Remote Resilience: Novel Applications of mHealth in Nicaragua's Cancer Control Program

NCT06921798 | Not Yet Recruiting

• 1 other identifier: HSR231558
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to test an mHealth intervention for cervical cancer prevention in under-screened women ages 25-64 on the Caribbean Coast of Nicaragua. The mHealth intervention combines a patient-centered mobile app, a provider portal, and connectivity to the National Breast and Cervical Cancer Surveillance System (SIVIPCAN). The mHealth intervention will be combined with HPV primary screening for cervical cancer. The main questions it aims to answer are, when integrated into an HPV-based screening program: Is the mHealth intervention acceptable? Is the mHealth intervention feasible? Researchers will compare the intervention group (mHealth intervention) to the control group (standard care). Participants will: Receive HPV-based cervical screening. Intervention group: Through the patient-centered app, participants will receive "results ready" notification and navigation to the clinic for follow-up. Control group: Participants will receive "results ready" notification and navigation to the clinic for follow-up through existing communication channels.

Conditions

HPV Infection; Cervical Cancers

Keywords

mHealth; Nicaragua; Cervical Cancer Screening; HPV; HPV Screening; HPV Testing

Outcome Measures

Primary Outcomes (2)

• Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program

  The Systems Usability Scale (minimum 1, maximum 5, higher scores mean more positive outcome).

  2-4 weeks after enrollment in the study

• Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program

  (2) the uMobile App Rating Scale (minimum 1, maximum 4, higher scores mean more positive outcome).

  2-4 weeks after enrollment in the study

Secondary Outcomes (1)

• mHealth Intervention Impacts

  2-4 weeks after enrollment in the study

Study Arms (2)

Control

NO INTERVENTION

Receives cervical screening, does not receive the mHealth intervention

Intervention

EXPERIMENTAL

Receives cervical screening, receives the mHealth intervention

Other: mHealth

Interventions

mHealth OTHER

This mHealth intervention is designed to provide health education, and to notify study participants when their result is ready and it is time for them to return to the healthcare clinic for follow up.

Intervention

Eligibility Criteria

• Age: 25 Years - 64 Years
• Gender Eligibility Details: Anyone with a cervix is eligible to participate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between ages of 25-64
• Owns smart phone with Android operating system
• Lives on the Caribbean Coast of Nicaragua

You may not qualify if:

• Pap test or cervical screen in the last year
• Pregnant currently

Sponsors & Collaborators

• University of Virginia: lead

Related Publications (4)

• Capote Negrin LG. Epidemiology of cervical cancer in Latin America. Ecancermedicalscience. 2015 Oct 8;9:577. doi: 10.3332/ecancer.2015.577. eCollection 2015.

  PMID: 26557875 BACKGROUND

• Holme F, Maldonado F, Martinez-Granera OB, Rodriguez JM, Almendarez J, Slavkovsky R, Bansil P, Thomson KA, Jeronimo J, de Sanjose S. HPV-based cervical cancer screening in Nicaragua: from testing to treatment. BMC Public Health. 2020 Apr 15;20(1):495. doi: 10.1186/s12889-020-08601-z.

  PMID: 32295562 BACKGROUND

• Mitchell EM, Lothamer H, Garcia C, Marais AD, Camacho F, Poulter M, Bullock L, Smith JS. Acceptability and Feasibility of Community-Based, Lay Navigator-Facilitated At-Home Self-Collection for Human Papillomavirus Testing in Underscreened Women. J Womens Health (Larchmt). 2020 Apr;29(4):596-602. doi: 10.1089/jwh.2018.7575. Epub 2019 Sep 18.

  PMID: 31532298 BACKGROUND

• Mitchell EM, Hall KM, Doede A, Rong A, McLean Estrada M, Granera OB, Maldonado F, Al Kallas H, Bravo-Rodriguez C, Forero M, Pokam Tchuisseu Y, Dillingham RA. Feasibility and acceptability of self-collection of Human Papillomavirus samples for primary cervical cancer screening on the Caribbean Coast of Nicaragua: A mixed-methods study. Front Oncol. 2023 Jan 20;12:1020205. doi: 10.3389/fonc.2022.1020205. eCollection 2022.

  PMID: 36741739 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Emma M Mitchell, PhD, RN

  University of Virginia School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma M Mitchell, PhD, RN, CPH

CONTACT

4342433962; emm6z@virginia.edu

Souad Benloukil, MD, CCRC

CONTACT

434-466-6314; sb2jx@virginia.edu

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: Associate Professor

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: April 10, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: April 10, 2025

Record last verified: 2025-04