Cervical CancerNCT03155581
Increasing Attendance to Cervical Cancer-screening Among Immigrants
A study testing User intervention and Health professional intervention in people with Cervical Cancer, run by University of Bergen.
Trial summary
Although health-related interventions should become increasingly diversity-sensitive, there will always be a need of adapting specific interventions to some immigrant populations. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- User intervention and Health professional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 30 Jun 2018
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the women: Women from Somalia and Pakistan living in the intervention areas
- For the health professionals: GPs working in the intervention areas
Who cannot join
None listed.
About this study
Official title: A Community-based Health Intervention Trial to Increase Attendance to Cervical Cancer-screening Program Among Immigrants in Norway.
Although health-related interventions should become increasingly diversity-sensitive, there will always be a need of adapting specific interventions to some immigrant populations. Adapting selected services to the individual cultural and religious background is necessary to reduce health inequalities and provide effective health care and is dependent on the active involvement of users. In this proposal the investigators present a community-based health intervention trial with two parallel interventions aimed at increasing participation of immigrant women to the existing cervical cancer-screening program. Through this study, the investigators will provide new practice-based knowledge and a firmer evidence base to improve health interventions that can contribute to equal health care and good health for all - including the immigrant population.
Based on identified barriers and factors that influence the interactions between immigrants and health care professionals for screening of cervical cancer in Norway, the investigators have develop two adapted interventions. One strategy will target immigrant women, and the other one will focus on general practitioners. Thus, this proposal will specifically contribute to the development of personalized health prevention interventions for the most common cancer-screening program in Norway, with a focus on immigrant's personal circumstances and health care needs.
Read the detailed description
Goals and objectives of the project The present study is designed to evaluate the effectiveness of two different community-based strategies to increase the attendance to the cervical cancer screening prevention program. Interventions have been developed together with stakeholders and conducted in two different geographical areas in Norway. Each intervention group will be compared to a control population in the same county in the first place. The main outcome to compare will be the percentage of women in each group attending to the screening program. However, the investigators will not only focus on this quantitative outcome, but also on the underlying processes determining how communities and individuals change their behaviour.
Secondly, the effect of the interventions measured quantitatively will be compared to each other in order to be able to prioritise one of the two strategies if needed, although strategies will probably be complementary. A particular interest of the interventions is to examine whether and how immigrant women respond to different intervention strategies.
Methods This study is designed as a community-based health intervention trial. A key feature of such trials is the allocation of intact communities or clusters of individuals rather than individuals themselves to different intervention groups.
The study will rely on both quantitative and qualitative evaluation of the interventions. For the quantitative part,each of the two interventions will be compared to its control. In addition, the effects of the interventions will be compared. Additionally, to know how the interventions increased (or not) attendance to the screening program post-intervention focus groups among intervention subjects will be conducted.
Interventions, participants and participating areas Two different intervention strategies have developed, one of them meant to increase awareness and attendance among users, and the other one targeting health professionals.
- User intervention Area and design The developed User intervention will be implemented in the counties of Akershus and Buskerud. Women from Somalia and Pakistan were chosen as targets for this intervention after previous analyses for register data. Sample size was calculated for an increase in cancer screening participation from 0.45 to 0.55 with 80% power and 5% significance level. The investigators tried several intra class correlation (ICC) levels, and ended dividing the area in 16 clusters that were matched according to the calculated number of female immigrants aged 20 to 66 from Somalia and Pakistan. After assuring that pairs were not naturally linked by a mosque or other natural known gather centre for these populations, clusters were randomly assigned to intervention or control groups. Participants All women from Somalia and Pakistan living in the intervention clusters compose the intervention groups; immigrant women from the same countries of origin living in control clusters will be control participants. It is estimated that 625 and 915 women in screening age from Somalia and Pakistan respectively live in the study area (Akershus and Buskerud). Approximately half part of the women from each country will be in the intervention clusters. Intervention Bilingual key women from the two chosen countries were recruited and trained as peer educators for their respective communities to increase awareness regarding the importance of cervical cancer prevention and to help peers overcome detected barriers and increase attendance to screening. The strategy to achieve these goals relied upon meetings with the women organised according to their practical needs, using videos and other interactive materials.
- Heath professional intervention Area The developed Heath professional intervention will be implemented in Bergen. Sample size was calculated for an increase in cancer screening participation for non-Western immigrants (all groups together) from 0.45 to 0.55 with 80% power and 5% significance level. The investigators tried several intra class correlation (ICC) levels, and finally divided the area in 20 clusters that were matched according to the cluster size and the calculated number of female non-Western immigrants aged 20 to 66. The clusters were thereafter randomly assigned to intervention or control groups. Participants All General practitioners working in the intervention cluster areas were assigned to the intervention group; similarly, health professionals working in the other clusters will be chosen as controls. Women will for the analyses be linked to their general practitioner through the General Practice Database. Intervention Based on the existing evidence and on interviews conducted with health professionals, an appropriate intervention was developed to increase awareness of the health professionals involved in screening working in the chosen areas. Health professionals in the intervention areas will be contacted by letter and a personal appointment was made to explain the intervention. No change in "screening as usual" will be implemented for health professionals working in the control areas.
- Post-intervention qualitative studies Among participants included in the intervention areas, focus groups/in depth-interviews will be conducted right after the interventions are implemented among both users and health professionals to understand whether and how each of the interventions worked.
Measurements The study relies on both quantitative and qualitative evaluation of the interventions.
- Outcome information on screening attendance for intervention and control groups will be obtained from the Norwegian Cytology registry, where all pap smears taken in Norway are registered. The leader of the Norwegian Cytology register is part of the Reference group for this study, and this register can provide data for the variables Morphology (if the test is taken, if it is normal or pathological) and date for test for all women in Norway after the necessary permissions are given. This register will be then linked at the individual level to the Norwegian National Registry in order to obtain information regarding immigrant background, country of origin as explained below, reason for migration and length of stay in Norway for all 25 to 69 years old registered in Norway, in addition to other socioeconomic variables (age, education, income level, work status, cluster area for those in intervention and control areas, geographical centrality, civil status, husbands' immigrant background and GP's immigrant background) that will be used to adjust our results, and to two variables from the GP database (GP's age and gender) to identify the GPs in the intervention and control groups in the Health professional strategy. Data will be linked by Statistics Norway before being accessible to the researchers. However, since ethnicity is considered sensitive data, and in order to make the dataset completely anonymous for the research group, we will only apply for the following groups with regard to country of origin (see page 1 for approximate numbers): Norway, Western Europe, Eastern Europe, Middle-East, South-East, South Asia, Africa, North America, Central and South America, Poland, Sweden, Pakistan and Somalia. As explained below, data will be obtained for several years (2012-2018) in order to be able to distinguish secular trends in attendance to cervical screening versus the effect due to our intervention. Data will be stored in a secure server at the University of Bergen (BIOS, Core Facility for Biostatistics and Data Analyses) in an anonymised form.
- In addition, the process of how communities and individuals change their behaviour will be studied using a qualitative approach to the intervention groups after the interventions. These data will do not include any information that can lead to personal identification of the women.
- Conditions
- Cervical Cancer
- Being tested
- User intervention, Health professional intervention
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
User interventionBehavioural
To make participants aware of the lack of participation in screening programs and its consequences, and help to manage obstacles to participation
Health professional interventionBehavioural
To provide information on the low attendance of migrants to cervical cancer screening and tools to improve the situation
| Study group | Role | What they receive |
|---|---|---|
| User intervention | Other | Bilingual key women from Somalia and Pakistan trained as peer educators for their respective communities will meet the women to increase awareness regarding the importance of cervical cancer prevention and to help peers overcome detected barriers and increase attendance to screening during meetings with the women organised according to their practical needs, using videos and interactive material Receives: Behavioral: User intervention |
| Health professional intervention | Other | General practitioners working in the intervention areas are contacted by letter and an appointment is made for a short meeting to increase awareness of the health professionals involved in screening working in the chosen areas. Material is given(posters and reminding objects) to remind practitioners of the intervention and invite women attending to the center to make an appointment with their GP. No change in "screening as usual" will be implemented for health professionals working in the control areas. Receives: Behavioral: Health professional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in cervical cancer screening
Registered in national cancer register (yes/no), if the woman has been registered with a Pap-smear or not
Measured: 1 year
Secondary outcomes (1)
Process of behavior change
Interviews with women and health professionals: How the intervention has worked/not worked
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Feb 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Model description
- One intervention targeting women, the other one targeting health professionals.
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Centre for Minority Health Research
- Responsible party
- Principal investigator, Esperanza Diaz, University of Bergen
- Investigators
- Esperanza Diaz, MD, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155581
- Sponsor's protocol ID
- 2015/1156
- Status last verified
- Dec 2018
- First submitted
- 11 May 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
Qureshi SA, Igland J, Moen K, Gele A, Kumar B, Diaz E. Effect of a community-based intervention to increase participation in cervical cancer screening among Pakistani and Somali women in Norway. BMC Public Health. 2021 Jun 30;21(1):1271. doi: 10.1186/s12889-021-11319-1.
PubMed 34193096Moen KA, Kumar B, Igland J, Diaz E. Effect of an Intervention in General Practice to Increase the Participation of Immigrants in Cervical Cancer Screening: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e201903. doi: 10.1001/jamanetworkopen.2020.1903.
PubMed 32236530Qureshi SA, Gele A, Kour P, Moen KA, Kumar B, Diaz E. A community-based intervention to increase participation in cervical cancer screening among immigrants in Norway. BMC Med Res Methodol. 2019 Jul 12;19(1):147. doi: 10.1186/s12874-019-0795-8.
PubMed 31299912
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Health Intervention Trial to Increase Attendance to Cervical Cancer-screening Program Among Immigrants in Norway.
- ClinicalTrials.gov ID
- NCT03155581
- Acronym / sponsor ID
- 2015/1156
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Norwegian Centre for Minority Health Research
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 May 2017 (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.
Although health-related interventions should become increasingly diversity-sensitive, there will always be a need of adapting specific interventions to some immigrant populations. Adapting selected services to the individual cultural and religious background is necessary to reduce health inequalities and provide effective health care and is dependent on the active involvement of users. In this proposal the investigators present a community-based health intervention trial with two parallel interventions aimed at increasing participation of immigrant women to the existing cervical cancer-screening program. Through this study, the investigators will provide new practice-based knowledge and a firmer evidence base to improve health interventions that can contribute to equal health care and good health for all - including the immigrant population.
Based on identified barriers and factors that influence the interactions between immigrants and health care professionals for screening of cervical cancer in Norway, the investigators have develop two adapted interventions. One strategy will target immigrant women, and the other one will focus on general practitioners. Thus, this proposal will specifically contribute to the development of personalized health prevention interventions for the most common cancer-screening program in Norway, with a focus on immigrant's personal circumstances and health care needs.
Detailed description
Goals and objectives of the project The present study is designed to evaluate the effectiveness of two different community-based strategies to increase the attendance to the cervical cancer screening prevention program. Interventions have been developed together with stakeholders and conducted in two different geographical areas in Norway. Each intervention group will be compared to a control population in the same county in the first place. The main outcome to compare will be the percentage of women in each group attending to the screening program. However, the investigators will not only focus on this quantitative outcome, but also on the underlying processes determining how communities and individuals change their behaviour.
Secondly, the effect of the interventions measured quantitatively will be compared to each other in order to be able to prioritise one of the two strategies if needed, although strategies will probably be complementary. A particular interest of the interventions is to examine whether and how immigrant women respond to different intervention strategies.
Methods This study is designed as a community-based health intervention trial. A key feature of such trials is the allocation of intact communities or clusters of individuals rather than individuals themselves to different intervention groups.
The study will rely on both quantitative and qualitative evaluation of the interventions. For the quantitative part,each of the two interventions will be compared to its control. In addition, the effects of the interventions will be compared. Additionally, to know how the interventions increased (or not) attendance to the screening program post-intervention focus groups among intervention subjects will be conducted.
Interventions, participants and participating areas Two different intervention strategies have developed, one of them meant to increase awareness and attendance among users, and the other one targeting health professionals.
- User intervention Area and design The developed User intervention will be implemented in the counties of Akershus and Buskerud. Women from Somalia and Pakistan were chosen as targets for this intervention after previous analyses for register data. Sample size was calculated for an increase in cancer screening participation from 0.45 to 0.55 with 80% power and 5% significance level. The investigators tried several intra class correlation (ICC) levels, and ended dividing the area in 16 clusters that were matched according to the calculated number of female immigrants aged 20 to 66 from Somalia and Pakistan. After assuring that pairs were not naturally linked by a mosque or other natural known gather centre for these populations, clusters were randomly assigned to intervention or control groups. Participants All women from Somalia and Pakistan living in the intervention clusters compose the intervention groups; immigrant women from the same countries of origin living in control clusters will be control participants. It is estimated that 625 and 915 women in screening age from Somalia and Pakistan respectively live in the study area (Akershus and Buskerud). Approximately half part of the women from each country will be in the intervention clusters. Intervention Bilingual key women from the two chosen countries were recruited and trained as peer educators for their respective communities to increase awareness regarding the importance of cervical cancer prevention and to help peers overcome detected barriers and increase attendance to screening. The strategy to achieve these goals relied upon meetings with the women organised according to their practical needs, using videos and other interactive materials.
- Heath professional intervention Area The developed Heath professional intervention will be implemented in Bergen. Sample size was calculated for an increase in cancer screening participation for non-Western immigrants (all groups together) from 0.45 to 0.55 with 80% power and 5% significance level. The investigators tried several intra class correlation (ICC) levels, and finally divided the area in 20 clusters that were matched according to the cluster size and the calculated number of female non-Western immigrants aged 20 to 66. The clusters were thereafter randomly assigned to intervention or control groups. Participants All General practitioners working in the intervention cluster areas were assigned to the intervention group; similarly, health professionals working in the other clusters will be chosen as controls. Women will for the analyses be linked to their general practitioner through the General Practice Database. Intervention Based on the existing evidence and on interviews conducted with health professionals, an appropriate intervention was developed to increase awareness of the health professionals involved in screening working in the chosen areas. Health professionals in the intervention areas will be contacted by letter and a personal appointment was made to explain the intervention. No change in "screening as usual" will be implemented for health professionals working in the control areas.
- Post-intervention qualitative studies Among participants included in the intervention areas, focus groups/in depth-interviews will be conducted right after the interventions are implemented among both users and health professionals to understand whether and how each of the interventions worked.
Measurements The study relies on both quantitative and qualitative evaluation of the interventions.
- Outcome information on screening attendance for intervention and control groups will be obtained from the Norwegian Cytology registry, where all pap smears taken in Norway are registered. The leader of the Norwegian Cytology register is part of the Reference group for this study, and this register can provide data for the variables Morphology (if the test is taken, if it is normal or pathological) and date for test for all women in Norway after the necessary permissions are given. This register will be then linked at the individual level to the Norwegian National Registry in order to obtain information regarding immigrant background, country of origin as explained below, reason for migration and length of stay in Norway for all 25 to 69 years old registered in Norway, in addition to other socioeconomic variables (age, education, income level, work status, cluster area for those in intervention and control areas, geographical centrality, civil status, husbands' immigrant background and GP's immigrant background) that will be used to adjust our results, and to two variables from the GP database (GP's age and gender) to identify the GPs in the intervention and control groups in the Health professional strategy. Data will be linked by Statistics Norway before being accessible to the researchers. However, since ethnicity is considered sensitive data, and in order to make the dataset completely anonymous for the research group, we will only apply for the following groups with regard to country of origin (see page 1 for approximate numbers): Norway, Western Europe, Eastern Europe, Middle-East, South-East, South Asia, Africa, North America, Central and South America, Poland, Sweden, Pakistan and Somalia. As explained below, data will be obtained for several years (2012-2018) in order to be able to distinguish secular trends in attendance to cervical screening versus the effect due to our intervention. Data will be stored in a secure server at the University of Bergen (BIOS, Core Facility for Biostatistics and Data Analyses) in an anonymised form.
- In addition, the process of how communities and individuals change their behaviour will be studied using a qualitative approach to the intervention groups after the interventions. These data will do not include any information that can lead to personal identification of the women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One intervention targeting women, the other one targeting health professionals.
| Arm | Type | Receives |
|---|---|---|
| User intervention | Other | Behavioral: User interventionBilingual key women from Somalia and Pakistan trained as peer educators for their respective communities will meet the women to increase awareness regarding the importance of cervical cancer prevention and to help peers overcome detected barriers and increase attendance to screening during meetings with the women organised according to their practical needs, using videos and interactive material |
| Health professional intervention | Other | Behavioral: Health professional interventionGeneral practitioners working in the intervention areas are contacted by letter and an appointment is made for a short meeting to increase awareness of the health professionals involved in screening working in the chosen areas. Material is given(posters and reminding objects) to remind practitioners of the intervention and invite women attending to the center to make an appointment with their GP. No change in "screening as usual" will be implemented for health professionals working in the control areas. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For the women: Women from Somalia and Pakistan living in the intervention areas
- For the health professionals: GPs working in the intervention areas
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| User interventionTo make participants aware of the lack of participation in screening programs and its consequences, and help to manage obstacles to participation | Behavioural | User intervention |
| Health professional interventionTo provide information on the low attendance of migrants to cervical cancer screening and tools to improve the situation | Behavioural | Health professional intervention |
Primary outcome
Participation in cervical cancer screening
Time frame: 1 year
Registered in national cancer register (yes/no), if the woman has been registered with a Pap-smear or not
1 secondary outcome
Process of behavior change
Time frame: 1 year
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 19 Dec 2018.
- Derived from this study: PubMed 34193096Qureshi SA, Igland J, Moen K, Gele A, Kumar B, Diaz E. Effect of a community-based intervention to increase participation in cervical cancer screening among Pakistani and Somali women in Norway. BMC Public Health. 2021 Jun 30;21(1):1271. doi: 10.1186/s12889-021-11319-1.
- Derived from this study: PubMed 32236530Moen KA, Kumar B, Igland J, Diaz E. Effect of an Intervention in General Practice to Increase the Participation of Immigrants in Cervical Cancer Screening: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e201903. doi: 10.1001/jamanetworkopen.2020.1903.
- Derived from this study: PubMed 31299912Qureshi SA, Gele A, Kour P, Moen KA, Kumar B, Diaz E. A community-based intervention to increase participation in cervical cancer screening among immigrants in Norway. BMC Med Res Methodol. 2019 Jul 12;19(1):147. doi: 10.1186/s12874-019-0795-8.
- Individual participant dataSharing planned: No. No plan
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Esperanza Diaz, MD, PhD principal investigator
University of Bergen
Questions about this trial
What is this clinical trial studying?
A study testing User intervention and Health professional intervention in people with Cervical Cancer, run by University of Bergen.
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 2 inclusion and 0 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 19 Dec 2018. 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?
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?
Participation in cervical cancer screening (time frame: 1 year). 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 NCT03155581, which also lists 3 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 19 Dec 2018.