Catch A Vibe - 24-00864

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Ecologic or community

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

343 Participants
are grouped into 4 trial groups
Group A: Patients on or initiating LAI-PrEP as part of standard of care
Group B: Medical Staff who work with patients on LAI-PrEP
Group C: CBO Partners who work with patients on LAI-PrEP linkage and addressing HRSN
Group D: Patients who decline LAI-PrEP as part of standard of care

Trial outcomes

Primary outcomes

1

Completion Rate of HRSN Screener

Time frame
Baseline; Month 4; Month 8; Month 12

Secondary outcomes

1

Percentage of Participants who Identify Financial Insecurity as an HRSN

Time frame
Baseline; Month 4; Month 8; Month 12
2

Percentage of Participants who Identify Transportation as an HRSN

Time frame
Baseline; Month 4; Month 8; Month 12
3

Percentage of Participants who Identify Food Insecurity as an HRSN

Time frame
Baseline; Month 4; Month 8; Month 12
4

Percentage of Participants who Identify Legal Assistance as an HRSN

Time frame
Baseline; Month 4; Month 8; Month 12

Other outcomes

Sponsors and contacts

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