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Expanding PrEP By Embedding Unannounced SNAPS Navigators in High STI Testing Clinical Sites

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ClinicalTrials.gov Identifier: NCT04207151
Recruitment Status : Completed
First Posted : December 20, 2019
Last Update Posted : February 9, 2023
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE December 16, 2019
First Posted Date  ICMJE December 20, 2019
Last Update Posted Date February 9, 2023
Actual Study Start Date  ICMJE July 22, 2019
Actual Primary Completion Date January 9, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
  • Change in PrEP prescriptions [ Time Frame: Visits 3 months, 6 months, and 12 months ]
    Change in rate of PrEP prescriptions at H+H/Bellevue among those in care for 1-year before study period and during 1-year study period by gender, race/ethnicity, age, insurance type, and preferred language.
  • Change in the knowledge of HIV [ Time Frame: Visit baseline, Visit 12 months ]
    Through pre and post qualitative interviews, the perceived HIV risk, knowledge and attitudes regarding PrEP, and facilitators and barriers regarding PrEP use will be analyzed.
  • Change in the number of HIV cases [ Time Frame: Visit 12 months ]
    The number of HIV cases averted and distribution of these cases among disproportionately-impacted groups will be assessed to determine if intervention is effective
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Expanding PrEP By Embedding Unannounced SNAPS Navigators in High STI Testing Clinical Sites
Official Title  ICMJE Expanding PrEP By Embedding Unannounced SNAPS Navigators in High Sexually Transmitted Infection (STI) Testing Clinical Sites
Brief Summary The goal of this study is to assess the impact of an intervention, known as SNAPS, to expand Preexposure Prophylaxis (PrEP) prescriptions at Health + Hospitals (H+H)/Bellevue. In addition, evaluating whether this intervention, ie SNAPS, helps patients get on PrEP and stay on PrEP to prevent STIs like HIV. PrEP is a medication that needs to be taken on a regular basis in order to be effective to prevent HIV transmission.
Detailed Description

The objective of the investigator's proposal is to evaluate the effectiveness of an intervention to (1) increase PrEP initiation overall, (2) increase uptake among groups disproportionately impacted by the HIV pandemic, and (3) to preserve high PrEP retention while expanding use. In addition, the proposal includes innovative secondary outcomes of (4) identifying barriers and facilitators of PrEP use that may be unique to urban safety-net populations, and (5) estimating the HIV infections averted due to greater PrEP uptake from the intervention.

The intervention is multi-level yet, targets the "weakest chains in the link" of PrEP initiation at safety-net hospitals designed for scalability, sustainability, and implementability across a wide range of settings. It consists of Surveillance by STI testing, Navigation by unannounced patient navigators to the Sexual Health Clinic (SHC), Accelerated follow-up with providers with PrEP expertise, Point-of-care PrEP counseling and laboratory testing, and Seamless, consistent, longitudinal, comprehensive care (SNAPS).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hiv
  • Sexually Transmitted Infection
Intervention  ICMJE Behavioral: SNAPS intervention
The intervention is multi-level yet, targets the "weakest chains in the link" of PrEP initiation at safety-net hospitals designed for scalability, sustainability, and implementability across a wide range of settings. It consists of Surveillance by STI testing, Navigation by unannounced patient navigators to the Sexual Health Clinic (SHC), Accelerated follow-up with providers with PrEP expertise, Point-of-care PrEP counseling and laboratory testing, and Seamless, consistent, longitudinal, comprehensive care (SNAPS). SNAPS will selectively target those care settings where PrEP prescribing is particularly rare or absent (eg, OB/GYN). Study team will utilize a quasi- experimental design to compare rates of PrEP uptake overall, PrEP initiation in disproportionately-impacted groups, and PrEP retention pre-versus post-initiation of SNAPS, controlling for secular trends.
Study Arms  ICMJE
  • No Intervention: Standard of Care
    Participants will receive HIV and STI testing, clinical monitoring, client centered counseling and PrEP prescriptions as standard of care, this includes scheduled visits every three months.
  • Experimental: Pre- and Post- SNAPS intervention
    In addition to the standard of care treatment, approximately twenty subjects will be selected for interview pre- and post-SNAPS intervention to assess PrEP facilitators and barriers for uptake. Participants of interest include cis- and trans-women, for which there is limited data regarding PrEP and HIV prevention.
    Intervention: Behavioral: SNAPS intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 9, 2023
Actual Primary Completion Date January 9, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Historical comparison group:

  • all adults ≥18 years of age prescribed PrEP at H+H/Bellevue one year prior to SNAPS intervention initiation.

Prospective group:

  • all patients will be considered for study participation who are accessing care at H+H/Bellevue ≥ 18 years of age,
  • have unknown HIV status,
  • requesting STI testing/treatment or inquiring about PrEP or PEP in the ED or urgent care, OB/GYN, and Dermatology clinics.

Exclusion Criteria:

  • patients who are HIV positive
  • refuse consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04207151
Other Study ID Numbers  ICMJE 19-00060
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Only by NYU/Bellevue researchers
Current Responsible Party NYU Langone Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NYU Langone Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Pitts, MD New York University
PRS Account NYU Langone Health
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP