An interventional study of 8-type HPV genotype restriction in Cervical Cancer and Prevention, sponsored by Beth Israel Deaconess Medical Center. Active, not recruiting at 1 site in Botswana. Open to female participants aged 25 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Diagnostic
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's enrollment of 3,000 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: 8-type HPV genotype restriction
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.
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
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
Plan to share: Yes — Data will be made available upon reasonable request with appropriate data transfer agreements in place.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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