Clinical trial NCT06921798: Remote Resilience: Novel Applications of mHealth in Nicaragua's Cancer Control Program
Official title: Remote Resilience: Novel Applications of mHealth in Nicaragua's Cancer Control Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HPV Infection
Cervical Cancers
Keywords: mHealth
Nicaragua
Cervical Cancer Screening
HPV
HPV Screening
HPV Testing
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program
timeFrame: 2-4 weeks after enrollment in the study
measure: Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program
timeFrame: 2-4 weeks after enrollment in the study
Secondary outcomes:
measure: mHealth Intervention Impacts
timeFrame: 2-4 weeks after enrollment in the study
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia School of Nursing
name: Emma M Mitchell, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capote Negrin LG. Epidemiology of cervical cancer in Latin America. Ecancermedicalscience. 2015 Oct 8;9:577. doi: 10.3332/ecancer.2015.577. eCollection 2015.
citation: 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.
citation: 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.
citation: 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.