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临床试验/NCT06915844
NCT06915844进行中(未招募)不适用

Strengthening HPV Vaccination and Adolescent Health Research Program (SHARP) in Tanzania

Jhpiego1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Jhpiego
入组人数
3,000
试验地点
1
主要终点
Number/proportion of adolescent girls vaccinated for HPV

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
9 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Intervention

Experimental

The intervention arm will receive an adapted integrated adolescent health service package including HPV vaccination for 9-14 years, vision screening, nutritional services, comprehensive age-appropriate health education, appropriate screenings and referrals.

干预措施: SHARP Tanzania (Behavioral)

Comparison

No Intervention

The comparison arm will receive routine adolescent health services including existing school-based integrated packages.

结局指标

主要结局

Number/proportion of adolescent girls vaccinated for HPV

时间窗: Baseline (before intervention start) and at endline (after ~6 months intervention); monthly (program data)

This is an effectiveness measure that captures the HPV coverage among adolescent girls residing in the study areas.

Number/proportion of adolescent girls intending to get HPV vaccine

时间窗: Endline (after ~6 months intervention)

This measure, captured through the survey, aggregates those who have received HPV vaccination in the past 6 months as well as those who express an intention to get vaccinated in the next 6 months.

次要结局

  • Number/proportion of participants with HPV knowledge(Endline (after ~6 months intervention))
  • Number/proportion of participants with positive attitudes towards integrated services(Endline (after ~6 months intervention))

研究者

发起方
Jhpiego
申办方类型
Other
责任方
Sponsor

研究点 (1)

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