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Active, Not Recruiting

NCT Number: NCT04242823

Primary HPV-based Cervical Cancer Screening Algorithms 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cis-gender female or transgender male (must have a cervix)
  • ≥25 years of age
  • Competent to understand study procedures and give informed consent.

Exclusion criteria

  • Currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy)
  • Previous hysterectomy
  • Previous diagnosis of cervical cancer

Treatment and study plan

8-type HPV genotype restriction

Diagnostic 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.

Primary outcomes

  1. 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

  2. Determine the persistence of HPV infection in WLHIV at the pre-specified follow-up interval

    Time frame: 5 years

  3. Determine the clearance of HPV infection in WLHIV at the pre-specified follow-up interval

    Time frame: 5 years

  4. Determine the incidence of HPV infection in WLHIV at the pre-specified follow-up interval

    Time frame: 5 years

  5. 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

  6. 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

  7. Analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.

    Time frame: 5 years

Secondary outcomes

  1. 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

  2. Evaluate the performance of a novel HPV assay as a stand-alone screening tool in our high-prevalence HIV population

    Time frame: 3 years

  3. 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

  4. Evaluate the impact of patient characteristics and and risk factors on the incidence of cervical dysplasia

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Botswana Harvard AIDS Institute Partnership
  • University of Botswana

Registry information

Official study title

Performance of Two-stage Cervical Cancer Screening Algorithms Using Primary High-risk Human Papillomavirus Testing in Botswana

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jan 27, 2020
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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