Reducing Disparities in Rural HIV Prevention

HIV Infections Clinical Trial

Official title:

Reducing Disparities in Rural HIV Prevention With Telemedicine PrEP and Postal Lab Kits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319613
• Other study ID #: 21-2514
• Status: Completed
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: July 18, 2023

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

HIV and Sexually Transmitted Infection (STI) rates are increasing in rural areas including rural Colorado. Many rural residents find it difficult to access HIV and STI prevention services.

In this study, an online survey on HIV and STI Prevention and best practices to provide access to prevention will be administered to rural residents in three zip 3 zones in rural Colorado. In addition to the baseline survey, study participants who are interested and medically eligible may initiate PrEP services with the University of Colorado HIV Prevention Program and receive PrEP through telemedicine visits, mailed home lab kits, and mailed medication. Persistence in PrEP care, acceptability, and feasibility of telemedicine and home lab kits will be measured.

Description:

HIV and Sexually Transmitted Infection (STI) rates are increasing in rural areas including rural Colorado. Many rural residents find it difficult to access HIV and STI prevention services. The goal of this study is to understand the risk for HIV and STIs, views on PrEP, and to determine if access to telemedicine visits and home lab kits increases engagement in PrEP services and persistence in care for at-risk rural populations.

An online survey on HIV and STI Prevention and best practices to provide access to prevention will be administered to rural residents in three zip 3 zones in rural Colorado, comprised of increased proportions of minority residents (Hispanic, Native American, and Black). In addition to the baseline survey, study participants who are interested and medically eligible may initiate PrEP services with the University of Colorado HIV Prevention Program and receive PrEP through telemedicine visits, mailed home lab kits, and mailed medication. Persistence in PrEP care, acceptability, and feasibility of telemedicine and home lab kits will be measured through baseline and follow-up survey questionnaires and clinical chart reviews for those engaged in PrEP care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Colorado rural or frontier county residents, Adults (age 18+)

2. Access to internet, smart phone or tablet to participate in online surveys

3. Able to complete online surveys in English or Spanish

Exclusion Criteria:

1. Residence in an urban Colorado county

2. HIV positive status

3. No internet, smart phone, or tablet access

4. Unable to complete online surveys in English or Spanish

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

Other:
• Virtual clinical visits with home lab kits and mailed HIV PrEP
Rural participants who enter PrEP care with University of Colorado HIV Prevention Program will receive PrEP services via telemedicine with home lab kits and mailed HIV PrEP

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence in PrEP care	The proportion of study participants persisting in PrEP care at 12 months, stratified by race, ethnicity, zip 3 region, and type of insurance coverage.	12 months
Secondary	Medication adherence	Describe PrEP medication adherence rates at 12 months (as determined by pharmacy refill data) for rural CO PrEP users who utilize Telemedicine PrEP services and postal lab kits.	12 months
Secondary	Feasibility of Telemedicine visits	Describe feasibility of Telemedicine visits as determined by survey response and completion of quarterly visits.	12 months
Secondary	Acceptability of Telemedicine visits	Describe acceptability of Telemedicine visits as determined by survey response and completion of quarterly visits.	12 months
Secondary	Feasibility of postal lab kits	Describe feasibility of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.	12 months
Secondary	Acceptability of postal lab kits	Describe acceptability of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.	12 months
Secondary	HIV seroconversion	Describe rate of HIV seroconversion in cohort at 12 months.	12 months