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

Not Applicable

Completed

• Conditions: Sexually Transmitted Infection; Hiv
• Interventions: Behavioral: SNAPS intervention

• Registration Number: NCT04207151
• Lead Sponsor: 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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-07-22
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-20
• Primary Completion: 2023-01-09
• Study Completion: 2023-01-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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Exclusion Criteria

• patients who are HIV positive
• refuse consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre- and Post- SNAPS intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in the knowledge of HIV	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 PrEP prescriptions	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 number of HIV cases	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

Trial Locations

Locations (1)

NYU Langone; 🇺🇸 New York, New York, United States