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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Retention

Secondary study objectives

TelePrEP Acceptability

TelePrEP Feasibility

Other study objectives

TelePrEP Satisfaction

TelePrEP visit rate

Uptake TelePrEP

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

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

1. We will identify youth potentially eligibile for PrEP using tenfovir alefenamide/emtricitabine (TAF/FTC). 2. Eligible youth will be contacted for rapid (same day) consenting and enrollment. 3. 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. 4. TelePrEP visits may be carried out in the setting of the participant's choosing and may include home or at a community organization. 5. 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. 6. TelePrEP(or in-person visits as needed) will be conducted by a skilled multidisciplinary team one month after initiation and then every three months.

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