Cervical Cancer ScreeningTelemedineNCT07482306
Introducing a Telemedicine Strategy to Deliver Cervical Cancer Screening Results in El Salvador
A study testing Telemedicine in people with Cervical Cancer Screening, run by The Cleveland Clinic at 1 site in El Salvador.
Trial summary
Telemedicine, the use of telecommunication technologies to provide healthcare services remotely, has grown exponentially in the last decade. The COVID-19 pandemic highlighted the potential of these approaches as routine clinical interactions transitioned from in-person to virtual modalities around the world. Read more about this study
- Who is it for?
- Ages 30 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Telemedicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,103 participants
- Where
- 1 siteEl Salvador
- Study dates
- 31 Jan 2024to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 30-59
Who cannot join
- No history of cervical cancer
- No HPV testing in the past 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Telemedicine, the use of telecommunication technologies to provide healthcare services remotely, has grown exponentially in the last decade. The COVID-19 pandemic highlighted the potential of these approaches as routine clinical interactions transitioned from in-person to virtual modalities around the world. While some telemedicine applications are only feasible in high-resource settings, other types have been shown to be effective in low and middle-income countries (LMICs). Interventions that utilize mobile devices such as cellular phones and digital tablets, collectively known as mobile health or mHealth, may enable greater patient access to some services and reduce the strain on resource-limited health systems. Here we describe the use of an mHealth strategy to facilitate delivery of cervical cancer screening results in El Salvador.
Read the detailed description
Telemedicine, the use of telecommunication technologies to provide healthcare services remotely, has grown exponentially in the last decade. While some telemedicine applications are only feasible in high-resource settings, other types have been shown to be effective in low and middle-income countries (LMICs). Interventions that utilize mobile devices such as cellular phones and digital tablets, collectively known as mobile health or mHealth, may enable greater patient access to some services and reduce the strain on resource-limited health systems. Here we describe the use of an mHealth strategy to facilitate delivery of cervical cancer screening results in El Salvador.
This was a cross-sectional comparative study in primary health clinics of the Paracentral region of El Salvador. Eight clinics matched for size and location (rural vs. urban) were assigned to either the intervention (n=4) or the control condition (n=4). Recruitment continued in the clinics' catchment areas until the target of 550 women in each group was reached for a total of 1,100 participants. Given previous research, we expected that 12% of all women (n=66 in each group or 132 total) would be HPV+, while the remainder would be HPV- (n=484 in each group or 968 total). Using a Fisher's exact test with one-sided 0.10 type 1 error, a sample of 126 HPV+ women (63 in each group) would have 80% power to detect a 14% increase (80% vs 94%) in the proportion of women who obtained their test results. For those with HPV- results, using a Fisher's exact test with two-sided 0.05 type 1 error, a sample of 880 women (440 in each group) would have 80% power to detect a 10% increase (60% vs 70%) in the proportion who obtained their results.
Women were recruited to the study during screening visits at the participating clinics. Eligibility criteria were similar to those of the HPV screening program. Women aged 30 to 59, with no history of cervical cancer, no HPV testing in the last 5 years, and willing and able to provide informed consent were included. Those with no access to a working mobile phone were excluded. Informed consent procedures and an intake questionnaire were administered by experienced research assistants before participants underwent HPV sampling.
In the intervention group, all screened women received a SMS text message when their test results became available. Texts were sent automatically through Twilio (Twilio Inc., San Francisco, CA), a commercially available digital platform embedded into the study's REDCap database. The text messages were developed by native Spanish speakers in consultation with MoH personnel to ensure they were brief, clear, and understandable at a basic reading level. For HPV+ women, the text stated that the test had been processed and that the individual needed to return to the local clinic to receive their results. This ensured that this group of individuals received counseling and indications for follow-up treatment. Texts also included a telephone number to call in case of questions. For HPV- women in the intervention group, the message stated that the test result was negative and recommended that the recipient be re-screened in 5 years. A phone number was also included in case of questions. In the control group, all women regardless of HPV status followed the routine procedure of scheduling an appointment after 30 days to receive their results in-person at their primary care clinic. A survey was administered to ascertain delivery of HPV test results and to evaluate acceptability of the result delivery method. In the intervention group, HPV- women were administered the survey via phone call 4 weeks after screening. After three unanswered phone call attempts, a community health worker visited the home to conduct the survey. For participants who were required to pick up their test results in person (i.e., HPV+ positive women in the intervention group, HPV+ and HPV- women in the control group), the survey was conducted when they returned to the clinic. Women who did not show up after 30 days or missed their previously scheduled appointment were contacted at least three times via phone call or received a home visit by a community health worker to remind them to pick up their results.
Fisher's exact test was used to compare the proportion of women who received their results in each group within 45 days. Descriptive statistics were used to compare sociodemographic variables and results of the acceptability survey.
- Conditions
- Cervical Cancer Screening
- Being tested
- Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineBehavioural
Women receive their screening results via SMS message instead of in person
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Active comparator | Received screening result through SMS message Receives: Behavioral: Telemedicine |
| Control | No intervention | Received screening result in person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of results received
Proportion of women who received their results in each group
Measured: 45 days
Proportion of results received
Proportion of women who received their results in each group within 45 days
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start31 Jan 2024
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Miriam Cremer, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482306
- Sponsor's protocol ID
- 22-562
- Other IDs
- 3R01CA218195-04S2
- Acronym
- Telemedine
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing a Telemedicine Strategy to Deliver Cervical Cancer Screening Results in El Salvador
- ClinicalTrials.gov ID
- NCT07482306
- Acronym / sponsor ID
- Telemedine / 22-562
- Conditions
- Cervical Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,103 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Mar 2026 (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.
Telemedicine, the use of telecommunication technologies to provide healthcare services remotely, has grown exponentially in the last decade. The COVID-19 pandemic highlighted the potential of these approaches as routine clinical interactions transitioned from in-person to virtual modalities around the world. While some telemedicine applications are only feasible in high-resource settings, other types have been shown to be effective in low and middle-income countries (LMICs). Interventions that utilize mobile devices such as cellular phones and digital tablets, collectively known as mobile health or mHealth, may enable greater patient access to some services and reduce the strain on resource-limited health systems. Here we describe the use of an mHealth strategy to facilitate delivery of cervical cancer screening results in El Salvador.
Detailed description
Telemedicine, the use of telecommunication technologies to provide healthcare services remotely, has grown exponentially in the last decade. While some telemedicine applications are only feasible in high-resource settings, other types have been shown to be effective in low and middle-income countries (LMICs). Interventions that utilize mobile devices such as cellular phones and digital tablets, collectively known as mobile health or mHealth, may enable greater patient access to some services and reduce the strain on resource-limited health systems. Here we describe the use of an mHealth strategy to facilitate delivery of cervical cancer screening results in El Salvador.
This was a cross-sectional comparative study in primary health clinics of the Paracentral region of El Salvador. Eight clinics matched for size and location (rural vs. urban) were assigned to either the intervention (n=4) or the control condition (n=4). Recruitment continued in the clinics' catchment areas until the target of 550 women in each group was reached for a total of 1,100 participants. Given previous research, we expected that 12% of all women (n=66 in each group or 132 total) would be HPV+, while the remainder would be HPV- (n=484 in each group or 968 total). Using a Fisher's exact test with one-sided 0.10 type 1 error, a sample of 126 HPV+ women (63 in each group) would have 80% power to detect a 14% increase (80% vs 94%) in the proportion of women who obtained their test results. For those with HPV- results, using a Fisher's exact test with two-sided 0.05 type 1 error, a sample of 880 women (440 in each group) would have 80% power to detect a 10% increase (60% vs 70%) in the proportion who obtained their results.
Women were recruited to the study during screening visits at the participating clinics. Eligibility criteria were similar to those of the HPV screening program. Women aged 30 to 59, with no history of cervical cancer, no HPV testing in the last 5 years, and willing and able to provide informed consent were included. Those with no access to a working mobile phone were excluded. Informed consent procedures and an intake questionnaire were administered by experienced research assistants before participants underwent HPV sampling.
In the intervention group, all screened women received a SMS text message when their test results became available. Texts were sent automatically through Twilio (Twilio Inc., San Francisco, CA), a commercially available digital platform embedded into the study's REDCap database. The text messages were developed by native Spanish speakers in consultation with MoH personnel to ensure they were brief, clear, and understandable at a basic reading level. For HPV+ women, the text stated that the test had been processed and that the individual needed to return to the local clinic to receive their results. This ensured that this group of individuals received counseling and indications for follow-up treatment. Texts also included a telephone number to call in case of questions. For HPV- women in the intervention group, the message stated that the test result was negative and recommended that the recipient be re-screened in 5 years. A phone number was also included in case of questions. In the control group, all women regardless of HPV status followed the routine procedure of scheduling an appointment after 30 days to receive their results in-person at their primary care clinic. A survey was administered to ascertain delivery of HPV test results and to evaluate acceptability of the result delivery method. In the intervention group, HPV- women were administered the survey via phone call 4 weeks after screening. After three unanswered phone call attempts, a community health worker visited the home to conduct the survey. For participants who were required to pick up their test results in person (i.e., HPV+ positive women in the intervention group, HPV+ and HPV- women in the control group), the survey was conducted when they returned to the clinic. Women who did not show up after 30 days or missed their previously scheduled appointment were contacted at least three times via phone call or received a home visit by a community health worker to remind them to pick up their results.
Fisher's exact test was used to compare the proportion of women who received their results in each group within 45 days. Descriptive statistics were used to compare sociodemographic variables and results of the acceptability survey.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Active comparator | Behavioral: TelemedicineReceived screening result through SMS message |
| Control | No intervention | –Received screening result in person |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 30-59
Key exclusion criteria (2 listed)
- No history of cervical cancer
- No HPV testing in the past 5 years
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 |
|---|---|---|
| TelemedicineWomen receive their screening results via SMS message instead of in person | Behavioural | Telemedicine |
Primary outcome
Proportion of results received
Time frame: 45 days
Proportion of women who received their results in each group
Proportion of results received
Time frame: 45 days
Proportion of women who received their results in each group within 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Miriam Cremer, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Cervical Cancer Screening, run by The Cleveland Clinic at 1 site in El Salvador.
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 1 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: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of results received (time frame: 45 days). 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?
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 3 Aug 2026.