Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Cancer Prevention
• Intervention / Treatment: Behavioral: In-person training; Behavioral: Coaching; Behavioral: Virtual training; Behavioral: Prompts

• Study Type: Interventional
• Enrollment (Estimated): 7000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • Partners in Hope

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Condition 1: In-person training	Behavioral: In-person training; An in-person educational session.
Experimental: Condition 2: In-person training + Prompt	Behavioral: In-person training; An in-person educational session.; Behavioral: Prompts; Visual aide to remind providers to discuss cervical cancer prevention methods.
Experimental: Condition 3: In-person training + Coaching	Behavioral: In-person training; An in-person educational session.; Behavioral: Coaching; Short video vignettes plus reinforcing messages
Experimental: Condition 4: In-person training + Prompt + Coaching	Behavioral: In-person training; An in-person educational session.; Behavioral: Coaching; Short video vignettes plus reinforcing messages; Behavioral: Prompts; Visual aide to remind providers to discuss cervical cancer prevention methods.
Experimental: Condition 5: Virtual training	Behavioral: Virtual training; A virtual educational session.
Experimental: Condition 6: Virtual training + Prompt	Behavioral: Virtual training; A virtual educational session.; Behavioral: Prompts; Visual aide to remind providers to discuss cervical cancer prevention methods.
Experimental: Condition 7: Virtual training + Coaching	Behavioral: Coaching; Short video vignettes plus reinforcing messages; Behavioral: Virtual training; A virtual educational session.
Experimental: Condition 8: Virtual training + Prompt + Coaching	Behavioral: Coaching; Short video vignettes plus reinforcing messages; Behavioral: Virtual training; A virtual educational session.; Behavioral: Prompts; Visual aide to remind providers to discuss cervical cancer prevention methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Months 7-18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Months 7-18

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the implementation strategies	Health workers will be asked a set of questions to assess their perceived acceptability of the implementation strategies, based on the Theoretical Framework of Acceptability questionnaire, and these will be combined into an acceptability score (ranging from 0-27 with a higher score indicating greater acceptability). We will compare the average acceptability score between groups with and without each intervention component.	Months 1-9

Collaborators and Investigators

• Sponsor: New York University
• Collaborators: National Cancer Institute (NCI); University of California, Los Angeles; Partners in Hope, Inc.
• Investigators: Principal Investigator: Corrina Moucheraud, New York University; Principal Investigator: Risa M Hoffman, University of California, Los Angeles; Principal Investigator: Sam Phiri, Partners in Hope, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: June 3, 2025
• First Submitted That Met QC Criteria: June 3, 2025
• First Posted (Actual): June 11, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: IRB-FY2025-9686; 1U01CA294756 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Fully deidentified survey data and focus group discussion transcripts
• IPD Sharing Access Criteria: Survey data will be deposited into a data repository after it has been fully de-identified. De-identified focus group discussion data will be available on a by-request basis via a data repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No