Telemedicine for PrEP Throughout Mississippi

Study Overview
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Brief Summary
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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
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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.

Official Title
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Telemedicine for PrEP Throughout Mississippi

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Tele-PrEP Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-PrEP Intervention<br>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<br>* Telemedicine conferences with PrEP-specialists<br>|

What is the study measuring?
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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 |