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OpenTrials
Completed

NCT Number: NCT05319613

Reducing Disparities in Rural HIV Prevention

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual clinical visits with home lab kits and mailed HIV PrEP

Other

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

Primary outcomes

  1. 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

  1. Medication adherence

    Time frame: 12 months

    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.

  2. Feasibility of Telemedicine visits

    Time frame: 12 months

    Describe feasibility of Telemedicine visits as determined by survey response and completion of quarterly visits.

  3. Acceptability of Telemedicine visits

    Time frame: 12 months

    Describe acceptability of Telemedicine visits as determined by survey response and completion of quarterly visits.

  4. Feasibility of postal lab kits

    Time frame: 12 months

    Describe feasibility of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.

  5. Acceptability of postal lab kits

    Time frame: 12 months

    Describe acceptability of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.

  6. HIV seroconversion

    Time frame: 12 months

    Describe rate of HIV seroconversion in cohort at 12 months.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2022
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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