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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA275113 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
Despite the increased risk of cervical cancer (CC) among women living with HIV (WLWH), access to CC screening in Nigeria remains limited. While advances in prevention programs and antiretroviral therapy have reduced other AIDS-associated malignancies, CC risk in WLWH persists. This study aims to leverage Nigeria's existing HIV treatment infrastructure to integrate home-based CC (HCC) screening for WLWH.
The approach involves adapting the MoMent (MOther MENTor) peer-based HIV support program to include HCC screening and evaluating its implementation and sustainability using the Consolidated Framework for Implementation Research (CFIR) and RE-AIM frameworks. The study has three key aims:
Stakeholder input, including perspectives from WLWH, peer counselors, clinical managers, and policymakers, will guide the program's design and execution. By integrating stakeholder insights and addressing systemic challenges, the study aims to advance CC control in Nigeria and provide a scalable model for implementing cancer control strategies for people living with HIV in low- and middle-income countries globally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women living with HIV | During the screening process:
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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Mother Mentor program | Behavioral | The MOther MENTor (MoMent) program in Nigeria pairs trained treatment-experienced Women living with HIV (WLWH), known as Mentor Mothers (MMs), with new mothers who are newly diagnosed with HIV to improve access to and retention in HIV care |
| Measure | Description | Time Frame |
|---|---|---|
| Program Reach | 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. | Baseline, Month 6, Month 18 |
| Effectiveness of the Program | Effectiveness 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 recurrence of hrHPV or cervical precancerous lesions post-treatment, and correlation of these results with CD4 and HIV viral load. | Baseline, Month 6, Month 18 |
| Adoption of the program | Adoption will be measured through the proportions of MMs who complete training and WLWH who return self-collected (SC) samples | Baseline, Month 6, Month 18 |
| Fidelity of the program | Will be measured by peer leaders' monitoring of practices, as well as measuring system barriers and added MoMent program costs per completed home screening | Baseline, Month 6, Month 18 |
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Inclusion Criteria:
- Patients must be able to perform vaginal self-collection as well as give informed consent
Exclusion Criteria:
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Aim 1: The stakeholder deliberation conferences will include stakeholders from the following groups:
Aim 2: This study will only include WLWH aged 25-50. Pregnant individuals will not be included due to the potential for treatment of precancerous lesions. All individuals who partake in the study will be older than 18 and capable of providing informed consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Flowers, MD, MPH | Contact | 404-712-3522 | Lflowe2@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Flowers, MD, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APIN Health Initiatives | Recruiting | Abuja | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40895387 | Derived | Ogunsola 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. |
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Data shared:
De-identified sociodemographic data (e.g., race/ethnicity, age). Health behavior and health care utilization data from medical records. Cervical pathology results, HPV testing data, laboratory tests (e.g., CD4 and viral load), prescribed HIV medications, and adherence data.
Qualitative data from in-depth interviews and focus group discussions, coded and anonymized.
Start Date: After primary analyses have been completed and results are published (expected within 12 months of study completion).
End Date: Indefinitely, contingent on adherence to data-sharing agreements
Researchers will submit a Data Analysis Request Form, detailing their proposed analysis, purpose, and data needed.
Data access will be granted following review and approval. Approved users will sign a Data Use and Confidentiality Agreement. Anonymized data will be shared securely via a designated data repository or encrypted file transfer.
Researchers must commit to using the data for specified purposes, implementing secure data storage, and destroying or returning the data after analyses are completed.
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| GeneXpert HPV test | Diagnostic Test | A cervical cancer screening tool. |
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| University of Ibadan | Recruiting | Ibadan | Nigeria |
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| Nigeria Institute of Medical Research (NIMR | Recruiting | Lagos | Nigeria |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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