Entre Herman@s: Promoting Health Among Latino MSM

Sponsor
Charles Drew University of Medicine and Science (Other)
Overall Status
Recruiting
CT.gov ID
NCT05805306
Collaborator
St. John's Community Health (Other)
248
1
2
9.6
25.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Entre Herman@s
  • Behavioral: Vaccines for Health
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
248 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Promoting HIV PrEP Among MSM: a Randomized Control Trial - Aim 3
Anticipated Study Start Date :
Apr 15, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants that start using PrEP [90 days]

    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.

  2. Number of participants that get vaccinated [90 days]

    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.

Secondary Outcome Measures

  1. Number of participants who increase their willingness to use PrEP [90 days]

    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.

  2. Number of participants who increase their willingness to get vaccinated [90 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charles R. Drew University of Medicine and Science Los Angeles California United States 90059

Sponsors and Collaborators

  • Charles Drew University of Medicine and Science
  • St. John's Community Health

Investigators

  • Principal Investigator: Homero del Pino, PhD, MS, Charles Drew University of Medicine and Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Homero del Pino, Associate Professor, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT05805306
Other Study ID Numbers:
  • 1995640-1
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Homero del Pino, Associate Professor, Charles Drew University of Medicine and Science
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2023