Phase 4
Completed N=136
Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women
Source: ClinicalTrials.gov NCT02584140 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Adherence to PrEP — 22; 11; 30; 54 Participants
◆ Published Evidence
Emerging
11citations · ~2 / year
Pre-Exposure Prophylaxis Perspectives, Sociodemographic Characteristics, and HIV Risk Profiles of Cisgender Women Seeking and Initiating PrEP in a US Demonstration Project.
Summary
The purpose of this study is to test a program that uses drug level monitoring, text messaging ("iTAB") and personalized counseling with HIV prevention services, including PrEP (medicine that can help prevent HIV infection when taken daily).
Linked Publications (2)
-
Pre-Exposure Prophylaxis Perspectives, Sociodemographic Characteristics, and HIV Risk Profiles of Cisgender Women Seeking and Initiating PrEP in a US Demonstration Project.
-
The impact of intimate partner violence on PrEP adherence among U.S. Cisgender women at risk for HIV.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to PrEP |
22; 11; 30; 54; 19; 21 | — |
| SECONDARY Number of Participants Experiencing Treatment-Emergent Adverse Events |
72; 64 | — |
| SECONDARY Number of HIV Infections |
— | — |
| SECONDARY Correlates of PrEP Adherence |
58; 50; 28; 55; 44; 37 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Female at birth and identifies as female gender
- Age 18 years or older
- Able to understand and provide consent in English or Spanish
- HIV negative by 4th generation test (Ag/Ab test) or combination of enzymeimmunoassay (EIA) and HIV RNA
- Creatinine clearance ≥ 60 ml/min (via Cockcroft-Gault formula)
At-Risk Criteria (at least one):
- Condomless sex in the last 3 months with one or more male partners of unknown HIV status known to be at substantial risk of HIV infection (IDU, bisexual, sex for goods, recently incarcerated, from a country with HIV prevalence >1%, interpersonal Partner Violence);
- STI (rectal or vaginal gonorrhea or syphilis) diagnosis during the last 6 months.
- Previous post-exposure prophylaxis (PEP) use during the last 12 months.
- Has at least one HIV-infected sexual partner for ≥4 weeks.
- Sex for exchange of money, goods or services
Exclusion Criteria
- Pregnancy at enrollment.
- Any condition, which in the opinion of the provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PrEP medication dosing, such as active, untreated or unstable major mental illness (i.e. untreated psychotic disorder).
- Use of prohibited medications, in particular, agents known to be nephrotoxic or drugs slow in renal excretion.
- Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
- Signs or symptoms suspicious for Primary HIV Infection (PHI).
Data sourced from ClinicalTrials.gov (NCT02584140) and the linked publication. 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.