Testing Two Models of PrEP Delivery in OBGYN Clinics

Hiv Clinical Trial

Official title:

Testing Two Service Models of PrEP Delivery in OBGYN Clinics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05015855
• Other study ID #: 2021-13268
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• 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.
• 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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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