Telemedicine for PrEP Throughout Mississippi

NCT ID: NCT03840382

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2022-05-04

Brief Summary

This study will develop and test a program to deliver PrEP care in underserved communities in Mississippi (MS) through telemedicine, distance-based, clinical care delivered in local community based organizations (CBOs). The intervention will be developed in collaboration with medical specialists at the University of Mississippi Medical Center (UMMC) and local CBO stakeholders (providers, administrators and patients). Approximately 75 individuals will be recruited from CBOs in MS. Participants will be able to receive PrEP counseling in the CBO and PrEP care via telemedicine from a PrEP specialist at UMMC. Participants will complete three assessments in the six months after enrolling. Our study will provide a wealth of information about PrEP-related outcomes and HIV testing among MS residents living in underserved communities. If successful, this program will be able to be disseminated to other CBOs in the South.

Detailed Description

Uptake of PrEP in the southern United States has been slow, especially in areas distant from academic medical centers that provide PrEP care. Despite underserved populations in the South having alarmingly high rates of HIV, a large percentage of at-risk individuals are not engaged in PrEP care due to limited access to academic medical centers. Mississippi (MS), the site of this proposed project, has the seventh highest incidence of HIV of any state and CBOs that provide HIV/STI testing outside of urban areas report that very few of their at-risk individuals use PrEP. Unfortunately, physicians outside of academic centers are often reluctant to prescribe PrEP because they lack the expertise, training, and the support necessary to provide comprehensive HIV prevention care. Those are at-risk do not seek PrEP from academic centers because of stigma, travel burdens, and financial concerns. To overcome these barriers, this project will develop and pilot test a program to deliver PrEP care in underserved remote communities in MS through telemedicine clinical care delivered in local CBOs. Telemedicine will allow specialists to provide care at a distance and while simultaneously enhancing the capacity of local CBOs to provide quality HIV testing and counseling, PrEP treatment, and linkage to HIV care if needed. It will allow patients to receive the highest level of medical care from trusted CBOs within their local communities. It will also enhance the CBO's mission by allowing it to provide a new, high-quality medical service.

Conditions

HIV/AIDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tele-PrEP Intervention

The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care.

Group Type: EXPERIMENTAL

Tele-PrEP Intervention

Intervention Type: BEHAVIORAL

Telemedicine conferences with PrEP-specialists

Interventions

Tele-PrEP Intervention

Telemedicine conferences with PrEP-specialists

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years old or older
• Presented at a collaborating CBO for HIV testing during trial months
• PrEP eligible based on HIV Risk Checklist
• Able to read and speak English
• Able to give meaningful consent as determined by research staff
• No known HIV infection

Exclusion Criteria

• None

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

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Larry K. Brown

Director, Division of Child and Adolescent Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry K Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

James B Brock, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

407618

Identifier Type: -

Identifier Source: org_study_id