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NCT Number: NCT07762066

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

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.

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Key information

Conditions

HIV

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fenway Health

Boston, Massachusetts, 02215, United States

Location status: Recruiting

About this study

Among older gay and bisexual men living with HIV (OGBMLH), depression and loneliness are significantly more prevalent than among their heterosexual and HIV-negative peers. These elevated rates are driven in part by intersectional stigma (e.g. from age, HIV status, sexual orientation, etc.) and social isolation and/or family rejection. As a result, OGBMLH who experience depression and/or loneliness are more likely to experience cognitive decline, increased morbidity and mortality, and decreased overall quality of life. LGBTQ+-affirming community services for elders offer a promising avenue for providing socialization, many OGBMLH do not access these resources, likely due to anticipated discrimination and structural barriers to care. Interventions are needed to address these barriers so that OGBMLH can connect and engage with affirming community services, thereby building social support and reducing their depression and loneliness.

Guided by the ADAPT-ITT model, we developed and refined the Bridge to Belonging (B2B) intervention through two formative aims: focus group discussions with OGBMLH (Aim 1) and community experts and elder service providers (Aim 2). This process led to the B2B intervention, which is a peer-delivered, manualized program designed to increase engagement in LGBTQ+-affirming community services as a way to reduce depression and loneliness among OGBMLH. B2B aims to foster this engagement by utilizing a) a cognitive behavioral therapy-based Friendship Enrichment Program to build social skills; b) Peer Mentoring to model and support engagement in community services; and c) connecting participants to affirming elder services including meal programs, support groups, and social activities. The current study will conduct a proof-of-concept pilot (Aim 3; N=40) to assess the primary outcomes of feasibility (e.g. recruitment, delivery, retention rates, etc.). and acceptability (e.g. quantitative satisfaction measures and qualitative exit interviews of participants) of the B2B intervention. The study will assess pre-to-post changes in depression (PHQ-9), loneliness (UCLA Loneliness Scale), instrumental activities of daily living (OARS), antiretroviral adherence (Wilson's), HIV viral load, and quality of life (QOLS). Should the intervention demonstrate adequate feasibility and acceptability, and the hypothesized pathway of increasing engagement with affirming community services as a mechanism to reduce depression and loneliness be supported, we will be well-positioned to conduct a fully powered efficacy trial to assess B2B's scalability as a community-integrated behavioral health intervention for OGBMLH.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. PHQ-9 Score at 3-Month Follow-Up

    Time frame: Week 12

    Compare mean scores on the Patient Health Questionnaire-9 (PHQ-9) of participants randomized to the intervention to those randomized to the control condition immediately following the intervention. The PHQ-9 ranges from 0 to 27, with higher scores indicating greater depression severity.

  2. PHQ-9 Score at 6-Month Follow-Up

    Time frame: Week 24

    Compare mean scores on the Patient Health Questionnaire-9 (PHQ-9) of participants randomized to the intervention to those randomized to the control condition 3 months after the intervention. The PHQ-9 ranges from 0 to 27, with higher scores indicating greater depression severity.

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

    Time frame: Week 12

    Compare mean scores on the UCLA Loneliness Scale (20-item, Version 3) of participants randomized to the intervention to those randomized to the control condition immediately following the intervention. The scale ranges from 20 to 80, with higher scores indicating greater loneliness.

  4. UCLA Loneliness Scale Score at 6-Month Follow-Up

    Time frame: Week 24

    Compare mean scores on the UCLA Loneliness Scale (20-item, Version 3) of participants randomized to the intervention to those randomized to the control condition 3 months after the intervention. The scale ranges from 20 to 80, with higher scores indicating greater loneliness.

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

    Time frame: Week 12

    Compare mean scores on the Older Americans Resources and Services (OARS) Instrumental Activities of Daily Living questionnaire of participants randomized to the intervention to those randomized to the control condition immediately following the intervention. The composite score ranges from 0 to 17, with higher scores indicating greater functional independence.

  6. OARS Instrumental Activities of Daily Living Score at 6-Month Follow-Up

    Time frame: Week 24

    Compare mean scores on the Older Americans Resources and Services (OARS) Instrumental Activities of Daily Living questionnaire of participants randomized to the intervention to those randomized to the control condition 3 months after the intervention. The composite score ranges from 0 to 17, with higher scores indicating greater functional independence.

  7. VAS Antiretroviral Adherence at Baseline

    Time frame: Baseline

    Percentage of antiretroviral medication taken in the past 4 weeks, as reported by participants on a scale of 0-100%, with higher percentages indicating greater adherence.

  8. VAS Antiretroviral Adherence at 3-Month Follow-Up

    Time frame: Week 12

    Percentage of antiretroviral medication taken in the past 4 weeks, as reported by participants on a scale of 0-100%, with higher percentages indicating greater adherence.

  9. VAS Antiretroviral Adherence at 6-Month Follow-Up

    Time frame: Week 24

    Percentage of antiretroviral medication taken in the past 4 weeks, as reported by participants on a scale of 0-100%, with higher percentages indicating greater adherence.

  10. Viral Suppression at 6-Month Follow-Up

    Time frame: Week 24

    Compare the proportion of participants randomized to the intervention to those randomized to the control condition who are virally suppressed, when data is available from medical records.

  11. Flanagan's QOLS Score at 3-Month Follow-Up

    Time frame: Week 12

    Compare mean scores on Flanagan's Quality of Life Scale (QOLS) of participants randomized to the intervention to those randomized to the control condition immediately following the intervention. The QOLS ranges from 16 to 112, with higher scores indicating better quality of life.

  12. Flanagan's QOLS Score at 6-Month Follow-Up

    Time frame: Week 24

    Compare mean scores on Flanagan's Quality of Life Scale (QOLS) of participants randomized to the intervention to those randomized to the control condition 3 months after the intervention. The QOLS ranges from 16 to 112, with higher scores indicating better quality of life.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Fenway Community Health

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: B2B

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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