HPV InfectionNCT06921798
Remote Resilience: Novel Applications of mHealth in Nicaragua's Cancer Control Program
A study testing mHealth in people with HPV Infection and Cervical Cancers, run by University of Virginia.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, Cervical Cancers
- What is being tested?
- mHealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between ages of 25-64
- Owns smart phone with Android operating system
- Lives on the Caribbean Coast of Nicaragua
Who cannot join
- Pap test or cervical screen in the last year
- Pregnant currently
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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?
Read more
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.
Read the 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).
- Conditions
- HPV Infection, Cervical Cancers
- Being tested
- mHealth
- Keywords
- mHealth, Nicaragua, Cervical Cancer Screening, HPV, HPV Screening, HPV Testing
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receives cervical screening, does not receive the mHealth intervention |
| Intervention | Experimental | Receives cervical screening, receives the mHealth intervention Receives: Other: mHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 2-4 weeks after enrollment in the study
Secondary outcomes (1)
mHealth Intervention Impacts
- Lost to follow-up (total number in control and intervention group)
- Time from initial screen through follow up treatment (measured in days)
Measured: 2-4 weeks after enrollment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma McKim Mitchell, University of Virginia
- Investigators
- Emma M Mitchell, PhD, RN, Principal investigator, University of Virginia School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921798
- Sponsor's protocol ID
- HSR231558
- Status last verified
- Apr 2025
- First submitted
- 5 Feb 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Capote Negrin LG. Epidemiology of cervical cancer in Latin America. Ecancermedicalscience. 2015 Oct 8;9:577. doi: 10.3332/ecancer.2015.577. eCollection 2015.
PubMed 26557875Holme 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.
PubMed 32295562Mitchell 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.
PubMed 31532298Mitchell 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.
PubMed 36741739
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Resilience: Novel Applications of mHealth in Nicaragua's Cancer Control Program
- ClinicalTrials.gov ID
- NCT06921798
- Acronym / sponsor ID
- HSR231558
- Conditions
- HPV Infection, Cervical Cancers
- Keywords
- mHealth, Nicaragua, Cervical Cancer Screening, HPV, HPV Screening, HPV Testing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receives cervical screening, does not receive the mHealth intervention |
| Intervention | Experimental | Other: mHealthReceives cervical screening, receives the mHealth intervention |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between ages of 25-64
- Owns smart phone with Android operating system
- Lives on the Caribbean Coast of Nicaragua
Key exclusion criteria (2 listed)
- Pap test or cervical screen in the last year
- Pregnant currently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealthThis 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. | Other | Intervention |
Primary outcome
Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program
Time frame: 2-4 weeks after enrollment in the study
The Systems Usability Scale (minimum 1, maximum 5, higher scores mean more positive outcome).
Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program
Time frame: 2-4 weeks after enrollment in the study
(2) the uMobile App Rating Scale (minimum 1, maximum 4, higher scores mean more positive outcome).
1 secondary outcome
mHealth Intervention Impacts
Time frame: 2-4 weeks after enrollment in the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Background: PubMed 26557875Capote Negrin LG. Epidemiology of cervical cancer in Latin America. Ecancermedicalscience. 2015 Oct 8;9:577. doi: 10.3332/ecancer.2015.577. eCollection 2015.
- Background: PubMed 32295562Holme 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.
- Background: PubMed 31532298Mitchell 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.
- Background: PubMed 36741739Mitchell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma M Mitchell, PhD, RN principal investigator
University of Virginia School of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing mHealth in people with HPV Infection and Cervical Cancers, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma M Mitchell, PhD, RN, CPH (4342433962, emm6z@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability/feasibility of integrating provider mHealth intervention into cervical cancer screening program (time frame: 2-4 weeks after enrollment in the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06921798, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.