Cervical CancersNCT06942286
Primary HPV Self-Collection in Indonesia
A study testing HPV Self-Collection in people with Cervical Cancers and CIN - Cervical Intraepithelial Neoplasia, run by Dharmais National Cancer Center Hospital at 3 sites in Indonesia.
Trial summary
The purpose of this study is to implement human papillomavirus (HPV) self-collection in Indonesia. Read more about this study
- Who is it for?
- Ages 30 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancers, CIN - Cervical Intraepithelial Neoplasia, Human Papillomavirus (HPV)
- What is being tested?
- HPV Self-Collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 3 sitesIndonesia
- Study dates
- 13 Aug 2025to Apr 2027
- 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 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30-69 years old
- Have not had a Pap test within the last 3 years or an HPV test within the last 5 years
- Have never been diagnosed with cervical cancer or high-grade dysplasia
- Have no history of hysterectomy with cervical removal
- Expressed willingness to participate in the study, including conducting HPV self-collection, follow-up treatment, and related surveys
Who cannot join
- Being pregnant or within 6 weeks postpartum
- Women who have never engaged in sexual activity
- Medical, psychiatric, or other conditions that may interfere with compliance with protocols, security assessments, and/or ability/competence to give informed consent
- Adults who do not have the capacity to give consent may be excluded, as participants must be able to perform activities required by the protocol
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia3 sites
Puskesmas Depok
Depok, West Java
Dharmais National Cancer Center Hospital
Jakarta, Jakarta Special Capital Region, 11420
Puskesmas Lebak
Lebak, Banten
About this study
Official title: HPV DNA Screening With Self-Collection Method and Its Management in the Context of Population-Based Cervical Cancer Screening Pilot Project in Indonesia
The purpose of this study is to implement human papillomavirus (HPV) self-collection in Indonesia.
Read the detailed description
After participants give informed consent, they will receive a short educational session about cervical cancer and HPV, after which they will be offered the opportunity to undergo primary HR-HPV testing via self-collection. Participants will be contacted within 4 weeks with their results. Those who test positive for high-risk HPV will receive a follow-up appointment, at which time visual assessment with acetic acid and/or colposcopy will be performed. Those with detectable lesions and/or HPV 16/18+ will undergo treatment with thermal ablation. If they are ineligible for thermal ablation, they will undergo cervical biopsy, endocervical curettage, and/or loop electrosurgical excision procedure (LEEP) as indicated. Anyone with suspicion for cancer will undergo biopsies and referral to a gynecologic oncologist.
- Being tested
- HPV Self-Collection
- Keywords
- Human Papilomavirus (HPV), Cervical Cancer, Cervical Dysplasia, HPV Self-Collection, HPV Self-Sampling, Primary HPV Test
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Self-CollectionDiagnostic test
Participants will perform HPV self-collection.
| Study group | Role | What they receive |
|---|---|---|
| HPV Self-Collection | Experimental | Participants will perform HPV self-collection. Receives: Diagnostic Test: HPV Self-Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of HPV Self-Collection
number of subjects with valid HPV test results from self-collection / number of eligible subjects
Measured: from enrollment to receipt of results, up to 8 weeks
Secondary outcomes (6)
HPV Self-Collection Invitation Coverage
number of subjects with valid HPV test results from self-collection / total eligible population in the catchment area
Measured: from enrollment to receipt of results, up to 8 weeks
HPV Self-Collection Participation Rate
number of subjects with samples received at the laboratory / number of invited subjects
Measured: from enrollment to receipt of results, up to 8 weeks
Examination Coverage of HPV Self-Collection
number of subjects with samples received at the laboratory / total eligible population in the catchment area
Measured: from enrollment to receipt of results, up to 8 weeks
HPV Self-Collection Acceptance Rate
number of subjects who perform self-collection / number of subjects given HPV self-collection kits and instructions
Measured: from enrollment to specimen collection, up to 2 weeks
Preference for HPV Self-Collection
number of subjects who choose self-collection / number of subjects who answered survey questions
Measured: from enrollment to specimen collection, up to 2 weeks
Patient Follow-up Rate
number of subjects who receive VIA follow-up within 60 days / number of subjects with positive HPV tests
Measured: from receipt of results to follow-up exam, up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start13 Aug 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dharmais National Cancer Center Hospital
- Sponsor type
- Other government
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Widyorini L Hanafi, MD, Principal investigator, Dharmais National Cancer Center HospitalDian T Sinulingga, MD, M.Epid, Principal investigator, Dharmais National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942286
- Sponsor's protocol ID
- DP.04.03/11.10/041/2025
- Status last verified
- Sep 2025
- First submitted
- 9 Apr 2025
- Last updated
- 17 Sep 2025
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV DNA Screening With Self-Collection Method and Its Management in the Context of Population-Based Cervical Cancer Screening Pilot Project in Indonesia
- ClinicalTrials.gov ID
- NCT06942286
- Acronym / sponsor ID
- DP.04.03/11.10/041/2025
- Keywords
- Human Papilomavirus (HPV), Cervical Cancer, Cervical Dysplasia, HPV Self-Collection, HPV Self-Sampling, Primary HPV Test
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Dharmais National Cancer Center HospitalOther government
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 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 purpose of this study is to implement human papillomavirus (HPV) self-collection in Indonesia.
Detailed description
After participants give informed consent, they will receive a short educational session about cervical cancer and HPV, after which they will be offered the opportunity to undergo primary HR-HPV testing via self-collection. Participants will be contacted within 4 weeks with their results. Those who test positive for high-risk HPV will receive a follow-up appointment, at which time visual assessment with acetic acid and/or colposcopy will be performed. Those with detectable lesions and/or HPV 16/18+ will undergo treatment with thermal ablation. If they are ineligible for thermal ablation, they will undergo cervical biopsy, endocervical curettage, and/or loop electrosurgical excision procedure (LEEP) as indicated. Anyone with suspicion for cancer will undergo biopsies and referral to a gynecologic oncologist.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV Self-Collection | Experimental | Diagnostic Test: HPV Self-CollectionParticipants will perform HPV self-collection. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30-69 years old
- Have not had a Pap test within the last 3 years or an HPV test within the last 5 years
- Have never been diagnosed with cervical cancer or high-grade dysplasia
- Have no history of hysterectomy with cervical removal
- Expressed willingness to participate in the study, including conducting HPV self-collection, follow-up treatment, and related surveys
Key exclusion criteria (4 listed)
- Being pregnant or within 6 weeks postpartum
- Women who have never engaged in sexual activity
- Medical, psychiatric, or other conditions that may interfere with compliance with protocols, security assessments, and/or ability/competence to give informed consent
- Adults who do not have the capacity to give consent may be excluded, as participants must be able to perform activities required by the protocol
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 |
|---|---|---|
| HPV Self-CollectionParticipants will perform HPV self-collection. | Diagnostic test | HPV Self-Collection |
Primary outcome
Success Rate of HPV Self-Collection
Time frame: from enrollment to receipt of results, up to 8 weeks
number of subjects with valid HPV test results from self-collection / number of eligible subjects
6 secondary outcomes
HPV Self-Collection Invitation Coverage
Time frame: from enrollment to receipt of results, up to 8 weeks
HPV Self-Collection Participation Rate
Time frame: from enrollment to receipt of results, up to 8 weeks
Examination Coverage of HPV Self-Collection
Time frame: from enrollment to receipt of results, up to 8 weeks
HPV Self-Collection Acceptance Rate
Time frame: from enrollment to specimen collection, up to 2 weeks
Preference for HPV Self-Collection
Time frame: from enrollment to specimen collection, up to 2 weeks
Patient Follow-up Rate
Time frame: from receipt of results to follow-up exam, up to 60 days
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 17 Sep 2025.
- 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.
Widyorini L Hanafi, MD principal investigator
Dharmais National Cancer Center Hospital
Dian T Sinulingga, MD, M.Epid principal investigator
Dharmais National Cancer Center Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Self-Collection in people with Cervical Cancers and CIN - Cervical Intraepithelial Neoplasia, run by Dharmais National Cancer Center Hospital at 3 sites in Indonesia.
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 4 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. 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?
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?
Success Rate of HPV Self-Collection (time frame: from enrollment to receipt of results, up to 8 weeks). 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 17 Sep 2025.