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TelePrEP for HIV Prevention

N/A

Recruiting

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

Study Summary

This trial is testing a new way to provide PrEP, a preventative medication for HIV, to youth in Colorado. The goal is to see if this new telemedicine delivery of PrEP is acceptable and feasible and if it results in successful initiation, persistence, and retention on oral PrEP.

Who is the study for?

This trial is for young individuals assigned male at birth, who have had male sex partners in the past 6 months and are HIV negative. They must be eligible for PrEP based on CDC guidance, agree to TelePrEP visits, and willing to use or obtain insurance coverage. It's not for pregnant individuals, those with HIV or acute HIV concerns until ruled out, cisgender women, transgender men, or persons whose only risk is from injection drug use.Check my eligibility

What is being tested?

The study tests a telemedicine delivery of pre-exposure prophylaxis (TelePrEP) aimed at preventing HIV in youth. The goal is to see if this approach helps them start and stay on PrEP treatment over 12 months by overcoming barriers like lack of interest and low perceived risk.See study design

What are the potential side effects?

While specific side effects aren't listed here as it's about service delivery rather than a new medication, typical PrEP-related side effects can include nausea, headache, stomach pain, weight loss and sometimes more serious effects like kidney problems or bone density loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Retention

Secondary outcome measures

TelePrEP Acceptability

TelePrEP Feasibility

Other outcome measures

TelePrEP Satisfaction

TelePrEP visit rate

Uptake TelePrEP

Trial Design

1Treatment groups

Experimental Treatment

Group I: Telemedicine for pre-exposure prophylaxis of HIVExperimental Treatment1 Intervention

We will identify youth potentially eligibile for PrEP using tenfovir alefenamide/emtricitabine (TAF/FTC). Eligible youth will be contacted for rapid (same day) consenting and enrollment. Participants who consent to the study will undergo a PrEP initiation visit either the same day or within two weeks with a provider. The initial visit may be in-person or via Telemedicine. TelePrEP visits may be carried out in the setting of the participant's choosing and may include home or at a community organization. Recommended laboratory testing will be arranged as part of the PrEP initiation visit. HIV testing will be carried out as well as Centers for Disease Control and Prevention (CDC)-recommended laboratory testing will be obtained. TelePrEP(or in-person visits as needed) will be conducted by a skilled multidisciplinary team one month after initiation and then every three months.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor

1,084 Previous Clinical Trials

848,379 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,426 Total Patients Enrolled

Media Library

TelePrEP Clinical Trial Eligibility Overview. Trial Name: NCT05520905 — N/A

HIV (Human Immunodeficiency Virus) Research Study Groups: Telemedicine for pre-exposure prophylaxis of HIV

HIV (Human Immunodeficiency Virus) Clinical Trial 2023: TelePrEP Highlights & Side Effects. Trial Name: NCT05520905 — N/A

TelePrEP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05520905 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor recruiting geriatric participants?

"The parameters for eligibility in this clinical trial necessitate that all applicants are between 14 and 24 years of age. An additional 21 studies have been prepared specifically for those under 18, while 61 trials target elderly individuals over the age of 65."

Answered by AI

Are there any restrictions for participants in this clinical experiment?

"This clinical trial is recruiting 100 people aged between 14 and 24, who have been diagnosed with HIV. Additionally, potential participants must meet the following requirements: HIV negative status; eligibility for Prep using emtricitabine/tenofovir alafenamide (brand name Descovy) as per CDC guidance; male gender assigned at birth; consent to TelePrEP visits; willingness to use existing insurance coverage or assistance in obtaining alternative forms of funding such as Title X funds or charity care; previous unprotected intercourse within a six month period or diagnosis of bacterial STI."

Answered by AI

Are participants currently being accepted into this experiment?

"The trial in question, which was initially published on November 30th 2022, is not currently seeking participants. Nevertheless, there are still 83 other clinical trials actively recruiting individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TelePrEP for At-risk Youth in Colorado

2023. "TelePrEP for At-risk Youth in Colorado". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05520905.

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