Cervix CancerC-3001B-P-CS7NCT07624123
Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women Living 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 Zimbabwe.
Trial summary
This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE)-3001-B 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
- 17,734 participants
- Where
- 1 siteZimbabwe
- Study dates
- Sep 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 the Zimbabwe National Screening 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 Visual Inspection with Acetic Acid and Cervicography (VIAC), 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 <6 weeks 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zimbabwe1 site
University of Zimbabwe Clinical Trials Research Centre
Harare, 263-772287143
Bothwell T Guzha, MD, 263-772287143, bothwellguzha@gmail.com
Bothwell T Guzha, 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 (CASCADE-3001-B)
This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE)-3001-B 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 (CHWs) 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 feasibility phase of 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 main study phase of the C3001-B trial will include a total of 20 clinics which will be enrolled in a stepped-wedge cluster randomized into Models 1 and 2 as described below. The feasibility phase of the study (C3001B-P-CS7) will include a total of 6 clinics, and the main phase of the study, if approved, will include 20 clinics. Trial dates and sample sizes are estimated for 26 clinics total. The feasibility phase of 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.
- Conditions
- Cervix Cancer, HIV Infections, HPV Infection
- Being tested
- Model 1- Screening in Clinic Only, Model 2 - Screening in Clinic and Community
- Keywords
- self-collection, screening
- 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 and Cervicography (VIAC), 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 Community Health workers (CHWs). 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 Clinics | 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 community health workers (CHWs)(Model 2).
Standard-of-care for Model 1 is defined as HPV self-collection when available or Visual Inspection with Acetic Acid and Cervicography (VIAC) 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 posted3 Jun 2026
- Study startSep 2026 (estimated)
- 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
- Stepped Wedged Trial (Parallel Assignment for feasibility phase; Stepped Wedged Trial for Main Study Phase).
- Masking
- None (open label)
- Enrolment
- 17,734 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer Smith, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer CenterJennifer Tang, MD, Study chair, UNC Lineberger Comprehensive Cancer CenterMichael 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)Lameck Chinula, MD, Study director, University of North Carolina, Chapel HillLisa Spees, PhD, Study director, University of North Carolina, Chapel HillChemtai Mungo, MD MPH, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624123
- Sponsor's protocol ID
- 25-0894
- Other IDs
- UG1CA284918, UG1CA275403, U24CA275417
- Acronym
- C-3001B-P-CS7
- Status last verified
- Sep 2026
- First submitted
- 28 May 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 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 (CASCADE-3001-B)
- ClinicalTrials.gov ID
- NCT07624123
- Acronym / sponsor ID
- C-3001B-P-CS7 / 25-0894
- Conditions
- Cervix Cancer, HIV Infections, HPV Infection
- Keywords
- self-collection, screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 17,734 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 3 Jun 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)-3001-B 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 (CHWs) 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 feasibility phase of 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 main study phase of the C3001-B trial will include a total of 20 clinics which will be enrolled in a stepped-wedge cluster randomized into Models 1 and 2 as described below. The feasibility phase of the study (C3001B-P-CS7) will include a total of 6 clinics, and the main phase of the study, if approved, will include 20 clinics. Trial dates and sample sizes are estimated for 26 clinics total. The feasibility phase of 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedged Trial (Parallel Assignment for feasibility phase; Stepped Wedged Trial for Main Study Phase).
| 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 Clinics | 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 the Zimbabwe National Screening 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 (4 listed)
- Have had their cervix removed
- Are pregnant or <6 weeks 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
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 and Cervicography (VIAC), 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 Community Health workers (CHWs). 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 Clinics |
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 community health workers (CHWs)(Model 2). Standard-of-care for Model 1 is defined as HPV self-collection when available or Visual Inspection with Acetic Acid and Cervicography (VIAC) 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 2 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
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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.
Jennifer Smith, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
Jennifer Tang, MD study chair
UNC Lineberger Comprehensive Cancer Center
Michael Hudgens, PhD study director
University of North Carolina, Chapel Hill
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 Zimbabwe.
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 4 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: opening soon, as of the sponsor's last update on 2 Sep 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 Zimbabwe. 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 Smith, PhD (919-445-6911, 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 2 Sep 2026.