HPVALONDEPISTHPVNCT07438080
Concordance and Acceptability of Self-screening Compared to Screening Carried Out by a Health Professional for HPV, a Risk Factor for Anal Cancer, by Swab in People Living With HIV. A Randomized Controlled Crossover Study
A study testing Public health workshop in community in people with HPV, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in France.
Trial summary
Comunity health actions are set up in populations of women aged 30 to 65 in vulnerable situations living in the outlying areas of Reunion Island. The idea is to evaluate those action on health Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- HPV
- What is being tested?
- Public health workshop in community
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Apr 2025to 1 Mar 2028
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 30 to 65,
- In a vulnerable situation (beneficiary of a state or departmental social service, or referred by a charity),
- Resident in one of the two municipalities targeted by the study,
- Supported by the social services of one of the two municipalities targeted by the study,
- Having agreed to participate in sexual health awareness meetings organized on site
Who cannot join
- Refusing to participate in the study
- Having had a hysterectomy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Cegidd Saint Paul
Saint-Paul
Emmanuelle THORE, Dr, 0262 45 30 30, direction@chor.re
Dr Emmanuelle THORE
- Recruiting
CegiDD Saint Pierre
Saint-Pierre
Dr Phuong TRAN, 0262 35 96 10 ext. +262, promotion.drci@chu-reunion.fr
About this study
Comunity health actions are set up in populations of women aged 30 to 65 in vulnerable situations living in the outlying areas of Reunion Island.
The idea is to evaluate those action on health
- Conditions
- HPV
- Being tested
- Public health workshop in community
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Public health workshop in communityOther
- Cervical cancer screening awareness workshops, conducted in small groups through focus groups.
-2) Proposal for an HPV self-test (vaginal self-swab to detect high-risk HPV) as part of an individual consultation for participants who are not up-to-date with their cervical cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| participant | Experimental | 1. Awareness workshops on uterine cancer screening - small group workshops conducted in the form of discussion groups
2. Proposal for an HPV self-test (vaginal self-swab to detect high-risk HPV) as part of an individual consultation for participants whose CC screening is not up to date Receives: Other: Public health workshop in community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of women who complete cervical cancer screening after the community health intervention,
Rate of women aged 30 to 65 years living in vulnerable areas of Reunion Island who complete cervical cancer screening (HPV test or Pap smear) within 3months after the community health intervention, as documented in medical records or screening databases.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start9 Apr 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438080
- Sponsor's protocol ID
- 2023/CHU/37
- Other IDs
- 2023-A02588-37
- Acronym
- ALONDEPISTHPV
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance and Acceptability of Self-screening Compared to Screening Carried Out by a Health Professional for HPV, a Risk Factor for Anal Cancer, by Swab in People Living With HIV. A Randomized Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT07438080
- Acronym / sponsor ID
- ALONDEPISTHPV / 2023/CHU/37
- Conditions
- HPV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 27 Feb 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.
Comunity health actions are set up in populations of women aged 30 to 65 in vulnerable situations living in the outlying areas of Reunion Island.
The idea is to evaluate those action on health
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participant | Experimental | Other: Public health workshop in community1. Awareness workshops on uterine cancer screening - small group workshops conducted in the form of discussion groups 2. Proposal for an HPV self-test (vaginal self-swab to detect high-risk HPV) as part of an individual consultation for participants whose CC screening is not up to date |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 30 to 65,
- In a vulnerable situation (beneficiary of a state or departmental social service, or referred by a charity),
- Resident in one of the two municipalities targeted by the study,
- Supported by the social services of one of the two municipalities targeted by the study,
- Having agreed to participate in sexual health awareness meetings organized on site
Key exclusion criteria (2 listed)
- Refusing to participate in the study
- Having had a hysterectomy
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 |
|---|---|---|
| Public health workshop in community1) Cervical cancer screening awareness workshops, conducted in small groups through focus groups. -2) Proposal for an HPV self-test (vaginal self-swab to detect high-risk HPV) as part of an individual consultation for participants who are not up-to-date with their cervical cancer screening. | Other | participant |
Primary outcome
Rate of women who complete cervical cancer screening after the community health intervention,
Time frame: 3 months
Rate of women aged 30 to 65 years living in vulnerable areas of Reunion Island who complete cervical cancer screening (HPV test or Pap smear) within 3months after the community health intervention, as documented in medical records or screening databases.
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 27 Feb 2026.
Related trials for HPV
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Public health workshop in community in people with HPV, run by Centre Hospitalier Universitaire de la Réunion at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Emmanuelle THORE, dr (+262 262 74 23 80, direction@chor.re), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of women who complete cervical cancer screening after the community health intervention, (time frame: 3 months). 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 27 Feb 2026.