Clinical trial NCT02584140: Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women
Official title: Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Prevention
Keywords: PrEP
Pre-exposure Prophylaxis
HIV Prevention
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: California HIV/AIDS Research Program
name: Los Angeles County Department of Public Health
name: AIDS Project Los Angeles
First posted: 2015-10-22
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled participants will receive daily oral emtricitabine/tenofovir disoproxil fumarate, adherence counseling, and daily text message reminders.
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

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).

Primary outcomes:
measure: Adherence to PrEP
timeFrame: Week 4 to Week 48
Secondary outcomes:
measure: Number of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: Baseline to Week 48
measure: Number of HIV Infections
timeFrame: Baseline to Week 48
measure: Correlates of PrEP Adherence
timeFrame: Baseline to Week 48
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: APLA Health & Wellness' Gleicher / Chen Health Center
state: California
city: Los Angeles
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA
state: California
city: Los Angeles
country: United States
facility: USC 5P21 Rand Schrader Clinic
state: California
city: Los Angeles
country: United States
facility: T.H.E. at Ruth Temple
state: California
city: San Diego
country: United States
facility: UCSD Antiviral Research Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Raphael Landovitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD
name: Sheldon Morris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blumenthal J, Landovitz R, Jain S, He F, Kofron R, Ellorin E, Ntim GM, Stockman JK, Corado K, Rivet Amico K, Moore DJ, Morris S. Pre-Exposure Prophylaxis Perspectives, Sociodemographic Characteristics, and HIV Risk Profiles of Cisgender Women Seeking and Initiating PrEP in a US Demonstration Project. AIDS Patient Care STDS. 2021 Dec;35(12):481-487. doi: 10.1089/apc.2021.0114.