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

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ClinicalTrials.gov Identifier: NCT03778164
Recruitment Status : Not yet recruiting
First Posted : December 18, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Sarit Golub, Hunter College of City University of New York

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).

Condition or disease Intervention/treatment Phase
HIV Infections Other: Fast Track Partner Services-Sexual Health Intervention Other: Partner Services Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study uses a cross sectional stepped wedge cluster randomized design
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Prevention Systems to Reduce Disparities for High Priority Populations
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. Acceptance of HIV Testing [ Time Frame: 1 month ]
    Whether or not contacts offered testing by the Partner Services program accept HIV testing

  2. PrEP/ARV Initiation [ Time Frame: 3 months ]
    Whether or not contacts start ARV medication in the field or at their referral visit

  3. Linkage to PrEP/HIV Care [ Time Frame: 6 months ]
    Whether or not contacts attend their navigation visit to receive ongoing PrEP or HIV services


Secondary Outcome Measures :
  1. STI testing [ Time Frame: 3 months ]
    Whether or not contacts accept STI testing in the field or at their referral visit



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778164


Contacts
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Contact: Sarit A Golub, PhD, MPH 212.396.6304 sarit.golub@hunter.cuny.edu

Sponsors and Collaborators
Hunter College of City University of New York

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Responsible Party: Sarit Golub, Professor, Hunter College of City University of New York
ClinicalTrials.gov Identifier: NCT03778164     History of Changes
Other Study ID Numbers: R01MH115835 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases