HIVNCT06751030
Community, Home-based Education, Screening Services Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria
An observational study of HIV and Cervical Cancer, run by Emory University at 3 sites in Nigeria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- HIV, Cervical Cancer
- What is being tested?
- The Mother Mentor program and GeneXpert HPV test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 3 sitesNigeria
- Study dates
- 3 Dec 2024to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Adult
Study population: Aim 1: The stakeholder deliberation conferences will include stakeholders from the following groups: * State and National Policymakers * Organizational-clinical managers * Mentor mothers * Women living with HIV (WLWH) Since this is a socio-behavioral component, pregnant individuals may partake. All individuals who take part in this portion of the study will be above 18 and capable of providing informed consent. 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.
Who may be able to join
- Patients must be able to perform vaginal self-collection as well as give informed consent
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria3 sites, 3 recruiting
- Recruiting
APIN Health Initiatives
Abuja
Olabanjo Ogunsola
- Recruiting
University of Ibadan
Ibadan
Olutosin Awolude, MBBS, MSc
- Recruiting
Nigeria Institute of Medical Research (NIMR
Lagos
Oliver Ezechi, MBBS,PhD
About this study
Official title: Community, Home-based Education, Screening Services (CHESS) Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria
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.
Read the detailed description
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:
- Adapting the MoMent program to promote home-based HPV screening and follow-up treatment through stakeholder deliberation.
- Implementing and assessing the program's reach, effectiveness, adoption, and fidelity with a sample of 1,500 WLWH.
- Conducting a post-implementation evaluation to identify barriers and enablers for program maintenance and scalability.
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.
- Conditions
- HIV, Cervical Cancer
- Being tested
- The Mother Mentor program, GeneXpert HPV test
- Keywords
- Women Living With HIV, cervical cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Mother Mentor programBehavioural
Also called MoMent Program
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
GeneXpert HPV testDiagnostic test
A cervical cancer screening tool.
| Study group | Role | What they receive |
|---|---|---|
| Women living with HIV | 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. Receives: Behavioral: The Mother Mentor program; Diagnostic Test: GeneXpert HPV test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline, Month 6, Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start3 Dec 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lisa Flowers, Emory University
- Investigators
- Lisa Flowers, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751030
- Sponsor's protocol ID
- STUDY00004817
- Other IDs
- U01CA275113
- Status last verified
- Aug 2025
- First submitted
- 20 Dec 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40895387
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community, Home-based Education, Screening Services (CHESS) Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria
- ClinicalTrials.gov ID
- NCT06751030
- Acronym / sponsor ID
- STUDY00004817
- Conditions
- HIV, Cervical Cancer
- Keywords
- Women Living With HIV, cervical cancer screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Adapting the MoMent program to promote home-based HPV screening and follow-up treatment through stakeholder deliberation.
- Implementing and assessing the program's reach, effectiveness, adoption, and fidelity with a sample of 1,500 WLWH.
- Conducting a post-implementation evaluation to identify barriers and enablers for program maintenance and scalability.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women living with HIV | – | Behavioral: The Mother Mentor program, Diagnostic Test: GeneXpert HPV testDuring 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Aim 1: The stakeholder deliberation conferences will include stakeholders from the following groups: * State and National Policymakers * Organizational-clinical managers * Mentor mothers * Women living with HIV (WLWH) Since this is a socio-behavioral component, pregnant individuals may partake. All individuals who take part in this portion of the study will be above 18 and capable of providing informed consent. 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.
Key inclusion criteria (1 listed)
- Patients must be able to perform vaginal self-collection as well as give informed consent
Key exclusion criteria (6 listed)
- Male gender
- Age <25 or >50
- Unknown or negative HIV status
- Pregnancy
- Hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Mother Mentor programAlso: MoMent ProgramThe 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 | Behavioural | Women living with HIV |
| GeneXpert HPV testA cervical cancer screening tool. | Diagnostic test | Women living with HIV |
Primary outcome
Program Reach
Time frame: Baseline, Month 6, Month 18
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.
Effectiveness of the Program
Time frame: Baseline, Month 6, Month 18
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.
Adoption of the program
Time frame: Baseline, Month 6, Month 18
Adoption will be measured through the proportions of MMs who complete training and WLWH who return self-collected (SC) samples
Fidelity of the program
Time frame: Baseline, Month 6, Month 18
Will be measured by peer leaders' monitoring of practices, as well as measuring system barriers and added MoMent program costs per completed home screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Derived from this study: PubMed 40895387Ogunsola 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Flowers, MD, MPH principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Cervical Cancer, run by Emory University at 3 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Flowers, MD, MPH (404-712-3522, Lflowe2@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Reach (time frame: Baseline, Month 6, Month 18). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06751030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.