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Measuring Real-Time Influences of Mental and Tangible Resources on Men's TB Treatment Lapses and Adherence Behaviors

Award Number: R21AI163977
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/05/2021
PERIOD OF PERFORMANCE END DATE: 07/31/2023

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Measuring Real-Time Influences of Mental and Tangible Resources on Men's TB Treatment Lapses and Adherence Behaviors - PROJECT ABSTRACT In 2018, approximately 10 million people developed TB disease globally, of which men aged ≥15 years accounted for over 50% of the cases. South African national TB prevalence studies have reported that men had a higher burden of TB, a lower case detection and larger reporting gaps compared to women. An analysis of South Africa's TB care cascade revealed that only 53% of TB patients completed treatment. Most strikingly, TB in South Africa is responsible for a large proportion of the difference in life expectancy between men and women. For South Africa to contribute to the End TB Strategy target of halving TB incidence by 2025, it is imperative to implement effective interventions to support engagement and retention in TB care, especially among men. This study will develop a method to gather factors and resources influencing TB treatment in real-time, by integrating modified ecological momentary assessments (mEMA) with medication event-monitoring system (MEMS) and assessing its feasibility. This study will be conducted over two aims. In Aim 1, we will integrate EMA and MEMS and then determine functionality and usability. This aim will be conducted over two phases. In Phase 1, the research study team will integrate the Wisepill technology (MEMS) with REDCap and conduct a functionality simulation with study staff. In Phase 2, a usability assessment of the mEMA-MEMS platform will be conducted with 20 participants, 10 men and 10 women. This phase will involve a think-aloud method and 30-day test using the mEMA-MEMS platform with a study mobile phone. Findings will inform the final mEMA-MEMS platform for Aim 2. In Aim 2, we will conduct an observational cohort study with 60 participants (30 men and 30 women) initiating TB treatment. All participants will be trained on how to use the mEMA-MEMS platform and provided a study mobile phone. Every 28 days, they will return to the clinic study site to refill their Wisepill with medication. During the study, each participant will receive random and event mEMAs based on their dosing behaviors. Participants will be interviewed at enrollment, during continuation and post-continuation stages of treatment, to assess feasibility, acceptability, willingness and safety using interviews and surveys. We will also collect preliminary data to understand psychosocial and contextual factors influential in TB treatment across the continuum, results will be used to inform subsequent study design. The results of this study will inform a larger R01 observational study that will determine what resources are needed at particular times during treatment to support adherence, and determine what resources are generalizable to all and distinctive for men such that an intervention may be developed and tested to support their adherence and TB treatment outcomes.


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: 2022 ( Subtotal = $137,283 )
2022	2022	DESMOND TUTU HIV FOUNDATION	FHS WERHNER BEIT NORTH ANZOI RD	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	000	2	8/17/2022	NON-COMPETING CONTINUATION	$137,283
														Subtotal = $137,283

Issue Date FY: 2021 ( Subtotal = $172,079 )
2021	2021	DESMOND TUTU HIV FOUNDATION	FHS WERHNER BEIT NORTH ANZOI RD	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	000	1	8/4/2021	NEW	$172,079
														Subtotal = $172,079

Grand Total All Awards = $309,362

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Measuring Real-Time Influences of Mental and Tangible Resources on Men's TB Treatment Lapses and Adherence Behaviors

Award Number: R21AI163977

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/05/2021

PERIOD OF PERFORMANCE END DATE: 07/31/2023

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