NCT07475702

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Jan 2026Mar 2028

Study Start

First participant enrolled

January 13, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

March 25, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

March 5, 2026

Last Update Submit

March 20, 2026

Conditions

Help-Seeking BehaviorPre-exposure Prophylaxis UseCondomless SexRisky Health Behavior

Outcome Measures

Primary Outcomes (1)

  • Self-reported condomless anal intercourse

    From baseline to end the of intervention, at twelve months.

Secondary Outcomes (2)

  • Self-Esteem

    From enrollment to the end of intervention at 12 months

  • Social Support

    From enrollment to the end of intervention, at 12 months.

Study Arms (2)

Intervention Community

OTHER

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.

Behavioral: Moon and Sun Brothers: A Community Prevention Intervention

Control Community

NO INTERVENTION

Participants in the control arm will be unexposed to the intervention components.

Interventions

Moon and Sun Brothers: A Community Prevention InterventionBEHAVIORAL

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).

Intervention Community

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified male, which includes transmasculine
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco State University

San Francisco, California, 94132, United States

RECRUITING

Chicago Queer Latine Collaborative

Chicago, Illinois, 60607, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Help-Seeking BehaviorUnsafe SexHealth Risk Behaviors

Interventions

Moon

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorSexual BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Earth, PlanetPlanetsSolar SystemAstronomical ObjectsAstronomical PhenomenaPhysical Phenomena

Central Study Contacts

Emma V Sanchez-Vaznaugh, ScD

CONTACT

415-405-2832emmav@sfsu.edu

Rita Melendez, PhD

CONTACT

rmelende@sfsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study is designed as a quasi-experimental, with a community intervention group and a control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 16, 2026

Study Start

January 13, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

March 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified Individual participant data collected as part of this intervention.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The IPD and supporting information will be available after all specific analyses have been completed (on or about 7/31/2029), and available 36 months thereafter.
Access Criteria
Researchers engaged in independent scientific research may request access to the IPD by submitting a research proposal and a statistical analysis plan. After review and approval of the proposal, a signed data sharing agreement is required before the data can be accessed.

Locations

US(2)