Evaluation of an Mhealth Intervention to Increase Adherence to Triage of HPV+ Women

NCT02561208 | Withdrawn

• 1 other identifier: 01-CE_CCU
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cervical cancer remains a serious health problem, particularly in developing countries. It is the leading cause of cancer death among women and mainly affects women of low socioeconomic status. Evidence has shown that HPV-test self-collection can reduce social and health services barriers to screening and increase coverage. However, high coverage will not result in a decrease of disease burden if women are not diagnosed/treated. The HPV-test indicates whether a woman is positive or not, and a triage test is needed to identify HPV-positive women who need to perform diagnostic procedures. Several triage methods are available. In Argentina, cytology is used as triage method; therefore, all HPV-positive women who have performed self-collection at home need to attend health centers to undergo cytology. However, the proportion of women who have completed triage is low, therefore new innovative strategies are needed to increase attendance to cytology of these women. This study will be carried out in Jujuy, one of the Argentinian provinces with highest cervical cancer mortality rates and where HPV- self-collection has been introduced as programmatic strategy for screening under-users. This trial is population-based cluster-randomized study that aims to evaluate the effectiveness of a mHealth intervention versus usual care to increase adherence to cytological triage among women with HPV-positive self-collected tests. An overall number of 240 Community Health Workers (CHWs) from the Primary Health Care System (PHCS) of the Province of Jujuy will be randomized into two groups:

1. 1.mHealth Intervention Group: Women with HPV self-collected tests will receive a mixed intervention which includes counseling through an interactive Apps specifically devised to increase adherence to triage which will be run on a tablet, and SMS text messages to remind them to attend triage. In addition, Heads of CHWs, chiefs of gynecology services and CHWs will receive reminders via e-mails and SMS message to contact women if after 60 days from the HPV-results HPV+ they have not performed triage.
2. 2.Usual Care Group: Women with HPV self-collected tests receive usual care.

Conditions

Patient Adherence

Keywords

Patient adherence; Mobile Health; HPV DNA Tests; Self-collected

Outcome Measures

Primary Outcomes (1)

• Number of HPV test positive women with Pap test registered in SITAM

  Adherence to triage will be considered for each CHW. This will be defined as the number of women with Pap smears within 90 days registered in SITAM (SITAM is the national online information system that registers screening/diagnosis/treatment events from women attending the public health system). There will be a comparison of the percentage of HPV-positive women that did the Pap test in the mHealth intervention group and the Usual Care group.

  90 days

Study Arms (2)

mHealth Intervention Group

ACTIVE COMPARATOR

Women with HPV self-collected tests will receive a mixed intervention which includes counseling through an interactive Apps and SMS text messages.

Other: mHealth Intervention Group

Usual Care Group

NO INTERVENTION

Women with HPV self-collected tests receive usual care.

Interventions

mHealth Intervention Group OTHER

Women with HPV self-collected tests will receive a mixed intervention which includes counseling through an interactive Apps specifically devised to increase adherence to triage which will be run on a tablet, and SMS text messages (SMS message) to remind them to attend triage. In addition, Heads of CHWs, chiefs of gynecology services and CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage.

mHealth Intervention Group

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 30 years and older living in a household visited by Community Health Workers (CHWs).

You may not qualify if:

• Women with a previous HPV test.
• Women with precancerous lesion or cervical cancer.
• Current pregnancy.
• Women with Mental disability.

Sponsors & Collaborators

• Centro de Estudio de Estado y Sociedad: lead

Related Publications (14)

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  BACKGROUND

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  PMID: 18847555 BACKGROUND

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  PMID: 18852164 BACKGROUND

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  PMID: 22051739 BACKGROUND

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  PMID: 24433684 BACKGROUND

• Giorgi Rossi P, Marsili LM, Camilloni L, Iossa A, Lattanzi A, Sani C, Di Pierro C, Grazzini G, Angeloni C, Capparucci P, Pellegrini A, Schiboni ML, Sperati A, Confortini M, Bellanova C, D'Addetta A, Mania E, Visioli CB, Sereno E, Carozzi F; Self-Sampling Study Working Group. The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600). Br J Cancer. 2011 Jan 18;104(2):248-54. doi: 10.1038/sj.bjc.6606040. Epub 2010 Dec 21.

  PMID: 21179038 BACKGROUND

• Leniz J, Barriga MI, Lagos M, Ibanez C, Puschel K, Ferreccio C. HPV vaginal self-sampling among women non-adherent to Papanicolaou screening in Chile. Salud Publica Mex. 2013 Apr;55(2):162-9. doi: 10.1590/s0036-36342013000200007.

  PMID: 23546407 BACKGROUND

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  PMID: 22021733 BACKGROUND

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  PMID: 25617202 BACKGROUND

• Arrossi S, Thouyaret L, Laudi R, Marin O, Ramirez J, Paolino M, Herrero R, Campanera A. Implementation of HPV-testing for cervical cancer screening in programmatic contexts: The Jujuy demonstration project in Argentina. Int J Cancer. 2015 Oct 1;137(7):1709-18. doi: 10.1002/ijc.29530. Epub 2015 Apr 15.

  PMID: 25807897 BACKGROUND

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  PMID: 21152712 BACKGROUND

• Katz N, Gaiano A, Pérez Carrega M, Vizzotti C. Vacuna contra el virus del papiloma humano: resultados a un año de su incorporación al calendario nacional de vacunación. Rev Argent Salud Pública 4(14): 44-46, 2013.

  BACKGROUND

• World Health Organization. Cervical cancer screening information system: Argentina. [Internet]. Lyon: World Health Organization [cited 2015 September 21]. Available from: http://www.who.int/ehealth/resources/compendium_ehealth2012_3.pdf?ua=1

  BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Silvina Arrossi, PhD

  Center of Study of State and Society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 25, 2015
• Study Start: July 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 27, 2020

Record last verified: 2020-01