Entre Herman@s: Promoting Health Among Latino MSM

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805306
• Other study ID #: 1995640-1
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2024
• Source: Charles Drew University of Medicine and Science
• Contact: Homero del Pino, PhD, MS
• Phone: 2132588079
• Email: homerodelpino[@]cdrewu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Charles R. Drew University of Medicine and Science	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Charles Drew University of Medicine and Science	St. John's Community Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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