Feasibility of an Ingestible Sensor System to Measure PrEP Adherence in YMSM
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|ClinicalTrials.gov Identifier: NCT02891720|
Recruitment Status : Unknown
Verified September 2016 by Hektoen Institute for Medical Research.
Recruitment status was: Not yet recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Device: Proteus Sensor System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of an Ingestible Sensor System to Measure PrEP Adherence in YMSM|
|Study Start Date :||June 2017|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2019|
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.
- Number of HIV-negative YMSM taking part in PSS intervention who adhere to PrEP medication [ Time Frame: Up to 33 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891720
|Contact: Gregory Huhn, MD||(312) firstname.lastname@example.org|