HPV Vaccine Integrated Service Implementation Research in Ethiopia

NCT06667323 | Not Yet Recruiting

• 2 other identifiers: 1861.2024GAVI100001742
• Study Type: interventional
• Target: 1,140
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this implementation research study is to understand whether a package of community-based interventions can increase access to and uptake of the human papillomavirus (HPV) vaccine among very young adolescent girls in rural Ethiopia. The main questions this study aims to answer are:

• Can a package of community-based interventions increase delivery of routine HPV vaccination to girls aged 9-14 in rural Ethiopia?
• Is an intervention model that incorporates strategies that address gender norms and gender-specific barriers more effective at increasing delivery of routine HPV vaccination than a model that does not explicitly address gender?
• What is the acceptability, feasibility, cost, and potential for maintenance and scale of an integrated health intervention to delivery routine HPV vaccination in rural Ethiopia? To evaluate the effectiveness of the intervention, researchers will compare HPV vaccination within regions where the new intervention model is being implemented (intervention areas) to regions where the new routine HPV vaccination delivery model is not being implemented (comparison areas) for approximately 1 year before the new intervention model is implemented and for approximately 1 year after the start of implementation to compare changes over time and between intervention and comparison areas. The study will evaluate the effect of the intervention on HPV vaccination delivery using routine health facility data. To understand acceptability, feasibility, implementation, and potential for scale, the study will enroll participants including health officials and providers, adolescents girls receiving HPV vaccination and other services in intervention areas, and their parents/caregivers. These participants may be asked to participate in one or more of the following:
• Completing a short questionnaire after receiving health services, including HPV vaccination, and their knowledge and attitudes towards HPV vaccination and experiences of care
• Participating in an interview or a focus group discussion to discuss HPV vaccination services and the role of the intervention in delivering care

Conditions

Papillomavirus Vaccines; HPV Vaccines; HPV Vaccine Acceptability; HPV Vaccine Attitudes; HPV Vaccinations; HPV Vaccine Knowledge; Adolescent Health; Adolescent Health Services; Integrated Community-based Intervention Package

Keywords

Implementation Science; Implementation Research

Outcome Measures

Primary Outcomes (1)

• HPV vaccine delivery

  Number of HPV vaccinations provided to girls aged 9-14 years old per facility per month

  The primary outcome measure is an aggregated, facility-level outcome which will be assessed at the facility-month level using aggregated routine service statistics data over a period of up to 36 months

Study Arms (2)

Integrated health service delivery for very young adolescent girls

EXPERIMENTAL

The intervention will be implemented in four non-randomly selected districts (woreda) in the Oromia, Sidama, and Somali regions of Ethiopia: Gomma, Sokoru, Hawella, and Owbare. In intervention areas, the intervention (a complex, supply- and demand-side implementation model with the primary objective of increasing access to HPV vaccination and other health services for very young adolescent girls \[aged 9-14 years\]) will be developed in the study's phase 1, a rapid formative phase. It is anticipated that the intervention will include supply- and demand-side components, such as household mobilization by community health workers through Ethiopia's Health Extension Program, strengthened linkages between households and community-based health posts, and routinized HPV and adolescent health service delivery in communities at the health post level.

Other: Integrated health service delivery for very young adolescent girls

Standard of care

NO INTERVENTION

Four non-randomly selected districts (woreda) in the Oromia, Sidama, and Somali regions of Ethiopia have been selected as concurrent comparison areas: Dedo, Gera, Teticha, and Dembel. These areas will conduct HPV vaccination (and any other adolescent health service delivery) through the standard-of-care procedures.

Interventions

Integrated health service delivery for very young adolescent girls OTHER

The proposed HPV-VISION intervention will aim to increase girl-centered access to HPV vaccination and other VYA services through an integrated, routine, community-based delivery model that incorporates household mobilization efforts with enhanced service delivery at the health post level.

Integrated health service delivery for very young adolescent girls

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• \- Does not provide informed consent
• Girl: aged 9-14 years, female
• Caregiver: Parent/legal guardian of eligible 9-14-year-old girl (above); 18 years of age or older
• Girl: Does not provide informed assent, including to audio-recording, Parent/legal guardian does not provide consent
• Caregiver: Does not provide informed consent, including to audio-recording
• Girl accompanied by adult (18+) parent/legal guardian: Aged 9-14 years old; Female; Received a VYA health services supported by the program\*, including HPV vaccination, on the date of recruitment
• Girl accompanied by an/other adult(s) (18+): Aged 9-14 years old; Female; Received a VYA health services supported by the program\*, including HPV vaccination, on the date of recruitment
• Girl accompanied by an/other minor(s) only: Aged 9-14 years old; Female; Received a VYA health services supported by the program\*, including HPV vaccination, on the date of recruitment
• Girl completely unaccompanied: Aged 9-14 years old; Female; Received a VYA health services supported by the program\*, including HPV vaccination, on the date of recruitment
• Caregiver: Parent/legal guardian or caregiver of eligible 9-14-year-old girl (above); Accompanying eligible 9-14-year-old girl (above) during care/service visit; 18 years of age or older
• Girl accompanied by adult (18+) parent/legal guardian: Does not provide informed assent; Parent/legal guardian does not provide consent; Requires urgent medical treatment or referral
• Girl accompanied by an/other adult(s) (18+): • Does not provide informed assent; Caregiver does not provide permission; Requires urgent medical treatment or referral
• Girl accompanied by an/other minor(s) only or completely unaccompanied: Does not provide informed assent; Requires urgent medical treatment or referral
• Caregiver: Does not provide informed consent

Sponsors & Collaborators

• Population Services International: lead
• Addis Ababa University: collaborator
• Federal Democratic Republic of Ethiopia Ministry of Health: collaborator

Study Officials

• Wakgari Deressa, PhD MPH

  College of Health Sciences, Addis Ababa University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire W Rothschild, PhD, MS

CONTACT

206-909-6982; crothschild@psi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-assigned intervention treatment with concurrent comparison clusters

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 31, 2024
• Study Start: October 31, 2024
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF