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NCT Number: NCT07015957

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.

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Key information

Conditions

Cervical Cancer Prevention

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Partners in Hope

Lilongwe, Malawi

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In-person training

Behavioral

An in-person educational session.

Virtual training

Behavioral

A virtual educational session.

coaching

Behavioral

Short video vignettes plus reinforcing messages

PROMPTS

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Difference in prevalence of completing a cervical cancer prevention program

    Time frame: Months 7-18

    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.

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

    Time frame: Months 7-18

    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.

Other outcomes

  1. Acceptability of the implementation strategies

    Time frame: Months 1-9

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Corrina Moucheraud

CONTACT

[email protected]

212-992-6129

Risa M Hoffman

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • National Cancer Institute (NCI)
  • Partners in Hope, Inc.
  • University of California, Los Angeles

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jun 11, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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