Clinical trial NCT03840382: Telemedicine for PrEP Throughout Mississippi
Official title: Telemedicine for PrEP Throughout Mississippi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Mississippi Medical Center
First posted: 2019-02-15
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction)
timeFrame: Assessed at 3 months
measure: Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 6 Months Post-intervention (Electronic Medical Record Extraction)
timeFrame: Assessed at 6 months
measure: Number of Participants Who Received a PrEP Medication Prescription at 3 Months (Electronic Medical Record Extraction)
timeFrame: Assessed at 3 months
measure: Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction)
timeFrame: Assessed at 6 months
measure: Adherence to PrEP (Self-report)
timeFrame: Assessed at 3 months and 6 months
measure: Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record )
timeFrame: Assessed at 3 months
measure: Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record)
timeFrame: Assessed at 6 months
Secondary outcomes:
measure: PrEP Knowledge
timeFrame: Assessed at 3 months and 6 months
measure: Motivational Readiness for PrEP and PrEP-related Care
timeFrame: Assessed at 3 months and 6 months
measure: Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8)
timeFrame: Assessed at 3 months and 6 months
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: Rhode Island Hospital
name: Larry K Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mississippi Medical Center
name: James B Brock, MD
role: PRINCIPAL_INVESTIGATOR
References: