- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07475702
Moon and Sun Brothers: A Community Prevention Intervention (Hermanos de Luna y Sol)
The goal of this quasi-experimental, community intervention is to reduce HIV sexual risk among Latino immigrant bisexual men or men who have sex with men. The main questions the study aims to answer are:
Does the intervention improve sexual risk behaviors? Does the intervention increase self-esteem and social support? Are self-esteem and social support mediators in the link between the intervention and sexual risk? Researchers will compare information from the intervention versus control participants to answer the above questions.
Participants in the intervention arm will take part in:
- One day-long (8-hour) group retreat.
- Weekly discussion groups.
- Community events and civic engagement activities.
- Prevention counseling. Participants in the control arm will not be part of any activity.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emma V Sanchez-Vaznaugh, ScD
- Phone Number: 415-405-2832
- Email: emmav@sfsu.edu
Study Contact Backup
- Name: Rita Melendez, PhD
- Email: rmelende@sfsu.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94132
- Recruiting
- San Francisco State University
-
Contact:
- Emma V Sanchez-Vaznaugh, ScD
- Phone Number: 415-405-2832
- Email: emmav@sfsu.edu
-
Contact:
- Maria E Acosta, MPH
- Phone Number: 415-405-2832
- Email: macosta3@sfsu.edu
-
Sub-Investigator:
- Rita Melendez, PhD
-
-
Illinois
-
Chicago, Illinois, United States, 60607
- Recruiting
- Chicago Queer Latine Collaborative
-
Contact:
- Pedro A Serrano, MPH, DrPH (c)
- Phone Number: 708-683-9304
- Email: pserrano@sfsu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Identify as male.
- Latino/x/e
- Report having sex with men only, or both men and women in the last 12 months.
- Speaks, reads/writes in Spanish.
- ≥18 years of age.
- Has access to a computer, laptop, tablet or smart phone device.
- Be willing to participate in the study.
- Be able to provide informed consent.
Exclusion Criteria:
- Populations younger than 18 years.
- Individuals who have participated in an Hermanos de Luna y Sol program in either the intervention or control group locations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention Community
Over the course of twelve months, study participants will participate in: 1) One day-long (8-hour) group retreat (dosage: 100%); 2) Weekly discussion groups (dosage: minimum of 50% of weekly sessions); 3) Community participation (dosage: minimum of 5 civic engagement activities; 50% of community events); and 4) Prevention counseling sessions (dosage: minimum of 1 session).
Intervention participants will take part in all four components.
|
The is a community-based, group intervention delivered in Spanish, using a quasi-experimental design, to reduce HIV sexual risk among Hispanic immigrants who identify as gay/bisexual men or men who have sex with men (GBMSM).
|
|
No Intervention: Control Community
Participants in the control arm will be unexposed to the intervention components.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-reported condomless anal intercourse
Time Frame: From baseline to end the of intervention, at twelve months.
|
From baseline to end the of intervention, at twelve months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Esteem
Time Frame: From enrollment to the end of intervention at 12 months
|
We will assess self-esteem using the 20-item Inner Strength Scale adapted for this study with response options and corresponding scores as follows: never (0), rarely (1), sometimes (2), often (4) and very often (4).
The scores ranged from 0 to 80 with higher scores denoting higher degrees of inner strength.
|
From enrollment to the end of intervention at 12 months
|
|
Social Support
Time Frame: From enrollment to the end of intervention, at 12 months.
|
We will assess social support using a 20-item questionnaire developed by Krause, measuring social embeddedness (contact with friends and family) and enacted support from others (which entail emotional, tangible and informational support).
These items are scored (coding in parentheses) based on the following responses: never (0), rarely (1), sometimes (2), often (3) and very often (4).
The scores range from 0-80, with higher scores denoting a higher degree of social support.
|
From enrollment to the end of intervention, at 12 months.
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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