HIVB2BNCT07762066
Bridge to Belonging: Peer Led Intervention to Reduce Loneliness and Depression Among Older Gay and Bisexual Men
A study testing B2B Intervention in people with HIV, run by Fenway Community Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV
- What is being tested?
- B2B Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fenway Health
Boston, Massachusetts, 02215
Abigail W Batchelder, PhD, MPH, 617-358-7640, abigail.batchelder@bmc.org
About this study
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.
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- B2B Intervention, Control condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B2B InterventionBehavioural
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 conditionBehavioural
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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.) Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through Week 25
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
OARS Instrumental Activities of Daily Living Score at 6-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 3 months after the intervention. The composite score ranges from 0 to 17, with higher scores indicating greater functional independence.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start6 May 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenway Community Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762066
- Sponsor's protocol ID
- IRB2024-15
- Other IDs
- R21AG087792
- Acronym
- B2B
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridge to Belonging: Peer Led Intervention to Reduce Loneliness and Depression Among Older Gay and Bisexual Men
- ClinicalTrials.gov ID
- NCT07762066
- Acronym / sponsor ID
- B2B / IRB2024-15
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fenway Community HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 May 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B2B Intervention | Experimental | Behavioral: B2B InterventionThis 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 | Active comparator | Behavioral: Control conditionThe 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.) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B2B InterventionThis 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. | Behavioural | B2B Intervention |
| Control conditionThe 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.) | Behavioural | Control |
Primary outcome
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.
12 secondary outcomes
PHQ-9 Score at 3-Month Follow-Up
Time frame: Week 12
PHQ-9 Score at 6-Month Follow-Up
Time frame: Week 24
UCLA Loneliness Scale Score at 3-Month Follow-Up
Time frame: Week 12
UCLA Loneliness Scale Score at 6-Month Follow-Up
Time frame: Week 24
OARS Instrumental Activities of Daily Living Score at 3-Month Follow-Up
Time frame: Week 12
OARS Instrumental Activities of Daily Living Score at 6-Month Follow-Up
Time frame: Week 24
VAS Antiretroviral Adherence at Baseline
Time frame: Baseline
VAS Antiretroviral Adherence at 3-Month Follow-Up
Time frame: Week 12
VAS Antiretroviral Adherence at 6-Month Follow-Up
Time frame: Week 24
Viral Suppression at 6-Month Follow-Up
Time frame: Week 24
Flanagan's QOLS Score at 3-Month Follow-Up
Time frame: Week 12
Flanagan's QOLS Score at 6-Month Follow-Up
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B2B Intervention in people with HIV, run by Fenway Community Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail W Batchelder, PhD, MPH (6173587640, abigail.batchelder@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Through end of enrollment, anticipated September 7, 2026). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.