Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention

NCT07015957 | Recruiting Phase 4 DMC

• 2 other identifiers: IRB-FY2025-96861U01CA294756
• Study Type: interventional
• Target: 7,000
• Locations: 1 country
• Sites: 1

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. 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. 2.What is the acceptability, appropriateness, feasibility, and cost of these implementation strategies.
3. 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.

Conditions

Cervical Cancer Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difference in prevalence of completing a cervical cancer prevention program

  Months 7-18

• Difference in prevalence of initiating a cervical cancer prevention program among those uninitiated

  Months 7-18

Other Outcomes (1)

• Acceptability of the implementation strategies

  Months 1-9

Study Arms (8)

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

Interventions

Prompts BEHAVIORAL

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

Condition 2: In-person training + Prompt; Condition 4: In-person training + Prompt + Coaching; Condition 6: Virtual training + Prompt; Condition 8: Virtual training + Prompt + Coaching

In-person training BEHAVIORAL

An in-person educational session.

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 training BEHAVIORAL

A virtual educational session.

Condition 5: Virtual training; Condition 6: Virtual training + Prompt; Condition 7: Virtual training + Coaching; Condition 8: Virtual training + Prompt + Coaching

Coaching BEHAVIORAL

Short video vignettes plus reinforcing messages

Condition 3: In-person training + Coaching; Condition 4: In-person training + Prompt + Coaching; Condition 7: Virtual training + Coaching; Condition 8: Virtual training + Prompt + Coaching

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of California, Los Angeles: collaborator
• Partners in Hope, Inc.: collaborator
• New York University: lead

Study Sites (1)

Partners in Hope

Lilongwe, Malawi

RECRUITING

Study Officials

• Corrina Moucheraud

  New York University

  PRINCIPAL INVESTIGATOR

• Risa M Hoffman

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Sam Phiri

  Partners in Hope, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corrina Moucheraud

CONTACT

212-992-6129; c.moucheraud@nyu.edu

Risa M Hoffman

CONTACT

RHoffman@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

MA (1)