Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention

New York University (NYU)

Status and phase: Active, not recruiting; Phase 4

Conditions: Cervical Cancer Prevention

Treatments: Behavioral: Virtual training; Behavioral: In-person training; Behavioral: Prompts; Behavioral: Coaching

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07015957

1U01CA294756 (U.S. NIH Grant/Contract)

IRB-FY2025-9686

Details and patient eligibility

About

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.

Enrollment: 7,000 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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7,000 participants in 8 patient groups

Condition 1: In-person training

Active Comparator group

Treatment:

Behavioral: In-person training

Condition 2: In-person training + Prompt

Experimental group

Treatment:

Behavioral: Prompts

Behavioral: In-person training

Condition 3: In-person training + Coaching

Experimental group

Treatment:

Behavioral: Coaching

Behavioral: In-person training

Condition 4: In-person training + Prompt + Coaching

Experimental group

Treatment:

Behavioral: Coaching

Behavioral: Prompts

Behavioral: In-person training

Condition 5: Virtual training

Experimental group

Treatment:

Behavioral: Virtual training

Condition 6: Virtual training + Prompt

Experimental group

Treatment:

Behavioral: Prompts

Behavioral: Virtual training

Condition 7: Virtual training + Coaching

Experimental group

Treatment:

Behavioral: Coaching

Behavioral: Virtual training

Condition 8: Virtual training + Prompt + Coaching

Experimental group

Treatment:

Behavioral: Coaching

Behavioral: Prompts

Behavioral: Virtual training