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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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.)
Fenway Health
Boston, Massachusetts, United States
RECRUITINGFeasibility 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through Week 25
PHQ-9 Score at 3-Month Follow-Up
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.
Time frame: Week 12
PHQ-9 Score at 6-Month Follow-Up
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.
Time frame: Week 24
UCLA Loneliness Scale Score at 3-Month Follow-Up
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.
Time frame: Week 12
UCLA Loneliness Scale Score at 6-Month Follow-Up
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.
Time frame: Week 24
OARS Instrumental Activities of Daily Living Score at 3-Month Follow-Up
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.
Time frame: Week 12
OARS Instrumental Activities of Daily Living Score at 6-Month Follow-Up
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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.
Time frame: Week 24
VAS Antiretroviral Adherence at 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.
Time frame: Baseline
VAS Antiretroviral Adherence at 3-Month Follow-Up
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.
Time frame: Week 12
VAS Antiretroviral Adherence at 6-Month Follow-Up
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.
Time frame: Week 24
Viral Suppression at 6-Month Follow-Up
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.
Time frame: Week 24
Flanagan's QOLS Score at 3-Month Follow-Up
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.
Time frame: Week 12
Flanagan's QOLS Score at 6-Month Follow-Up
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.
Time frame: Week 24