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Evaluation of a mHealth Intervention to Increase Adherence to Triage of Self-collected HPV+ Women (ATICA Project) (ATICA)

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ClinicalTrials.gov Identifier: NCT03478397
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : April 6, 2021
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Deakin University
Information provided by (Responsible Party):
Centro de Estudio de Estado y Sociedad

Brief Summary:

Cervical cancer is a serious public health problem reflecting social and gender inequalities in health. Currently, new technologies based on HPV DNA detection allow 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 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 Community Health Workers (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 intervention will include SMS messages sent to HPV+ women to inform them when results are available, and subsequent SMS messages as reminders. For those HPV+ women who did not have a triage within 60 days of the HPV test result, CHWs will receive an e-mail and SMS message so they can visit these women for in-person counseling. For the implementation evaluation, 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 other health problems. Findings from the implementation evaluation will be applicable to programs that are planning to incorporate HPV self-collection. 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.


Condition or disease Intervention/treatment Phase
Patient Adherence Other: Multicomponent mHealth Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mixed-Methods Approach to Evaluate a mHealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed Self-collection
Actual Study Start Date : December 5, 2018
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : April 30, 2020

Arm Intervention/treatment
Active Comparator: Multicomponent mHealth Intervention
Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage.
Other: Multicomponent mHealth Intervention
Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage

No Intervention: Usual Care
Women with HPV self-collected tests receive usual care. Upon opting for the HPV self-collected test, women will be instructed to go to the health care center in 30 days to pick up the results.



Primary Outcome Measures :
  1. Percentage of women with triage Pap smears at 120 days after HPV results [ Time Frame: 120 days ]
    The percentage of women with triage Pap smears at 120 days after HPV results are registered in the national screening information system (SITAM). This will allow measurement of the overall effect of the multi-component intervention including two periods: a) the 60 day period between the Test results and the SMS message and e-mail sent to Community Health Workers (CHW) (days 1-59); and b) the 60 day period between the SMS message and e-mail sent to CHWs and triage measurement (days 60-120)


Secondary Outcome Measures :
  1. Percentage of women with triage Pap smears at 60 days after HPV results [ Time Frame: 60 days ]
    The percentage of women with triage Pap smears at 60 days after HPV results are registered in SITAM (days 1-59). This outcome will allow us to measure the individual effect of the SMS messages sent to women (before CHWs receive prompts to contact non compliant HPV+ women).



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

In the Randomized Controlled Trial we will recruit a minimum of 4000 women, aged 30 and older living in the province of Jujuy, Argentina.

Inclusion criteria are:

  1. Having performed self-collection of HPV-testing.
  2. Mentally competent to understand the consent form.
  3. Able to communicate with study staff.
  4. Being able to provide a mobile phone telephone number.

Exclusion Criteria:

  • Current pregnancy.
  • Women with Mental disability.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478397


Locations
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Argentina
Multiple facilities
San Salvador De Jujuy, Jujuy, Argentina
Sponsors and Collaborators
Centro de Estudio de Estado y Sociedad
Dana-Farber Cancer Institute
Deakin University
Investigators
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Principal Investigator: Silvina Arrossi, Phd CEDES/CONICET
Publications:
World Health Organization (WHO). WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention. Geneva: World Health Organization (WHO); 2013. Available in: http://apps.who.int/iris/bitstream/10665/94830/1/9789241548694_eng.pdf (accessed October 2, 2016).
Instituto Nacional de Estadísticas y Censos (INDEC). Encuesta Nacional sobre Acceso y Uso de Tecnologías de la Información y la Comunicación (ENTIC). Resultados del tercer trimestre de 2011. Buenos Aires: INDEC; 2012. Available from: http://www.indec.gov.ar/uploads/informesdeprensa/entic_06_13.pdf (accessed October 3, 2015).
Teddlie C, Tashakkori A. Major issues and controversies in the use of mixed methods in the social and behavioral sciences. In Tashakkori A & Teddlie C (Eds.). Handbook of mixed methods in the social and behavioral sciences (pp. 3-50). Thousand Oaks, CA: Sage; 2003
Cuberli M, Arrossi S. Consejería para la prevención del cáncer de cuello de útero. Propuestas para una mejor comunicación con las mujeres durante el tamizaje, seguimiento y tratamiento. Buenos Aires: Instituto Nacional del Cáncer (INC); 2013.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centro de Estudio de Estado y Sociedad
ClinicalTrials.gov Identifier: NCT03478397    
Other Study ID Numbers: 2017-911
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centro de Estudio de Estado y Sociedad:
cervical cancer prevention
self-collection HPV test
mHealth
Argentina