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Supporting Tailored And Responsive PrEP in Rural North Carolina
NA trial testing PrEP Navigation Services in HIV Pre-Exposure Prophylaxis in 17 participants. Completed in 1 June 2025.
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 17 |
| Start date | 31 August 2023 |
| Primary completion | 2 May 2025 |
| Estimated completion | 1 June 2025 |
| Sites | 1 location across United States |
University of North Carolina, Chapel Hill
Adults 18 to 39, any sex, with HIV Pre-Exposure Prophylaxis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of participants with verified self-reported pre-exposure prophylaxis (PrEP) use (first dose, oral or injectable PrEP)1 at or before 3 months, defined as the number verified to start PrEP divided by the total number of participants in each arm
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 0.33 | |
| STARR NC Standard-of-Care Control Condition | 0.10 |
Proportion of participants with verified self-reported PrEP use (first dose, oral or injectable PrEP) at or before 6 months, defined as the number verified to start PrEP divided by the total number of participants in each arm
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 0.50 | |
| STARR NC Standard-of-Care Control Condition | 0.13 |
Number of participants with on-time PrEP refills and/or injections noted in Electronic Health Record (EHR) over first 3 months divided by number initiating PrEP over first 3 months
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 0.50 | |
| STARR NC Standard-of-Care Control Condition | 0.00 |
Number of participants with on-time PrEP refills and/or injections noted in EHR over first 6 months divided by number initiating PrEP over first 6 months
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 0.00 | |
| STARR NC Standard-of-Care Control Condition | 0.00 |
Among those who initiate PrEP, average number of consecutive months PrEP used, based on date of first and last dose over first 3 months of follow-up, as indicated through survey self-report and visits/prescriptions noted in the EHR.
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 1.76 | ± 0.21 |
| STARR NC Standard-of-Care Control Condition | 3.29 | ± NA |
Among those who initiate PrEP, average number of consecutive months PrEP used, based on date of first and last dose over first 6 months of follow-up, as indicated through survey self-report and visits/prescriptions noted in the EHR
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 1.34 | ± 0.79 |
| STARR NC Standard-of-Care Control Condition | 3.29 | ± NA |
Among those who initiate daily oral PrEP, average number of days PrEP used, based on self-reported recall of doses taken in past 30 days.
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 16.50 | ± 16.26 |
| STARR NC Standard-of-Care Control Condition | 28.00 | ± NA |
Among those who initiate daily oral PrEP, average number of days PrEP used, based on self-reported recall of doses taken in past 30 days.
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 0 | ± NA |
| STARR NC Standard-of-Care Control Condition | 0 | ± NA |
Number of PrEP initiators with PrEP concentrations detected at the 3-month study follow-up visit, based on intraerythrocytic Tenofovir diphosphate (TFV-DP) collected as Dried Blood Spot (DBS) divided by the number who initiated oral PrEP
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 0.00 | |
| STARR NC Standard-of-Care Control Condition | 0.00 |
Number of PrEP initiators with PrEP concentrations detected at the 6-month study follow-up visit, based on intraerythrocytic TFV-DP collected as DBS divided by the number who initiated oral PrEP
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 0.00 | |
| STARR NC Standard-of-Care Control Condition | 0.00 |
Number with a positive clinical test result for human immunodeficiency virus (HIV) obtained from state, clinic, or commercial lab results, or verified participant-uploaded results, divided by the number tested for HIV prior to the 3-month visit, as indicated by state, clinic, commercial, or self-uploaded indication of receiving a test
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 0.00 |
Number with a positive clinical test result for HIV obtained from state, clinic, or commercial lab results, or verified participant-uploaded results, divided by the number tested for HIV prior to the 6-month visit, as indicated by state, clinic, commercial, or self-uploaded indication of receiving a test
| Group | Value | 95% CI |
|---|---|---|
| STARR NC Intervention Condition | 0.00 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05984030.
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