Recruiting

B2B Intervention

Sponsor:

Fenway Community Health

Code:

NCT07762066

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

B2B Intervention

Control condition

Study Details

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

Study ID

NCT07762066

Start date

May 6, 2026

Status verified date

May, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Control

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.)

Interventions

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.

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 measure

  • Feasibility of recruitment [ Time Frame: Through end of enrollment, anticipated September 7, 2026 ]
  • Proportion of Intervention-Arm Participants Completing at Least One B2B Session [ Time Frame: Up to 11 weeks ]
  • Perceived Feasibility and Satisfaction with B2B, Assessed via Qualitative Exit Interviews [ Time Frame: Week 25 ]
  • Fidelity to B2B Intervention Content, Assessed via Post-Session Fidelity Checklist [ Time Frame: Up to 11 weeks ]
  • B2B Intervention Satisfaction, Assessed via Modified Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Up to 11 weeks ]
  • Retention Feasibility, Proportion of Enrolled Participants Completing Follow-Up Assessment [ Time Frame: Through Week 25 ]

Central Contacts and Locations

Central contacts

Abigail W Batchelder, PhD, MPH

6173587640abigail.batchelder@bmc.org

Locations

Fenway Health

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Abigail W Batchelder, PhD, MPH

617-358-7640abigail.batchelder@bmc.org

More Information

Sponsor

Fenway Community Health

Last update posted

Aug 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fenway Community Health on 2026-08-13.