NCT06751030
Community, Home-based Education, Screening Services Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria
At risk: Primary completion moved at least 2 years 1 month later.
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Record History
All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗
Notable Primary and study completion pushed from Jun 2026 to Aug 2028 Show 5 more changesShow less
- Enrollment closed, study ongoing
- Site details revised at 3 of 3 sites
- Publications: details revised at 1 of 1 entry
- Eligibility criteria expanded, about 4 words
- Study description expanded, about 3 words
- Minor Start date changed from estimate of Jan 2025 to Dec 3, 2024v2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Arms and interventions
During the screening process: * Women testing negative for high-risk HPV (HrHPV) will complete participation one year after their test results, at which time they will be invited to retest. * Women living with HIV (WLWH) testing positive for HrHPV will have endpoints based on treatment outcomes: * Other HrHPV types (not 16/18/45): * Endpoint: One year post-VIA (visual inspection with acetic acid). * VIA-positive patients will receive thermal ablation treatment. * VIA-negative patients will have repeat VIA or standard screening after one year. * HrHPV types 16/18/45: * Endpoint: Two years post-treatment. * Follow-up includes repeat HPV self-collection, VIA, biopsies, and further treatment (thermal ablation or excision) if needed. WLWH testing positive for HrHPV 16/18/45 via self-collection will be notified by a Mentor Mother, who, along with Nigerian clinical staff, will assist in scheduling VIA. Treatment follows the standard of care protocol.
Behavioral: The Mother Mentor program
Diagnostic tests: GeneXpert HPV test
Sites
3 sites in 1 country