Clinical trial NCT07015957: Kupewa: Optimizing Strategies to Implement Provider Recommendation of HPV Vaccination for Adolescent Girls and Young Women With HIV in Malawi
Official title: Kupewa: Optimizing Strategies to Implement Provider Recommendation of HPV Vaccination for Adolescent Girls and Young Women With HIV in Malawi
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Human Papilloma Virus (HPV)
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of California, Los Angeles
name: Partners in Hope, Inc.
First posted: 2025-06-11
Enrollment: 7000
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in rate of HPV vaccination recommendation
timeFrame: Months 7-18
Secondary outcomes:
measure: Difference in prevalence of completion of HPV vaccine series
timeFrame: Months 7-18
measure: Difference in prevalence of initiating HPV vaccine series among the unvaccinated
timeFrame: Months 7-18
Other outcomes:
measure: Acceptability of the implementation strategies
timeFrame: Months 1-9
Locations:
city: Lilongwe
country: Malawi
facility: Partners in Hope
Study officials:
affiliation: New York University
name: Corrina Moucheraud
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Risa M Hoffman
role: PRINCIPAL_INVESTIGATOR
affiliation: Partners in Hope, Inc.
name: Sam Phiri
role: PRINCIPAL_INVESTIGATOR
References: