Entre Herman@s: Promoting Health Among Latino MSM

Study Overview
=================
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.

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

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Entre Herman@s
* Behavioral: Vaccines for Health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Latino Men Who Have Sex with Men 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). Exclusion Criteria: Latino Men Who Have Sex with Men are unable to provide consent or they do not meet any of the criteria above Inclusion Criteria: Siblings 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 Exclusion Criteria: Siblings are unable to provide consent or they do not meet any of the criteria above

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEP Promotion<br> | Behavioral: Entre Herman@s<br>* 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.<br>|
| Placebo Comparator: Vaccine Promotion<br> | Behavioral: Vaccines for Health<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Men Who Have Sex with Men, Latino men, HIV PrEP, Siblings