AgingNCT07831759
Geri Pride: Feasibility Pilot of a Group Intervention for Older Veterans
A study testing Geri Pride Health Promotion Group in people with Aging and Veterans, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
There are over one million Veterans who identify as lesbian, gay, bisexual, (LGB) or a related identity. Older LGB Veterans face unique hurdles as they age, including stress, anxiety, heart disease, cancer, decreased ability to perform activities of daily living, delayed care, and increased likelihood of entering a… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Veterans, Social Determinants of Health
- What is being tested?
- Geri Pride Health Promotion Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2027to 31 Jul 2030
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets Pride in All Who Served (PAWS) clinical care service delivery screening criteria (e.g., identify as lesbian, gay, bisexual (LGB) or related identity, not experiencing acute symptoms that prevent meaningful participation in group-delivered care, able to access clinical care at a partnering site)
- Cognitively able to provide consent to participate in research
- 50 years or older at the time of enrollment
Who cannot join
- Unable to meet all inclusion criteria
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
William Bryant, PhD, (84-3) -5559 ext. 363383
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Christopher B Holland-Deguire, PsyD, 214-857-3794
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
Michelle Wilcox, LCSW-C, (80-1) -0396
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404-5015
Michelle M Hilgeman, PhD, (205) 554-2000 ext. 3278, Michelle.Hilgeman@va.gov
Susan D Hopkins, (205) 554-2000 ext. 3674, Susan.Hopkins@va.gov
About this study
Official title: Geri Pride: an Adapted Intervention to Support Healthy Aging of Sexual and Gender Minority Veterans
There are over one million Veterans who identify as lesbian, gay, bisexual, (LGB) or a related identity. Older LGB Veterans face unique hurdles as they age, including stress, anxiety, heart disease, cancer, decreased ability to perform activities of daily living, delayed care, and increased likelihood of entering a nursing home. Sparse social networks and limited access to aging resources are common for LGB Veterans and contribute to adverse outcomes. The proposed study will partner with older Veterans to adapt and test a virtual structured group that promotes healthy aging, self-acceptance, and connection to health-related resources. This study aims to improve Veterans' health and well-being through increased resilience, positive healthcare engagement, and access to resources that support older Veterans' needs. There are currently no other VA programs designed to address the unmet needs of older LGB Veterans. By learning more about how to serve subgroups of Veterans more effectively, this study will also improve outcomes for all older Veterans and their care partners.
Read the detailed description
Background: Older Veterans with lesbian, gay, bisexual and related identities are vulnerable to preventable differences in health outcomes. These stress-related outcomes can be traced to social, occupational, and economic mistreatment over the lifespan. Pride in All Who Served (PAWS) is an evidence-based practice that serves LGB Veterans of all ages and has been implemented in over 70 VAs with over 1000 Veteran participants. Though it was designed as a broad health promotion group, the absence of key content relevant to aging dampens its impact for older Veterans.
Significance to VA: There are currently no interventions or clinical trials that address the unmet needs of older LGB Veterans in VHA. This proposal aligns with VA priorities to address preventable health differences and the needs of aging Veterans.
Innovation and Impact: This study will adapt a novel and vital intervention for the growing population of older LGB Veterans. By addressing the structural factors that have contributed to health vulnerabilities for LGB Veterans it will also address the pressing needs of aging, promote resilience, and provide a means for aging LGB Veterans to engage positively in their health.
Specific Aims: 1) Aim 1 focuses on adapting PAWS with input from older LGB Veterans, experienced PAWS facilitators, and key clinical leaders and operations partners (e.g., Geriatrics and Extended Care services). We will then pilot the new intervention to assess feasibility and related outcomes ahead of a full-scale RCT in the future. Specifically, Aim 2 will assess the feasibility, fidelity, and acceptability of the intervention for Veterans, clinicians, clinical leaders, and operational partners. 3) Aim 3 evaluates Veteran-centered measures by examining the preliminary effects of the new intervention. Preliminary outcomes will include mental health, psychosocial, and healthy aging-related outcomes such as anxiety, resilience, social connection, healthcare engagement, risk of long-term care, and advance care planning.
Methodology: Interview and focus group data from clinicians, operational partners, and PAWS facilitators and past participants will be used to create the new intervention. The FRAME approach will be used to track and evaluate adaptations to the PAWS intervention to create the new intervention (i.e., Geri-Pride). For the single-arm pilot, between 48-64 Veterans who identify as LGB or a related identity and who are 50 years of age and older will be recruited to the pilot. The pilot is powered to detect change in anxiety as measured by 3-point pre-post differences in the Generalized Anxiety Disorder (GAD-7) score. During the pilot, fidelity will be assessed using a fidelity check list. Geri-Pride will be evaluated for acceptability of the intervention and feasibility for a future clinical trial via interviews with PAWS interventionists, Veteran participants, VA clinical leaders, and operational partners. For all aims, interviews and focus group content will be analyzed using rapid qualitative analysis. VA CDW and GECDAC data files will also be extracted to measure potential signals of impact on healthcare utilization and related outcomes (e.g., risk for admission to long- term care, financial hardship, and housing instability). Feasibility for a future clinical trial will also be assessed on outcomes such as recruitment, retention, measurement completion, etc.
Path to Translation/Implementation: Results of this proposal will generate a first of its kind intervention designed to meet the needs of older LGB Veterans. The new intervention will then be tested in a fully powered, randomized clinical trial in a subsequent Merit. If the results indicate promising impacts on Veteran outcomes, the investigators will partner with the Office of Geriatrics and Extended Care and related offices to further test and disseminate programs like this one across VA.
- Conditions
- Aging, Veterans, Social Determinants of Health, Health Disparate Minority and Vulnerable Populations
- Being tested
- Geri Pride Health Promotion Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geri Pride Health Promotion GroupBehavioural
A structured, health promotion intervention adapted from the VA Pride in All Who Served program that covers a different topic each week related to healthy aging, internalized stress, what matters most/goals of care, social connections and care networks, VA and community resources, and other topics that promote well-being.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Manualized, structured, health promotion group delivered over tele-health or in a hybrid format. Receives: Behavioral: Geri Pride Health Promotion Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention in the Intervention (Feasibility Indicator)
The primary indicator of intervention feasibility will be retention rate, operationalized as the % of enrolled participants who complete the intervention as tracked on attendance logs (observational data). Feasible retention in this multi-session psychosocial intervention is set at >60% given anticipated intervention duration, prior trials with the parent intervention, and population comorbidities.
Measured: Active intervention-delivery period
Generalized Anxiety Disorder Score (GAD-7)
Symptoms of anxiety will be assessed using a 7-item self-report measure used frequently in clinical care settings within VHA. It will be completed by Veterans before and after the group.
Measured: Pre/Post Measures will be collected within approximately 1 month before the first session, and within 1 month of the last session. Time between pre and post measures will be approximately 4-6 months apart.
Secondary outcomes (1)
Patient Health Questionnaire (PHQ-9)
Symptoms of depression will be assessed on a 9-item self-report measure of depression symptoms that is used frequently in clinical care settings within VHA. It will be completed by Veterans before and after the group.
Measured: Pre/Post Measures will be collected within approximately 1 month before the first session, and within 1 month of the last session. Time between pre and post measures will be approximately 4-6 months apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Jul 2027 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a behavioral health intervention development and adaptation study that will adapt an existing VA intervention called Pride in All Who Served (PAWS) for older Veterans in Year 1. The resulting structured group intervention will then be tested beginning in Year 2 of the study for feasibility, acceptability, and preliminary indicators of impact on clinical and social outcomes.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michelle Marie Hilgeman, PhD, Principal investigator, Tuscaloosa VA Medical Center, Tuscaloosa, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831759
- Sponsor's protocol ID
- HSR2-005-24W
- Other IDs
- 1I01RD000615-01A2
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geri Pride: an Adapted Intervention to Support Healthy Aging of Sexual and Gender Minority Veterans
- ClinicalTrials.gov ID
- NCT07831759
- Acronym / sponsor ID
- HSR2-005-24W
- Conditions
- Aging, Veterans, Social Determinants of Health, Health Disparate Minority and Vulnerable Populations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 21 Sep 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.
There are over one million Veterans who identify as lesbian, gay, bisexual, (LGB) or a related identity. Older LGB Veterans face unique hurdles as they age, including stress, anxiety, heart disease, cancer, decreased ability to perform activities of daily living, delayed care, and increased likelihood of entering a nursing home. Sparse social networks and limited access to aging resources are common for LGB Veterans and contribute to adverse outcomes. The proposed study will partner with older Veterans to adapt and test a virtual structured group that promotes healthy aging, self-acceptance, and connection to health-related resources. This study aims to improve Veterans' health and well-being through increased resilience, positive healthcare engagement, and access to resources that support older Veterans' needs. There are currently no other VA programs designed to address the unmet needs of older LGB Veterans. By learning more about how to serve subgroups of Veterans more effectively, this study will also improve outcomes for all older Veterans and their care partners.
Detailed description
Background: Older Veterans with lesbian, gay, bisexual and related identities are vulnerable to preventable differences in health outcomes. These stress-related outcomes can be traced to social, occupational, and economic mistreatment over the lifespan. Pride in All Who Served (PAWS) is an evidence-based practice that serves LGB Veterans of all ages and has been implemented in over 70 VAs with over 1000 Veteran participants. Though it was designed as a broad health promotion group, the absence of key content relevant to aging dampens its impact for older Veterans.
Significance to VA: There are currently no interventions or clinical trials that address the unmet needs of older LGB Veterans in VHA. This proposal aligns with VA priorities to address preventable health differences and the needs of aging Veterans.
Innovation and Impact: This study will adapt a novel and vital intervention for the growing population of older LGB Veterans. By addressing the structural factors that have contributed to health vulnerabilities for LGB Veterans it will also address the pressing needs of aging, promote resilience, and provide a means for aging LGB Veterans to engage positively in their health.
Specific Aims: 1) Aim 1 focuses on adapting PAWS with input from older LGB Veterans, experienced PAWS facilitators, and key clinical leaders and operations partners (e.g., Geriatrics and Extended Care services). We will then pilot the new intervention to assess feasibility and related outcomes ahead of a full-scale RCT in the future. Specifically, Aim 2 will assess the feasibility, fidelity, and acceptability of the intervention for Veterans, clinicians, clinical leaders, and operational partners. 3) Aim 3 evaluates Veteran-centered measures by examining the preliminary effects of the new intervention. Preliminary outcomes will include mental health, psychosocial, and healthy aging-related outcomes such as anxiety, resilience, social connection, healthcare engagement, risk of long-term care, and advance care planning.
Methodology: Interview and focus group data from clinicians, operational partners, and PAWS facilitators and past participants will be used to create the new intervention. The FRAME approach will be used to track and evaluate adaptations to the PAWS intervention to create the new intervention (i.e., Geri-Pride). For the single-arm pilot, between 48-64 Veterans who identify as LGB or a related identity and who are 50 years of age and older will be recruited to the pilot. The pilot is powered to detect change in anxiety as measured by 3-point pre-post differences in the Generalized Anxiety Disorder (GAD-7) score. During the pilot, fidelity will be assessed using a fidelity check list. Geri-Pride will be evaluated for acceptability of the intervention and feasibility for a future clinical trial via interviews with PAWS interventionists, Veteran participants, VA clinical leaders, and operational partners. For all aims, interviews and focus group content will be analyzed using rapid qualitative analysis. VA CDW and GECDAC data files will also be extracted to measure potential signals of impact on healthcare utilization and related outcomes (e.g., risk for admission to long- term care, financial hardship, and housing instability). Feasibility for a future clinical trial will also be assessed on outcomes such as recruitment, retention, measurement completion, etc.
Path to Translation/Implementation: Results of this proposal will generate a first of its kind intervention designed to meet the needs of older LGB Veterans. The new intervention will then be tested in a fully powered, randomized clinical trial in a subsequent Merit. If the results indicate promising impacts on Veteran outcomes, the investigators will partner with the Office of Geriatrics and Extended Care and related offices to further test and disseminate programs like this one across VA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a behavioral health intervention development and adaptation study that will adapt an existing VA intervention called Pride in All Who Served (PAWS) for older Veterans in Year 1. The resulting structured group intervention will then be tested beginning in Year 2 of the study for feasibility, acceptability, and preliminary indicators of impact on clinical and social outcomes.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Geri Pride Health Promotion GroupManualized, structured, health promotion group delivered over tele-health or in a hybrid format. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets Pride in All Who Served (PAWS) clinical care service delivery screening criteria (e.g., identify as lesbian, gay, bisexual (LGB) or related identity, not experiencing acute symptoms that prevent meaningful participation in group-delivered care, able to access clinical care at a partnering site)
- Cognitively able to provide consent to participate in research
- 50 years or older at the time of enrollment
Key exclusion criteria (1 listed)
- Unable to meet all inclusion criteria
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 |
|---|---|---|
| Geri Pride Health Promotion GroupA structured, health promotion intervention adapted from the VA Pride in All Who Served program that covers a different topic each week related to healthy aging, internalized stress, what matters most/goals of care, social connections and care networks, VA and community resources, and other topics that promote well-being. | Behavioural | Intervention Group |
Primary outcome
Participant Retention in the Intervention (Feasibility Indicator)
Time frame: Active intervention-delivery period
The primary indicator of intervention feasibility will be retention rate, operationalized as the % of enrolled participants who complete the intervention as tracked on attendance logs (observational data). Feasible retention in this multi-session psychosocial intervention is set at >60% given anticipated intervention duration, prior trials with the parent intervention, and population comorbidities.
Generalized Anxiety Disorder Score (GAD-7)
Time frame: Pre/Post Measures will be collected within approximately 1 month before the first session, and within 1 month of the last session. Time between pre and post measures will be approximately 4-6 months apart.
Symptoms of anxiety will be assessed using a 7-item self-report measure used frequently in clinical care settings within VHA. It will be completed by Veterans before and after the group.
1 secondary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: Pre/Post Measures will be collected within approximately 1 month before the first session, and within 1 month of the last session. Time between pre and post measures will be approximately 4-6 months apart.
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Michelle Marie Hilgeman, PhD principal investigator
Tuscaloosa VA Medical Center, Tuscaloosa, AL
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geri Pride Health Promotion Group in people with Aging and Veterans, run by VA Office of Research and Development at 4 sites 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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Michelle M Hilgeman, PhD ((205) 554-2000 ext. 3278, Michelle.Hilgeman@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention in the Intervention (Feasibility Indicator) (time frame: Active intervention-delivery period). The study lists 2 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 21 Sep 2026.