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

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fast Track Partner Services-Sexual Health Intervention
Partner Services Standard of Care
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Hunter College of CUNYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fast Track Intervention

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Acceptance of HIV Testing
Whether or not contacts offered testing by the Partner Services program accept HIV testing
PrEP/ARV Initiation
Whether or not contacts start ARV medication in the field or at their referral visit
Linkage to PrEP/HIV Care
Whether or not contacts attend their navigation visit to receive ongoing PrEP or HIV services

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2018
Last Updated
February 27, 2023
Sponsor
Hunter College of City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT03778164
Brief Title
Improving Prevention Systems to Reduce Disparities for High Priority Populations
Acronym
FastTrack
Official Title
Improving Prevention Systems to Reduce Disparities for High Priority Populations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study uses a cross sectional stepped wedge cluster randomized design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fast Track Intervention
Arm Type
Experimental
Arm Description
This arm refers to the new Partner Services-Sexual Health intervention offered to contacts by the Partner Services program
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
This arm refers to the current standard practice for partners contacted by the Partner Services program
Intervention Type
Other
Intervention Name(s)
Fast Track Partner Services-Sexual Health Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Partner Services Standard of Care
Intervention Description
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 Information:
Title
Acceptance of HIV Testing
Description
Whether or not contacts offered testing by the Partner Services program accept HIV testing
Time Frame
1 month
Title
PrEP/ARV Initiation
Description
Whether or not contacts start ARV medication in the field or at their referral visit
Time Frame
3 months
Title
Linkage to PrEP/HIV Care
Description
Whether or not contacts attend their navigation visit to receive ongoing PrEP or HIV services
Time Frame
6 months
Secondary Outcome Measure Information:
Title
STI testing
Description
Whether or not contacts accept STI testing in the field or at their referral visit
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Contacts referred to the Partner Services program during the study time period Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarit A Golub, PhD, MPH
Phone
212.396.6304
Email
sarit.golub@hunter.cuny.edu
Facility Information:
Facility Name
Hunter College of CUNY
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarit A Golub
Phone
121-396-6304
Email
sgolub@hunter.cuny.edu

12. IPD Sharing Statement

Learn more about this trial

Improving Prevention Systems to Reduce Disparities for High Priority Populations

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