Clinical trial · Observational
Community, Home-based Education, Screening Services Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria
Community, Home-based Education, Screening Services (CHESS) Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria
- 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)
The goal of this observational study is to focus on adapting and implementing a program to promote HPV and cervical cancer (CC) screening and follow-up treatment for HIV-positive women, with three specific aims: * Adaptation: Use stakeholder deliberation to tailor the successful MoMent program for this population. * Implementation and Assessment: Deploy the adapted MoMent program and evaluate its reach, effectiveness, adoption, and fidelity. * Evaluation: Conduct a post-implementation process evaluation to identify barriers and facilitators to the program's maintenance and sustainability.
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 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GeneXpert HPV test | Diagnostic Test | — | UNRESOLVED |
| The Mother Mentor program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women living with HIV
- description
- 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.
- interventionNames
- Behavioral: The Mother Mentor program
- Diagnostic Test: GeneXpert HPV test
Primary outcomes (4)
- measure
- Program Reach
- timeFrame
- Baseline, Month 6, Month 18
- description
- Reach evaluated through the provision of home test kits to eligible women, returned samples, number of WLWH positive for high-risk HPV (hrHPV) treated, persistence or reoccurrence of hrHPV or cervical precancerous lesions post-treatment, and correlation of these results with CD4 and HIV viral load.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: \- Patients must be able to perform vaginal self-collection as well as give informed consent Exclusion Criteria: * Male gender * Age \<25 or \>50 * Unknown or negative HIV status * Pregnancy * Hysterectomy * Inability to give informed consent Inability/refusal to perform vaginal self-collection
References
Publications (1)
- DERIVEDOgunsola O, Gaydos LM, Ajayi O, Dieci M, Kaonga N, Awolude O, Ezemelue P, Staple T, Salami K, Idigbe I, Ezechi O, Flowers L. The CHESS Protocol: A Mixed-Methods Evaluation of an HPV Screening Intervention for Women Living With HIV in Nigeria. Int J Public Health. 2025 Aug 14;70:1608716. doi: 10.3389/ijph.2025.1608716. eCollection 2025. PMID 40895387