Patient Adherence Clinical Trial
Official title:
Evaluation of an Mhealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed HPV-Test Self-collection
NCT number | NCT02561208 |
Other study ID # | 01-CE_CCU |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | July 2016 |
Verified date | January 2020 |
Source | Centro de Estudio de Estado y Sociedad |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. 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. Usual Care Group: Women with HPV self-collected tests receive usual care.
A database built specifically for the study will be used; it will include data about
randomization Group, agreement to participate in the study and socio-demographic data. Data
on HPV-testing and triage will be uploaded importing the data from SITAM, using the Unique
Identification Number (DNI).
Data Analysis
Effectiveness to enhance adherence to cytological triage: Adherence to triage will be
considered for each CHW. This will be defined as the number of women with triage smears
within 30, 60 and 90 days. There will be a comparison of the percentage of HPV-positive women
that did the Pap test within those time intervals in the mHealth intervention group and the
Usual Care group. The effect of the mHealth intervention against usual care will be estimated
using a means difference test or a non-parametric test for independent samples.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years and older |
Eligibility |
Inclusion criteria: - Women 30 years and older living in a household visited by Community Health Workers (CHWs). Exclusion criteria: - Women with a previous HPV test. - Women with precancerous lesion or cervical cancer. - Current pregnancy. - Women with Mental disability. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centro de Estudio de Estado y Sociedad |
Arbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, Dillner L, Minozzi S, Bellisario C, Banzi R, Zhao FH, Hillemanns P, Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014 Feb;15(2):172-83. doi: 10.1016/S1470-2045(13)70570-9. Epub 2014 Jan 14. Review. — View Citation
Arrossi S, Paolino M, Sankaranarayanan R. Challenges faced by cervical cancer prevention programs in developing countries: a situational analysis of program organization in Argentina. Rev Panam Salud Publica. 2010 Oct;28(4):249-57. — View Citation
Arrossi S, Thouyaret L, Herrero R, Campanera A, Magdaleno A, Cuberli M, Barletta P, Laudi R, Orellana L; EMA Study team. Effect of self-collection of HPV DNA offered by community health workers at home visits on uptake of screening for cervical cancer (the EMA study): a population-based cluster-randomised trial. Lancet Glob Health. 2015 Feb;3(2):e85-94. doi: 10.1016/S2214-109X(14)70354-7. — View Citation
Arrossi S, Thouyaret L, Laudi R, Marín O, Ramírez 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. — View Citation
Cuzick J, Arbyn M, Sankaranarayanan R, Tsu V, Ronco G, Mayrand MH, Dillner J, Meijer CJ. Overview of human papillomavirus-based and other novel options for cervical cancer screening in developed and developing countries. Vaccine. 2008 Aug 19;26 Suppl 10:K29-41. doi: 10.1016/j.vaccine.2008.06.019. Review. — View Citation
Dillner J, Rebolj M, Birembaut P, Petry KU, Szarewski A, Munk C, de Sanjose S, Naucler P, Lloveras B, Kjaer S, Cuzick J, van Ballegooijen M, Clavel C, Iftner T; Joint European Cohort Study. Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study. BMJ. 2008 Oct 13;337:a1754. doi: 10.1136/bmj.a1754. — View Citation
Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. GLOBOCAN 2012 v1.0. Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr.
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. — View Citation
Gök M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW, Voorhorst F, Beliën JA, Babovic M, Snijders PJ, Meijer CJ. HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ. 2010 Mar 11;340:c1040. doi: 10.1136/bmj.c1040. Erratum in: BMJ. 2016 May 18;353:i2823. — View Citation
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.
Lazcano-Ponce E, Lorincz AT, Cruz-Valdez A, Salmerón J, Uribe P, Velasco-Mondragón E, Nevarez PH, Acosta RD, Hernández-Avila M. Self-collection of vaginal specimens for human papillomavirus testing in cervical cancer prevention (MARCH): a community-based randomised controlled trial. Lancet. 2011 Nov 26;378(9806):1868-73. doi: 10.1016/S0140-6736(11)61522-5. Epub 2011 Nov 1. — View Citation
Léniz J, Barriga MI, Lagos M, Ibáñez 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. — View Citation
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
Zehbe I, Moeller H, Severini A, Weaver B, Escott N, Bell C, Crawford S, Bannon D, Paavola N. Feasibility of self-sampling and human papillomavirus testing for cervical cancer screening in First Nation women from Northwest Ontario, Canada: a pilot study. BMJ Open. 2011 Feb 26;1(1):e000030. doi: 10.1136/bmjopen-2010-000030. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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