Clinical trial NCT06915844: Integrated HPV Vaccination and Adolescent Health in Tanzania
Official title: Strengthening HPV Vaccination and Adolescent Health Research Program (SHARP) in Tanzania
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Integrated Care
Adolescent
HPV
Lead sponsor: Jhpiego
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 3000
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Cervical cancer is a serious global public health problem, particularly in sub-Saharan Africa, where it is the leading cause of cancer in women, with around 70,722 new cases each year. Vaccination against human papillomavirus (HPV) prevents cervical cancer and is usually given to children around 9 to 15 years of age. HPV vaccination has been incorporated into many countries' Expanded Programs on Immunization, but often faces optimization and uptake challenges. SHARP is an implementation research initiative in Tanzania, Nigeria, and Côte d'Ivoire that is looking at the potential of combining HPV vaccination with with adolescent primary care/preventive health services - how this might work and its effect on the uptake of the HPV vaccine and other services.

Objective: To describe the feasibility, acceptability, effectiveness and sustainability of a locally-designed integrated adolescent health service package, including HPV vaccination in Tanzania. Specifically, this study aims to adapt an existing school based primary health care approaches, making service delivery not only more convenient but also more effective in addressing the specific needs of adolescents- focusing on out of school adolescents - in communities, and health facilities.

Methods: This is a quasi-experimental research study using a post intervention comparison approach to assess differences between an intervention group and a comparison group over time. It will use mixed methods drawing on quantitative surveys, qualitative interviews, service time motion assessment, and administrative data. The study will be conducted in two regions, each with an intervention and comparison district. The adapted adolescent integrated health intervention will be implemented in the intervention districts with routine service provision in comparison areas. Monthly administrative service coverage data and endline surveys will be conducted in up to 2880 households with 1400 parents/caregivers and 1600 adolescents will assess effectiveness by looking at changes in service uptake and coverage, as well in knowledge, attitudes, and practices towards HPV vaccination and integrated services. At endline, up to 68 in-depth interviews will be conducted with program managers, health officials, service providers, school authorities, community influencers and leaders, and adolescents and parents/caregivers will assess feasibility, acceptability and sustainability.


Eligibility criteria: Inclusion Criteria:

* Adolescents: Age: 9 to 15; Residence in the study regions; Parental or guardian permission is required; Provides assent and agrees to participate in the study.
* Parents/caregivers: Be the parent or legal guardian of an adolescent aged 9 to 15 years; Residence in the study regions; Provides informed consent and agrees to participate in the study.

Exclusion Criteria:

* People who have time constraints; participants who have medical conditions that make them unable to participate; those residing outside study health regions; those who do not provide consent/assent to participate.

Primary outcomes:
measure: Number/proportion of adolescent girls vaccinated for HPV
timeFrame: Baseline (before intervention start) and at endline (after ~6 months intervention); monthly (program data)
measure: Number/proportion of adolescent girls intending to get HPV vaccine
timeFrame: Endline (after ~6 months intervention)
Secondary outcomes:
measure: Number/proportion of participants with HPV knowledge
timeFrame: Endline (after ~6 months intervention)
measure: Number/proportion of participants with positive attitudes towards integrated services
timeFrame: Endline (after ~6 months intervention)
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences (MUHAS)
Study officials:
affiliation: Jhpiego
name: Pooja Sripad, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: