Testing Two Models of PrEP Delivery in OBGYN Clinics

NCT ID: NCT05015855

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2024-05-01

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.

Detailed Description

The Albert Einstein College of Medicine (Einstein), the HIV Center for Clinical and Behavioral Studies (HIV Center), the Montefiore Medical Center Department of Obstetrics and Gynecology (OBGYN, Implementing Partner) and the Alliance for Positive Change (Alliance, Implementing and Community Partner) will compare two healthcare models that integrate PrEP into OBGYN services. Both models are acceptable standards of care and represent evidence-based approaches to the provision of care. This study is the first example of comparing these interventions in a head-to-head, comparative-effectiveness model. Both groups will benefit from maintained access, enhanced assessment with the PrEP screening tool, and physicians will all receive an evidence-based PrEP education seminar with supporting materials and ongoing access to education and resources. MODEL 1, 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. The goal is that PrEP be provided by a trusted provider with whom the patient has an ongoing relationship. In MODEL 2, NP-PC PrEP, all the same provisions and practices present in Model 1 will be present however, a telehealth opportunity with a Nurse Practitioner (NP) will be provided. A skilled and PrEP-trained NP will deliver PrEP services via telemedicine visits

Conditions

Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

OBGYN-PrEP

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.

Group Type: PLACEBO_COMPARATOR

OBGYN-PrEP

Intervention Type: 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

NP-PC PrEP

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

Group Type: EXPERIMENTAL

NP-PC PrEP

Intervention Type: 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.

Interventions

NP-PC PrEP

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.

Intervention Type: OTHER

OBGYN-PrEP

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥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

Exclusion Criteria

• <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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Atrio, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

5P30AI124414

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021-13268

Identifier Type: -

Identifier Source: org_study_id