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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to reduce HIV cases among Latino men who have sex with men by involving their siblings in promoting the use of PrEP, a medication that helps prevent HIV. Participants will either learn how to discuss PrEP with their brothers or talk about other vaccines, such as those for COVID and Hepatitis, as part of the Entre Herman@s program. The trial seeks Latino men under 40 who are HIV-negative and have not recently used PrEP, along with their siblings who are open to discussing healthcare issues.

As an unphased trial, this study offers participants the chance to contribute to innovative strategies in HIV prevention within their community.

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 prior data suggests that the Entre Herman@s Program is safe for HIV prevention?

Research has shown that the Entre Herman@s program aims to encourage the use of PrEP (pre-exposure prophylaxis) to prevent HIV. PrEP is safe and effective in lowering the risk of HIV infection, especially for men who have sex with men. Studies indicate that PrEP is usually well-tolerated, with only a few side effects. Common side effects might include nausea or headaches, but these are generally mild.

The Entre Herman@s program does not involve taking any medication. It focuses on encouraging conversations between siblings to raise health awareness and promote PrEP use. Therefore, the program poses no direct safety concerns. Participants can feel confident that the program is safe, as it centers on communication and education. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Entre Herman@s Program for HIV prevention because it focuses on culturally tailored education and community engagement to promote PrEP (pre-exposure prophylaxis) usage. Unlike standard HIV prevention methods, which often rely on general awareness campaigns, this program specifically targets Latino communities, addressing cultural barriers and enhancing accessibility. The innovative approach of fostering community-based advocacy and education is expected to increase PrEP adoption rates, ultimately reducing new HIV infections in these underserved populations.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research has shown that involving family members in health discussions can help prevent HIV. A review of 28 studies found that family involvement in care leads to fewer unmet health needs and better health outcomes. The Entre Herman@s program in this trial targets Latino men who have sex with men, using siblings to promote the use of PrEP, a medicine that helps prevent HIV. Participants may join the PrEP Promotion arm, which employs this family involvement strategy. Evidence from similar programs indicates that family involvement can boost awareness and use of preventive measures like PrEP. This approach leverages close family ties to support healthier choices and reduce HIV cases. ^{1 2 6 7 8}

Who Is on the Research Team?

Homero del Pino, PhD, MS

Principal Investigator

Charles Drew University of Medicine and Science

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-hiv-infections-3-2023-bc6a4

Entre Herman@s Program for HIV Prevention The review of 28 studies indicates that effective case management can lead to decreased mortality, better retention in care, reduced unmet needs, and lower ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05805306

Entre Herman@s: Promoting Health Among Latino MSM The goal of this study is to decrease HIV incidence in Latino men who have sex with men by engaging their siblings in PrEP-use promotion.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003639

Contingency Management and Pre-Exposure Prophylaxis ... Conclusions. Results from this protocol are anticipated to yield novel findings regarding the impact and scalability of CoMPASS to promote HIV prevention among ...

4. dailybruin.com dailybruin.com/2024/05/21/sibling-support-helps-lgbtq-latino-men-take-hiv-prevention-measures-study-finds

Sibling support helps LGBTQ+ Latino men take HIV ... The National Institutes of Health-funded study – titled “Entre Herman@s ... The number of family-based HIV prevention for Latinos is almost zero.

5. ctv.veeva.com ctv.veeva.com/study/entre-herman-s-promoting-health-among-latino-msm

Entre Herman@s: Promoting Health Among Latino MSM This is a randomized controlled trial with an attention placebo control group. The goal of this study is to decrease HIV incidence in Latino ...

6. trialx.com trialx.com/clinical-trials/listings/222835/entre-hermans-promoting-health-among-latino-msm/

Entre Herman@s: Promoting Health Among Latino MSM This is a randomized controlled trial with an attention placebo control group. The goal of this study is to decrease HIV incidence in Latino men who have sex ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05805306?keyword=%22Men%22

Entre Herman@s: Promoting Health Among Latino MSM This is a randomized controlled trial with an attention placebo control group. The goal of this study is to decrease HIV incidence in Latino men who have ...

8. researchgate.net researchgate.net/publication/318652268_Efficacy_safety_and_effect_on_sexual_behaviour_of_on-demand_pre-exposure_prophylaxis_for_HIV_in_men_who_have_sex_with_men_An_observational_cohort_study

Efficacy, safety, and effect on sexual behaviour of on- ... There is scientific evidence that shows this modality provides effective HIV prevention for SMM engaging in condomless anal sex [10] [11] [12].