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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06921798
Enrollment
3000
Registered
2025-04-10
Start date
2025-04-15
Completion date
2029-05-31
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancers, HPV Infection

Keywords

mHealth, Nicaragua, Cervical Cancer Screening, HPV, HPV Screening, HPV Testing

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.

Detailed description

Cervical cancer, a preventable cancer of disparities, is the primary cause of cancer death for women in Nicaragua. The World Health Organization (WHO) adopted an elimination strategy for cervical cancer within the next 100 years, and outlined specific targets to meet by 2030: vaccination (90% of girls before age 15); screening/early detection (70% of women get a high-quality screen by 35 and again at 45); and treatment (90% of pre-cancerous and cancerous lesions treated). As the majority of the burden of cervical cancer exists in low- and middle-income countries (LMICs), significant research into the development, implementation, and cost-effectiveness of community-based cervical cancer screening models using HPV primary screening has developed a strong evidence-base for the acceptability and feasibility of this modality. However, significant geographic variability exists in successfully improving patient health outcomes and preventing cervical cancer, particularly in rural and remote geographic areas. In Nicaragua, significant intra-country variability exists in terms of yearly participation in cervical cancer screening by eligible women, and likelihood of lifetime screening, depending on geographic region. There is a demonstrated need for culturally tailored, regionally specific innovations in evidence-based HPV primary cervical screening programs. Researchers at the University of Virginia have worked with community partner non-governmental organization Fundacion Movicancer over the past several years to develop and create an mHealth platform that combines: (1) a patient-centered mobile application (app) called Azulado with (2) a provider-focused portal, as well as integration of the provider-focused portal with the (3) National Cervical Cancer Surveillance System (SIVIPCAN).

Interventions

OTHERmHealth

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.

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program2-4 weeks after enrollment in the studyThe Systems Usability Scale (minimum 1, maximum 5, higher scores mean more positive outcome).

Secondary

MeasureTime frameDescription
mHealth Intervention Impacts2-4 weeks after enrollment in the study1. Lost to follow-up (total number in control and intervention group) 2. Time from initial screen through follow up treatment (measured in days)

Contacts

Primary ContactEmma M Mitchell, PhD, RN, CPH
emm6z@virginia.edu4342433962
Backup ContactSouad Benloukil, MD, CCRC
sb2jx@virginia.edu434-466-6314

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026