Reducing Disparities in Rural HIV Prevention

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Infections
• Intervention / Treatment: Other: Virtual clinical visits with home lab kits and mailed HIV PrEP

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Telemedicine Clinical Care; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: HIV Prevention, Access, Rural Communities
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: 21-2514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with other researchers. De-identified aggregate data will be shared at completion of study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No