CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,389 enrolled
Drug / intervention
Multicomponent mHealth Interventionother
Likely dose
Not stated in record
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Search/NCT03478397
NCT03478397N/ACompleted

Mixed-Methods Approach to Evaluate a mHealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed Self-collection

Centro de Estudio de Estado y Sociedad·interventional·Posted Mar 27, 2018·Updated Apr 19, 2024

In Brief

A clinical study evaluating Multicomponent mHealth Intervention for Patient Adherence. Completed, enrolled 5,389 participants across 1 site.

Detailed Summary

Background: Cervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for self-collection with the potential to increase coverage, but still requires triage to identify which HPV+ women need diagnostic and treatment procedures. However, achieving high levels of triage adherence can be challenging, especially among socially vulnerable women. The ATICA protocol (Application of Communication and Information Technologies to Self-Collection, for its initials in Spanish), aimed at evaluating the implementation strategy and the effectiveness of a multi-component mobile health (mHealth) intervention to increase adherence to triage among women with HPV+ self-collected tests. Methods: Researchers will use an effectiveness-implementation hybrid type I trial with a mixed-methods evaluation approach. A cluster randomized trial design including 200 community health workers (CHWs) will evaluate whether the mHealth intervention increases adherence to triage among HPV+ women who self-collected at home during a CHW visit within 120 days after a positive result. The intervention includes an initial mobile phone text message (SMS) alert and subsequent reminders sent to HPV+ women. For those who do not adhere to triage within 60 days of a positive HPV test, an email and SMS will be sent to the CHWs to promote contact with these women during home visits. Reserchers will use the Consolidated Framework for Implementation Research (CFIR) as an organizing and analytic framework to evaluate the implementation of the intervention while also drawing on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). Researchers will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 27, 2018
Enrollment StartDec 5, 2018
Primary CompletionNov 30, 2019
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.3 years ago

Interventions

Multicomponent mHealth Interventionother

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