Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women (AEGiS)

University of California, Los Angeles (UCLA)

Status and phase

Completed

Phase 4

Conditions

HIV Prevention

Treatments

Behavioral: Adherence Counseling

Drug: Daily Oral PrEP

Behavioral: Text Messaging

Study type

Interventional

Funder types

Other

Identifiers

NCT02584140

15-001583

Details and patient eligibility

About

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).

Full description

This is an open-label single-arm longitudinal clinical trial to estimate medication adherence and retention in a PrEP HIV prevention program that implements a combination intervention strategy that uses text-messages (iTAB) and a staged adherence counseling support strategy titrated from real-time drug levels in women at-risk for HIV acquisition.

A total of 135 participants will receive the combined intervention of text messaging adherence reminders and adherence support. The text messaging system consists of daily, personalized, automated 2-way text messages to maintain adherence and retention. Participants that have a low intracellular tenofovir diphosphate (TFV-DP) concentration will receive escalated, targeted adherence support. All participants will receive access to PrEP in accordance with standardized comprehensive methods of prescribing and clinical assessments that include safety monitoring as well as regular HIV and sexually transmitted infection (STI) screening. All participants will be followed for 48 weeks after enrollment and will receive a post study follow-up at 60 weeks. The primary endpoint will be measured at 48 weeks.

Enrollment

136 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).