Improving Prevention Systems to Reduce Disparities for High Priority Populations

HIV Infections Clinical Trial

— FastTrack  

Official title:

Improving Prevention Systems to Reduce Disparities for High Priority Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03778164
• Other study ID #: R01MH115835
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2023
• Source: Hunter College of City University of New York
• Contact: Sarit A Golub, PhD, MPH
• Phone: 212.396.6304
• Email: sarit.golub[@]hunter.cuny.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1150
• Est. completion date: October 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Hunter College of CUNY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hunter College of City University of New York

Country where clinical trial is conducted

United States, 

Outcome

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