Telemedicine for PrEP Throughout Mississippi

HIV/AIDS Clinical Trial

— Tele-PrEP  

Official title:

Telemedicine for PrEP Throughout Mississippi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03840382
• Other study ID #: 407618
• Status: Completed
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: May 4, 2022

Study information

• Verified date: November 2023
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction)	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.	Assessed at 3 months
Primary	Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 6 Months Post-intervention (Electronic Medical Record Extraction)	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.	Assessed at 6 months
Primary	Number of Participants Who Received a PrEP Medication Prescription at 3 Months (Electronic Medical Record Extraction)	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.	Assessed at 3 months
Primary	Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction)	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.	Assessed at 6 months
Primary	Adherence to PrEP (Self-report)	Self-reported number of days a PrEP dose was missed in the past 30 days. Ranging from 0 to 30.	Assessed at 3 months and 6 months
Primary	Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record )	Number of participants with 0-2 PrEP medication refills in past 3 months (extracted from electronic medical record at 3-month follow-up).	Assessed at 3 months
Primary	Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record)	Number of Participants With 0-2 PrEP Refills in past 3 months (extracted from electronic medical record at 6-month follow-up).	Assessed at 6 months
Secondary	PrEP Knowledge	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.	Assessed at 3 months and 6 months
Secondary	Motivational Readiness for PrEP and PrEP-related Care	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.	Assessed at 3 months and 6 months
Secondary	Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8)	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.	Assessed at 3 months and 6 months