Several efficacy trials of pre-exposure prophylaxis (daily antiretroviral therapy to prevent HIV acquisition in uninfected persons with sexual exposures) have failed because of poor adherence to medications. To ensure accurate, longitudinal measurement of pill ingestion with real-time monitoring, we plan to develop DOT Diary (D2), a smartphone application that uses artificial intelligence for measuring pill taking using Directly Observed Therapy. This patented technology will be combined with a daily sexual diary for use in future PrEP observational and efficacy trials. Such an approach provides aggregated data for individual participants, study sites, and trials overall, that facilitates realtime feedback to maximize adherence. We plan a 3 stage process for building and evaluating D2. First, we will assess the assess the reliability and validity of the automated DOT tool to identify attempts to cheat and over-report pill taking, as well as to evaluate the sensitivity of the measure to detecting 1- to 3-week interruptions in pill use. Second, we will develop and optimize the feasibility and acceptability of D2 for participants and study staff in tracking participation ver time, and providing real-time adherence feedback to study participants. Lastly, we will run a 24-week pilot study of D2 for high-risk men who have sex with men to evaluate the plausibility that this tool can be successfully used to measure and optimize adherence in future PrEP trials.
Many studies of pre-exposure prophylaxis or PrEP (giving an anti-HIV medication to an HIV uninfected person to prevent infection from their HIV positive sex partner) have failed to tell us whether or not the medication prevents infection, because very few of the study volunteers took the pills regularly. We will be developing and testing a new technology called DOT Diary (D2) that will be used by PrEP study volunteers to take pictures (using their smartphones) of themselves taking their pills, and also using their phones to keep track of their sexual practices. This will allow future studies to provide extra support for study volunteers not taking their medicines regularly, and to figure out whether or not the medications prevent new HIV infections.
| Spinelli, Matthew A; Scott, Hyman M; Vittinghoff, Eric et al. (2018) Brief Report: A Panel Management and Patient Navigation Intervention Is Associated With Earlier PrEP Initiation in a Safety-Net Primary Care Health System. J Acquir Immune Defic Syndr 79:347-351 |
| Spinelli, Matthew A; Scott, Hyman M; Vittinghoff, Eric et al. (2018) Provider Adherence to Pre-exposure Prophylaxis Monitoring Guidelines in a Large Primary Care Network. Open Forum Infect Dis 5:ofy099 |
| Spinelli, Matthew A; Scott, Hyman M; Vittinghoff, Eric et al. (2018) Note: High interest in doxycycline for sexually transmitted infection post-exposure prophylaxis (doxycycline-PEP) in a multi-city survey of men who have sex with men (MSM) using a social-networking app. Sex Transm Dis : |
