Organizational Partnerships for Healthy LivingPhase 1NCT05912842
Forging Sustainable Solutions for HIV Continuity of Care Through Medical-legal Partnerships
A Phase 1 study testing Organizational Partnerships for Healthy Living in people with Organizational Partnerships for Healthy Living and Standard of Care, run by Temple University at 1 site in United States.
Trial summary
The goal of this study is to test the Organizational Partnerships for Healthy Living (OPAHL) intervention through a feasibility and acceptability trial. OPAHL is an innovative, multilevel intervention package intended for health care organizations serving people living with HIV (PLWH). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Organizational Partnerships for Healthy Living, Standard of Care
- What is being tested?
- Organizational Partnerships for Healthy Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living with HIV (as confirmed by medical record)
- 18 years or older
- HIV viral load of more than 200 copies/mL (as confirmed by medical record)
- Willing and able to consent to participate in the trial (including accessing their medical records at the health care organization)
- No intent to relocate within the 6 months following their enrollment in the study
Who cannot join
- -Individuals who self-report having been sentenced to serve under state or federal custody, with a sentence to begin within 6 months from proposed enrollment in the study
Trial locations and contacts
1 site in 1 country.
Miguel Munoz-Laboy, DrPH contact
United States1 site, 1 recruiting
- Recruiting
TPAC
Philadelphia, Pennsylvania, 19102
Omar Martinez
About this study
The goal of this study is to test the Organizational Partnerships for Healthy Living (OPAHL) intervention through a feasibility and acceptability trial. OPAHL is an innovative, multilevel intervention package intended for health care organizations serving people living with HIV (PLWH). It was developed through a prior study (grant #: R21 MH115820) using intervention mapping methodology and community-scientific collaborative boards. OPAHL consists of: 1) training (7/8hours) for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health harming legal risks and needs, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) case management training on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-location of legal services in health care agencies through MLP inter-organizational partnership within 3 months; and 5) organizationally tailored implementation of best-practice communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. The specific aims of this study are: 1) to refine the OPAHL intervention prototype for implementation with PLWH with detectable viral loads and 2) to test the feasibility, acceptability and preliminary effects sizes of OPAHL. Given the current COVID-19 pandemic, the study will also explore MLP opportunities that respond at the intersection of HIV/AIDS and COVID-19 prevention and treatment.
Read the detailed description
A health-harming legal need is a social problem that adversely affects a person's health or access to health care and which is better remedied through the combination of legal care and health care. Medical legal partnerships (MLPs) have been underutilized as structural interventions; however, they could help improve HIV care continuum outcomes in health care organizations. The goal of this study is to test the Organizational Partnerships for Healthy Living (OPAHL) intervention through a feasibility and acceptability trial. OPAHL is an innovative, multilevel intervention package intended for health care organizations serving people living with HIV (PLWH). It was developed through a prior study (grant #: R21 MH115820) using intervention mapping methodology and community-scientific collaborative boards. OPAHL consists of: 1) training (7/8hours) for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health harming legal risks and needs, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) case management training on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-location of legal services in health care agencies through MLP inter-organizational partnership within 3 months; and 5) organizationally tailored implementation of best-practice communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. The specific aims of this study are: 1) to refine the OPAHL intervention prototype for implementation with PLWH with detectable viral loads and 2) to test the feasibility, acceptability and preliminary effects sizes of OPAHL. Given the current COVID-19 pandemic, the study will also explore MLP opportunities that respond at the intersection of HIV/AIDS and COVID-19 prevention and treatment. Two health care organizations serving PLWH Philadelphia, PA that do not currently provide any form of legal services to their patients will participate in this trial (n=200 PLWH). The proposed study is in response to PA-20-141: Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional). It is also responsive to two of the areas of high priority research of NIMH Division of AIDS Research (Develop and test interventions to improve HIV treatment outcomes; Advance the development and testing of interventions delivered beyond the individual level). Completion of this project will result in the development of an intervention package to optimize HIV services for a highly vulnerable population whose HIV care is affected by health-harming legal needs.
- Being tested
- Organizational Partnerships for Healthy Living, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organizational Partnerships for Healthy LivingBehavioural
Also called OPHAL
Component 1 is a comprehensive training for all MLP care providers delivered to clinical, social and behavioral, and legal staff together to establish a collaborative environment. Component 2 consists of the screening tool and screening protocol that is designed to identify health-harming legal needs of PLWH patients. Component 3 includes the provision of legal support through partnership with the Legal Clinic for the Disabled.
Standard of CareBehavioural
Comparison arm health organization will only receive the HIV standard of care (U.S. CDC HIV standard of care) and referral to legal aid.
| Study group | Role | What they receive |
|---|---|---|
| Medical Legal Partnerships | Experimental | Component 1 is a comprehensive training for all MLP care providers delivered to clinical, social and behavioral, and legal staff together to establish a collaborative environment. Component 2 consists of the screening tool and screening protocol that is designed to identify health-harming legal needs of PLWH patients. Component 3 includes the provision of legal support through partnership with the Legal Clinic for the Disabled. Upon a positive legal needs screening, the case manager connects the patient to this attorney, at which point the patient, after signing a letter of engagement, becomes a client and can now address the identified legal issue(s) with legal representation. Receives: Behavioral: Organizational Partnerships for Healthy Living |
| Standard of Care | Active comparator | Comparison arm health organization will only receive the HIV standard of care (U.S. CDC HIV standard of care) and referral to legal aid. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
HIV viral load through HIV Nucleic Acid Amplification Test (NAAT) HIV by PCR HIV RNA Test
Measured: 6 months
Secondary outcomes (2)
Engagement in HIV Care
HIV primary care appointments and services at health organization (Attendance in the prior 3 months)
Measured: 6 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
The Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 is a gauge of general healthcare-related quality of life.Response options are presented as 5-point (as well as a single 11-point) rating scales. The scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Oct 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organizational Partnerships for Healthy LivingStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigative team will conduct a clustered-randomized small-scale trial in two HIV treatment services organizations in Philadelphia. One agency will be randomized to the OPAHL intervention, consisting of integrated legal support (n=100 PLWH) and one agency will be randomized to the standard of care, legal aid referral (n=100 PLWH).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912842
- Sponsor's protocol ID
- R34MH125718
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forging Sustainable Solutions for HIV Continuity of Care Through Medical-legal Partnerships
- ClinicalTrials.gov ID
- NCT05912842
- Acronym / sponsor ID
- R34MH125718
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 22 Jun 2023 (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.
The goal of this study is to test the Organizational Partnerships for Healthy Living (OPAHL) intervention through a feasibility and acceptability trial. OPAHL is an innovative, multilevel intervention package intended for health care organizations serving people living with HIV (PLWH). It was developed through a prior study (grant #: R21 MH115820) using intervention mapping methodology and community-scientific collaborative boards. OPAHL consists of: 1) training (7/8hours) for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health harming legal risks and needs, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) case management training on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-location of legal services in health care agencies through MLP inter-organizational partnership within 3 months; and 5) organizationally tailored implementation of best-practice communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. The specific aims of this study are: 1) to refine the OPAHL intervention prototype for implementation with PLWH with detectable viral loads and 2) to test the feasibility, acceptability and preliminary effects sizes of OPAHL. Given the current COVID-19 pandemic, the study will also explore MLP opportunities that respond at the intersection of HIV/AIDS and COVID-19 prevention and treatment.
Detailed description
A health-harming legal need is a social problem that adversely affects a person's health or access to health care and which is better remedied through the combination of legal care and health care. Medical legal partnerships (MLPs) have been underutilized as structural interventions; however, they could help improve HIV care continuum outcomes in health care organizations. The goal of this study is to test the Organizational Partnerships for Healthy Living (OPAHL) intervention through a feasibility and acceptability trial. OPAHL is an innovative, multilevel intervention package intended for health care organizations serving people living with HIV (PLWH). It was developed through a prior study (grant #: R21 MH115820) using intervention mapping methodology and community-scientific collaborative boards. OPAHL consists of: 1) training (7/8hours) for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health harming legal risks and needs, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) case management training on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-location of legal services in health care agencies through MLP inter-organizational partnership within 3 months; and 5) organizationally tailored implementation of best-practice communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. The specific aims of this study are: 1) to refine the OPAHL intervention prototype for implementation with PLWH with detectable viral loads and 2) to test the feasibility, acceptability and preliminary effects sizes of OPAHL. Given the current COVID-19 pandemic, the study will also explore MLP opportunities that respond at the intersection of HIV/AIDS and COVID-19 prevention and treatment. Two health care organizations serving PLWH Philadelphia, PA that do not currently provide any form of legal services to their patients will participate in this trial (n=200 PLWH). The proposed study is in response to PA-20-141: Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional). It is also responsive to two of the areas of high priority research of NIMH Division of AIDS Research (Develop and test interventions to improve HIV treatment outcomes; Advance the development and testing of interventions delivered beyond the individual level). Completion of this project will result in the development of an intervention package to optimize HIV services for a highly vulnerable population whose HIV care is affected by health-harming legal needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigative team will conduct a clustered-randomized small-scale trial in two HIV treatment services organizations in Philadelphia. One agency will be randomized to the OPAHL intervention, consisting of integrated legal support (n=100 PLWH) and one agency will be randomized to the standard of care, legal aid referral (n=100 PLWH).
| Arm | Type | Receives |
|---|---|---|
| Medical Legal Partnerships | Experimental | Behavioral: Organizational Partnerships for Healthy LivingComponent 1 is a comprehensive training for all MLP care providers delivered to clinical, social and behavioral, and legal staff together to establish a collaborative environment. Component 2 consists of the screening tool and screening protocol that is designed to identify health-harming legal needs of PLWH patients. Component 3 includes the provision of legal support through partnership with the Legal Clinic for the Disabled. Upon a positive legal needs screening, the case manager connects the patient to this attorney, at which point the patient, after signing a letter of engagement, becomes a client and can now address the identified legal issue(s) with legal representation. |
| Standard of Care | Active comparator | Behavioral: Standard of CareComparison arm health organization will only receive the HIV standard of care (U.S. CDC HIV standard of care) and referral to legal aid. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Living with HIV (as confirmed by medical record)
- 18 years or older
- HIV viral load of more than 200 copies/mL (as confirmed by medical record)
- Willing and able to consent to participate in the trial (including accessing their medical records at the health care organization)
- No intent to relocate within the 6 months following their enrollment in the study
Key exclusion criteria (1 listed)
- -Individuals who self-report having been sentenced to serve under state or federal custody, with a sentence to begin within 6 months from proposed enrollment in the study
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 |
|---|---|---|
| Organizational Partnerships for Healthy LivingAlso: OPHALComponent 1 is a comprehensive training for all MLP care providers delivered to clinical, social and behavioral, and legal staff together to establish a collaborative environment. Component 2 consists of the screening tool and screening protocol that is designed to identify health-harming legal needs of PLWH patients. Component 3 includes the provision of legal support through partnership with the Legal Clinic for the Disabled. | Behavioural | Medical Legal Partnerships |
| Standard of CareComparison arm health organization will only receive the HIV standard of care (U.S. CDC HIV standard of care) and referral to legal aid. | Behavioural | Standard of Care |
Primary outcome
Viral Suppression
Time frame: 6 months
HIV viral load through HIV Nucleic Acid Amplification Test (NAAT) HIV by PCR HIV RNA Test
2 secondary outcomes
Engagement in HIV Care
Time frame: 6 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Miguel Munoz-Laboy, DrPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Organizational Partnerships for Healthy Living in people with Organizational Partnerships for Healthy Living and Standard of Care, run by Temple University 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 5 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Martinez, JD (7862084340, omar.martinez@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression (time frame: 6 months). 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 23 Jun 2023.