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Completed

NCT Number: NCT03778164

Improving Prevention Systems to Reduce Disparities for High Priority Populations

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).

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Key information

About this study

The original project as designed (described above) needed to be modified as a result of the COVID-19 pandemic. The pilot was conducted as planned, but the main trial was changed to a single-arm implementation science project, due to the implementation and service delivery constraints on the NYC HD resulting from COVID.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Contacts referred to the Partner Services program during the study time period

Exclusion criteria

  • None

Treatment and study plan

Fast Track Partner Services-Sexual Health Intervention

Other

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.

Primary outcomes

  1. Acceptance of HIV Testing

    Time frame: 1 month

    Whether or not contacts offered testing by the Partner Services program accept HIV testing

  2. PrEP/ARV Initiation

    Time frame: 3 months

    Whether or not contacts start ARV medication in the field or at their referral visit

  3. Linkage to PrEP/HIV Care

    Time frame: 6 months

    Whether or not contacts attend their navigation visit to receive ongoing PrEP or HIV services

Secondary outcomes

  1. STI testing

    Time frame: 3 months

    Whether or not contacts accept STI testing in the field or at their referral visit

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Registry information

Acronym: FastTrack

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 19, 2018
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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