Clinical trial · Interventional
Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women
Evaluating the Accuracy of Portable Colposcopy and Prevalent HPV Genotypes Among HIV Positive Women in Haiti
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding unavailable to perform study.
Summary
Brief summary (as posted)
This study will evaluate the effectiveness of portable colposcopy when compared to conventional colposcopy (25x magnification of the cervix, the gold standard) and Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted low-resource method). Half the participants will be evaluated for cervical pathology by portable colposcopy after VIA assessment, while the other half will be evaluated by conventional colposcopy. This study also will use collected lab specimens for human papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus (HIV)-positive women.
Conditions
Conditions (3)
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 |
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
| Human Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional colposcopy (Wallach Zoomscope) | Device | — | UNRESOLVED |
| Portable colposcopy (Cerviscope) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Portable colposcopy
- description
- Diagnostic evaluation with 8x magnification portable colposcopy after visual inspection with acetic acid
- interventionNames
- Device: Portable colposcopy (Cerviscope)
- type
- ACTIVE_COMPARATOR
- label
- Conventional colposcopy
- description
- Diagnostic evaluation with standard 25x magnification conventional colposcopy after visual inspection with acetic acid
- interventionNames
- Device: Conventional colposcopy (Wallach Zoomscope)
Primary outcomes (3)
- measure
- Number of accurate high-grade squamous intraepithelial lesion (HSIL) diagnoses by visualization method
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Female * 25-60 years old * Pre-tested as positive for human papillomavirus (HPV) Exclusion Criteria: * Pre-tested as negative for human papillomavirus (HPV) * Pregnant at time of enrollment * Prior hysterectomy * \< 25 or \> 60 years old * Male
References
Publications (0)
Data not yet available