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.

Public Health Relevance

This study will evaluate the effectiveness of a of a multi-component mHealth intervention to increase adherence to triage among women with HPV+ self-collected tests. In addition it will evaluate the implementation using two key frameworks: The RE-AIM and the Consolidated Framework for Implementation Research (CFIR). Findings from this project are vital to inform local and regional cancer control programs about the implementation of automated SMS messages to increase adherence to triage of HPV+ women. Its methodology might be also applied to the diagnoses and treatment stages and could be adapted to other cancers, such as breast and colon cancer. In addition, this innovative study will serve as a model of work and will contribute to the consolidation of Implementation research in Latin America, which is still at its early stages of development.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA218306-01
Application #
9365804
Study Section
Dissemination and Implementation Research in Health Study Section (DIRH)
Program Officer
Kobrin, Sarah
Project Start
2017-09-01
Project End
2020-08-31
Budget Start
2017-09-01
Budget End
2018-08-31
Support Year
1
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Center for the Study of State / Society
Department
Type
DUNS #
971835780
City
Buenos Aires
State
Country
Argentina
Zip Code
C1173AAA