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

NCT03478397 | Completed Results

• 1 other identifier: 2017-911
• Study Type: interventional
• Target: 5,389
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patient Adherence

Keywords

cervical cancer prevention; self-collection HPV test; mHealth; Argentina

Outcome Measures

Primary Outcomes (1)

• Percentage of Women With Triage Pap Smears at 120 Days After HPV Results

  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)

  120 days

Secondary Outcomes (1)

• Percentage of Women With Triage Pap Smears at 60 Days After HPV Results

  60 days

Study Arms (2)

Multicomponent mHealth Intervention

ACTIVE COMPARATOR

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

Usual Care

NO INTERVENTION

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.

Interventions

Multicomponent mHealth Intervention OTHER

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

Multicomponent mHealth Intervention

Eligibility Criteria

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

You may qualify if:

• In the Randomized Controlled Trial we will recruit a minimum of 4000 women, aged 30 and older living in the province of Jujuy, Argentina.
• Having performed self-collection of HPV-testing.
• Mentally competent to understand the consent form.
• Able to communicate with study staff.
• Being able to provide a mobile phone telephone number.

You may not qualify if:

• Current pregnancy.
• Women with Mental disability.

Sponsors & Collaborators

• Centro de Estudio de Estado y Sociedad: lead
• Dana-Farber Cancer Institute: collaborator
• Deakin University: collaborator

Study Sites (1)

Multiple facilities

San Salvador de Jujuy, Jujuy Province, Argentina

Location

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MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Silvina Arrossi
• Organization: CEDES

silviarrossi2020@gmail.com

541148651007

Study Officials

• Silvina Arrossi, Phd

  CEDES/CONICET

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: December 5, 2018
• Primary Completion: November 30, 2019
• Study Completion: August 31, 2020
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2023-11

Locations

AR (1)