Entre Herman@s: Promoting Health Among Latino MSM

Promoting HIV PrEP Among MSM: a Randomized Control Trial - Aim 3

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Entre Herman@s; Behavioral: Vaccines for Health

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90059
      • Charles R. Drew University of Medicine and Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Latino Men Who Have Sex with Men

1. self-identify as Latino
2. identify as male
3. be <40 years old
4. report HIV-negative status
5. be willing to talk about MSM healthcare issues with a sibling
6. either (a) have never used PrEP or (b) stopped using PrEP at least 90 days ago
7. missing most recent COVID vaccine
8. missing Hepatitis (A or B) vaccines
9. missing Mpox vaccine
10. 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).

Exclusion Criteria: Latino Men Who Have Sex with Men

1. are unable to provide consent or
2. they do not meet any of the criteria above

Inclusion Criteria: Siblings

1. at least 18 years old
2. report a close relationship his/her LMSM brother <40 years old
3. be willing to talk about MSM healthcare issues with his/her LMSM brother

Exclusion Criteria: Siblings

1. are unable to provide consent or
2. they do not meet any of the criteria above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PrEP Promotion	Behavioral: Entre Herman@s; 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.
Placebo Comparator: Vaccine Promotion	Behavioral: Vaccines for Health; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who increase their willingness to use PrEP	This measures whether participants progress along the stages of change (e.g., pre-contemplation, contemplation, action) in their willingness to try PrEP if it were available to them. Tool: Stages of Change questionnaire administered at baseline and 90 days.	90 days
Number of participants who increase their willingness to get vaccinated	This measures whether participants progress along the stages of change (e.g., pre-contemplation, contemplation, action) in their willingness to get vaccinated against COVID, Hep A/B, or MPOX if it were available to them. Tool: Stages of Change questionnaire administered at baseline and 90 days.	90 days

Collaborators and Investigators

• Sponsor: Charles Drew University of Medicine and Science
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); St. Johns Community Health
• Investigators: Principal Investigator: Homero del Pino, PhD, MS, Charles Drew University of Medicine and Science

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2023
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HIV PrEP; Men Who Have Sex with Men; Siblings; Latino men
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Behavior; Sexual Behavior; Sexuality; HIV Infections; Homosexuality; Population Characteristics; Biological Products; Complex Mixtures; Vaccines; Health
• Other Study ID Numbers: 1995640-1; U54MD007598 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No