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Telemedicine for PrEP Throughout Mississippi (Tele-PrEP)

Primary Purpose

HIV/AIDS

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-PrEP Intervention
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Mississippi Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tele-PrEP Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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)
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)
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)

Secondary Outcome Measures

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
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).
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).
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).

Full Information

First Posted
January 28, 2019
Last Updated
April 26, 2022
Sponsor
Rhode Island Hospital
Collaborators
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03840382
Brief Title
Telemedicine for PrEP Throughout Mississippi
Acronym
Tele-PrEP
Official Title
Telemedicine for PrEP Throughout Mississippi
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
University of Mississippi Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-PrEP Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tele-PrEP Intervention
Intervention Description
Telemedicine conferences with PrEP-specialists
Primary Outcome Measure Information:
Title
Appointment attendance at 3 months post-intervention (electronic medical record extraction)
Description
Attendance at a telemedicine for PrEP appointment with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record
Time Frame
Assessed at 3 months
Title
Appointment attendance at 6 months post-intervention (electronic medical record extraction)
Description
Attendance at a telemedicine for PrEP appointment with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record
Time Frame
Assessed at 6 months
Title
Receipt of PrEP medication prescription at 3 months (electronic medical record extraction)
Description
PrEP medication was prescribed in past 3 months, extracted for patient's electronic medical record
Time Frame
Assessed at 3 months
Title
Receipt of PrEP medication prescription at 6 months (electronic medical record extraction)
Description
PrEP medication was prescribed in past 3 months, extracted for patient's electronic medical record
Time Frame
Assessed at 6 months
Title
Change in adherence to PrEP (self-report)
Description
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)
Time Frame
Assessed at 3 months and 6 months
Title
Number of PrEP medication refills at 3 months (electronic medical record extraction)
Description
Number of PrEP refills in past 3 months (extracted from electronic medical record)
Time Frame
Assessed at 3 months
Title
Number of PrEP medication refills at 6 months (electronic medical record extraction)
Description
Number of PrEP refills in past 3 months (extracted from electronic medical record)
Time Frame
Assessed at 6 months
Secondary Outcome Measure Information:
Title
PrEP knowledge
Description
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
Time Frame
Assessed at Baseline, 3 months, and 6 months
Title
Motivational readiness for PrEP and PrEP-related care
Description
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).
Time Frame
Assessed at Baseline, 3 months, and 6 months
Title
Intervention acceptability (SEF)
Description
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).
Time Frame
Assessed at 3 months and 6 months
Title
Intervention acceptability (CSQ-8)
Description
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).
Time Frame
Assessed at 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Larry K Brown, MD
Phone
(401)-793-8808
Email
lkbrown@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
James B Brock, MD
Phone
(601) 984-5560
Email
jbbrock@umc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry K Brown, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James B Brock, MD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James B Brock, MD

12. IPD Sharing Statement

Learn more about this trial

Telemedicine for PrEP Throughout Mississippi

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