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Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention

Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07015957
Enrollment
7000
Registered
2025-06-11
Start date
2025-07-08
Completion date
2029-08-01
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer Prevention

Brief 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. Which implementation strategies produce the greatest increase in provider recommendation for, and uptake of, cervical cancer prevention tools among people receiving HIV care. 2. What is the acceptability, appropriateness, feasibility, and cost of these implementation strategies. 3. 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.

Interventions

An in-person educational session.

A virtual educational session.

BEHAVIORALCoaching

Short video vignettes plus reinforcing messages

BEHAVIORALPrompts

Visual aide to remind providers to discuss cervical cancer prevention methods.

Sponsors

New York University
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
University of California, Los Angeles
CollaboratorOTHER
Partners in Hope, Inc.
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in prevalence of discussions surrounding methods of cervical cancer preventionMonths 7-18Discussions 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.

Secondary

MeasureTime frameDescription
Difference in prevalence of completing a cervical cancer prevention programMonths 7-18Completing 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.
Difference in prevalence of initiating a cervical cancer prevention program among those uninitiatedMonths 7-18This 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.

Countries

Malawi

Contacts

PRINCIPAL_INVESTIGATORCorrina Moucheraud

New York University

PRINCIPAL_INVESTIGATORRisa M Hoffman

University of California, Los Angeles

PRINCIPAL_INVESTIGATORSam Phiri

Partners in Hope, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026