Health TrialsbyHealthPanel

Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention

ConditionCervical Cancer Prevention
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age9+
SponsorNew York University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

7,000 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Condition 1: In-person trainingActive comparator 1 intervention
Group B: Condition 2: In-person training + PromptExperimental treatment 2 interventions
Group C: Condition 3: In-person training + CoachingExperimental treatment 2 interventions
Group D: Condition 4: In-person training + Prompt + CoachingExperimental treatment 3 interventions
Group E: Condition 5: Virtual trainingExperimental treatment 1 intervention
Group F: Condition 6: Virtual training + PromptExperimental treatment 2 interventions
Group G: Condition 7: Virtual training + CoachingExperimental treatment 2 interventions
Group H: Condition 8: Virtual training + Prompt + CoachingExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
Months 7-18

Secondary outcomes

1

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.

Time frame
Months 7-18
2

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.

Time frame
Months 7-18

Other outcomes

1

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.

Time frame
Months 1-9

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

University of California, Los Angeles

Collaborator

Partners in Hope, Inc.

Collaborator

Source ClinicalTrials.gov
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