An interventional study of Proteus Sensor System in Human Immunodeficiency Virus, sponsored by Hektoen Institute for Medical Research. Not yet recruiting. Open to male participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-07.
Sponsored by Hektoen Institute for Medical Research · Not applicable, Interventional, and Prevention
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.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's planned enrollment of 100 is close to the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Hektoen Institute for Medical Research is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Young men who meet all of the following criteria are eligible for inclusion:
Meet one the following sexual risk criteria:
Exclusion Criteria
Young men who meet any of the following criteria will be excluded:
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 will 12 weeks of FTC/TDS standard of care (SOC) first. At 12-week intervals participants will crossover to the next condition.
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.
Number of HIV-negative YMSM taking part in PSS intervention who adhere to PrEP medication
Time frame: Up to 33 months
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Hektoen Institute for Medical Research