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

NYU Langone Health

Status: Completed

Conditions: Sexually Transmitted Infection; Hiv

Treatments: Behavioral: SNAPS intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04207151

19-00060

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

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.

Pre- and Post- SNAPS intervention

Experimental group

Description:

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.

Treatment:

Behavioral: SNAPS intervention