Telemedicine for PrEP Throughout Mississippi

NCT03840382 | Completed Results

• 1 other identifier: 407618
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (7)

• Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction)

  Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 3 months post-intervention.

  Assessed at 3 months

• Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 6 Months Post-intervention (Electronic Medical Record Extraction)

  Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 6 months post-intervention.

  Assessed at 6 months

• Number of Participants Who Received a PrEP Medication Prescription at 3 Months (Electronic Medical Record Extraction)

  Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 3-month follow-up.

  Assessed at 3 months

• Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction)

  Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 6-month follow-up.

  Assessed at 6 months

• Adherence to PrEP (Self-report)

  Self-reported number of days a PrEP dose was missed in the past 30 days. Ranging from 0 to 30.

  Assessed at 3 months and 6 months

• Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record )

  Number of participants with 0-2 PrEP medication refills in past 3 months (extracted from electronic medical record at 3-month follow-up).

  Assessed at 3 months

• Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record)

  Number of Participants With 0-2 PrEP Refills in past 3 months (extracted from electronic medical record at 6-month follow-up).

  Assessed at 6 months

Secondary Outcomes (3)

• PrEP Knowledge

  Assessed at 3 months and 6 months

• Motivational Readiness for PrEP and PrEP-related Care

  Assessed at 3 months and 6 months

• Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8)

  Assessed at 3 months and 6 months

Study Arms (1)

Tele-PrEP Intervention

EXPERIMENTAL

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.

Behavioral: Tele-PrEP Intervention

Interventions

Tele-PrEP Intervention BEHAVIORAL

Telemedicine conferences with PrEP-specialists

Tele-PrEP Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Rhode Island Hospital: lead
• University of Mississippi Medical Center: collaborator

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, 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

Results Point of Contact

• Title: Dr. Larry Brown
• Organization: Rhode Island Hospital

lkbrown@lifespan.org

+1 (401) 793-8808

Study Officials

• Larry K Brown, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• James B Brock, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Child and Adolescent Psychiatry

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 15, 2019
• Study Start: December 19, 2019
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2023-11

Locations

US (1)