N/A
N=217
Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System
Pre-exposure Prophylaxis
Bottom Line
View on ClinicalTrials.gov: NCT03729570 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up — 17; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ePrEP (Other)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Emory University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up |
17; 7 | — |
| SECONDARY Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up |
15; 20 | — |
Summary
The premise for the study is that a tailored approach for rural young men who have sex with men (YMSM), addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of Pre-exposure Prophylaxis (PrEP) initiation and persistence in care.
Eligibility Criteria
Inclusion Criteria
- Assigned male at birth
- Age 18-29 (inclusive)
- Live in a study state (Georgia, Mississippi, North Carolina, Alabama)
- Able to provide informed consent and complete survey instruments in English
- Willing to provide complete contact information (including 2 alternate contacts)
- Able and willing to provide identification verification for viewing confirmation only
- Laboratory confirmed HIV negative
- Owns a smartphone capable of running the study app
- Male sex partners in past 6 months or clinician discretion of epidemiologic context of HIV risk
- Behavioral/epidemiological indication for PrEP :
- History of inconsistent or no condom use with more than one partner
- History of inconsistent or no condom use with one partner who is not mutually monogamous
- HIV-positive sexual partner
- Any sexually transmitted infection (STI) diagnosed in past 6 months
- Commercial sex work
- African American MSM reporting anal sex in the past 6 months
- Clinician discretion based on epidemiologic context of HIV risk
- Willing to take FDA-approved daily oral PrEP
- Willing to use study-provided PrEP navigation services
- Willing to self-collect specimens
Exclusion Criteria
- HIV positive (self-report or laboratory confirmed)
- Chronic Hepatitis B or no verification of hepatitis B vaccination
- Currently enrolled in any HIV prevention trial (biomedical)
- Currently taking oral PrEP based on self-report
- Creatinine clearance <60 ml/min based on the Cockcroft-Gault equation
- Symptoms of acute HIV infection within the prior 30 days
- Contraindications to oral PrEP
- Personal diagnosis or family history of hemophilia
- Health insurance with Kaiser Permanente (unable to prescribe PrEP through the study)
- Investigator discretion to exclude anyone whose best interest is not to participate
- Evidence of fraudulent participation, such as duplicate Internet Protocol (IP) address, multiple screening attempts, duplicate emails, etc
Data sourced from ClinicalTrials.gov (NCT03729570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.