Feasibility of an Ingestible Sensor System to Measure PrEP Adherence in YMSM

The goal of this study is to evaluate an integrated technology system that confirms ingestion of oral PrEP, monitors adherence both in real-time and longitudinally, and provides visual feedback mechanisms to promote enhanced adherence behaviors.

Study Overview

• Status: Unknown
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Device: Proteus Sensor System

Detailed Description

In order to evaluate the feasibility and acceptability of the PSS for FTC/TDF PrEP, 100 HIV-negative YMSM will be randomized in the Advances in Technology to Enhance Adherence Monitoring (A-TEAM) pilot study to 12 weeks of daily FTC/TDF with the PSS versus daily FTC/TDF standard-of-care (SOC), then each arm will crossover to 12 weeks of daily FTC/TDF without the sensor system versus with the sensor system, respectively. PrEP will be provided by the study (see Gilead letter) and other aspects of PrEP clinical care will be consistent with the PrEP Clinic's standard practices based on CDC clinical guidelines. The detection accuracy of the PSS will be correlated with DBS-determined TFV-DP and FTC-TP levels obtained monthly from participants. A relationship between TVF-DP in DBS and adherence to FTC/TDF PrEP in the preceding 1-3 months has previously been characterized. These adherence categories were implemented in iPrEx OLE and consisted of: below lower limit of quantitation (BLQ), >BLQ to 349 fmol per punch (fewer than two tablets per week), 350-699 fmol per punch (two or three tablets per week), 700-1249 fmol per punch (four to six tablets per week), and 1250 fmol per punch or more (daily dosing). Real-time visual feedback of medication ingestion will be provided to the participant via the PSS and transmitted to the study team. A weekly text message with estimated HIV risk reduction based upon the DBS algorithm will be transmitted to participants after the initial first week of FTC/TDF dosing. Finally, in-depth qualitative exploration of barriers and facilitators to use of the PSS components will be completed through individual interviews as well as focus group discussions with participants. Participants will also provide feedback on text messages regarding PrEP protection as well as suggestions for other potential methods to receive performance data.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregory Huhn, MD; Phone Number: (312) 572-4575; Email: ghuhn@cookcountyhhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria

Young men who meet all of the following criteria are eligible for inclusion:

• PrEP-eligible YMSM
• Ages 18-24
• Biologically born male
• Report interest in PrEP
• Intend to use PrEP for a full 6 month period
• Eligible to be a PrEP patient at the CORE Center PrEP Clinic

• Meet one the following sexual risk criteria:

  • Have an HIV-positive sexual partner
  • Had recent bacterial STI
  • Report high numbers of sexual partners
  • Report history of inconsistent or no condom use
  • Report exchange/transactional sex.

Exclusion Criteria

Young men who meet any of the following criteria will be excluded:

• HIV+
• Creatinine clearance <60 cc/min)
• Allergy to topical adhesive
• Acute gastrointestinal symptoms
• History of major GI surgery
• Presence of an implanted electronic medical device.
• Subjects who are receiving any of the following medications:Nephrotoxic drugs (e.g., cidofovir, amphotericin, aminoglycosides, dapsone, tacrolimus, foscarnet, ACE inhibitors), all diuretics, drugs that may interfere with TFV excretion (e.g., (Val)ganciclovir, Cyclosporin A, Sirolimus, Antineoplastics), drugs (not including mineral and vitamin supplements) used for treatment of osteoporosis (e.g., alendronate and other bisphosphonates, teriparatide, denosumab, and calcitonin), chronic use of oral or systemic steroids (i.e., daily use for two weeks or more is not allowed), experimental medications that are not Food and Drug Administration (FDA)-approved, and FTC/TDF (Truvada®) received outside of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM A: Proteus Sensor System (PSS) First; ARM A will receive Proteus Sensor System (PSS) first. At 12-week intervals participants will crossover to the next condition.	Device: Proteus Sensor System; The Proteus Sensor System (PSS) intervention includes 12 weeks of daily FTC/TDF with a weekly text messages transmitted to participants with estimated HIV risk reduction based upon the DBS algorithm.
No Intervention: ARM B: SOC First; ARM B will 12 weeks of FTC/TDS standard of care (SOC) first. At 12-week intervals participants will crossover to the next condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of HIV-negative YMSM taking part in PSS intervention who adhere to PrEP medication	Up to 33 months

Collaborators and Investigators

• Sponsor: Hektoen Institute for Medical Research
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start: June 1, 2017
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R01AI122308 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Findings from this study will provide pharmacokinetic data along with evidence of the feasibility and acceptability of the novel Proteus adherence monitoring system for use among young MSM who are highly vulnerable to HIV infection. Audiences for dissemination are: 1) scientists; 2) primary and secondary prevention practitioners; and 3) YMSM, their partners, and their friends/families. Traditional dissemination vehicles will be used including manuscripts and presentations at international and national meetings. To facilitate integration of the findings into the public health arena, the protocol team will work closely with their YAB and present findings in forums attended by community-based organizations, such as local PrEP trainings and workshops.