Improving Prevention Systems to Reduce Disparities for High Priority Populations

NCT03778164 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1150

Last updated 2023-03-01

No results posted yet for this study

Summary

This project collaborates with the New York City Department of Health and Mental Hygiene (NYC DOHMH) to develop and test a field-based comprehensive sexual health intervention for HIV-exposed contacts notified by its Partner Services (i.e., HIV contact tracing) program. The goal of the study is to develop and test the impact of this new intervention on improving rates of HIV testing, linkage to HIV prevention/care, and PrEP uptake among highest risk contacts recently exposed to HIV. We will conduct a 6-month pilot project, followed by a cross-sectional stepped wedge cluster randomized trial in which 12 clusters of NYC neighborhoods are exposed to the intervention sequentially, with three clusters moving from control to intervention every 6 months (n = 1150). Primary outcomes are HIV testing, timely PrEP/ARV uptake, and linkage to PrEP/HIV care. Secondary outcomes are STD testing and receipt of STD treatment (if indicated).

Conditions

  • HIV Infections

Interventions

OTHER

Fast Track Partner Services-Sexual Health Intervention

The Partner Services-Sexual Health Intervention enhances the current standard of care by introducing four service innovations to the DOHMH Partner Services program: (1) enhanced field-based combination HIV and STI testing; (2) immediate field-based ARV/PrEP start; (3) navigation to a sexual health clinic for test results and treatment; and (4) enhanced linkage support to facilitate ongoing PrEP or HIV care.

OTHER

Partner Services Standard of Care

Participants in neighborhoods that have not yet been assigned to the intervention condition in the stepped wedge trial will receive standard Partner Services components, including field-based HIV testing and referral to clinical sites for HIV prevention or treatment.

Sponsors & Collaborators

  • Hunter College of City University of New York

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-07-31
Completion
2023-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03778164 on ClinicalTrials.gov