Clinical trial NCT05319613: Reducing Disparities in Rural HIV Prevention
Official title: Reducing Disparities in Rural HIV Prevention With Telemedicine PrEP and Postal Lab Kits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Infections
Keywords: HIV Prevention, Access, Rural Communities
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2022-04-08
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Convenience sample of baseline community survey participants who elect to enter clinical PrEP care
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Persistence in PrEP care
timeFrame: 12 months
Secondary outcomes:
measure: Medication adherence
timeFrame: 12 months
measure: Feasibility of Telemedicine visits
timeFrame: 12 months
measure: Acceptability of Telemedicine visits
timeFrame: 12 months
measure: Feasibility of postal lab kits
timeFrame: 12 months
measure: Acceptability of postal lab kits
timeFrame: 12 months
measure: HIV seroconversion
timeFrame: 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
References: