An interventional study of PATHH in Housing Instability and Health and Social Services, sponsored by Friends Research Institute, Inc.. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Friends Research Institute, Inc. · Not applicable, Interventional, and Supportive care
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.
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.
Friends Research Institute, Inc. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: PATHH
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.
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.
Also known as: Patient Navigation for Housing and Health
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.
Time frame: 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).
Time frame: 6-months from departure or discharge from the emergency shelter stay
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3-, 6-, and 12-months post enrollment.
Plan to share: No — The study team will only share deidentified data after study outcomes have been analyzed to an NIH approved depository.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Friends Research Institute, Inc.