Cervical CancerNCT04242823
Primary HPV-based Cervical Cancer Screening Algorithms in Botswana
A study testing 8-type HPV genotype restriction in people with Cervical Cancer and Prevention, run by Beth Israel Deaconess Medical Center at 1 site in Botswana.
Trial summary
Primary high-risk human papillomavirus (HPV) testing has become first line screening for cervical cancer in high-income countries. The feasibility of this approach in low- and middle-income countries (LMICs) is less clear, as is the role of HPV testing among women living with human immunodeficiency virus (HIV). Read more about this study
- Who is it for?
- Ages 25 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Prevention
- What is being tested?
- 8-type HPV genotype restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteBotswana
- Study dates
- 22 Feb 2021to 1 Feb 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 25 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cis-gender female or transgender male (must have a cervix)
- ≥25 years of age
- Competent to understand study procedures and give informed consent.
Who cannot join
- Currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy)
- Previous hysterectomy
- Previous diagnosis of cervical cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of Two-stage Cervical Cancer Screening Algorithms Using Primary High-risk Human Papillomavirus Testing in Botswana
Primary high-risk human papillomavirus (HPV) testing has become first line screening for cervical cancer in high-income countries. The feasibility of this approach in low- and middle-income countries (LMICs) is less clear, as is the role of HPV testing among women living with human immunodeficiency virus (HIV). The proposed study seeks to evaluate the accuracy of cervical cancer screening algorithms using primary HPV testing followed by various forms of visual evaluation, including visual inspection with acetic acid (VIA), colposcopy and HPV genotype restriction for the detection of high-grade cervical dysplasia, using histology as the gold standard. We will validate the AmpFire Assay for HPV self-sampling in our setting. We will evaluate optimal screening intervals in women living with HIV (WLHIV) in an HPV-based cervical cancer screening program and compare triage strategies for positive HPV results at WHO recommended screening intervals for WLHIV. We also seek to understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study. Finally, we will analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.
- Conditions
- Cervical Cancer, Prevention
- Being tested
- 8-type HPV genotype restriction
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-type HPV genotype restrictionDiagnostic test
Participants will undergo primary hrHPV testing and if positive will be referred for VIA per Botswana and WHO guidelines. Participants will also undergo colposcopy and biopsy at the time of VIA. The performance of triage with 8-type HPV genotype restriction will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Baseline screening cohort | Other | This group undergoes HPV testing using self-collected swabs. Triage evaluation occurs in all women who test HPV positive which includes visual inspection with acetic acid and colposcopy. The WLHIV in the cohort who test HPV positive at baseline but who have concurrent benign histopathology results will be invited back for re-screening at a 2-year interval, and undergo similar HPV testing and triage procedures. The WLHIV in the cohort who test HPV negative at baseline will be invited back for re-screening at a 3-year interval and undergo similar HPV testing and triage procedures. Receives: Diagnostic Test: 8-type HPV genotype restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the sensitivity, specificity, PPV and NPV of triage of primary human papillomavirus testing with 8-type HPV genotype restriction to visual inspection with acetic acid and colposcopy
Measured: 3 years
Determine the persistence of HPV infection in WLHIV at the pre-specified follow-up interval
Measured: 5 years
Determine the clearance of HPV infection in WLHIV at the pre-specified follow-up interval
Measured: 5 years
Determine the incidence of HPV infection in WLHIV at the pre-specified follow-up interval
Measured: 5 years
Quantify the incidence of cervical intraepithelial lesion grade 2 or worse in women living with HIV who were baseline HPV positive but with benign pathology at 2 year interval screening
Measured: 5 years
Quantify the incidence of cervical intraepithelial lesion grade 2 or worse in women living with HIV who were baseline HPV negative at 3 year interval screening
Measured: 5 years
Analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.
Measured: 5 years
Secondary outcomes (4)
Understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study.
Measured: 6 years
Evaluate the performance of a novel HPV assay as a stand-alone screening tool in our high-prevalence HIV population
Measured: 3 years
Evaluate the impact of patient demographic and clinical factors, such as number of sexual partners, smoking, HIV status and related HIV immune markers, on risk of cervical dysplasia
Measured: 5 years
Evaluate the impact of patient characteristics and and risk factors on the incidence of cervical dysplasia
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start22 Feb 2021
- Primary completion1 Feb 2026
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Botswana, Botswana Harvard AIDS Institute Partnership
- Responsible party
- Principal investigator, Rebecca Luckett, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242823
- Sponsor's protocol ID
- 2019P001130
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2020
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request with appropriate data transfer agreements in place.
Publications
Luckett R, Zhang BX, Gompers A, George J, Modest A, Bazzett-Matabele L, Vuylsteke P, Kula M, Monare B, Botha MH, Shapiro RL, Ramogola-Masire D, Grover S. High-grade cervical disease and cervical cancer in women aged 50 years and older compared with younger women: examining prevalence by HIV status in two large prospective cohorts in Botswana. BMJ Open. 2024 Oct 29;14(10):e089375. doi: 10.1136/bmjopen-2024-089375.
PubMed 39477271Luckett R, Ramogola-Masire D, Gompers A, Moraka N, Moyo S, Sedabadi L, Tawe L, Kashamba T, Gaborone K, Mathoma A, Noubary F, Kula M, Grover S, Dreyer G, Botha MH, Makhema J, Shapiro R, Hacker MR. Triage of HPV positivity in a high HIV prevalence setting: A prospective cohort study comparing visual triage methods and HPV genotype restriction in Botswana. Int J Gynaecol Obstet. 2024 May;165(2):507-518. doi: 10.1002/ijgo.15225. Epub 2023 Nov 10.
PubMed 37950533
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Two-stage Cervical Cancer Screening Algorithms Using Primary High-risk Human Papillomavirus Testing in Botswana
- ClinicalTrials.gov ID
- NCT04242823
- Acronym / sponsor ID
- 2019P001130
- Conditions
- Cervical Cancer, Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- University of Botswana, Botswana Harvard AIDS Institute Partnership
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 27 Jan 2020 (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.
Primary high-risk human papillomavirus (HPV) testing has become first line screening for cervical cancer in high-income countries. The feasibility of this approach in low- and middle-income countries (LMICs) is less clear, as is the role of HPV testing among women living with human immunodeficiency virus (HIV). The proposed study seeks to evaluate the accuracy of cervical cancer screening algorithms using primary HPV testing followed by various forms of visual evaluation, including visual inspection with acetic acid (VIA), colposcopy and HPV genotype restriction for the detection of high-grade cervical dysplasia, using histology as the gold standard. We will validate the AmpFire Assay for HPV self-sampling in our setting. We will evaluate optimal screening intervals in women living with HIV (WLHIV) in an HPV-based cervical cancer screening program and compare triage strategies for positive HPV results at WHO recommended screening intervals for WLHIV. We also seek to understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study. Finally, we will analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline screening cohort | Other | Diagnostic Test: 8-type HPV genotype restrictionThis group undergoes HPV testing using self-collected swabs. Triage evaluation occurs in all women who test HPV positive which includes visual inspection with acetic acid and colposcopy. The WLHIV in the cohort who test HPV positive at baseline but who have concurrent benign histopathology results will be invited back for re-screening at a 2-year interval, and undergo similar HPV testing and triage procedures. The WLHIV in the cohort who test HPV negative at baseline will be invited back for re-screening at a 3-year interval and undergo similar HPV testing and triage procedures. |
Who may qualify
- Ages
- 25 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cis-gender female or transgender male (must have a cervix)
- ≥25 years of age
- Competent to understand study procedures and give informed consent.
Key exclusion criteria (3 listed)
- Currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy)
- Previous hysterectomy
- Previous diagnosis of cervical cancer
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 |
|---|---|---|
| 8-type HPV genotype restrictionParticipants will undergo primary hrHPV testing and if positive will be referred for VIA per Botswana and WHO guidelines. Participants will also undergo colposcopy and biopsy at the time of VIA. The performance of triage with 8-type HPV genotype restriction will be evaluated. | Diagnostic test | Baseline screening cohort |
Primary outcome
Compare the sensitivity, specificity, PPV and NPV of triage of primary human papillomavirus testing with 8-type HPV genotype restriction to visual inspection with acetic acid and colposcopy
Time frame: 3 years
Determine the persistence of HPV infection in WLHIV at the pre-specified follow-up interval
Time frame: 5 years
Determine the clearance of HPV infection in WLHIV at the pre-specified follow-up interval
Time frame: 5 years
Determine the incidence of HPV infection in WLHIV at the pre-specified follow-up interval
Time frame: 5 years
Quantify the incidence of cervical intraepithelial lesion grade 2 or worse in women living with HIV who were baseline HPV positive but with benign pathology at 2 year interval screening
Time frame: 5 years
Quantify the incidence of cervical intraepithelial lesion grade 2 or worse in women living with HIV who were baseline HPV negative at 3 year interval screening
Time frame: 5 years
Analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.
Time frame: 5 years
4 secondary outcomes
Understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study.
Time frame: 6 years
Evaluate the performance of a novel HPV assay as a stand-alone screening tool in our high-prevalence HIV population
Time frame: 3 years
Evaluate the impact of patient demographic and clinical factors, such as number of sexual partners, smoking, HIV status and related HIV immune markers, on risk of cervical dysplasia
Time frame: 5 years
Evaluate the impact of patient characteristics and and risk factors on the incidence of cervical dysplasia
Time frame: 5 years
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 Apr 2026.
- Derived from this study: PubMed 39477271Luckett R, Zhang BX, Gompers A, George J, Modest A, Bazzett-Matabele L, Vuylsteke P, Kula M, Monare B, Botha MH, Shapiro RL, Ramogola-Masire D, Grover S. High-grade cervical disease and cervical cancer in women aged 50 years and older compared with younger women: examining prevalence by HIV status in two large prospective cohorts in Botswana. BMJ Open. 2024 Oct 29;14(10):e089375. doi: 10.1136/bmjopen-2024-089375.
- Derived from this study: PubMed 37950533Luckett R, Ramogola-Masire D, Gompers A, Moraka N, Moyo S, Sedabadi L, Tawe L, Kashamba T, Gaborone K, Mathoma A, Noubary F, Kula M, Grover S, Dreyer G, Botha MH, Makhema J, Shapiro R, Hacker MR. Triage of HPV positivity in a high HIV prevalence setting: A prospective cohort study comparing visual triage methods and HPV genotype restriction in Botswana. Int J Gynaecol Obstet. 2024 May;165(2):507-518. doi: 10.1002/ijgo.15225. Epub 2023 Nov 10.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request with appropriate data transfer agreements in place.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-type HPV genotype restriction in people with Cervical Cancer and Prevention, run by Beth Israel Deaconess Medical Center at 1 site in Botswana.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. 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 Botswana. 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?
Compare the sensitivity, specificity, PPV and NPV of triage of primary human papillomavirus testing with 8-type HPV genotype restriction to visual inspection with acetic acid and colposcopy (time frame: 3 years). The study lists 7 primary outcomes in all. 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 NCT04242823, which also lists 2 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 27 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.