Clinical trial · Interventional
2-stage Cervical Cancer Screening in Botswana
Development of a Two-stage Cervical Cancer Screening Algorithm for Botswana
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cervical cancer is the leading cause of cancer death among women in Botswana. The burden of cervical cancer is largely related to the high prevalence of HIV in Botswana (22%), as HIV is known to be a significant risk factor for cervical cancer. Cervical cancer screening is life-saving and has been shown to reduce cervical cancer incidence in multiple settings. Yet, there is no consensus on appropriate screening algorithms for women living with HIV, across resource settings. Botswana is in a unique position, relative to its neighbors in Sub-Saharan Africa, in that there exists capacity for advanced screening modalities, including primary high risk human papilloma virus (hrHPV) testing and cytology-based screening. To address this issue, this study seeks to evaluate two-stage cervical cancer screening algorithms for women living with HIV in Botswana using hrHPV testing. The protocols include hrHPV testing followed by Pap Smear evaluation, VIA and colposcopy. These same participants will be invited back at one-year for cervical cancer screening using hrHPV testing (followed by triage testing) in order to inform guidelines on the frequency of HPV testing in women living with HIV. The evidence generated will be critical to guiding cervical cancer screening in HIV-infected women across resource settings.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HIV/AIDS | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-stage screen | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 2-stage screen
- description
- All patients will be enrolled in the two-stage cervical cancer screening protocol
- interventionNames
- Diagnostic Test: 2-stage screen
Primary outcomes (5)
- measure
- Performance of HPV-Pap screening algorithm
- timeFrame
- 2 months
- description
- Measurement of the sensitivity, specificity and positive predictive value of Pap smear in predicting cervical precancer and cancer in HPV positive, HIV positive women.
- measure
- Performance of HPV-VIA screening algorithm
- timeFrame
- 2 months
- description
- Measurement of the sensitivity, specificity and positive predictive value of VIA in predicting cervical precancer and cancer in HPV positive, HIV positive women.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * ≥25 years of age * HIV-positive * Competent to understand study procedures and give informed consent. Exclusion Criteria: * Currently pregnant * Currently menstruating or having persistent vaginal discharge * Previous hysterectomy * Previous diagnosis of cervical cancer
References
Publications (38)
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- BACKGROUNDEllerbrock TV, Chiasson MA, Bush TJ, Sun XW, Sawo D, Brudney K, Wright TC Jr. Incidence of cervical squamous intraepithelial lesions in HIV-infected women. JAMA. 2000 Feb 23;283(8):1031-7. doi: 10.1001/jama.283.8.1031. PMID 10697063
- BACKGROUNDChin KM, Sidhu JS, Janssen RS, Weber JT. Invasive cervical cancer in human immunodeficiency virus-infected and uninfected hospital patients. Obstet Gynecol. 1998 Jul;92(1):83-7. doi: 10.1016/s0029-7844(98)00140-9. PMID 9649099
- BACKGROUNDPeirson L, Fitzpatrick-Lewis D, Ciliska D, Warren R. Screening for cervical cancer: a systematic review and meta-analysis. Syst Rev. 2013 May 24;2:35. doi: 10.1186/2046-4053-2-35. PMID 23706117
- BACKGROUNDGibb RK, Martens MG. The impact of liquid-based cytology in decreasing the incidence of cervical cancer. Rev Obstet Gynecol. 2011;4(Suppl 1):S2-S11. PMID 21617785
- BACKGROUNDde Martel C, Ferlay J, Franceschi S, Vignat J, Bray F, Forman D, Plummer M. Global burden of cancers attributable to infections in 2008: a review and synthetic analysis. Lancet Oncol. 2012 Jun;13(6):607-15. doi: 10.1016/S1470-2045(12)70137-7. Epub 2012 May 9.