Cervix CancerCASCADE3001ANCT07428330
Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV
A study testing Model 1- Screening in Clinic Only and Model 2 - Screening in Clinic and Community in people with Cervix Cancer and HIV Infections, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Uganda.
Trial summary
This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE) C3001-A trial aims to assess how the introduction of a community-health-worker-facilitated model, in addition to the existing static clinic-only model, influences the rates of… Read more about this study
- Who is it for?
- Ages 25 to 49 years, women only
- Conditions the study is for
- Cervix Cancer, HIV Infections, HPV Infection
- What is being tested?
- Model 1- Screening in Clinic Only and Model 2 - Screening in Clinic and Community
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,597 participants
- Where
- 1 siteUganda
- Study dates
- 3 Feb 2026to Mar 2028
- Phase
- Interventional
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Are living with Human Immunodeficiency Virus (HIV)
- Are 25-49 years of age, or as recommended by Uganda's Ministry of Health Cervical Cancer Prevention and Control Guidelines
- Live in the catchment areas of or attend a study-eligible clinic
- Are eligible for Human Papillomavirus (HPV)-based cervicovaginal testing either because:
- They have never undergone cervical cancer screening before, or
- They have never undergone HPV-based testing before and are now due for Acetic Acid (VIA), per national guidelines, or
- They have previously undergone HPV-based testing, and are now due for follow-up HPV-based testing per national guidelines, and /or
- They underwent ablative or excisional treatment for presumed or confirmed cervical dysplasia >1 year ago and have not had any follow-up cervical cancer screening since treatment.
Who cannot join
- Have had their cervix removed
- Are pregnant or <3 months post-delivery
- Were positive on their most recent cervical cancer screening test and referred for further evaluation or treatment, but did not complete their referral
- Have previously been treated for invasive cervical cancer
- Clinic Inclusion Criteria
- Clinics selected for inclusion will include those clinics that provide Human Immunodeficiency Virus (HIV) care and distribute antiretroviral therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH).
- These clinics should also have the ability to collect their own data.
- Such clinics could be supported by national programs and bilateral donor-funded initiatives
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Franklin K Okwunze, MD contact
Uganda1 site, 1 recruiting
- Recruiting
Makerere University Walter Reed Program
Kampala, 16524
Betty Mwesigwa, MD, 256-312- 330400, bmwesigwa@muwrp.org
Betty Mwesigwa, MD
About this study
Official title: Comparison of Clinic-based Versus Clinic-plus Community Outreach-based Strategy Via HPV Self-Collection to Increase Uptake of Cervical Cancer Screening Among Women Living With HIV: a Cluster Randomized Trial
This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE) C3001-A trial aims to assess how the introduction of a community-health-worker-facilitated model, in addition to the existing static clinic-only model, influences the rates of cervical cancer screening uptake among women living with HIV (WLWH). This study involves offering human papillomavirus (HPV) self-collection for cervical cancer screening to eligible WLWH.
The 'CASCADE' Network is a clinical trials network aimed at improving cervical cancer screening, management, and pre-cancer treatment for WLWH, in various healthcare settings. The network will conduct implementation trials to improve the triage of HPV-positive WLWH, as well as algorithms to optimize access to and options for effective treatment. Trials will be conducted using a mixed-methods approach aimed at assessing implementation strategies and outcomes and their potential to integrate into existing health systems.
Read more
Further understanding of HPV-based community-based strategies to reach WLWH, and the acceptability, feasibility, appropriateness, and cost of these strategies will be valuable for cervical cancer screening programs serving WLWH. Inputs from various 'CASCADE' Clinical Sites (CS) regarding feasible screening outreach options available in their settings for WLWH have guided this study that focuses on evaluating a pragmatic HPV self-collection implementation model to improve access to screening.
While it is clear that HPV self-collection is a highly acceptable and feasible screening option, creating opportunities to conduct self-collection in alternative venues outside the clinic premises, and with the guidance of and facilitation by trusted community healthcare workers is an important implementation strategy that needs to be evaluated and considered for its potential benefit. Studies have not yet evaluated a community-based approach for HPV self-collection kit distribution among WLWH - who may have different characteristics, preferences, and access to screening services than women not living with HIV. Providing WLWH with the option of receiving HPV self-collection kits in their own homes or other community-based settings ('community-based HPV self-collection') is a novel implementation strategy that could improve cervical cancer screening rates among eligible women. Therefore, this novel trial aims to evaluate the feasibility and effectiveness of implementing community-based HPV self-collection among WLWH.
Read the detailed description
The study is a parallel, 1:1, open label, cluster randomized trial to evaluate two implementation models to increase access to HPV self-collection for cervical cancer screening among WLWH. The C3001-A trial will include a total of 33 clinics which will be randomized into Models 1 and 2 as described below. The feasibility phase of the study (C3001A-P-CS1) will include a total of 6 clinics, and the main phase of the study, if approved, will include 27 additional clinics. Trial dates and sample sizes are estimated for 33 clinics total.
- Conditions
- Cervix Cancer, HIV Infections, HPV Infection
- Being tested
- Model 1- Screening in Clinic Only, Model 2 - Screening in Clinic and Community
- Keywords
- screening, self-collection
- Medical subject headings
- Uterine Cervical Neoplasms, HIV Infections, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model 1- Screening in Clinic OnlyDiagnostic test
Model 1 involves only the recommended standard-of-care of cervical cancer screening Human Papillomavirus (HPV) self-collection, if available, or Visual Inspection with Acetic Acid (VIA), if HPV-based testing is not available) to clients who are due for screening at clinics that distribute Antiretroviral Therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH). Efforts will be made to ensure availability of HPV kits for Model 1 clinics.
Model 2 - Screening in Clinic and CommunityDiagnostic test
Model 2 will include clinic-based Human Papillomavirus (HPV) self-collection, as well as the implementation strategy of providing community-based distribution for HPV self-collection via Facility-link facilitator (FLF)s. Women living with Human Immunodeficiency Virus (WLWH) who are due and overdue for cervical cancer screening will be identified via line lists and appointment directories.
| Study group | Role | What they receive |
|---|---|---|
| Participants enrolled at Model 1 Clinics | Experimental | Women living with Human Immunodeficiency Virus (WLWH) enrolled at Model 1 Clinic. Receives: Diagnostic Test: Model 1- Screening in Clinic Only |
| Participants enrolled at Model 2 Clinic s | Experimental | Women living with Human Immunodeficiency Virus (WLWH) enrolled at Model 2 Clinics. Receives: Diagnostic Test: Model 2 - Screening in Clinic and Community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical cancer monthly screening rates
Monthly cervical cancer screening rates among Women living with Human Immunodeficiency Virus (WLWH) will be compared between two models: (1) standard-of-care screening at static clinics only (Model 1) , and (2) Human Papillomavirus (HPV) self-collection offered at static clinics and through a community-based strategy by facility link facilitators (FLFs)(Model 2).
Standard-of-care for Model 1 is defined as HPV self-collection when available or Visual Inspection with Acetic Acid (VIA) when HPV-based screening is not available.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start3 Feb 2026
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization is performed at the facility level. There will not be participant level randomization.
- Masking
- None (open label)
- Enrolment
- 7,597 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Jennifer Tang, MD, Study chair, UNC Lineberger Comprehensive Cancer CenterJennifer Smith, PhD, Study chair, UNC Lineberger Comprehensive Cancer CenterBetty Mwesigwa, MD, Principal investigator, Makerere University Walter Reed ProgramMichael Hudgens, PhD, Study director, University of North Carolina, Chapel HillKatie Mollan, PhD, Study director, University of North Carolina, Chapel HillVikrant Sahasrabuddhe, MBBS, MPH, DrPH, Study director, Division of Cancer Prevention (DCP), NCIMonica Etima, MD, Study director, Makerere University Walter Reed ProgramGrace Mirembe, MD, Study director, Makerere University Walter Reed Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428330
- Sponsor's protocol ID
- 24-0684
- Other IDs
- UG1CA275412, UG1CA275403, U24CA275417
- Acronym
- CASCADE3001A
- Status last verified
- May 2026
- First submitted
- 16 Feb 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified research data will be made available to qualified researchers upon request one year after publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinic-based Versus Clinic-plus Community Outreach-based Strategy Via HPV Self-Collection to Increase Uptake of Cervical Cancer Screening Among Women Living With HIV: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT07428330
- Acronym / sponsor ID
- CASCADE3001A / 24-0684
- Conditions
- Cervix Cancer, HIV Infections, HPV Infection
- Keywords
- screening, self-collection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,597 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 Feb 2026 (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.
This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE) C3001-A trial aims to assess how the introduction of a community-health-worker-facilitated model, in addition to the existing static clinic-only model, influences the rates of cervical cancer screening uptake among women living with HIV (WLWH). This study involves offering human papillomavirus (HPV) self-collection for cervical cancer screening to eligible WLWH.
The 'CASCADE' Network is a clinical trials network aimed at improving cervical cancer screening, management, and pre-cancer treatment for WLWH, in various healthcare settings. The network will conduct implementation trials to improve the triage of HPV-positive WLWH, as well as algorithms to optimize access to and options for effective treatment. Trials will be conducted using a mixed-methods approach aimed at assessing implementation strategies and outcomes and their potential to integrate into existing health systems.
Further understanding of HPV-based community-based strategies to reach WLWH, and the acceptability, feasibility, appropriateness, and cost of these strategies will be valuable for cervical cancer screening programs serving WLWH. Inputs from various 'CASCADE' Clinical Sites (CS) regarding feasible screening outreach options available in their settings for WLWH have guided this study that focuses on evaluating a pragmatic HPV self-collection implementation model to improve access to screening.
While it is clear that HPV self-collection is a highly acceptable and feasible screening option, creating opportunities to conduct self-collection in alternative venues outside the clinic premises, and with the guidance of and facilitation by trusted community healthcare workers is an important implementation strategy that needs to be evaluated and considered for its potential benefit. Studies have not yet evaluated a community-based approach for HPV self-collection kit distribution among WLWH - who may have different characteristics, preferences, and access to screening services than women not living with HIV. Providing WLWH with the option of receiving HPV self-collection kits in their own homes or other community-based settings ('community-based HPV self-collection') is a novel implementation strategy that could improve cervical cancer screening rates among eligible women. Therefore, this novel trial aims to evaluate the feasibility and effectiveness of implementing community-based HPV self-collection among WLWH.
Detailed description
The study is a parallel, 1:1, open label, cluster randomized trial to evaluate two implementation models to increase access to HPV self-collection for cervical cancer screening among WLWH. The C3001-A trial will include a total of 33 clinics which will be randomized into Models 1 and 2 as described below. The feasibility phase of the study (C3001A-P-CS1) will include a total of 6 clinics, and the main phase of the study, if approved, will include 27 additional clinics. Trial dates and sample sizes are estimated for 33 clinics total.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization is performed at the facility level. There will not be participant level randomization.
| Arm | Type | Receives |
|---|---|---|
| Participants enrolled at Model 1 Clinics | Experimental | Diagnostic Test: Model 1- Screening in Clinic OnlyWomen living with Human Immunodeficiency Virus (WLWH) enrolled at Model 1 Clinic. |
| Participants enrolled at Model 2 Clinic s | Experimental | Diagnostic Test: Model 2 - Screening in Clinic and CommunityWomen living with Human Immunodeficiency Virus (WLWH) enrolled at Model 2 Clinics. |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Are living with Human Immunodeficiency Virus (HIV)
- Are 25-49 years of age, or as recommended by Uganda's Ministry of Health Cervical Cancer Prevention and Control Guidelines
- Live in the catchment areas of or attend a study-eligible clinic
- Are eligible for Human Papillomavirus (HPV)-based cervicovaginal testing either because:
- They have never undergone cervical cancer screening before, or
Key exclusion criteria (8 listed)
- Have had their cervix removed
- Are pregnant or <3 months post-delivery
- Were positive on their most recent cervical cancer screening test and referred for further evaluation or treatment, but did not complete their referral
- Have previously been treated for invasive cervical cancer
- Clinic Inclusion Criteria
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 |
|---|---|---|
| Model 1- Screening in Clinic OnlyModel 1 involves only the recommended standard-of-care of cervical cancer screening Human Papillomavirus (HPV) self-collection, if available, or Visual Inspection with Acetic Acid (VIA), if HPV-based testing is not available) to clients who are due for screening at clinics that distribute Antiretroviral Therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH). Efforts will be made to ensure availability of HPV kits for Model 1 clinics. | Diagnostic test | Participants enrolled at Model 1 Clinics |
| Model 2 - Screening in Clinic and CommunityModel 2 will include clinic-based Human Papillomavirus (HPV) self-collection, as well as the implementation strategy of providing community-based distribution for HPV self-collection via Facility-link facilitator (FLF)s. Women living with Human Immunodeficiency Virus (WLWH) who are due and overdue for cervical cancer screening will be identified via line lists and appointment directories. | Diagnostic test | Participants enrolled at Model 2 Clinic s |
Primary outcome
Cervical cancer monthly screening rates
Time frame: Up to 1 month
Monthly cervical cancer screening rates among Women living with Human Immunodeficiency Virus (WLWH) will be compared between two models: (1) standard-of-care screening at static clinics only (Model 1) , and (2) Human Papillomavirus (HPV) self-collection offered at static clinics and through a community-based strategy by facility link facilitators (FLFs)(Model 2). Standard-of-care for Model 1 is defined as HPV self-collection when available or Visual Inspection with Acetic Acid (VIA) when HPV-based screening is not available.
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 28 May 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified research data will be made available to qualified researchers upon request one year after publication.
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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.
Franklin K Okwunze, MD contact
Jennifer Tang, MD study chair
UNC Lineberger Comprehensive Cancer Center
Jennifer Smith, PhD study chair
UNC Lineberger Comprehensive Cancer Center
Betty Mwesigwa, MD principal investigator
Makerere University Walter Reed Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model 1- Screening in Clinic Only and Model 2 - Screening in Clinic and Community in people with Cervix Cancer and HIV Infections, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Uganda.
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 8 inclusion and 8 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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 Jennifer S Smith, PhD (919-966-4432, jennifers@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical cancer monthly screening rates (time frame: Up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.