Housing InstabilityPATHHNCT07911722
A Patient Navigation Trial for Housing and Health (PATHH)
A study testing PATHH in people with Housing Instability and Health and Social Services, run by Friends Research Institute, Inc. at 1 site in United States.
Trial summary
This study will describe and evaluate the experiences and outcomes of women who have survived violence and also have medical needs. The intervention being tested is a service called 'PATHH', a patient navigation service that extends after a stay in an emergency shelter. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Housing Instability, Health and Social Services
- What is being tested?
- PATHH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2026to Aug 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identify as a woman;
- are age 18 or older
- report a history of physical or sexual violence in the last year using the Revised Conflict Tactics Scale
- report a qualifying health condition requiring ongoing engagement in healthcare and commonly occurring in this population, including substance use disorder, depression, and/or HIV.
Who cannot join
- current stable housing
- inability or unwillingness to provide informed consent in English.
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
Friends Research Institute
Philadelphia, Pennsylvania, 19122
Karen Alexander, PhD, 9084510141, kalexander@friendsresearch.org
Karen B Alexander, PhD
About this study
Official title: A Patient Navigation Trial for Housing and Health (PATHH): A Randomized Controlled Trial
This study will describe and evaluate the experiences and outcomes of women who have survived violence and also have medical needs. The intervention being tested is a service called 'PATHH', a patient navigation service that extends after a stay in an emergency shelter. Some people who join the study will work with the PATHH patient navigator, and some will receive standard care at the community shelter. Participants who are assigned the PATHH navigator will receive additional support and help linking with services in the community during and after their emergency shelter stay. By doing this study, how patient navigation services affect the health and housing stability among women who have survived violence will be better understood.
Read the detailed description
Enrollment in this randomized controlled trial will last 12 months. Participants will be asked to complete four research visits consisting of surveys and a saliva sample to test for recent drug and alcohol use. The first research visit (baseline) will occur at the emergency shelter or at the drop-in center. Additional research visits will occur 3-, 6-, and 12-months after discharge from the emergency shelter.
Participants will be randomly assigned to one of two groups: Usual Care or PATHH Patient Navigation. PATHH Patient Navigation participants will be asked to meet with a navigator while they are receiving services at the emergency shelter and/or drop-in center, and after they leave the emergency shelter for 3-months. The navigators will visit with participants in-person and can also communicate by phone, text, and email. They will work with participants to offer support and help linking participants with recommended health and housing services. The primary outcomes are increased housing stability and health self-efficacy.
- Conditions
- Housing Instability, Health and Social Services
- Being tested
- PATHH
- Keywords
- women survivors of violence, patient navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATHHBehavioural
Also called Patient Navigation for Housing and Health
The intervention will consist of TAU services plus 12 weeks of services provided by a trained patient navigator. Patient Navigators will meet with the participants the day they are randomized to the intervention and will remain engaged with the participants throughout their emergency shelter stay. The navigator will continue to engage PATHH participants for 12 weeks post-discharge from emergency shelter.
| Study group | Role | What they receive |
|---|---|---|
| PATHH | Experimental | The intervention will consist of TAU services plus 12 weeks of services provided by a trained patient navigator. Patient Navigators will meet with the participants the day they are randomized to the intervention and will remain engaged with the participants throughout their emergency shelter stay. The navigator will continue to engage PATHH participants for 12 weeks post-discharge from emergency shelter. Receives: Behavioral: PATHH |
| Treatment as Usual | No intervention | Treatment as usual consists of routine services provided by housing and affiliated community organizations, which include case management services that assist with rent, transitional housing, food, clothes, and peer support services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Housing Stability
The primary outcome examining housing stability will be defined as obtaining housing (yes/no) within 6-months following departure from the emergency shelter stay. Housing will be inclusive of placements into transitional, supportive, and/or permanent housing locations and will be consistent with the Department of Housing and Urban Development (HUD) definition of stable housing, indicating any housing that meets safety standards and where the occupant has the rights and responsibilities of a tenant.
Measured: 6-months from departure or discharge from the emergency shelter stay
Health self-efficacy
Healthcare self-efficacy will be operationalized using the 22-item Patient Activation Measure (PAM81). The PAM is a reliable and valid measure that has demonstrated strong psychometric properties in several contexts and settings and assesses an individual's knowledge, skills, and confidence in managing their health needs and navigating health systems. Scores from PAM item responses are categorized into four levels of activation, ranging from Level 1 (the patient is disengaged and overwhelmed, and adherence is poor) to Level 4 (the patient has high health knowledge and maintaining health lifestyle is the focus).
Measured: 6-months from departure or discharge from the emergency shelter stay
Secondary outcomes (6)
Housing Insecurity
Perceptions of Housing Insecurity will be assessed through a 2-item Health Related Social Needs screening tool that assesses the current living situation and its perception of stability, decency and safety in terms of heat, pests, lead paint, water leaks, and other housing conditions. A positive screening result indicates greater housing insecurity or unmet housing-related needs.
Measured: 3-, 6- and 12- months post enrollment
Housing Instability
Perceptions of housing instability will be assessed using the Housing Instability Scale, which is a seven-item scale that was created and validated among survivors of domestic violence, with higher scores indicating greater housing instability. Scores range from 0 to 7, with higher scores indicating greater housing instability.
Measured: 3-, 6-, and 12-months post enrollment
Social Support
Social Support: Social support will be measured using the Medical Outcomes Study (MOS) Social Support Survey, a 19-item questionnaire. Responses will be transformed to a standardized scale ranging from 0 to 100, with higher scores indicating greater perceived availability of social support.
Measured: 3-, 6- and 12-months post enrollment
Global Health
Physical, social, and mental health functioning will be assessed through the Promis 10 Global Health scale. Possible scores range from 16.2 to 67.7 for physical health and 21.2 to 67.6 for mental health. Higher scores indicate better health functioning.
Measured: 3-, 6-, and 12-months post enrollment
Mental Health Symptoms
PHQ-8 will be used to assess depressive symptoms; total scores range from 0 to 24, with higher scores indicating greater depressive symptom severity.
Measured: 3-, 6-, 12- months post enrollment
History of Violence
Lifetime exposure to stressful and potentially traumatic events will be assessed using the 13-item Stressful Life Events Screening Questionnaire (SLESQ). The instrument assesses exposure to events such as life-threatening accidents, physical and sexual assault, and witnessing violence. Each event category is assessed using a yes/no response, with additional questions characterizing the exposure. The total score is calculated by summing the number of event categories endorsed, ranging from 0 to 13, with higher scores indicating greater lifetime exposure to potentially traumatic events.
Measured: 3-, 6-, and 12-months post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start11 Nov 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Housing InstabilityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Karen Alexander, PhD, Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911722
- Sponsor's protocol ID
- R01NR021987
- Other IDs
- R01NR021987-01
- Acronym
- PATHH
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study team will only share deidentified data after study outcomes have been analyzed to an NIH approved depository.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Navigation Trial for Housing and Health (PATHH): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07911722
- Acronym / sponsor ID
- PATHH / R01NR021987
- Conditions
- Housing Instability, Health and Social Services
- Keywords
- women survivors of violence, patient navigation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 3 Nov 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.
This study will describe and evaluate the experiences and outcomes of women who have survived violence and also have medical needs. The intervention being tested is a service called 'PATHH', a patient navigation service that extends after a stay in an emergency shelter. Some people who join the study will work with the PATHH patient navigator, and some will receive standard care at the community shelter. Participants who are assigned the PATHH navigator will receive additional support and help linking with services in the community during and after their emergency shelter stay. By doing this study, how patient navigation services affect the health and housing stability among women who have survived violence will be better understood.
Detailed description
Enrollment in this randomized controlled trial will last 12 months. Participants will be asked to complete four research visits consisting of surveys and a saliva sample to test for recent drug and alcohol use. The first research visit (baseline) will occur at the emergency shelter or at the drop-in center. Additional research visits will occur 3-, 6-, and 12-months after discharge from the emergency shelter.
Participants will be randomly assigned to one of two groups: Usual Care or PATHH Patient Navigation. PATHH Patient Navigation participants will be asked to meet with a navigator while they are receiving services at the emergency shelter and/or drop-in center, and after they leave the emergency shelter for 3-months. The navigators will visit with participants in-person and can also communicate by phone, text, and email. They will work with participants to offer support and help linking participants with recommended health and housing services. The primary outcomes are increased housing stability and health self-efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATHH | Experimental | Behavioral: PATHHThe intervention will consist of TAU services plus 12 weeks of services provided by a trained patient navigator. Patient Navigators will meet with the participants the day they are randomized to the intervention and will remain engaged with the participants throughout their emergency shelter stay. The navigator will continue to engage PATHH participants for 12 weeks post-discharge from emergency shelter. |
| Treatment as Usual | No intervention | –Treatment as usual consists of routine services provided by housing and affiliated community organizations, which include case management services that assist with rent, transitional housing, food, clothes, and peer support services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-identify as a woman;
- are age 18 or older
- report a history of physical or sexual violence in the last year using the Revised Conflict Tactics Scale
- report a qualifying health condition requiring ongoing engagement in healthcare and commonly occurring in this population, including substance use disorder, depression, and/or HIV.
Key exclusion criteria (2 listed)
- current stable housing
- inability or unwillingness to provide informed consent in English.
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 |
|---|---|---|
| PATHHAlso: Patient Navigation for Housing and HealthThe intervention will consist of TAU services plus 12 weeks of services provided by a trained patient navigator. Patient Navigators will meet with the participants the day they are randomized to the intervention and will remain engaged with the participants throughout their emergency shelter stay. The navigator will continue to engage PATHH participants for 12 weeks post-discharge from emergency shelter. | Behavioural | PATHH |
Primary outcome
Housing Stability
Time frame: 6-months from departure or discharge from the emergency shelter stay
The primary outcome examining housing stability will be defined as obtaining housing (yes/no) within 6-months following departure from the emergency shelter stay. Housing will be inclusive of placements into transitional, supportive, and/or permanent housing locations and will be consistent with the Department of Housing and Urban Development (HUD) definition of stable housing, indicating any housing that meets safety standards and where the occupant has the rights and responsibilities of a tenant.
Health self-efficacy
Time frame: 6-months from departure or discharge from the emergency shelter stay
Healthcare self-efficacy will be operationalized using the 22-item Patient Activation Measure (PAM81). The PAM is a reliable and valid measure that has demonstrated strong psychometric properties in several contexts and settings and assesses an individual's knowledge, skills, and confidence in managing their health needs and navigating health systems. Scores from PAM item responses are categorized into four levels of activation, ranging from Level 1 (the patient is disengaged and overwhelmed, and adherence is poor) to Level 4 (the patient has high health knowledge and maintaining health lifestyle is the focus).
6 secondary outcomes
Housing Insecurity
Time frame: 3-, 6- and 12- months post enrollment
Housing Instability
Time frame: 3-, 6-, and 12-months post enrollment
Social Support
Time frame: 3-, 6- and 12-months post enrollment
Global Health
Time frame: 3-, 6-, and 12-months post enrollment
Mental Health Symptoms
Time frame: 3-, 6-, 12- months post enrollment
History of Violence
Time frame: 3-, 6-, and 12-months post enrollment.
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 6 Nov 2026.
- Individual participant dataSharing planned: No. The study team will only share deidentified data after study outcomes have been analyzed to an NIH approved depository.
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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.
Karen Alexander, PhD principal investigator
Friends Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATHH in people with Housing Instability and Health and Social Services, run by Friends Research Institute, Inc. 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 4 inclusion and 2 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 6 Nov 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 Karen Alexander, PhD, RN (9084510141, kalexander@friendsresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Housing Stability (time frame: 6-months from departure or discharge from the emergency shelter stay). 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 6 Nov 2026.