Kupewa: Optimizing Strategies to Implement Provider Recommendation of HPV Vaccination for Adolescent Girls and Young Women With HIV in Malawi

Phase 4

Not yet recruiting

• Conditions: Human Papilloma Virus (HPV)

• Registration Number: NCT07015957
• Lead Sponsor: New York University

Brief Summary

The goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase provider recommendation of human papillomavirus (HPV) vaccination, and HPV vaccine uptake, among girls and young women 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, HPV vaccination among girls and young women 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 about HPV vaccination, coaching on how to give a HPV vaccination recommendation, and a system to remind health workers to offer the HPV vaccine to eligible clients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-15
• Study Start: 2025-07
• Primary Completion: 2026-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7000

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 have not completed the HPV vaccine series and 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 completed HPV vaccine series prior to study, or unable or unwilling to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Difference in rate of HPV vaccination recommendation	Months 7-18	HPV vaccination recommendation will be reported by girls/parents or young women following each routine HIV care visit. They will be asked whether the health worker spoke to them about HPV vaccination at their most recent routine HIV care visit. This rate is defined as the percentage of visits during which there is a recommendation of HPV vaccination. This rate will be compared between the groups with and without each intervention component.

Secondary Outcome Measures

Name	Time	Method
Difference in prevalence of completion of HPV vaccine series	Months 7-18	HPV vaccine dose(s) received will be reported by girls/parents or young women following each routine HIV care visit. They will be asked whether they received doses of the HPV vaccine. This prevalence is defined as the percentage of girls/young women who attain the recommended HPV vaccine dosage. This prevalence will be compared between the groups with and without each intervention component.
Difference in prevalence of initiating HPV vaccine series among the unvaccinated	Months 7-18	HPV vaccine dose(s) received will be reported by girls/parents or young women following each routine HIV care visit. They will be asked whether they received doses of the HPV vaccine. This prevalence is defined among those with zero doses at study entry, as the percentage of girls/young women who receive any doses of the HPV vaccine. This prevalence will be compared between the groups with and without each intervention component.

Trial Locations

Locations (1)

Partners in Hope; 🇲🇼 Lilongwe, Malawi