HIV InfectionsNCT05319613
Reducing Disparities in Rural HIV Prevention
A study testing Virtual clinical visits with home lab kits and mailed HIV PrEP in people with HIV Infections and Sexually Transmitted Infections, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Infections
- What is being tested?
- Virtual clinical visits with home lab kits and mailed HIV PrEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 18 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Reducing Disparities in Rural HIV Prevention With Telemedicine PrEP and Postal Lab Kits
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.
Read the 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.
- Conditions
- HIV Infections, Sexually Transmitted Infections
- Being tested
- Virtual clinical visits with home lab kits and mailed HIV PrEP
- Keywords
- HIV Prevention, Access, Rural Communities
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual clinical visits with home lab kits and mailed HIV PrEPOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual clinical visits with home lab kits and mailed HIV PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
Feasibility of Telemedicine visits
Describe feasibility of Telemedicine visits as determined by survey response and completion of quarterly visits.
Measured: 12 months
Acceptability of Telemedicine visits
Describe acceptability of Telemedicine visits as determined by survey response and completion of quarterly visits.
Measured: 12 months
Feasibility of postal lab kits
Describe feasibility of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.
Measured: 12 months
Acceptability of postal lab kits
Describe acceptability of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.
Measured: 12 months
HIV seroconversion
Describe rate of HIV seroconversion in cohort at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start9 Mar 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Convenience sample of baseline community survey participants who elect to enter clinical PrEP care
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319613
- Sponsor's protocol ID
- 21-2514
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2022
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. De-identified aggregate data will be shared at completion of study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disparities in Rural HIV Prevention With Telemedicine PrEP and Postal Lab Kits
- ClinicalTrials.gov ID
- NCT05319613
- Acronym / sponsor ID
- 21-2514
- Conditions
- HIV Infections, Sexually Transmitted Infections
- Keywords
- HIV Prevention, Access, Rural Communities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Convenience sample of baseline community survey participants who elect to enter clinical PrEP care
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Clinical Care | Other | Other: Virtual clinical visits with home lab kits and mailed HIV PrEPRural 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual clinical visits with home lab kits and mailed HIV PrEPRural 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 | Other | Telemedicine Clinical Care |
Primary outcome
Persistence in PrEP care
Time frame: 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.
6 secondary outcomes
Medication adherence
Time frame: 12 months
Feasibility of Telemedicine visits
Time frame: 12 months
Acceptability of Telemedicine visits
Time frame: 12 months
Feasibility of postal lab kits
Time frame: 12 months
Acceptability of postal lab kits
Time frame: 12 months
HIV seroconversion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. De-identified aggregate data will be shared at completion of study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual clinical visits with home lab kits and mailed HIV PrEP in people with HIV Infections and Sexually Transmitted Infections, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence in PrEP care (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.