Improving Prevention Systems to Reduce Disparities for High Priority Populations (FastTrack)

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).

Study Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: Fast Track Partner Services-Sexual Health Intervention; Other: Partner Services Standard of Care

• Study Type: Interventional
• Enrollment (Anticipated): 1150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Hunter College of CUNY
      • Contact: Sarit A Golub; Phone Number: 121-396-6304; Email: sgolub@hunter.cuny.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fast Track Intervention; This arm refers to the new Partner Services-Sexual Health intervention offered to contacts by the Partner Services program	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.
Active Comparator: Standard of Care; This arm refers to the current standard practice for partners contacted by the Partner Services program	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance of HIV Testing	Whether or not contacts offered testing by the Partner Services program accept HIV testing	1 month
PrEP/ARV Initiation	Whether or not contacts start ARV medication in the field or at their referral visit	3 months
Linkage to PrEP/HIV Care	Whether or not contacts attend their navigation visit to receive ongoing PrEP or HIV services	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STI testing	Whether or not contacts accept STI testing in the field or at their referral visit	3 months

Collaborators and Investigators

• Sponsor: Hunter College of City University of New York

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: R01MH115835 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No