Entre Herman@s: Promoting Health Among Latino MSM

NCT05805306 | Active Not Recruiting

• 2 other identifiers: 1995640-1U54MD007598
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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 with men by engaging their siblings in PrEP-use promotion. In the intervention arm, siblings will be trained to engage their gay brother in PrEP conversations. In the control arm, siblings will be trained to engage their gay brother in conversations about vaccines to prevent COVID, Hepatitis A/B, or MPOX.

Conditions

HIV Infections

Keywords

Men Who Have Sex with Men; Latino men; HIV PrEP; Siblings

Outcome Measures

Primary Outcomes (2)

• Number of participants that start using PrEP

  This measures how many participants in the experiment group started taking PrEP (baseline = 0 participants). Tool: Pictures. Participants will submit a picture of their pill bottle to report PrEP use.

  90 days

• Number of participants that get vaccinated

  This measures whether participants in the control group decided to get vaccinated for COVID, Hep A/B, or MPOX. Tool: Pictures. Participants will submit a picture of their proof-of-vaccination card to report vaccination status.

  90 days

Secondary Outcomes (2)

• Number of participants who increase their willingness to use PrEP

  90 days

• Number of participants who increase their willingness to get vaccinated

  90 days

Study Arms (2)

PrEP Promotion

EXPERIMENTAL

Behavioral: Entre Herman@s

Vaccine Promotion

PLACEBO COMPARATOR

Behavioral: Vaccines for Health

Interventions

Entre Herman@s BEHAVIORAL

The intervention unfolds as follows: (Week 1) the research team, Latino MSM, \& sibling will all engage in a PrEP Conversation followed by an individual Sibling Training for siblings to learn communication strategies for promoting health behaviors; (Week 2) we will send siblings reminders and a link to motivational interviewing techniques; (Week 3) we will conduct brief Follow-ups with siblings to determine if their brother changed his behavior; (Week 4) we will send a reminder to Latino MSM that they will have a follow-up the following week; (Week 5) we will conduct 30-day Follow-up with Latino MSM to determine if there was uptake of the new behavior change; (Week 7) same as week 5 above; (Week 10) send siblings information on motivational interviewing; (Week 12) final follow-up for both Latino MSM and siblings.

PrEP Promotion

Vaccines for Health BEHAVIORAL

The intervention unfolds as follows: (Week 1) the research team, Latino MSM, \& sibling will all engage in a Health Conversation about vaccines for COVID, Hep A/B, or MPOX, followed by an individual Sibling Training for siblings to learn communication strategies for promoting health behaviors; (Week 2) we will send siblings reminders and a link to motivational interviewing techniques; (Week 3) we will conduct brief Follow-ups with siblings to determine if their brother changed his behavior; (Week 4) we will send a reminder to Latino MSM that they will have a follow-up the following week; (Week 5) we will conduct 30-day Follow-up with Latino MSM to determine if there was uptake of the new behavior change; (Week 7) same as week 5 above; (Week 10) send siblings information on motivational interviewing; (Week 12) final follow-up for both Latino MSM and siblings.

Vaccine Promotion

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• self-identify as Latino
• identify as male
• be \<40 years old
• report HIV-negative status
• be willing to talk about MSM healthcare issues with a sibling
• either (a) have never used PrEP or (b) stopped using PrEP at least 90 days ago
• missing most recent COVID vaccine
• missing Hepatitis (A or B) vaccines
• missing Mpox vaccine
• meet CDC's PrEP eligibility criteria (be HIV-negative; any male sex partner in the past six months; not in a monogamous partnership with a recently tested, HIV-negative man; and at least one of the following: any anal sex without condoms in past 6 months, any sexually-transmitted infection (STI) diagnosed or reported in past 6 months, or is in an ongoing sexual relationship with an HIV-positive male partner).

You may not qualify if:

• are unable to provide consent or
• they do not meet any of the criteria above
• at least 18 years old
• report a close relationship his/her LMSM brother \<40 years old
• be willing to talk about MSM healthcare issues with his/her LMSM brother
• are unable to provide consent or
• they do not meet any of the criteria above

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• St. Johns Community Health: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Charles R. Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

HIV Infections; Homosexuality

Interventions

Vaccines; Health

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Population Characteristics

Study Officials

• Homero del Pino, PhD, MS

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: April 10, 2023
• Study Start: April 29, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)