Clinical trial · Interventional
Primary HPV-based Cervical Cancer Screening Algorithms in Botswana
Performance of Two-stage Cervical Cancer Screening Algorithms Using Primary High-risk Human Papillomavirus Testing in 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)
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
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 |
| Prevention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 8-type HPV genotype restriction | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Baseline screening cohort
- description
- 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.
- interventionNames
- Diagnostic Test: 8-type HPV genotype restriction
Primary outcomes (7)
- 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
- timeFrame
- 3 years
- measure
- Determine the persistence of HPV infection in WLHIV at the pre-specified follow-up interval
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cis-gender female or transgender male (must have a cervix) 2. ≥25 years of age 3. Competent to understand study procedures and give informed consent. Exclusion Criteria: 1. Currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy) 2. Previous hysterectomy 3. Previous diagnosis of cervical cancer
References
Publications (2)
- DERIVEDLuckett 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. PMID 39477271
- DERIVEDLuckett 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. PMID 37950533