Reducing Disparities in Rural HIV Prevention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections, Sexually Transmitted Infections

Intervention / Treatment
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* Other: Virtual clinical visits with home lab kits and mailed HIV PrEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Convenience sample of baseline community survey participants who elect to enter clinical PrEP care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Telemedicine Clinical Care<br>Rural participants who enter PrEP clinical care with University of Colorado HIV Prevention Program will receive care via telemedicine with mailed lab kits and mailed HIV PrEP. | Other: Virtual clinical visits with home lab kits and mailed HIV PrEP<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Feasibility of Telemedicine visits | Describe feasibility of Telemedicine visits as determined by survey response and completion of quarterly visits. | 12 months | 
| Acceptability of Telemedicine visits | Describe acceptability of Telemedicine visits as determined by survey response and completion of quarterly visits. | 12 months | 
| Feasibility of postal lab kits | Describe feasibility of postal lab kits, as determined by survey response and completion of quarterly lab monitoring. | 12 months | 
| Acceptability of postal lab kits | Describe acceptability of postal lab kits, as determined by survey response and completion of quarterly lab monitoring. | 12 months | 
| HIV seroconversion | Describe rate of HIV seroconversion in cohort at 12 months. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Prevention, Access, Rural Communities