Recruiting

Observational Study

Sponsor:

Hunter College of City University of New York

Code:

NCT03778164

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Fast Track Partner Services-Sexual Health Intervention

Partner Services Standard of Care

Study Details

Brief 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

Study ID

NCT03778164

Start date

Apr 1, 2021

Status verified date

Feb, 2023

Completion date

Oct 31, 2023

Anticipated

Primary completion date

Jul 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Design

Enrollment

1150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Fast Track Intervention

This arm refers to the new Partner Services-Sexual Health intervention offered to contacts by the Partner Services program

active comparator: Standard of Care

This arm refers to the current standard practice for partners contacted by the Partner Services program

Interventions

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.

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.

Primary outcome measure

  • Acceptance of HIV Testing [ Time Frame: 1 month ]
  • PrEP/ARV Initiation [ Time Frame: 3 months ]
  • Linkage to PrEP/HIV Care [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Sarit A Golub, PhD, MPH

212.396.6304sarit.golub@hunter.cuny.edu

Locations

Hunter College of CUNY

Recruiting

New York, New York, United States, 10065

Contacts

Sarit A Golub

121-396-6304sgolub@hunter.cuny.edu

More Information

Sponsor

Hunter College of City University of New York

Last update posted

Mar 1, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hunter College of City University of New York on 2023-03-01.