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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05319613
Other study ID # 21-2514
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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