Reducing Disparities in Rural HIV Prevention
Primary Purpose
HIV Infections, Sexually Transmitted Infections
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual clinical visits with home lab kits and mailed HIV PrEP
Sponsored by
About this trial
This is an interventional health services research trial for HIV Infections focused on measuring HIV Prevention, Access, Rural Communities
Eligibility Criteria
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
Sites / Locations
- University of Colorado HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Telemedicine Clinical Care
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Feasibility of Telemedicine visits
Describe feasibility of Telemedicine visits as determined by survey response and completion of quarterly visits.
Acceptability of Telemedicine visits
Describe acceptability of Telemedicine visits as determined by survey response and completion of quarterly visits.
Feasibility of postal lab kits
Describe feasibility of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.
Acceptability of postal lab kits
Describe acceptability of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.
HIV seroconversion
Describe rate of HIV seroconversion in cohort at 12 months.
Full Information
NCT ID
NCT05319613
First Posted
March 11, 2022
Last Updated
August 11, 2022
Sponsor
University of Colorado, Denver
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05319613
Brief Title
Reducing Disparities in Rural HIV Prevention
Official Title
Reducing Disparities in Rural HIV Prevention With Telemedicine PrEP and Postal Lab Kits
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Infections
Keywords
HIV Prevention, Access, Rural Communities
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Convenience sample of baseline community survey participants who elect to enter clinical PrEP care
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine Clinical Care
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual clinical visits with home lab kits and mailed HIV PrEP
Intervention Description
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 Outcome Measure Information:
Title
Persistence in PrEP care
Description
The proportion of study participants persisting in PrEP care at 12 months, stratified by race, ethnicity, zip 3 region, and type of insurance coverage.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Medication adherence
Description
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.
Time Frame
12 months
Title
Feasibility of Telemedicine visits
Description
Describe feasibility of Telemedicine visits as determined by survey response and completion of quarterly visits.
Time Frame
12 months
Title
Acceptability of Telemedicine visits
Description
Describe acceptability of Telemedicine visits as determined by survey response and completion of quarterly visits.
Time Frame
12 months
Title
Feasibility of postal lab kits
Description
Describe feasibility of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.
Time Frame
12 months
Title
Acceptability of postal lab kits
Description
Describe acceptability of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.
Time Frame
12 months
Title
HIV seroconversion
Description
Describe rate of HIV seroconversion in cohort at 12 months.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna V McGregor, MSN
Phone
720-848-0191
Email
donna.mcgregor@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Lawrence, MSW
Phone
720-848-0191
Email
lisa.lawrence@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna V McGregor, MSN
Phone
720-848-0191
Email
donna.mcgregor@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Lisa Lawrence
Phone
720-848-0191
Email
lisa.lawrence@cuanschutz.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers. De-identified aggregate data will be shared at completion of study.
Learn more about this trial
Reducing Disparities in Rural HIV Prevention
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