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Clinical Trials/NCT05319613
NCT05319613
Completed
Not Applicable

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

University of Colorado, Denver1 site in 1 country69 target enrollmentMarch 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
University of Colorado, Denver
Enrollment
69
Locations
1
Primary Endpoint
Persistence in PrEP care
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 9, 2022
End Date
July 18, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Colorado rural or frontier county residents, Adults (age 18+)
  • Access to internet, smart phone or tablet to participate in online surveys
  • Able to complete online surveys in English or Spanish

Exclusion Criteria

  • Residence in an urban Colorado county
  • HIV positive status
  • No internet, smart phone, or tablet access
  • Unable to complete online surveys in English or Spanish

Outcomes

Primary Outcomes

Persistence in PrEP care

Time Frame: 12 months

The proportion of study participants persisting in PrEP care at 12 months, stratified by race, ethnicity, zip 3 region, and type of insurance coverage.

Secondary Outcomes

  • Feasibility of postal lab kits(12 months)
  • Acceptability of Telemedicine visits(12 months)
  • Feasibility of Telemedicine visits(12 months)
  • Acceptability of postal lab kits(12 months)
  • Medication adherence(12 months)
  • HIV seroconversion(12 months)

Study Sites (1)

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