N/A
Completed N=17
Supporting Tailored And Responsive PrEP in Rural North Carolina
HIV Pre-Exposure Prophylaxis
Source: ClinicalTrials.gov NCT05984030 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Proportion of Participants Reporting PrEP Initiation by 3 Months — 0.33; 0.10 proportion of participants
Summary
This project consists of two phases to be completed over five years. Phase 1 (Aims 1 and 2) will be completed during Years 1-3 (R61). The Phase 1 study is a randomized trial of a multilevel HIV Pre-Exposure Prophylaxis (PrEP) intervention strategy in rural and peri-urban North Carolina sexually transmitted infection (STI) clinics, with primary outcome of PrEP uptake within 3 months of an index STI clinic visit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Reporting PrEP Initiation by 3 Months |
0.33; 0.10 | — |
| SECONDARY Proportion of Participants Reporting PrEP Initiation by 6 Months |
0.50; 0.13 | — |
| SECONDARY Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 3 Months |
0.50; 0.00 | — |
| SECONDARY Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 6 Months |
0.00; 0.00 | — |
| SECONDARY Average Number of Consecutive Months PrEP Used Over First 3 Months |
1.76; 3.29 | — |
| SECONDARY Average Number of Consecutive Months PrEP Used Over First 6 Months |
1.34; 3.29 | — |
| SECONDARY Average Number of Days PrEP Used Among Persons Initiating Daily Oral PrEP in the 30 Days Prior to the 3-month Visit. |
16.50; 28.00 | — |
| SECONDARY Average Number of Condomless Anal Sex Acts Protected by PrEP Among Persons Initiating Event-driven Oral PrEP in the 30 Days Prior to the 3-month Visit. |
— | — |
| SECONDARY Proportion of Injectable PrEP Initiators Reporting PrEP Use in the 90 Days Prior to the 3-month Visit |
— | — |
| SECONDARY Average Number of Days PrEP Used Among Persons Initiating Daily Oral PrEP in the 30 Days Prior to the 6-month Visit. |
0; 0 | — |
| SECONDARY Average Number of Condomless Anal Sex Acts Protected by PrEP Among Persons Initiating Event-driven Oral PrEP in the 30 Days Prior to the 6-month Visit. |
— | — |
| SECONDARY Proportion of Injectable PrEP Initiators Reporting PrEP Use in the 90 Days Prior to the 6-month Visit |
— | — |
| SECONDARY Proportion of Oral PrEP Initiators With Detected PrEP Concentrations in Blood at 3 Months |
0.00; 0.00 | — |
| SECONDARY Proportion of Oral PrEP Initiators With Detected PrEP Concentrations in Blood at 6 Months |
0.00; 0.00 | — |
| SECONDARY Proportion of Injectable PrEP Initiators Receiving All Prescribed Injections Through 3 Months |
— | — |
| SECONDARY Proportion of Injectable PrEP Initiators Receiving All Prescribed Injections Through 6 Months |
— | — |
| SECONDARY Proportion of Participants Who Test Positive for HIV Among Those Tested at or Prior to the 3-month Visit |
0.00 | — |
| SECONDARY Proportion of Participants Who Test Positive for HIV Among Those Tested at or Prior to the 6-month Visit |
0.00 | — |
| SECONDARY Proportion of Participants Who Test Positive for an STI Other Than HIV Among Those Tested at or Prior to the 3-month Visit |
0.00 | — |
| SECONDARY Proportion of Participants Who Test Positive for an STI Other Than HIV Among Those Tested at or Prior to the 6-month Visit |
0.00 | — |
| SECONDARY Average Self-reported Score on the PrEP Stigma Scale at 3 Months |
15.80; 16.71 | — |
| SECONDARY Average Self-reported Score on the PrEP Stigma Scale at 6 Months |
15.33; 14.8 | — |
Eligibility Criteria
Inclusion Criteria
- Report sexual activity with a male in the past 12 months
- Received HIV testing within 90 days pre-enrollment and not known to be HIV-positive at screening/enrollment by self-report
- Age 18-39 years
- Have daily smartphone access
- Be English speaking
- Deny current PrEP use
Exclusion Criteria
- Confirmed prior HIV-positive diagnosis
- Prior PrEP use (oral PrEP or injectable PrEP) within the last 3 months.
Data sourced from ClinicalTrials.gov (NCT05984030). 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. Informational only — not medical advice.