Reducing Disparities in Rural HIV Prevention

NCT ID: NCT05319613

Last Updated: 2024-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2023-07-18

Brief Summary

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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

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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.

Conditions

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HIV Infections Sexually Transmitted Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Convenience sample of baseline community survey participants who elect to enter clinical PrEP care
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Virtual clinical visits with home lab kits and mailed HIV PrEP

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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21-2514

Identifier Type: -

Identifier Source: org_study_id

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