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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

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.

Condition or disease Intervention/treatment Phase
Hiv Sexually Transmitted Infection Behavioral: SNAPS intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expanding PrEP By Embedding Unannounced SNAPS Navigators in High Sexually Transmitted Infection (STI) Testing Clinical Sites
Actual Study Start Date : July 22, 2019
Actual Primary Completion Date : January 9, 2023
Actual Study Completion Date : January 9, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



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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:

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

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): NCT04207151


Locations
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United States, New York
NYU Langone
New York, New York, United States, 10003
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Robert Pitts, MD New York University
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04207151    
Other Study ID Numbers: 19-00060
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only by NYU/Bellevue researchers

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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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Infections
Sexually Transmitted Diseases
Communicable Diseases
Genital Diseases
Urogenital Diseases
Disease Attributes
Pathologic Processes