Health-Related Social NeedsNCT07116629
Catch A Vibe - 24-00864
An observational study of Health-Related Social Needs, run by NYU Langone Health at 2 sites in United States.
Trial summary
This study evaluates a proposed community-based implementation strategy to scale up screening, identification, and intervention on Health-Related Social Needs (HRSN) among persons on Long-Acting Injectable Pre-exposure Prophylaxis (LAI-PrEP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health-Related Social Needs
- How many people
- 343 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2025to May 2028
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There are multiple participant groups: * Patients on or initiating LAI-PrEP as part of standard of care * Medical Staff who work with patients on LAI-PrEP * CBO Partner who work with patients on LAI-PrEP * Patients who decline LAI-PrEP as part of standard of care
Who may be able to join
- For Patient participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria:
- 18 years of age or older
- Does not have HIV AND vulnerable for HIV infection per WHO, NHS, and CDC recommendations
- On or initiating LAI-PrEP as part of standard of care prior to study participation
- Identify as either a Black/Latine cisgender woman OR Black/Latine MSM OR Transgender or Nonbinary Individual
- Capacity and willingness to provide consent
Show all 26Show fewer
- For Medical Staff participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria:
- 18 years of age or older
- Works with patients who go to the Bellevue Pride Center
- Be employed at NYU Langone Health or NYC H+H/Bellevue as one of the following occupations
- Physician
- Clinical Pharmacist
- Nurse
- Medical Phlebotomist
- Social Worker/Navigator
- Community Health Worker
- Medical Leader (i.e., director of services)
- For CBO Partner participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria:
- 18 years of age or older
- Works with patients who go to the Bellevue Pride Center
- Be employed at one of the established CBOs
- Capacity and willingness to provide consent
- For Patient Who Declines LAI-PrEP participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria:
- 18 years of age or older
- Declines LAI-PrEP as part of standard of care
- Capacity and willingness to provide consent
Who cannot join
- For Patient participant group: An individual who meets any of the following criteria will be excluded from participation in this study:
- Less than 18 years old
- Known HIV seropositive status or test positive at screening
- Does not identify as one of the listed priority populations
- Not fluent in either English or Spanish
- Not interested in HIV PrEP
Show all 25Show fewer
- Not willing to consent for study participation
- Does not reside within New York State
- Pregnant or planning to become pregnant at the time of consent.
- Without capacity to consent to participate in the study
- For Medical Staff participant group: An individual who meets any of the following criteria will be excluded from participation in this study:
- Do not work with patients who go to the Bellevue Pride Center
- Is not employed at NYU Langone Health or NYC/H+H Bellevue as one of the following occupations
- Physician
- Clinical Pharmacist
- Nurse
- Medical Phlebotomist
- Social Worker
- Community Health Worker
- Medical Leader (i.e., directors of services)
- For CBO Partner participant group: An individual who meets any of the following criteria will be excluded from participation in this study:
- Does not work with patients who go to the Bellevue Pride Center
- For Patient Who Declines LAI-PrEP participant group: An individual who meets any of the following criteria will be excluded from participation in this study:
- Less than 18 years old
- Interested in initiating LAI-PrEP as part of standard of care or on LAI-PrEP
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NYC Health + Hospitals/Bellevue
New York, New York, 10016
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Community-Based Intervention To Address Health-Related Social Needs For Patients On LAI-PrEP
This study evaluates a proposed community-based implementation strategy to scale up screening, identification, and intervention on Health-Related Social Needs (HRSN) among persons on Long-Acting Injectable Pre-exposure Prophylaxis (LAI-PrEP). To do so, (1) screening for HRSN will occur at provider visits every 4 months, (2) navigation and establishment of connections with community resources through collaboration with two established community-based organization (CBO) partners, and (3) development of a tracking system integrated into the Electronic Medical Record (EMR) for monitoring and assessment of referral outcomes.
- Conditions
- Health-Related Social Needs
- Keywords
- LAI-PrEP, Community Partnerships, Health-Related Social Needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients on or initiating LAI-PrEP as part of standard of care | Quantitative HRSN surveys will be administered to Patient participants at enrollment, 4-, 8-, and 12-month visits to evaluate changes in HRSN, barriers/facilitators to resolving HRSN, and the impact of HRSN on LAI-PrEP persistence and retention in HIV care. | |
| Medical Staff who work with patients on LAI-PrEP | Survey will be administered to Medical Staff participants 6 months after enrollment of the first patient participant. | |
| CBO Partners who work with patients on LAI-PrEP linkage and addressing HRSN | Survey will be administered to community-based organization (CBO) Partner participants 6 months after enrollment of the first patient participant. | |
| Patients who decline LAI-PrEP as part of standard of care | Survey will be administered to Patients Who Decline LAI-PrEP to better understand why they declined LAI-PrEP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate of HRSN Screener
Measured: Baseline; Month 4; Month 8; Month 12
Secondary outcomes (11)
Percentage of Participants who Identify Financial Insecurity as an HRSN
Measured: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Transportation as an HRSN
Measured: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Food Insecurity as an HRSN
Measured: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Legal Assistance as an HRSN
Measured: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Housing Insecurity and/or Homelessness as an HRSN
Measured: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Inadequate Housing as an HRSN
Measured: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Education as an HRSN
Measured: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Employment as an HRSN
Measured: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Childcare Issues as an HRSN
Measured: Baseline; Month 4; Month 8; Month 12
PrEP Persistence
Percentage of patients who remain on PrEP.
Measured: Baseline; Month 4; Month 8; Month 12
Retention in HIV Prevention Care
Percentage of patients who are retained in HIV prevention care.
Measured: Baseline; Month 4; Month 8; Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start22 Oct 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-Related Social NeedsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 343 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Pitts, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116629
- Sponsor's protocol ID
- 24-00684
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Requests should be directed to Robert.pitts@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-Based Intervention To Address Health-Related Social Needs For Patients On LAI-PrEP
- ClinicalTrials.gov ID
- NCT07116629
- Acronym / sponsor ID
- 24-00684
- Conditions
- Health-Related Social Needs
- Keywords
- LAI-PrEP, Community Partnerships, Health-Related Social Needs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 343 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 11 Aug 2025 (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 evaluates a proposed community-based implementation strategy to scale up screening, identification, and intervention on Health-Related Social Needs (HRSN) among persons on Long-Acting Injectable Pre-exposure Prophylaxis (LAI-PrEP). To do so, (1) screening for HRSN will occur at provider visits every 4 months, (2) navigation and establishment of connections with community resources through collaboration with two established community-based organization (CBO) partners, and (3) development of a tracking system integrated into the Electronic Medical Record (EMR) for monitoring and assessment of referral outcomes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients on or initiating LAI-PrEP as part of standard of care | – | –Quantitative HRSN surveys will be administered to Patient participants at enrollment, 4-, 8-, and 12-month visits to evaluate changes in HRSN, barriers/facilitators to resolving HRSN, and the impact of HRSN on LAI-PrEP persistence and retention in HIV care. |
| Medical Staff who work with patients on LAI-PrEP | – | –Survey will be administered to Medical Staff participants 6 months after enrollment of the first patient participant. |
| CBO Partners who work with patients on LAI-PrEP linkage and addressing HRSN | – | –Survey will be administered to community-based organization (CBO) Partner participants 6 months after enrollment of the first patient participant. |
| Patients who decline LAI-PrEP as part of standard of care | – | –Survey will be administered to Patients Who Decline LAI-PrEP to better understand why they declined LAI-PrEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are multiple participant groups: * Patients on or initiating LAI-PrEP as part of standard of care * Medical Staff who work with patients on LAI-PrEP * CBO Partner who work with patients on LAI-PrEP * Patients who decline LAI-PrEP as part of standard of care
Key inclusion criteria (26 listed)
- For Patient participant group: In order to be eligible for participation in this study, an individual must meet all of the following criteria:
- 18 years of age or older
- Does not have HIV AND vulnerable for HIV infection per WHO, NHS, and CDC recommendations
- On or initiating LAI-PrEP as part of standard of care prior to study participation
- Identify as either a Black/Latine cisgender woman OR Black/Latine MSM OR Transgender or Nonbinary Individual
Key exclusion criteria (25 listed)
- For Patient participant group: An individual who meets any of the following criteria will be excluded from participation in this study:
- Less than 18 years old
- Known HIV seropositive status or test positive at screening
- Does not identify as one of the listed priority populations
- Not fluent in either English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completion Rate of HRSN Screener
Time frame: Baseline; Month 4; Month 8; Month 12
11 secondary outcomes
Percentage of Participants who Identify Financial Insecurity as an HRSN
Time frame: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Transportation as an HRSN
Time frame: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Food Insecurity as an HRSN
Time frame: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Legal Assistance as an HRSN
Time frame: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Housing Insecurity and/or Homelessness as an HRSN
Time frame: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Inadequate Housing as an HRSN
Time frame: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Education as an HRSN
Time frame: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Identify Employment as an HRSN
Time frame: Baseline; Month 4; Month 8; Month 12
Percentage of Participants who Childcare Issues as an HRSN
Time frame: Baseline; Month 4; Month 8; Month 12
PrEP Persistence
Time frame: Baseline; Month 4; Month 8; Month 12
Retention in HIV Prevention Care
Time frame: Baseline; Month 4; Month 8; Month 12
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 26 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Requests should be directed to Robert.pitts@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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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.
Robert Pitts, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health-Related Social Needs, run by NYU Langone Health at 2 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 26 inclusion and 25 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Robert Pitts, MD (301-318-4376, robert.pitts@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate of HRSN Screener (time frame: Baseline; Month 4; Month 8; Month 12). 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 26 Jun 2026.