NCT07762066 · Fenway Community Health
Bridge to Belonging: Peer Led Intervention to Reduce Loneliness and Depression Among Older Gay and Bisexual Men
(B2B)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
B2B Intervention
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
Control condition
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.)
Primary outcome measures
Feasibility of recruitment
Time frame: Through end of enrollment, anticipated September 7, 2026
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.
Proportion of Intervention-Arm Participants Completing at Least One B2B Session
Time frame: Up to 11 weeks
Proportion of enrolled participants randomized to the intervention arm who complete at least one B2B session.
Perceived Feasibility and Satisfaction with B2B, Assessed via Qualitative Exit Interviews
Time frame: Week 25
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.
Fidelity to B2B Intervention Content, Assessed via Post-Session Fidelity Checklist
Time frame: Up to 11 weeks
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.
B2B Intervention Satisfaction, Assessed via Modified Client Satisfaction Questionnaire (CSQ-8)
Time frame: Up to 11 weeks
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.
Retention Feasibility, Proportion of Enrolled Participants Completing Follow-Up Assessment
Time frame: Through Week 25
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Boston, Massachusetts
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2026 · Source of record for eligibility and locations