Cervical CancerNCT05125380
Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia
A study testing VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine) and VIA (Visual Inspection with Acetic acid) in people with Cervical Cancer and STI, run by Lund University at 1 site in Ethiopia.
Trial summary
The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, STI, Human Papilloma Virus
- What is being tested?
- VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine) and VIA (Visual Inspection with Acetic acid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Dec 2021to Sep 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Can give consent, Age above 18
Who cannot join
- Women who have undergone hysterectomy
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
Adama and Geda Health Center
Ādama
Adamu Meghersa, adamumeghersa@yahoo.com
About this study
Official title: Evaluation of an Human Papillomavirus (HPV) Based Screening Algorithm for Low and Middle Income Countries, by Self-sampling in Ethiopia
The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC).
Specific aims are the following:
- To evaluate the algorithm using Visual Inspection with Acetic acid (VIA) and VIA together with Lugol's Iodine (VILI) as triage and to use HPV self-sample to follow up those treated and those with persisting HPV.
- To evaluate the prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae and other STIs in the cohort.
- To determine immune response profiles in high-risk HPV-positive women who cleared, persisted, or developed Cervical Intraepithelial Neoplasia 2/3 (CIN).
- To assess how specific cervicovaginal microbiota compositions are associated with HPV infection, cervical dysplasia, and cancer
- Conditions
- Cervical Cancer, STI, Human Papilloma Virus, Microbiota
- Being tested
- VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine), VIA (Visual Inspection with Acetic acid)
- Keywords
- LMIC Lowe Middle income country, Screening, Vaginal microbiota
- Medical subject headings
- Uterine Cervical Neoplasms, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)Diagnostic test
A triage test that involved a gynaecological exam that applies acetic acid and then Lugol's iodine on the surface of the external os of the cervix.
VIA (Visual Inspection with Acetic acid)Diagnostic test
A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix.
| Study group | Role | What they receive |
|---|---|---|
| 1- Triage arm for HPV pos women | Active comparator | HPV positive women Receives: Diagnostic Test: VIA (Visual Inspection with Acetic acid) |
| 2- Triage arm for HPV pos women | Experimental | HPV positive women Receives: Diagnostic Test: VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of VIA and VIA/VILI as triage test
All HPV pos women will have a cervical biopsy taken
Measured: 12 weeks
Secondary outcomes (2)
Prevalence of STI other than HPV
Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis
Measured: 8 weeks
Vaginal Microbiota composition
Assessed in HPV high risk pos women at initiation, who persist and who clear their infection
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Dec 2021
- Primary completion28 Oct 2023
- Study completionSep 2024 (estimated)
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.
- More trials run by Lund UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The whole cohort is offered an HPV self-sample. The HPV high risk positive women gets randomised into two arms VIA or VIA/VILI at the triage step.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Ababa University, Armauer Hansen Research Institute, Ethiopia, Adama Hospital Medical College, Ethiopia
- Responsible party
- Sponsor
- Investigators
- Adane Mihret, PhD, Principal investigator, Armauer Hansen Research Institute, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125380
- Sponsor's protocol ID
- FBKS 2019-6
- Status last verified
- Nov 2023
- First submitted
- 7 Oct 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mekuria S, Assiged N, Biazin H, Borgfeldt C, Abebe T, Mihret A, Forslund O, Jerkeman M. Assessing the feasibility of HPV screening for cervical cancer in pregnant women in Ethiopia. Sci Rep. 2025 Aug 28;15(1):31771. doi: 10.1038/s41598-025-15957-y.
PubMed 40877387Kebede HB, Mekuria S, Asegid N, Forslund O, Borgfeldt C, Jerkeman M, Mihret A, Abebe T. High-risk human papillomavirus genotypes in previously unscreened reproductive-age women in Ethiopia: A community-based cohort study. Int J Cancer. 2025 May 15;156(10):1995-2009. doi: 10.1002/ijc.35335. Epub 2025 Feb 14.
PubMed 39950735Mekuria SF, Biazin H, Abebe T, Borgfeldt C, Assegid N, Mihret A, Obsi Nemomsa R, Forslund O, Jerkeman M. Comparing visual inspection with acetic acid, with and without Lugol's Iodine for triage of HPV self-sample positive women in Ethiopia: a randomized controlled trial. Int J Gynecol Cancer. 2024 Nov 4;34(11):1691-1697. doi: 10.1136/ijgc-2024-005694.
PubMed 39362749
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Human Papillomavirus (HPV) Based Screening Algorithm for Low and Middle Income Countries, by Self-sampling in Ethiopia
- ClinicalTrials.gov ID
- NCT05125380
- Acronym / sponsor ID
- FBKS 2019-6
- Conditions
- Cervical Cancer, STI, Human Papilloma Virus, Microbiota
- Keywords
- LMIC Lowe Middle income country, Screening, Vaginal microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Addis Ababa University, Armauer Hansen Research Institute, Ethiopia, Adama Hospital Medical College, Ethiopia
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 18 Nov 2021 (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 overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC).
Specific aims are the following:
- To evaluate the algorithm using Visual Inspection with Acetic acid (VIA) and VIA together with Lugol's Iodine (VILI) as triage and to use HPV self-sample to follow up those treated and those with persisting HPV.
- To evaluate the prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae and other STIs in the cohort.
- To determine immune response profiles in high-risk HPV-positive women who cleared, persisted, or developed Cervical Intraepithelial Neoplasia 2/3 (CIN).
- To assess how specific cervicovaginal microbiota compositions are associated with HPV infection, cervical dysplasia, and cancer
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The whole cohort is offered an HPV self-sample. The HPV high risk positive women gets randomised into two arms VIA or VIA/VILI at the triage step.
| Arm | Type | Receives |
|---|---|---|
| 1- Triage arm for HPV pos women | Active comparator | Diagnostic Test: VIA (Visual Inspection with Acetic acid)HPV positive women |
| 2- Triage arm for HPV pos women | Experimental | Diagnostic Test: VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)HPV positive women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Can give consent, Age above 18
Key exclusion criteria (1 listed)
- Women who have undergone 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 |
|---|---|---|
| VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)A triage test that involved a gynaecological exam that applies acetic acid and then Lugol's iodine on the surface of the external os of the cervix. | Diagnostic test | 2- Triage arm for HPV pos women |
| VIA (Visual Inspection with Acetic acid)A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix. | Diagnostic test | 1- Triage arm for HPV pos women |
Primary outcome
Sensitivity and specificity of VIA and VIA/VILI as triage test
Time frame: 12 weeks
All HPV pos women will have a cervical biopsy taken
2 secondary outcomes
Prevalence of STI other than HPV
Time frame: 8 weeks
Vaginal Microbiota composition
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Derived from this study: PubMed 40877387Mekuria S, Assiged N, Biazin H, Borgfeldt C, Abebe T, Mihret A, Forslund O, Jerkeman M. Assessing the feasibility of HPV screening for cervical cancer in pregnant women in Ethiopia. Sci Rep. 2025 Aug 28;15(1):31771. doi: 10.1038/s41598-025-15957-y.
- Derived from this study: PubMed 39950735Kebede HB, Mekuria S, Asegid N, Forslund O, Borgfeldt C, Jerkeman M, Mihret A, Abebe T. High-risk human papillomavirus genotypes in previously unscreened reproductive-age women in Ethiopia: A community-based cohort study. Int J Cancer. 2025 May 15;156(10):1995-2009. doi: 10.1002/ijc.35335. Epub 2025 Feb 14.
- Derived from this study: PubMed 39362749Mekuria SF, Biazin H, Abebe T, Borgfeldt C, Assegid N, Mihret A, Obsi Nemomsa R, Forslund O, Jerkeman M. Comparing visual inspection with acetic acid, with and without Lugol's Iodine for triage of HPV self-sample positive women in Ethiopia: a randomized controlled trial. Int J Gynecol Cancer. 2024 Nov 4;34(11):1691-1697. doi: 10.1136/ijgc-2024-005694.
- 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.
Adane Mihret, PhD principal investigator
Armauer Hansen Research Institute, Ethiopia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine) and VIA (Visual Inspection with Acetic acid) in people with Cervical Cancer and STI, run by Lund University at 1 site in Ethiopia.
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 1 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 3 Nov 2023. 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 Ethiopia. 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?
Contact Selamawit Mekuria, MD (+46720123974, selamawit.mekuria@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of VIA and VIA/VILI as triage test (time frame: 12 weeks). 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 NCT05125380, 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 3 Nov 2023.