Telemedicine for PrEP Throughout Mississippi

Not Applicable

Completed

Conditions: HIV/AIDS

Interventions: Behavioral: Tele-PrEP Intervention

Registration Number: NCT03840382

Lead Sponsor: Rhode Island Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tele-PrEP Intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction)	Assessed at 3 months	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.
Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction)	Assessed at 6 months	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.
Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record )	Assessed at 3 months	Number of participants with 0-2 PrEP medication refills in past 3 months (extracted from electronic medical record at 3-month follow-up).
Adherence to PrEP (Self-report)	Assessed at 3 months and 6 months	Self-reported number of days a PrEP dose was missed in the past 30 days. Ranging from 0 to 30.
Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 6 Months Post-intervention (Electronic Medical Record Extraction)	Assessed at 6 months	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.
Number of Participants Who Received a PrEP Medication Prescription at 3 Months (Electronic Medical Record Extraction)	Assessed at 3 months	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.
Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record)	Assessed at 6 months	Number of Participants With 0-2 PrEP Refills in past 3 months (extracted from electronic medical record at 6-month follow-up).

Secondary Outcome Measures

Name	Time	Method
Motivational Readiness for PrEP and PrEP-related Care	Assessed at 3 months and 6 months	This measure was a subscale adapted from The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ), 2006. The motivational readiness to engage in PrEP care subscale consisted of eight items with 4-point Likert responses. The possible score range for this subscale is 8 to 32, with higher scores indicating higher motivation to engage in PrEP care.
Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8)	Assessed at 3 months and 6 months	Patients' perspective on the acceptability of using telemedicine for PrEP care was assessed with a modified version of the Client Satisfaction Questionnaire (CSQ-8). This measure was only given to participants who attended a PrEP-related telemedicine appointment. Scores for this measure could range from 2 to 8, with higher scores indicating greater satisfaction.
PrEP Knowledge	Assessed at 3 months and 6 months	This 5-item measure was used to assess knowledge (true/false/don't know) based on facts from the CDC and the San Francisco AIDS Foundation websites concerning PrEP. Scores for the measure could range from 0 to 5 with higher scores indicating greater PrEP knowledge.