Improving Prevention Systems to Reduce Disparities for High Priority Populations

NCT03778164 | Unknown DMC

• 1 other identifier: R01MH115835
• Study Type: interventional
• Target: 1,150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• STI testing

  3 months

Study Arms (2)

Fast Track Intervention

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Other: Partner Services Standard of Care

Interventions

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.

Fast Track Intervention

Partner Services Standard of Care OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Hunter College of City University of New York: lead

Study Sites (1)

Hunter College of CUNY

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Sarit A Golub, PhD, MPH

CONTACT

212.396.6304; sarit.golub@hunter.cuny.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study uses a cross sectional stepped wedge cluster randomized design

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 19, 2018
• Study Start: April 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

US (1)