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

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.

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).