Back to resultsEntre Herman@s: Promoting Health Among Latino MSM
Primary Purpose
HIV Infections
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Entre Herman@s
Vaccines for Health
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Men Who Have Sex with Men, Latino men, HIV PrEP, Siblings
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
Sites / Locations
- Charles R. Drew University of Medicine and ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PrEP Promotion
Vaccine Promotion
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05805306
First Posted
March 1, 2023
Last Updated
September 8, 2023
Sponsor
Charles Drew University of Medicine and Science
Collaborators
St. John's Community Health
1. Study Identification
Unique Protocol Identification Number
NCT05805306
Brief Title
Entre Herman@s: Promoting Health Among Latino MSM
Official Title
Promoting HIV PrEP Among MSM: a Randomized Control Trial - Aim 3
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles Drew University of Medicine and Science
Collaborators
St. John's Community Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Men Who Have Sex with Men, Latino men, HIV PrEP, Siblings
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PrEP Promotion
Arm Type
Experimental
Arm Title
Vaccine Promotion
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Entre Herman@s
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vaccines for Health
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants that start using PrEP
Description
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.
Time Frame
90 days
Title
Number of participants that get vaccinated
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Number of participants who increase their willingness to use PrEP
Description
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.
Time Frame
90 days
Title
Number of participants who increase their willingness to get vaccinated
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Homero del Pino, PhD, MS
Phone
2132588079
Email
homerodelpino@cdrewu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Petra Duran, BA
Phone
(323) 357-3428
Email
petraduran@cdrewu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Homero del Pino, PhD, MS
Organizational Affiliation
Charles Drew University of Medicine and Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles R. Drew University of Medicine and Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Irons, PhD
Email
leeirons@cdrewu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Entre Herman@s: Promoting Health Among Latino MSM
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