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

Phase 4

Completed

• Conditions: HIV Prevention
• Interventions: Behavioral: Text Messaging; Behavioral: Adherence Counseling; Drug: Daily Oral PrEP

• Registration Number: NCT02584140
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Study Start: 2016-05
• Primary Completion: 2019-05-15
• Study Completion: 2019-06-14
• Results First Submitted: 2020-05-11
• Results First Submitted QC: 2020-05-11
• Results First Posted: 2020-05-27
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AEGIS	Text Messaging	All participants will be assigned to this arm of the study.
AEGIS	Adherence Counseling	All participants will be assigned to this arm of the study.
AEGIS	Daily Oral PrEP	All participants will be assigned to this arm of the study.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlates of PrEP Adherence	Baseline to Week 48	Self-reported adherence by daily texting through iTAB will be correlated with TFV-DP concentrations in DBS
Number of Participants Experiencing Treatment-Emergent Adverse Events	Baseline to Week 48	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).
Number of HIV Infections	Baseline to Week 48	Number of new HIV infections observed among participants with at least one follow-up visit.

Trial Locations

Locations (5)

Los Angeles Biomedical Research Institute at Harbor-UCLA; 🇺🇸 Los Angeles, California, United States

T.H.E. at Ruth Temple; 🇺🇸 Los Angeles, California, United States

USC 5P21 Rand Schrader Clinic; 🇺🇸 Los Angeles, California, United States

APLA Health & Wellness' Gleicher / Chen Health Center; 🇺🇸 Los Angeles, California, United States

UCSD Antiviral Research Center; 🇺🇸 San Diego, California, United States