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DOT Diary (D2): Developing a mobile app with combined automated DOT and daily sexual diary for monitoring and improving PrEP adherence

Award Number: R01MH109320
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

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¿ DESCRIPTION (provided by applicant): 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2018	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC.	13300 CROSSROADS PKWY N STE 450	CITY OF INDUSTRY	CA	91746	LOS ANGELES	USA	Mental Health Research Grants	000	4	2/23/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $760,876 )
2018	2018	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC.	13300 CROSSROADS PKWY N STE 450	CITY OF INDUSTRY	CA	91746	LOS ANGELES	USA	Mental Health Research Grants	000	4	7/20/2018	NON-COMPETING CONTINUATION	$760,876
														Subtotal = $760,876

Issue Date FY: 2017 ( Subtotal = $992,570 )
2017	2017	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC.	13300 CROSSROADS PARKWAY NORTH SUITE 450	CITY OF INDUSTRY	CA	91746	LOS ANGELES	USA	Mental Health Research Grants	000	3	8/10/2017	NON-COMPETING CONTINUATION	$992,570
														Subtotal = $992,570

Issue Date FY: 2016 ( Subtotal = $1,045,760 )
2016	2016	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC	12801 Crossroads Parkway S.	CITY OF INDUSTRY	CA	91715	LOS ANGELES	USA	Mental Health Research Grants	001	2	8/18/2016	SUPPLEMENT FOR EXPANSION	$184,571
2016	2016	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC	12801 Crossroads Parkway S.	CITY OF INDUSTRY	CA	91715	LOS ANGELES	USA	Mental Health Research Grants	000	2	7/21/2016	NON-COMPETING CONTINUATION	$861,189
														Subtotal = $1,045,760

Issue Date FY: 2015 ( Subtotal = $1,079,742 )
2015	2015	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC	12801 Crossroads Parkway S.	CITY OF INDUSTRY	CA	91715	LOS ANGELES	USA	Mental Health Research Grants	000	1	9/21/2015	NEW	$1,079,742
														Subtotal = $1,079,742

Grand Total All Awards = $3,878,948

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DOT Diary (D2): Developing a mobile app with combined automated DOT and daily sexual diary for monitoring and improving PrEP adherence

Award Number: R01MH109320

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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