Telemedicine for PrEP Throughout Mississippi (Tele-PrEP)

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Tele-PrEP Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larry K Brown, MD; Phone Number: (401)-793-8808; Email: lkbrown@lifespan.org
• Study Contact Backup: Name: James B Brock, MD; Phone Number: (601) 984-5560; Email: jbbrock@umc.edu

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • University of Mississippi Medical Center
      • Contact: James B Brock, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Tele-PrEP Intervention; Telemedicine conferences with PrEP-specialists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appointment attendance at 3 months post-intervention (electronic medical record extraction)	Attendance at a telemedicine for PrEP appointment with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record	Assessed at 3 months
Appointment attendance at 6 months post-intervention (electronic medical record extraction)	Attendance at a telemedicine for PrEP appointment with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record	Assessed at 6 months
Receipt of PrEP medication prescription at 3 months (electronic medical record extraction)	PrEP medication was prescribed in past 3 months, extracted for patient's electronic medical record	Assessed at 3 months
Receipt of PrEP medication prescription at 6 months (electronic medical record extraction)	PrEP medication was prescribed in past 3 months, extracted for patient's electronic medical record	Assessed at 6 months
Change in adherence to PrEP (self-report)	Self-reported proportion of PrEP doses taken in past 3 months. (Change in adherence = self-reported adherence at 6 months - self-reported adherence at 3 months)	Assessed at 3 months and 6 months
Number of PrEP medication refills at 3 months (electronic medical record extraction)	Number of PrEP refills in past 3 months (extracted from electronic medical record)	Assessed at 3 months
Number of PrEP medication refills at 6 months (electronic medical record extraction)	Number of PrEP refills in past 3 months (extracted from electronic medical record)	Assessed at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP knowledge	15-item questionnaire to assess knowledge (true/false/don't know) based on facts from the CDC and the San Francisco AIDS Foundation websites concerning PrEP	Assessed at Baseline, 3 months, and 6 months
Motivational readiness for PrEP and PrEP-related care	Rollnick, S., Heather, N., Gold, R., Hall, W., 1992. Development of a short 'readiness to change' questionnaire for use in brief, opportunistic interventions among excessive drinkers. Br J Addict. 87, 743-754. Rollnick's Readiness Ruler will be used to assess motivation for engaging in PrEP care using two items from 1 (not ready) to 10 (ready to engage).	Assessed at Baseline, 3 months, and 6 months
Intervention acceptability (SEF)	Kennard, B., Brown, L., Hawkins, L., Risi, A., Radcliffe, J., Emslie, G. (2014). Development and implementation of health and wellness CBT for individuals with depression and HIV. Cogn Behav Pract. 21(2): 237-246. The Acceptability of Tele-PrEP by clients, CBO staff, administrators and UMMC physicians will be assessed with a modified version of the Session Evaluation Form (SEF).	Assessed at 3 months and 6 months
Intervention acceptability (CSQ-8)	Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., Nguyen, T.D. Assessment of client/patient satisfaction: Development of a general scale, Evaluation and Program Planning. 1979; 2, 197-207. The Acceptability of Tele-PrEP by clients, CBO staff, administrators and UMMC physicians will be assessed with a modified version of the Client Satisfaction Questionnaire (CSQ-8).	Assessed at 3 months and 6 months

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: University of Mississippi Medical Center
• Investigators: Principal Investigator: Larry K Brown, MD, Rhode Island Hospital; Principal Investigator: James B Brock, MD, University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 407618

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No