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

University of Virginia

Status: Not yet enrolling

Conditions: HPV Infection; Cervical Cancers

Treatments: Other: mHealth

Study type: Interventional

Funder types: Other

Identifiers

NCT06921798

HSR231558

Details and patient eligibility

About

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.

Full 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).

Enrollment: 3,000 estimated patients

Sex: Female

Ages: 25 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

Control

No Intervention group

Description:

Receives cervical screening, does not receive the mHealth intervention

Intervention

Experimental group

Description:

Receives cervical screening, receives the mHealth intervention

Treatment:

Other: mHealth