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Mixed-Methods approach to evaluate a mHealth intervention to increase adherence to triage of HPV+ women who have performed self-collection

Award Number: R01CA218306
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2017
PERIOD OF PERFORMANCE END DATE: 08/31/2022

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Mixed-Methods approach to evaluate a mHealth intervention to increase adherence to triage of HPV+ women who have performed self-collection - 7. Project summary/abstract PROJECT: Mixed-Methods approach to evaluate a mHealth intervention to increase adherence to triage of HPV+ women who have performed self-collection Cervical cancer is a serious public health problem reflecting social and gender inequalities in health. It is the third cause of cancer death among women in the world, with more than 85% of cases occurring in developing countries. Currently, the development of new technologies based on HPV DNA detection allows HPV self- collection, increasing screening coverage. In a self-collection based strategy, triage becomes a key step in the prevention process, as it is the first method to identify HPV+ women who will need diagnostic and treatment procedures. However, high adherence to triage is difficult to obtain, which is not surprising given that adherence to follow-up and treatment is a generalized problem in cervical cancer programs. Specific aims of the study are: 1. To evaluate the effectiveness of an innovative multi-component mHealth intervention to increase adherence to triage among women with HPV+ self-collected tests compared to usual care. 2. To evaluate the implementation strategy and identify barriers and facilitators to implementation of the multi-component mHealth intervention. The research study design will follow the structure of an effectiveness-implementation hybrid type I trial, and will use mix-method approach. A cluster randomized trial including 200 CHWs (clusters) and 4000 women will be used to evaluate the effectiveness of the multi-component mHealth intervention to increase adherence to cytology triage at 120 days after positive HPV testing. The mHealth intervention will include SMS messages sent to HPV+ women to inform them when results are available, and subsequent SMS messages as reminders. In addition, for those HPV+ women who did not had a triage cytology result within 60 days of the HPV test result, CHWs will receive an e-mail and SMS message so they can contact these women during home visits for specific counseling and support. For the implementation evaluation, the Consolidated Framework for Implementation Research (CFIR) will be used to guide qualitative data collection and analysis of factors that influence implementation. RE-AIM will be used to assess the Reach, Effectiveness, Adoption, Implementation and Maintenance of the Intervention. Results of this project will provide evidence on the effectiveness of the multi-component mHealth intervention to increase triage of HPV+ women, but it could be adapted to increase compliance of diagnoses/ treatment of cervical cancer and other health problems. Findings from the implementation evaluation will be highly applicable to programs that use or are planning to incorporate HPV self-collection in different settings and countries. In addition, the use of CFIR and RE-AIM in this innovative study will serve as a model of work, constituting an important advance in the use of Implementation Science in the Region.


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: 2023 ( Subtotal = $0 )
2023	2019	CENTRO DE ESTUDIOS DE ESTADO Y SOCIEDAD CEDES	SANCHEZ DE BUSTAMANTE 27	CIUDAD DE BUENOS AIRES				ARG	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	4/27/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	CENTRO DE ESTUDIOS DE ESTADO Y SOCIEDAD CEDES	SANCHEZ DE BUSTAMANTE 27	CIUDAD DE BUENOS AIRES				ARG	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	8/18/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $336,858 )
2019	2019	CENTRO DE ESTUDIOS DE ESTADO Y SOCIEDAD CEDES	SANCHEZ DE BUSTAMANTE 27	CIUDAD DE BUENOS AIRES		C1173AAA		ARG	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	8/30/2019	NON-COMPETING CONTINUATION	$336,858
														Subtotal = $336,858

Issue Date FY: 2018 ( Subtotal = $393,216 )
2018	2018	CENTRO DE ESTUDIOS DE ESTADO Y SOCIEDAD CEDES	SANCHEZ DE BUSTAMANTE 27	CIUDAD DE BUENOS AIRES		C1173AAA		ARG	21st Century Cures Act - Beau Biden Cancer Moonshot	000	2	8/29/2018	NON-COMPETING CONTINUATION	$393,216
														Subtotal = $393,216

Issue Date FY: 2017 ( Subtotal = $407,200 )
2017	2017	CENTRO DE ESTUDIOS DE ESTADO Y SOCIEDAD CEDES	SANCHEZ DE BUSTAMANTE 27	CIUDAD DE BUENOS AIRES		C1173AAA		ARG	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	8/29/2017	NEW	$407,200
														Subtotal = $407,200

Grand Total All Awards = $1,137,274

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Mixed-Methods approach to evaluate a mHealth intervention to increase adherence to triage of HPV+ women who have performed self-collection

Award Number: R01CA218306

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2017

PERIOD OF PERFORMANCE END DATE: 08/31/2022

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