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Reducing Disparities in Rural HIV Prevention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05319613
Enrollment
69
Registered
2022-04-08
Start date
2022-03-09
Completion date
2023-07-18
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sexually Transmitted Infections

Keywords

HIV Prevention, Access, Rural Communities

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.

Interventions

OTHERVirtual 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

Sponsors

Gilead Sciences
CollaboratorINDUSTRY
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Convenience sample of baseline community survey participants who elect to enter clinical PrEP care

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Persistence in PrEP care12 monthsThe proportion of study participants persisting in PrEP care at 12 months, stratified by race, ethnicity, zip 3 region, and type of insurance coverage.

Secondary

MeasureTime frameDescription
Feasibility of Telemedicine visits12 monthsDescribe feasibility of Telemedicine visits as determined by survey response and completion of quarterly visits.
Acceptability of Telemedicine visits12 monthsDescribe acceptability of Telemedicine visits as determined by survey response and completion of quarterly visits.
Medication adherence12 monthsDescribe 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.
Acceptability of postal lab kits12 monthsDescribe acceptability of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.
HIV seroconversion12 monthsDescribe rate of HIV seroconversion in cohort at 12 months.
Feasibility of postal lab kits12 monthsDescribe feasibility of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026