Testing Two Models of PrEP Delivery in OBGYN Clinics

NCT05015855 | Completed

• 2 other identifiers: 2021-132685P30AI124414
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The HIV Center for Clinical and Behavioral Studies, the Albert Einstein College of Medicine and the Alliance for Positive Change will test two healthcare models that integrate PrEP into OBGYN services. Model 1 is OBGYN-PrEP with 4 parts: (1) prioritize PrEP; (2) train providers in PrEP and intervention; (3) identify PrEP-appropriate women through a risk screen; and (4) monitor progress and fidelity to protocol. Model 2 is NP-PC PrEP in which PrEP provider burden is shifted to a Nurse Practitioner (NP) who will use a sex-positive approach to deliver PrEP services via telemedicine.

Conditions

Hiv

Keywords

HIV; PrEP

Outcome Measures

Primary Outcomes (2)

• Uptake of PrEP

  We will compare the patients in the NP-PC PrEP and OBGYN-PrEP arms on number of PrEP prescriptions written per 100 patients. The proportion of prescriptions written for PrEP eligible patients will be compared between the two groups (NP-PC vs OBGYN) via chi-square test.

  1 year

• Acceptability of intervention

  Acceptability will be assessed through qualitative in-depth interviews (IDIs) with OBGYN providers and PCs at Alliance at the end of the interventions to identify factors that facilitate or hinder the implementation of the intervention and to assess its acceptability. We will also conduct IDIs with 10 patients in each intervention arm.

  1 year

Study Arms (2)

OBGYN-PrEP

PLACEBO COMPARATOR

OBGYN-PrEP has 4 parts: (1) prioritize PrEP; (2) train providers in PrEP and intervention; (3) identify PrEP-appropriate women through a risk screen; and (4) monitor progress and fidelity to protocol.

Other: OBGYN-PrEP

NP-PC PrEP

EXPERIMENTAL

NP-PC PrEP incorporates the standard of care and practices in OBGYN-PrEP but enhances access to additional skilled providers, as the PrEP provider burden is shifted to a Nurse Practitioner (NP) who will use a sex-positive approach to deliver PrEP services via telemedicine

Other: NP-PC PrEP

Interventions

NP-PC PrEP OTHER

All participating providers will be provided standard education around PrEP and HIV prevention, but half of the providers will be randomized to also partner with a nurse practitioner who will provide additional consultation to patients.

NP-PC PrEP

OBGYN-PrEP OTHER

OBGYN-PrEP is based on PC4PrEP (R01MH107297) that has four steps: announce the policy that PrEP counseling is the responsibility of OBGYN providers to address the "purview paradox"; train providers to manage patients on PrEP; use a screening tool to identify women appropriate for PrEP; and implementation coaching to monitor and encourage PrEP counseling

OBGYN-PrEP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age Female (biological female at birth) Ability to speak and read English or Spanish Patient at Montefiore Medical Center, Eastchester Professional Center (EPC). No gross evidence of cognitive impairment precluding consent and participation Willing to have interview digitally recorded

You may not qualify if:

• \<18 years of age Not a female (biological female at birth)- We have excluded transgender women because their sexual and reproductive health issues and PrEP use differ from those of biological females. Does not speak English or Spanish Not a patient at Montefiore Medical Center, Eastchester Professional Center (EPC). Gross evidence of cognitive impairment precluding consent and participation Not willing to have interview digitally recorded

Sponsors & Collaborators

• Montefiore Medical Center: lead
• New York State Psychiatric Institute: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jessica Atrio, MD, MSc

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2021
• First Posted: August 20, 2021
• Study Start: September 20, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)