Uterine Cervical NeoplasmsNCT03118258
Improving Access to Cervical Cancer Screening
A study testing 'Pap smear' arm and 'Self-collected vaginal swab for HPV testing + pap smear triage' arm in people with Uterine Cervical Neoplasms, run by Médecins du Monde at 1 site in France.
Trial summary
Every year, in France, 3 000 women are diagnosed with cervical cancer, and 1 000 die each year. Recent studies highlighted regional, social and economical inequalities with respect to cervical cancer incidence. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- 'Pap smear' arm and 'Self-collected vaginal swab for HPV testing + pap smear triage' arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,258 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to Aug 2019
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between 25 and 65 years old
- Met within Doctors of the World programs
Who cannot join
- History of total hysterectomy (= ablation of uterus and cervix)
- Never had sexual intercourse
- Last pap smear test made during the three last years (ou first pap smear test during the last year)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Access to Cervical Cancer Screening for Women Living in Precarious Conditions Met Within Doctors of the World Programs
Every year, in France, 3 000 women are diagnosed with cervical cancer, and 1 000 die each year. Recent studies highlighted regional, social and economical inequalities with respect to cervical cancer incidence.
In France, the pap-smear test is currently the reference test in order to screen for cervical cancer and neoplasia (CIN). Screening and treatment reduced the incidence and the mortality due to cervical cancer by half in the two last decades. That said, many women are still not reached by prevention programs, especially women living in precarious conditions. In 2013, Doctors of the World France estimated that almost 70% of women aged 25 to 65 years old visiting its medical facilities had never had of a pap-smear test.
Read more
The main study objectives are :
Primary objective
To compare the proportion of individuals with abnormal cytology across two screening strategies in order to determine which strategy detects a greater proportion of individuals with abnormal cytology.
These two strategies consist of a preventive consultation followed by:
- Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm)
- An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive* ('self-collected vaginal swab for HPV-HR testing + Pap smear triage' study arm) *A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.
First of secondary objectives:
To evaluate the proportion of individuals who completed cervical cancer screening in each study arm in order to determine which strategy resulted in greater screening participation.
The above clarification of the study objectives and the related changes in the study protocole have been approved by the Comité de Protection des Personnes Ile de France IV.
Read the detailed description
Woman aged 25 to 65 years old met within one of Doctors of the World participating programs will be offered to attend a preventive consultation adressing sexual and reproductive health, and cervical cancer screening. Seven programs are taking part in this study (medical facilities and mobile health programs) in four french cities. Those programs aim to facilitate access to care for people who do not seek or have little access to health services and preventive health measures (lack of health insurance, living far from health services, knowing little about preventive health and how the health system works in France).
These two cervical screening strategies consist of a preventive consultation followed by:
- Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm)
- An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive* ('self-collected vaginal swab for HPV-HR testing + Pap smear triage' study arm) * A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.
The inclusion of participants in one or the other study arm will be done through randomization. There will be 11 one-month periods during wich women are invited to perform a self-collected vaginal swab and 11 one-month periods during which women are directly referred to a partner health facility for Pap smear testing. Each one-month period with an invitation to perform a self-collected vaginal swab is followed by a one-month period with direct patient referral for Pap smear testing. The allocation of the starting period has been randomized for each participating program.
Doctors of the World staff who will be offering this preventive health consultation received a specific training adressing sexual and reproductive health topics, cervical screening and counseling approaches. Illustrated tools have been specially developed for this purpose. Professional translators will be sought when needed.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- 'Pap smear' arm, 'Self-collected vaginal swab for HPV testing + pap smear triage' arm
- Keywords
- Vaginal HPV self-sampling, Pap test smear, cervical cancer screening, deprivation, sexual and reproductive health, Precariousness
- Medical subject headings
- Uterine Cervical Neoplasms, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Pap smear' armBehavioural
Women are invited to participate in a preventive consultation. Doctor of the World staff provides women with information in their mother tongue and uses visuals adressing cervical cancer, its causes and consequences and ways to prevent it.
This consultation is followed by direct patient referral for Pap smear testing in a partner health facility.
'Self-collected vaginal swab for HPV testing + pap smear triage' armBehavioural
Women are invited to participate in a preventive consultation. Doctor of the World staff provides women with information in their mother tongue and uses visuals adressing cervical cancer, its causes and consequences and ways to prevent it.
This consultation is followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive.
A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.
| Study group | Role | What they receive |
|---|---|---|
| Pap smear | Experimental | 'Pap smear' arm: women are invited to participate in a preventive consultation. This consultation is followed by direct patient referral for Pap smear testing in a partner health facility. Receives: Behavioral: 'Pap smear' arm |
| Self-collected vaginal swab for HPV testing + pap smear triage | Experimental | 'Self-collected vaginal swab for HPV testing + pap smear triage' arm : women are invited to participate in a preventive consultation. This consultation is followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive.
A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason. Receives: Behavioral: 'Self-collected vaginal swab for HPV testing + pap smear triage' arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women with abnormal cytology
Comparison of the proportion of women with abnormal cytology in each study arm
Measured: 4 months after the inclusion
Secondary outcomes (3)
Proportion of women who completed cervical screening
Comparison of the proportion of women who completed cervical screening in each study arm
Measured: 4 months after the inclusion
Proportion of women who acquired a specific set of knowledge about cervical cancer before and after the preventive consultation
Comparison of the proportion of women who acquired a specific set of knowledge before and after the preventive consultation, using the same five-item questionnaire
Measured: At baseline (before and after the preventive consultation)
Social determinants of completing cervical screening
Comparisons of medical, socio-demographical and educational characteristics of women who completed screening with that of women who did not.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2018
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The two strategies consist of a preventive consultation followed by: 1. Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm) 2. An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive\* \* A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason. ('self-collected vaginal swab for HPV-HR testing + Pap smear' triage study arm)
- Masking
- None (open label)
- Enrolment
- 1,258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Médecins du Monde
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Philippe de Botton, Principal investigator, Médecins du Monde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118258
- Sponsor's protocol ID
- 2016-A01597-44
- Status last verified
- Jan 2019
- First submitted
- 30 Mar 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reques L, Rolland C, Lallemand A, Lahmidi N, Aranda-Fernandez E, Lazzarino A, Bottero J, Hamers F, Bergeron C, Haguenoer K, Launoy G, Luhmann N. Comparison of cervical cancer screening by self-sampling papillomavirus test versus pap-smear in underprivileged women in France. BMC Womens Health. 2021 May 26;21(1):221. doi: 10.1186/s12905-021-01356-8.
PubMed 34039341
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Cervical Cancer Screening for Women Living in Precarious Conditions Met Within Doctors of the World Programs
- ClinicalTrials.gov ID
- NCT03118258
- Acronym / sponsor ID
- 2016-A01597-44
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Vaginal HPV self-sampling, Pap test smear, cervical cancer screening, deprivation, sexual and reproductive health, Precariousness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,258 participants (estimated)
- Lead sponsor
- Médecins du MondeUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- Aug 2019 (estimated)
- First posted
- 18 Apr 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.
Every year, in France, 3 000 women are diagnosed with cervical cancer, and 1 000 die each year. Recent studies highlighted regional, social and economical inequalities with respect to cervical cancer incidence.
In France, the pap-smear test is currently the reference test in order to screen for cervical cancer and neoplasia (CIN). Screening and treatment reduced the incidence and the mortality due to cervical cancer by half in the two last decades. That said, many women are still not reached by prevention programs, especially women living in precarious conditions. In 2013, Doctors of the World France estimated that almost 70% of women aged 25 to 65 years old visiting its medical facilities had never had of a pap-smear test.
The main study objectives are :
Primary objective
To compare the proportion of individuals with abnormal cytology across two screening strategies in order to determine which strategy detects a greater proportion of individuals with abnormal cytology.
These two strategies consist of a preventive consultation followed by:
- Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm)
- An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive* ('self-collected vaginal swab for HPV-HR testing + Pap smear triage' study arm) *A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.
First of secondary objectives:
To evaluate the proportion of individuals who completed cervical cancer screening in each study arm in order to determine which strategy resulted in greater screening participation.
The above clarification of the study objectives and the related changes in the study protocole have been approved by the Comité de Protection des Personnes Ile de France IV.
Detailed description
Woman aged 25 to 65 years old met within one of Doctors of the World participating programs will be offered to attend a preventive consultation adressing sexual and reproductive health, and cervical cancer screening. Seven programs are taking part in this study (medical facilities and mobile health programs) in four french cities. Those programs aim to facilitate access to care for people who do not seek or have little access to health services and preventive health measures (lack of health insurance, living far from health services, knowing little about preventive health and how the health system works in France).
These two cervical screening strategies consist of a preventive consultation followed by:
- Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm)
- An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive* ('self-collected vaginal swab for HPV-HR testing + Pap smear triage' study arm) * A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.
The inclusion of participants in one or the other study arm will be done through randomization. There will be 11 one-month periods during wich women are invited to perform a self-collected vaginal swab and 11 one-month periods during which women are directly referred to a partner health facility for Pap smear testing. Each one-month period with an invitation to perform a self-collected vaginal swab is followed by a one-month period with direct patient referral for Pap smear testing. The allocation of the starting period has been randomized for each participating program.
Doctors of the World staff who will be offering this preventive health consultation received a specific training adressing sexual and reproductive health topics, cervical screening and counseling approaches. Illustrated tools have been specially developed for this purpose. Professional translators will be sought when needed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The two strategies consist of a preventive consultation followed by: 1. Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm) 2. An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive* * A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason. ('self-collected vaginal swab for HPV-HR testing + Pap smear' triage study arm)
| Arm | Type | Receives |
|---|---|---|
| Pap smear | Experimental | Behavioral: 'Pap smear' arm'Pap smear' arm: women are invited to participate in a preventive consultation. This consultation is followed by direct patient referral for Pap smear testing in a partner health facility. |
| Self-collected vaginal swab for HPV testing + pap smear triage | Experimental | Behavioral: 'Self-collected vaginal swab for HPV testing + pap smear triage' arm'Self-collected vaginal swab for HPV testing + pap smear triage' arm : women are invited to participate in a preventive consultation. This consultation is followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive. A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women between 25 and 65 years old
- Met within Doctors of the World programs
Key exclusion criteria (3 listed)
- History of total hysterectomy (= ablation of uterus and cervix)
- Never had sexual intercourse
- Last pap smear test made during the three last years (ou first pap smear test during the last year)
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 |
|---|---|---|
| 'Pap smear' armWomen are invited to participate in a preventive consultation. Doctor of the World staff provides women with information in their mother tongue and uses visuals adressing cervical cancer, its causes and consequences and ways to prevent it. This consultation is followed by direct patient referral for Pap smear testing in a partner health facility. | Behavioural | Pap smear |
| 'Self-collected vaginal swab for HPV testing + pap smear triage' armWomen are invited to participate in a preventive consultation. Doctor of the World staff provides women with information in their mother tongue and uses visuals adressing cervical cancer, its causes and consequences and ways to prevent it. This consultation is followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive. A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason. | Behavioural | Self-collected vaginal swab for HPV testing + pap smear triage |
Primary outcome
Proportion of women with abnormal cytology
Time frame: 4 months after the inclusion
Comparison of the proportion of women with abnormal cytology in each study arm
3 secondary outcomes
Proportion of women who completed cervical screening
Time frame: 4 months after the inclusion
Proportion of women who acquired a specific set of knowledge about cervical cancer before and after the preventive consultation
Time frame: At baseline (before and after the preventive consultation)
Social determinants of completing cervical screening
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Derived from this study: PubMed 34039341Reques L, Rolland C, Lallemand A, Lahmidi N, Aranda-Fernandez E, Lazzarino A, Bottero J, Hamers F, Bergeron C, Haguenoer K, Launoy G, Luhmann N. Comparison of cervical cancer screening by self-sampling papillomavirus test versus pap-smear in underprivileged women in France. BMC Womens Health. 2021 May 26;21(1):221. doi: 10.1186/s12905-021-01356-8.
- 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.
Philippe de Botton principal investigator
Médecins du Monde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Pap smear' arm and 'Self-collected vaginal swab for HPV testing + pap smear triage' arm in people with Uterine Cervical Neoplasms, run by Médecins du Monde at 1 site in France.
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 3 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: status not confirmed, as of the sponsor's last update on 31 Jan 2019. 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 France. 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?
Results are not available in the source record.
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 women with abnormal cytology (time frame: 4 months after the inclusion). 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 NCT03118258, which also lists 1 linked publication.
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 31 Jan 2019.