoring to manage any potential side effects. ^{6 7 8 9 10}

How is the Entre Herman@s treatment for HIV prevention unique?

The Entre Herman@s program is unique because it focuses on community-based and culturally-sensitive approaches specifically designed for Latino populations, emphasizing personal development and relationship behavior to prevent HIV, unlike traditional medical or pharmaceutical interventions. ^{11 12 13 14 15}

Research Team

Homero del Pino, PhD, MS

Principal Investigator

Charles Drew University of Medicine and Science

Eligibility Criteria

This trial is for Latino men under 40 who have sex with men, are HIV-negative, haven't used PrEP recently or at all, and are missing certain vaccines. They must be open to discussing healthcare with a sibling and meet specific criteria like not being in a monogamous relationship with an HIV-negative partner.

Inclusion Criteria

self-identify as Latino

report HIV-negative status

either (a) have never used PrEP or (b) stopped using PrEP at least 90 days ago

Exclusion Criteria

You don't have any of the conditions mentioned above.

are unable to provide consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Siblings are trained to engage their gay brother in PrEP conversations or vaccine conversations

90 days

Follow-up

Participants are monitored for changes in willingness to use PrEP or get vaccinated, and actual uptake of PrEP or vaccines

90 days

Treatment Details

Interventions

• Entre Herman@s
• Vaccines for Health

Trial Overview The study compares two approaches: one where siblings encourage their gay brothers to use PrEP (a medication to prevent HIV), and another where they talk about getting vaccinated against COVID, Hepatitis A/B, or MPOX instead.

Participant Groups

Group I: PrEP Promotion Experimental Treatment 1 Intervention

Group II: Vaccine Promotion Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Charles Drew University of Medicine and Science

Lead Sponsor

Trials

54

Recruited

8,500+

St. Johns Community Health

Collaborator

Trials

1

Recruited

290+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

St. John's Community Health

Collaborator

Trials

1

Recruited

290+

Findings from Research

Case management models for HIV-positive individuals significantly improve health outcomes by linking patients to necessary health and social services, addressing their unique needs such as substance use or homelessness.

The review of 28 studies indicates that effective case management can lead to decreased mortality, better retention in care, reduced unmet needs, and lower risky behaviors among people living with or at risk of HIV/AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case management interventions for HIV-infected individuals. Ko, NY., Liu, HY., Lai, YY., et al.[2022]

A multidisciplinary HIV consult team implemented during hospitalization significantly improved engagement in care and virologic suppression among HIV-positive patients, with increases of 23.7% and 28.3% respectively for those receiving the consult.

Overall, hospitalization provided an opportunity to enhance HIV care outcomes, as all patients showed improved engagement and retention in care after hospitalization, highlighting the importance of targeted interventions in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV care cascade before and after hospitalization: impact of a multidisciplinary inpatient team in the US South. Nijhawan, AE., Bhattatiry, M., Chansard, M., et al.[2022]

HIV-positive patients with a case manager were more likely to adhere to antiretroviral medications and obtain HIV care within the past six months, indicating that case management improves health-seeking behaviors.

Patients with a case manager were also significantly less likely to engage in unprotected sex, suggesting that case management may help reduce sexual risk behaviors and improve overall clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Management: Steadfast Resource for Addressing Linkage to Care and Prevention with Hospitalized HIV-Infected Crack Users. Kenya, S., Chida, N., Cardenas, G., et al.[2020]

Pre-exposure prophylaxis (PrEP) has shown variable efficacy rates (0%-86%) in preventing HIV infection, with its effectiveness closely linked to adherence and the levels of antiretroviral drugs in the bloodstream.

PrEP is recommended by the WHO for individuals at high risk of HIV, and while adverse events are rare, there is a risk of developing drug-resistant strains in those who start PrEP without knowing they are already HIV positive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis: a useful tool to prevent human immunodeficiency virus infection? Pialoux, G., Delaugerre, C., Cotte, L., et al.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Factors impacting the provision of antiretroviral therapy to people living with HIV: the view from Haiti. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Case management interventions for HIV-infected individuals. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Larger is not necessarily better! Impact of HIV care unit characteristics on virological success: results from the French national representative ANRS-VESPA2 study. [2017]

4. England pubmed.ncbi.nlm.nih.gov

HIV care cascade before and after hospitalization: impact of a multidisciplinary inpatient team in the US South. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Case Management: Steadfast Resource for Addressing Linkage to Care and Prevention with Hospitalized HIV-Infected Crack Users. [2020]

6. France pubmed.ncbi.nlm.nih.gov

[HIV/AIDS prophylaxis following exposure]. [2016]

7. Netherlands pubmed.ncbi.nlm.nih.gov

[Post-exposure prophylaxis following exposure to HIV: adaptation to the situation may be indicated]. [2008]

8. England pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis: a useful tool to prevent human immunodeficiency virus infection? [2017]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Antiretroviral prophylaxis for sexual and injection drug use acquisition of HIV. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

HIV-Negative Partnered Men's Willingness to Use Non-Occupational Post-Exposure Prophylaxis and Associated Factors in a U.S. Sample of HIV-Negative and HIV-Discordant Male Couples. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Using Intervention Mapping to develop a programme to prevent sexually transmittable infections, including HIV, among heterosexual migrant men. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

The Solaar HIV prevention program for gay and bisexual Latino men: using social marketing to build capacity for service provision and evaluation. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

[HIV pre-exposure prophylaxis care in intersectoral collaboration : Interim analysis of a monocentric, prospective study in Germany]. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Feasibility and cohort development for HIV vaccine trials in Haiti. [2007]

15. United States pubmed.ncbi.nlm.nih.gov

Prevention of HIV among adolescents. [2021]