Cervical Cancer PreventionPhase 4NCT07015957
Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention
A Phase 4 study testing In-person training, Virtual training and Coaching in people with Cervical Cancer Prevention, run by New York University at 1 site in Malawi.
Trial summary
The goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase cervical cancer prevention in Malawi. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Prevention
- What is being tested?
- In-person training, Virtual training and Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 1 siteMalawi
- Study dates
- 8 Jul 2025to Aug 2029
- Phase
- Phase 4
- 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 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Health workers: People who provide medical care and counseling (typically medical assistants, clinical officers, and nurses), and interact with adolescent girls and young women aged 9-24 and/or their parents/caregivers.
- Clients: Non-pregnant females aged 9-24 (for those aged 9-17, their male or female parent/guardian will also be eligible for participation) who present for HIV care at a participating health facility during the study period.
Who cannot join
- Health workers: Less than 18 years of age, or not an active and regular provider of medical care or counseling at the facility, or unable or unwilling to provide informed consent.
- Clients: <9 or >24 years old, or pregnancy, or unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase cervical cancer prevention in Malawi. The main questions it aims to answer are:
- Which implementation strategies produce the greatest increase in provider recommendation for, and uptake of, cervical cancer prevention tools among people receiving HIV care.
- What is the acceptability, appropriateness, feasibility, and cost of these implementation strategies.
- What is the sustained effect of these implementation strategies. The implementation strategies will be conducted with health workers (clinical officers, nurses, and medical assistants): training, coaching, and a reminder system.
- Conditions
- Cervical Cancer Prevention
- Being tested
- In-person training, Virtual training, Coaching, Prompts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person trainingBehavioural
An in-person educational session.
Virtual trainingBehavioural
A virtual educational session.
CoachingBehavioural
Short video vignettes plus reinforcing messages
PromptsBehavioural
Visual aide to remind providers to discuss cervical cancer prevention methods.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: In-person training | Active comparator | Not described Receives: Behavioral: In-person training |
| Condition 2: In-person training + Prompt | Experimental | Not described Receives: Behavioral: In-person training; Behavioral: Prompts |
| Condition 3: In-person training + Coaching | Experimental | Not described Receives: Behavioral: In-person training; Behavioral: Coaching |
| Condition 4: In-person training + Prompt + Coaching | Experimental | Not described Receives: Behavioral: In-person training; Behavioral: Coaching; Behavioral: Prompts |
| Condition 5: Virtual training | Experimental | Not described Receives: Behavioral: Virtual training |
| Condition 6: Virtual training + Prompt | Experimental | Not described Receives: Behavioral: Virtual training; Behavioral: Prompts |
| Condition 7: Virtual training + Coaching | Experimental | Not described Receives: Behavioral: Virtual training; Behavioral: Coaching |
| Condition 8: Virtual training + Prompt + Coaching | Experimental | Not described Receives: Behavioral: Virtual training; Behavioral: Coaching; Behavioral: Prompts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in prevalence of discussions surrounding methods of cervical cancer prevention
Discussions about methods of cervical cancer prevention will be reported by clients following each routine HIV care visit. This rate is defined as the percentage of visits during which there is a discussion about methods of cervical cancer prevention. This rate will be compared between the groups with and without each intervention component.
Measured: Months 7-18
Secondary outcomes (2)
Difference in prevalence of completing a cervical cancer prevention program
Completing a cervical cancer prevention program will be reported by clients following each routine HIV care visit. This prevalence is defined as the percentage of clients who complete a cervical cancer prevention program. This prevalence will be compared between the groups with and without each intervention component.
Measured: Months 7-18
Difference in prevalence of initiating a cervical cancer prevention program among those uninitiated
This prevalence is defined among those who have not begun a cervical cancer prevention program at study entry. This prevalence will be compared between the groups with and without each intervention component.
Measured: Months 7-18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start8 Jul 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer PreventionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, Los Angeles, Partners in Hope, Inc.
- Responsible party
- Sponsor
- Investigators
- Corrina Moucheraud, Principal investigator, New York UniversityRisa M Hoffman, Principal investigator, University of California, Los AngelesSam Phiri, Principal investigator, Partners in Hope, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015957
- Sponsor's protocol ID
- IRB-FY2025-9686
- Other IDs
- 1U01CA294756
- Status last verified
- Aug 2026
- First submitted
- 3 Jun 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully deidentified survey data and focus group discussion transcripts
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention
- ClinicalTrials.gov ID
- NCT07015957
- Acronym / sponsor ID
- IRB-FY2025-9686
- Conditions
- Cervical Cancer Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, Los Angeles, Partners in Hope, Inc.
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 11 Jun 2025 (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 clinical trial is identify an effective and implementable set of implementation strategies to increase cervical cancer prevention in Malawi. The main questions it aims to answer are:
- Which implementation strategies produce the greatest increase in provider recommendation for, and uptake of, cervical cancer prevention tools among people receiving HIV care.
- What is the acceptability, appropriateness, feasibility, and cost of these implementation strategies.
- What is the sustained effect of these implementation strategies. The implementation strategies will be conducted with health workers (clinical officers, nurses, and medical assistants): training, coaching, and a reminder system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Condition 1: In-person training | Active comparator | Behavioral: In-person training |
| Condition 2: In-person training + Prompt | Experimental | Behavioral: In-person training, Behavioral: Prompts |
| Condition 3: In-person training + Coaching | Experimental | Behavioral: In-person training, Behavioral: Coaching |
| Condition 4: In-person training + Prompt + Coaching | Experimental | Behavioral: In-person training, Behavioral: Coaching, Behavioral: Prompts |
| Condition 5: Virtual training | Experimental | Behavioral: Virtual training |
| Condition 6: Virtual training + Prompt | Experimental | Behavioral: Virtual training, Behavioral: Prompts |
| Condition 7: Virtual training + Coaching | Experimental | Behavioral: Virtual training, Behavioral: Coaching |
| Condition 8: Virtual training + Prompt + Coaching | Experimental | Behavioral: Virtual training, Behavioral: Coaching, Behavioral: Prompts |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Health workers: People who provide medical care and counseling (typically medical assistants, clinical officers, and nurses), and interact with adolescent girls and young women aged 9-24 and/or their parents/caregivers.
- Clients: Non-pregnant females aged 9-24 (for those aged 9-17, their male or female parent/guardian will also be eligible for participation) who present for HIV care at a participating health facility during the study period.
Key exclusion criteria (2 listed)
- Health workers: Less than 18 years of age, or not an active and regular provider of medical care or counseling at the facility, or unable or unwilling to provide informed consent.
- Clients: <9 or >24 years old, or pregnancy, or unable or unwilling to provide informed consent.
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 |
|---|---|---|
| In-person trainingAn in-person educational session. | Behavioural | Condition 1: In-person training, Condition 2: In-person training + Prompt, Condition 3: In-person training + Coaching, Condition 4: In-person training + Prompt + Coaching |
| Virtual trainingA virtual educational session. | Behavioural | Condition 5: Virtual training, Condition 6: Virtual training + Prompt, Condition 7: Virtual training + Coaching, Condition 8: Virtual training + Prompt + Coaching |
| CoachingShort video vignettes plus reinforcing messages | Behavioural | Condition 3: In-person training + Coaching, Condition 4: In-person training + Prompt + Coaching, Condition 7: Virtual training + Coaching, Condition 8: Virtual training + Prompt + Coaching |
| PromptsVisual aide to remind providers to discuss cervical cancer prevention methods. | Behavioural | Condition 2: In-person training + Prompt, Condition 4: In-person training + Prompt + Coaching, Condition 6: Virtual training + Prompt, Condition 8: Virtual training + Prompt + Coaching |
Primary outcome
Difference in prevalence of discussions surrounding methods of cervical cancer prevention
Time frame: Months 7-18
Discussions about methods of cervical cancer prevention will be reported by clients following each routine HIV care visit. This rate is defined as the percentage of visits during which there is a discussion about methods of cervical cancer prevention. This rate will be compared between the groups with and without each intervention component.
2 secondary outcomes
Difference in prevalence of completing a cervical cancer prevention program
Time frame: Months 7-18
Difference in prevalence of initiating a cervical cancer prevention program among those uninitiated
Time frame: Months 7-18
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 5 Aug 2026.
- Individual participant dataSharing planned: Yes. Fully deidentified survey data and focus group discussion transcripts
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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. This study is not recruiting at the moment.
Corrina Moucheraud principal investigator
New York University
Risa M Hoffman principal investigator
University of California, Los Angeles
Sam Phiri principal investigator
Partners in Hope, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing In-person training, Virtual training and Coaching in people with Cervical Cancer Prevention, run by New York University at 1 site in Malawi.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 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 Malawi. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in prevalence of discussions surrounding methods of cervical cancer prevention (time frame: Months 7-18). 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 5 Aug 2026.