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

NCT02584140 | Completed Phase 4 Results

• 1 other identifier: 15-001583
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 5

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).

Conditions

HIV Prevention

Keywords

PrEP; Pre-exposure Prophylaxis; HIV Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants Experiencing Treatment-Emergent Adverse Events

  Baseline to Week 48

• Number of HIV Infections

  Baseline to Week 48

• Correlates of PrEP Adherence

  Baseline to Week 48

Study Arms (1)

AEGIS

OTHER

All participants will be assigned to this arm of the study.

Behavioral: Text Messaging; Behavioral: Adherence Counseling; Drug: Daily Oral PrEP

Interventions

Text Messaging BEHAVIORAL

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.

Also known as: iTAB

AEGIS

Adherence Counseling BEHAVIORAL

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.

Also known as: Integrate Next Step Counseling (iNSC), Targeted iNSC, PrEP Steps

AEGIS

Daily Oral PrEP DRUG

All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.

Also known as: PrEP

AEGIS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of California, San Diego: collaborator
• California HIV/AIDS Research Program: collaborator
• Los Angeles County Department of Public Health: collaborator
• AIDS Project Los Angeles: collaborator

Study Sites (5)

APLA Health & Wellness' Gleicher / Chen Health Center

Los Angeles, California, 90016, United States

Location

Los Angeles Biomedical Research Institute at Harbor-UCLA

Los Angeles, California, 90033, United States

Location

USC 5P21 Rand Schrader Clinic

Los Angeles, California, 90033, United States

Location

T.H.E. at Ruth Temple

Los Angeles, California, 90062, United States

Location

UCSD Antiviral Research Center

San Diego, California, 92103, United States

Location

Related Publications (2)

• Anderson KM, Blumenthal J, Jain S, Sun X, Amico KR, Landovitz R, Zachek CM, Morris S, Moore DJ, Stockman JK. The impact of intimate partner violence on PrEP adherence among U.S. Cisgender women at risk for HIV. BMC Public Health. 2024 May 31;24(1):1461. doi: 10.1186/s12889-024-18946-4.

  PMID: 38822300 DERIVED

• 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.

  PMID: 34851726 DERIVED

Results Point of Contact

• Title: Jill Blumenthal, MD
• Organization: UCSD Medical Center, Antiviral Research Center

jblumenthal@health.ucsd.edu

(619) 471-3913

Study Officials

• Raphael Landovitz, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Sheldon Morris, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All enrolled participants will receive daily oral emtricitabine/tenofovir disoproxil fumarate, adherence counseling, and daily text message reminders.

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 22, 2015
• Study Start: May 1, 2016
• Primary Completion: May 15, 2019
• Study Completion: June 14, 2019
• Last Updated: July 8, 2021
• Results First Posted: May 27, 2020

Record last verified: 2021-06

Locations

US (5)