NCT02891720

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

August 29, 2016

Last Update Submit

September 1, 2016

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

  • Number of HIV-negative YMSM taking part in PSS intervention who adhere to PrEP medication

    Up to 33 months

Study Arms (2)

ARM A: Proteus Sensor System (PSS) First

ACTIVE COMPARATOR

ARM A will receive Proteus Sensor System (PSS) first. At 12-week intervals participants will crossover to the next condition.

Device: Proteus Sensor System

ARM B: SOC First

NO INTERVENTION

ARM B will 12 weeks of FTC/TDS standard of care (SOC) first. At 12-week intervals participants will crossover to the next condition.

Interventions

Proteus Sensor SystemDEVICE

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.

ARM A: Proteus Sensor System (PSS) First

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Gregory Huhn, MD

CONTACT

(312) 572-4575ghuhn@cookcountyhhs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 7, 2016

Study Start

June 1, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2019

Last Updated

September 7, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

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.