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

Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California

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).

Study Overview

• Status: Completed
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: Text Messaging; Behavioral: Adherence Counseling; Drug: Daily Oral PrEP

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90016
      • APLA Health & Wellness' Gleicher / Chen Health Center
    • Los Angeles, California, United States, 90033
      • Los Angeles Biomedical Research Institute at Harbor-UCLA
    • Los Angeles, California, United States, 90033
      • USC 5P21 Rand Schrader Clinic
    • Los Angeles, California, United States, 90062
      • T.H.E. at Ruth Temple
    • San Diego, California, United States, 92103
      • UCSD Antiviral Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: AEGIS; All participants will be assigned to this arm of the study.

Behavioral: Text Messaging; All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.; Other Names: iTAB; Behavioral: Adherence Counseling; All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of <1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of <1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.; Other Names: Integrate Next Step Counseling (iNSC); Targeted iNSC; PrEP Steps; Drug: Daily Oral PrEP; All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.; Other Names: PrEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to PrEP	Adherence is measured by TFV-DP (tenofovir diphosphate) concentrations in Dried Blood Spots (DBS) suggestive of 6-7 doses per week.	Week 4 to Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Treatment-Emergent Adverse Events	Describe the safety and tolerability of daily emtricitabine/tenofovir disoproxil fumarate TDF/FTC given for PrEP including discontinuation for any adverse event, serious adverse events and adverse events (grade 2 or higher).	Baseline to Week 48
Number of HIV Infections	Number of new HIV infections observed among participants with at least one follow-up visit.	Baseline to Week 48
Correlates of PrEP Adherence	Self-reported adherence by daily texting through iTAB will be correlated with TFV-DP concentrations in DBS	Baseline to Week 48

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: University of California, San Diego; California HIV/AIDS Research Program; Los Angeles County Department of Public Health; AIDS Project Los Angeles
• Investigators: Principal Investigator: Raphael Landovitz, MD, University of California, Los Angeles; Principal Investigator: Sheldon Morris, MD, UCSD

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): June 14, 2019

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: PrEP; HIV Prevention; Pre-exposure Prophylaxis
• Other Study ID Numbers: 15-001583