Reducing Disparities in Rural HIV Prevention

NCT05319613 | Completed

• 1 other identifier: 21-2514
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Sexually Transmitted Infections

Keywords

HIV Prevention, Access, Rural Communities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Medication adherence

  12 months

• Feasibility of Telemedicine visits

  12 months

• Acceptability of Telemedicine visits

  12 months

• Feasibility of postal lab kits

  12 months

• Acceptability of postal lab kits

  12 months

Study Arms (1)

Telemedicine Clinical Care

OTHER

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

Interventions

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

Telemedicine Clinical Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Convenience sample of baseline community survey participants who elect to enter clinical PrEP care

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 8, 2022
• Study Start: March 9, 2022
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)