HPV Vaccine Integrated Service Implementation Research in Cameroon

NCT06683664 | Not Yet Recruiting

• 2 other identifiers: 1861.2.2024GAVI100001663
• Study Type: interventional
• Target: 40
• 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 and boys in the North and Far North Regions of Cameroon. The main questions this study aims to answer are:

• Can a package of community-based interventions increase delivery of routine HPV vaccination to boys and girls aged 9-13 in Cameroon's North and Far North Regions?
• What is the acceptability, feasibility, cost, and potential for maintenance and scale of an integrated health intervention to deliver routine HPV vaccination in Cameroon? 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 9 months 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. The study will be conducted in two phases, with the first phase focused on gathering formative data through interviews with key informants. This data will be used to inform the design of the intervention, which will be implemented and evaluated in phase 2. Only phase 1 of this study protocol has been currently approved. In phase 1, key informant interview participants will be asked to participate in a an interview to discuss HPV vaccination services and their perspectives on how to integrate HPV vaccination within existing community-based and health facility structures and programs. Key informants will include government officials, health program implementers, representatives from non-government organizations working on HPV vaccine delivery, and healthcare providers, as well as community leaders including school and religious leaders.

Conditions

Papillomavirus Vaccines; HPV Vaccinations; HPV Vaccines; HPV Vaccine Acceptability; HPV Vaccine Attitudes; HPV Vaccine Knowledge; Adolescent Health; Adolescent Health Services

Keywords

Implementation Science; Cameroon; Implementation Research; Mixed Methods

Outcome Measures

Primary Outcomes (1)

• HPV vaccine delivery

  Number of HPV vaccinations provided to adolescents aged 9-13 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 adolescents

EXPERIMENTAL

The intervention will be implemented in 90 non-randomly selected health facilities and their catchment areas located in the North and Far North Regions of Cameroon. 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 adolescents girls and boys \[aged 9-13 years\]) 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 engaged through the exiting Programme d'Accès aux Services de Santé de la Reproduction (PASSR), strengthened linkages between households and health facilities, and routinized HPV and adolescent health service delivery within communities.

Other: Integrated health service delivery for very young adolescents

Standard of care

NO INTERVENTION

90 non-randomly selected health facilities and their catchment areas supported by the Programme d'Accès aux Services de Santé de la Reproduction (PASSR) have been selected as concurrent comparison areas. These sites will conduct HPV vaccination (and other other adolescent health service delivery) through the standard-of-care procedures.

Interventions

Integrated health service delivery for very young adolescents OTHER

The proposed HPV-PASSREV intervention will aim to increase adolescent-centered access to HPV vaccination and other very young adolescent health services through an integrated, routine, community-based delivery model that incorporates household mobilization efforts with enhanced service delivery at the health facility and community levels.

Integrated health service delivery for very young adolescents

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Key informant identified by study and implementation teams (purposive sampling by key informant type)

You may not qualify if:

• Does not provide written informed consent

Sponsors & Collaborators

• Population Services International: lead
• Fobang Institutes for Innovations in Science and Technology: collaborator

Study Officials

• Wilfred Mbacham, ScD, DS

  Fobang Institutes for Innovations in Science and Technology

  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: November 8, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

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