Reducing Disparities in Rural HIV Prevention

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05319613
• Collaborator: Gilead Sciences (Industry)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21.7
• Patients Per Site Per Month: 4.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Sexually Transmitted Infections	Other: Virtual clinical visits with home lab kits and mailed HIV PrEP	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Convenience sample of baseline community survey participants who elect to enter clinical PrEP careConvenience sample of baseline community survey participants who elect to enter clinical PrEP care
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Reducing Disparities in Rural HIV Prevention With Telemedicine PrEP and Postal Lab Kits
• Actual Study Start Date: Mar 9, 2022
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Persistence in PrEP care [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 Outcome Measures

1. Medication adherence [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 [12 months]

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

3. Acceptability of Telemedicine visits [12 months]

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

4. Feasibility of postal lab kits [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 [12 months]

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

6. HIV seroconversion [12 months]

   Describe rate of HIV seroconversion in cohort at 12 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver
• Gilead Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT05319613
• Other Study ID Numbers: 21-2514
• First Posted: Apr 8, 2022
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Colorado, Denver: HIV Prevention, Access, Rural Communities
• Additional relevant MeSH terms: Infections; Communicable Diseases; Sexually Transmitted Diseases

Study Results

No Results Posted as of Aug 15, 2022