Bridge to Belonging: Peer Led Intervention to Reduce Loneliness and Depression Among Older Gay and Bisexual Men

NCT07762066 | Recruiting

• 2 other identifiers: IRB2024-15R21AG087792
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Older gay and bisexual men living with HIV (OGBMLH) are more likely to experience depression and loneliness, which can lead to negative health outcomes. This mixed-methods research study will assess the feasibility and acceptability of the Bridge to Belonging (B2B) intervention. B2B is a peer-delivered, manualized program designed to increase engagement in LGBTQ+-affirming elder services and thereby reduce loneliness and depression among OGBMLH. The program utilizes a) cognitive behavioral therapy-based Friendship Enrichment Program (FEP) to build social skills; b) Peer Mentoring (PM) to model and support engagement in community services; and c) connecting participants to affirming elder services such as meal programs, bereavement groups, social activities, etc. Interventions like B2B are essential to the NIH's goal of improving access to behavioral interventions through advances in HIV/AIDS research.

Conditions

HIV

Outcome Measures

Primary Outcomes (6)

• Feasibility of recruitment

  Proportion of eligible participants who agree to enroll in the study, tracked alongside number of screenings conducted, proportion of participants found eligible, and number of scheduled and missed study visits.

  Through end of enrollment, anticipated September 7, 2026

• Proportion of Intervention-Arm Participants Completing at Least One B2B Session

  Proportion of enrolled participants randomized to the intervention arm who complete at least one B2B session.

  Up to 11 weeks

• Perceived Feasibility and Satisfaction with B2B, Assessed via Qualitative Exit Interviews

  Perceived feasibility and satisfaction with the B2B intervention from the perspectives of intervention-arm participants and peer interventionists, assessed through semi-structured qualitative exit interviews. Responses will be analyzed thematically; no numeric composite score is generated.

  Week 25

• Fidelity to B2B Intervention Content, Assessed via Post-Session Fidelity Checklist

  Proportion of session content items rated as completed fully by peer facilitators, assessed via a study-developed checklist documenting delivery of each of the 10 B2B sessions' core content elements.

  Up to 11 weeks

• B2B Intervention Satisfaction, Assessed via Modified Client Satisfaction Questionnaire (CSQ-8)

  Participant satisfaction with the B2B intervention, measured via a modified 8-item Client Satisfaction Questionnaire (CSQ-8) administered after each of the 10 B2B sessions. The CSQ-8 ranges from 8 to 32, with higher scores indicating greater satisfaction.

  Up to 11 weeks

• Retention Feasibility, Proportion of Enrolled Participants Completing Follow-Up Assessment

  Proportion of enrolled participants who complete their final follow-up assessment. For control-arm participants, this is Research Visit 2 at Week 24. For intervention-arm participants, this is the exit interview at Week 25. Number of rescheduled and missed appointments will also be documented.

  Through Week 25

Secondary Outcomes (12)

• PHQ-9 Score at 3-Month Follow-Up

  Week 12

• PHQ-9 Score at 6-Month Follow-Up

  Week 24

• UCLA Loneliness Scale Score at 3-Month Follow-Up

  Week 12

• UCLA Loneliness Scale Score at 6-Month Follow-Up

  Week 24

• OARS Instrumental Activities of Daily Living Score at 3-Month Follow-Up

  Week 12

Study Arms (2)

B2B Intervention

EXPERIMENTAL

This 10-session peer-delivered intervention is designed to reduce depression and loneliness among OGBMLH by addressing barriers to engagement in LGBTQ+-affirming community services. The intervention involves group sessions facilitated by trained peer interventionists, drawing on two evidence-based components: the cognitive behavioral therapy-based Friendship Enrichment Program (FEP) to build social skills and Peer Mentoring (PM) to model and support engagement in community services. Sessions are structured around skill-building activities designed to a) reduce stigma-related barriers to community participation, b) create and strengthen social connections, and c) increase confident and motivation to engage in community services. Participants will also receive resource navigation as needed.

Behavioral: B2B Intervention

Control

ACTIVE COMPARATOR

The control condition will involve a resource guide of content related to local LGBTQ+-affirming community service (e.g., information related to community meal programs, social groups, etc.)

Behavioral: Control condition

Interventions

B2B Intervention BEHAVIORAL

This 10-session peer-delivered intervention is designed to reduce depression and loneliness among OGBMLH by addressing barriers to engagement in LGBTQ+-affirming community services. The intervention involves group sessions facilitated by trained peer interventionists, drawing on two evidence-based components: the cognitive behavioral therapy-based Friendship Enrichment Program (FEP) to build social skills and Peer Mentoring (PM) to model and support engagement in community services. Sessions are structured around skill-building activities designed to a) reduce stigma-related barriers to community participation, b) create and strengthen social connections, and c) increase confident and motivation to engage in community services. Participants will also receive resource navigation as needed.

B2B Intervention

Control condition BEHAVIORAL

The control condition will involve a resource guide of content related to local LGBTQ+-affirming community service (e.g., information related to community meal programs, social groups, etc.)

Control

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Cisgender male, transgender male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+ and provide evidence or documentation of HIV+ status
• Willing to release HIV-related health records
• Self-identify as a man who has sex with men
• Able to provide informed consent in English
• Be ≥50 years old
• Score at least a 2 on the PHQ-2 OR score at least a 4 on the UCLA Shortened Loneliness Scale

You may not qualify if:

• HIV-
• Does not self-identify as a man who has sex with men
• Is less than 50 years old
• Scores less than 2 on the PHQ-2 AND scores less than 4 on the UCLA Shortened Loneliness Scale

Sponsors & Collaborators

• Fenway Community Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Fenway Health

Boston, Massachusetts, 02215, United States

RECRUITING

Central Study Contacts

Abigail W Batchelder, PhD, MPH

CONTACT

6173587640; abigail.batchelder@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: August 13, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-05

Locations

US (1)