Cervical Cancer ScreeningNCT05256862
Improving Cervical Cancer Screening in Women Living With HIV Attending Chronic Disease Clinics in Semi-rural Tanzania
An observational study of Cervical Cancer Screening, run by University Hospital, Basel, Switzerland at 1 site in Tanzania.
Trial summary
This study is to analyse the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO), comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Data collection
- How many people
- 2,974 participants
- Where
- 1 siteTanzania
- Study dates
- 27 Jul 2021to 18 Oct 2024
- Phase
- Observational
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women will be informed during their routine control within HIV care about the study on improved CC screening procedures and referred to the study team if consenting. All interventions will be offered routinely to patients, but are not mandatory if they refuse them. Patients not consenting will be advised to seek regular services for CC screening according to the national guidelines. Apart from routine clinical visits, no additional visits are scheduled for this study unless medically indicated.
Who may be able to join
- WLWH enrolled in KIULARCO, who are at least 3 months on Anti-Retroviral Treatment (ART)
- 18-65 years of age
- Non-pregnant (reported)
- Signed informed consent
Who cannot join
- Pregnancy
- Known invasive cervical cancer
- Any condition interfering with visualization of the cervix
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Saint Francis Referral Hospital, Ifakara Health Institute (IHI, United Republic of Tanzania)
Ifakara
About this study
This study is to analyse the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO), comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022). It is to assess the performance of two novel diagnostic tests (QuantiGene-molecular profiling histology (QG-MPH) and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening.
Read the detailed description
Cervical cancer (CC) is the most common cancer among women living with HIV (WLWH) and the leading cause of cancer-related death in women in East Africa. Currently there are around 2800 WLWH in care at the Chronic Disease Clinic of Ifakara (CDCI), of whom only 8% attended CC screening services in the last three years.
This research project is to assess (with a mixed-method, before-/after-study) the impact of a bundle of procedures, which consists of: portable colposcopy, Human Papilloma Virus (HPV) testing and treatment of precancerous cervical lesions by Loop electrosurgical excision procedure (LEEP).
This study is also to analyze the prevalence of cervical disease in the cohort, stratified by stage and co-infections, as well as the acceptability, feasibility and costs.
Additionally, it will assess the performance of two novel diagnostic tests (QG-MPH and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening. This is an implementational study nested within the KIULARCO study consisting of two interacting parts: a pre/post assessment of the impact of the bundle of interventions with mixed-methods study design and the diagnostic tests accuracy (evaluated with a cross-sectional study). The treatment investigated is regarded as standard treatment.
- Conditions
- Cervical Cancer Screening
- Being tested
- Data collection
- Keywords
- women living with HIV (WLWH), cervical cancer, cervical cancer prevention clinic, cervical intraepithelial neoplasia, Human Papilloma Virus, Human Immunodeficiency Virus, Squamous Intraepithelial Lesion, Kilombero and Ulanga Anti-retroviral Cohort, QuantiGene-molecular profiling histology
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Acquired Immunodeficiency Syndrome, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
- on the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO) comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022)
- on the performance of three novel tests as triage tool in the screening algorithm, QG-MPH, Prevo-check® and PT Monitor®
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of WLWH attending CC screening
Number of WLWH attending CC screening in the period 08/2021 - 06/2022; Attendance of screening: for the pre-phase women undergoing Visual inspection with acetic acid (VIA), for the post- phase women performing cervical self-sampling.
Measured: one time assessment at Screening
Secondary outcomes (2)
Number of detected High Grade Squamous Intraepithelial Lesion /Cervical Cancer (HSIL/CC) in cervical self-samples by QuantiGene-molecular profiling histology (QG-MPH)
Diagnostic test accuracy in detecting High Grade Squamous Intraepithelial Lesion /Cervical Cancer (HSIL/CC) in cervical self-samples by QuantiGene-molecular profiling histology (QG-MPH)
Measured: one time assessment at Screening
Number of detected patients with Human Papilloma Virus (HPV) 16 and 18 induced Cervical Intraepithelial Neoplasia grade 3 or above (CIN3+) by Serum PT Monitor®.
Diagnostic test accuracy in detecting patients with Human Papilloma Virus (HPV) 16 and 18 induced Cervical Intraepithelial Neoplasia grade 3 or above (CIN3+) by Serum PT Monitor®.
Measured: one time assessment at Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start27 Jul 2021
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
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 Cervical Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,974 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland, Abviris Deutschland GmbH, Charité-University Medicine (Berlin, Germany), Swiss Tropical and Public Health Institute (Switzerland)
- Responsible party
- Sponsor
- Investigators
- Ivana Di Salvo, MD, Principal investigator, University Women's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256862
- Sponsor's protocol ID
- AO_2021-00006; bb22Kind
- Status last verified
- Mar 2025
- First submitted
- 10 Feb 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Di Salvo I, Mnzava D, Nicoletti GJ, Senkoro E, Ndege RC, Huang DJ, Makunja NT, Kassiga GI, Kaufmann AM, Weisser M, Kind AB. Upscaling cervical cancer screening and treatment for women living with HIV at a rural referral hospital in Tanzania: protocol of a before-and-after study exploring HPV testing and novel diagnostics. BMC Health Serv Res. 2023 Mar 10;23(1):234. doi: 10.1186/s12913-023-09113-3.
PubMed 36894985
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cervical Cancer Screening in Women Living With HIV Attending Chronic Disease Clinics in Semi-rural Tanzania
- ClinicalTrials.gov ID
- NCT05256862
- Acronym / sponsor ID
- AO_2021-00006; bb22Kind
- Conditions
- Cervical Cancer Screening
- Keywords
- women living with HIV (WLWH), cervical cancer, cervical cancer prevention clinic, cervical intraepithelial neoplasia, Human Papilloma Virus, Human Immunodeficiency Virus, Squamous Intraepithelial Lesion, Kilombero and Ulanga Anti-retroviral Cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,974 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland, Abviris Deutschland GmbH, Charité-University Medicine (Berlin, Germany), Swiss Tropical and Public Health Institute (Switzerland)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 25 Feb 2022 (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.
This study is to analyse the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO), comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022). It is to assess the performance of two novel diagnostic tests (QuantiGene-molecular profiling histology (QG-MPH) and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening.
Detailed description
Cervical cancer (CC) is the most common cancer among women living with HIV (WLWH) and the leading cause of cancer-related death in women in East Africa. Currently there are around 2800 WLWH in care at the Chronic Disease Clinic of Ifakara (CDCI), of whom only 8% attended CC screening services in the last three years.
This research project is to assess (with a mixed-method, before-/after-study) the impact of a bundle of procedures, which consists of: portable colposcopy, Human Papilloma Virus (HPV) testing and treatment of precancerous cervical lesions by Loop electrosurgical excision procedure (LEEP).
This study is also to analyze the prevalence of cervical disease in the cohort, stratified by stage and co-infections, as well as the acceptability, feasibility and costs.
Additionally, it will assess the performance of two novel diagnostic tests (QG-MPH and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening. This is an implementational study nested within the KIULARCO study consisting of two interacting parts: a pre/post assessment of the impact of the bundle of interventions with mixed-methods study design and the diagnostic tests accuracy (evaluated with a cross-sectional study). The treatment investigated is regarded as standard treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women will be informed during their routine control within HIV care about the study on improved CC screening procedures and referred to the study team if consenting. All interventions will be offered routinely to patients, but are not mandatory if they refuse them. Patients not consenting will be advised to seek regular services for CC screening according to the national guidelines. Apart from routine clinical visits, no additional visits are scheduled for this study unless medically indicated.
Key inclusion criteria (4 listed)
- WLWH enrolled in KIULARCO, who are at least 3 months on Anti-Retroviral Treatment (ART)
- 18-65 years of age
- Non-pregnant (reported)
- Signed informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Known invasive cervical cancer
- Any condition interfering with visualization of the cervix
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 |
|---|---|---|
| Data collectionData collection * on the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO) comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022) * on the performance of three novel tests as triage tool in the screening algorithm, QG-MPH, Prevo-check® and PT Monitor® | Other | – |
Primary outcome
Number of WLWH attending CC screening
Time frame: one time assessment at Screening
Number of WLWH attending CC screening in the period 08/2021 - 06/2022; Attendance of screening: for the pre-phase women undergoing Visual inspection with acetic acid (VIA), for the post- phase women performing cervical self-sampling.
2 secondary outcomes
Number of detected High Grade Squamous Intraepithelial Lesion /Cervical Cancer (HSIL/CC) in cervical self-samples by QuantiGene-molecular profiling histology (QG-MPH)
Time frame: one time assessment at Screening
Number of detected patients with Human Papilloma Virus (HPV) 16 and 18 induced Cervical Intraepithelial Neoplasia grade 3 or above (CIN3+) by Serum PT Monitor®.
Time frame: one time assessment at Screening
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 20 Mar 2025.
- Derived from this study: PubMed 36894985Di Salvo I, Mnzava D, Nicoletti GJ, Senkoro E, Ndege RC, Huang DJ, Makunja NT, Kassiga GI, Kaufmann AM, Weisser M, Kind AB. Upscaling cervical cancer screening and treatment for women living with HIV at a rural referral hospital in Tanzania: protocol of a before-and-after study exploring HPV testing and novel diagnostics. BMC Health Serv Res. 2023 Mar 10;23(1):234. doi: 10.1186/s12913-023-09113-3.
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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.
Ivana Di Salvo, MD principal investigator
University Women's Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer Screening, run by University Hospital, Basel, Switzerland at 1 site in Tanzania.
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 4 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: finished, as of the sponsor's last update on 20 Mar 2025. 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 Tanzania. 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?
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?
Number of WLWH attending CC screening (time frame: one time assessment at Screening). 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 NCT05256862, 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 20 Mar 2025.