Human Immunodeficiency VirusNCT02891720
Feasibility of an Ingestible Sensor System to Measure PrEP Adherence in YMSM
A study testing Proteus Sensor System in people with Human Immunodeficiency Virus, run by Hektoen Institute for Medical Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Proteus Sensor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Nov 2019
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Proteus Sensor System
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HIV-negative YMSM taking part in PSS intervention who adhere to PrEP medication
Measured: Up to 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJun 2017
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hektoen Institute for Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891720
- Sponsor's protocol ID
- R01AI122308
- Other IDs
- R01AI122308
- Status last verified
- Sep 2016
- First submitted
- 29 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Ingestible Sensor System to Measure PrEP Adherence in YMSM
- ClinicalTrials.gov ID
- NCT02891720
- Acronym / sponsor ID
- R01AI122308
- Conditions
- Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hektoen Institute for Medical ResearchUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jun 2017
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A: Proteus Sensor System (PSS) First | Active comparator | Device: Proteus Sensor SystemARM A will receive Proteus Sensor System (PSS) first. At 12-week intervals participants will crossover to the next condition. |
| 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- PrEP-eligible YMSM
- Ages 18-24
- Biologically born male
- Report interest in PrEP
- Intend to use PrEP for a full 6 month period
Key exclusion criteria (8 listed)
- HIV+
- Creatinine clearance <60 cc/min)
- Allergy to topical adhesive
- Acute gastrointestinal symptoms
- History of major GI surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteus Sensor SystemThe 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. | Device | ARM A: Proteus Sensor System (PSS) First |
Primary outcome
Number of HIV-negative YMSM taking part in PSS intervention who adhere to PrEP medication
Time frame: Up to 33 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Proteus Sensor System in people with Human Immunodeficiency Virus, run by Hektoen Institute for Medical Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Huhn, MD ((312) 572-4575, ghuhn@cookcountyhhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of HIV-negative YMSM taking part in PSS intervention who adhere to PrEP medication (time frame: Up to 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.