ClinicalTrials.gg
Active, not recruitingNCT06915844SHARP-TZUpdated Aug 13, 2025

Integrated HPV Vaccination and Adolescent Health in Tanzania

An interventional study of SHARP Tanzania in Integrated Care, Adolescent and HPV, sponsored by Jhpiego. Active, not recruiting at 1 site in Tanzania. Open to participants aged 9 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by Jhpiego · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
3,000
Allocation
Non-randomized
Ages
9 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Integrated Care
  • Adolescent
  • HPV
03

In context

Lead sponsor

Jhpiego is the lead sponsor of 32 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and agrees to participate in the study.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
3,000 participants (estimated)

Study arms

  • Experimental
    Intervention

    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.

    Behavioral: SHARP Tanzania

  • No intervention
    Comparison

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

Interventions

  • BehavioralSHARP Tanzania

    Building on existing adolescent health services, including HPV+, this intervention adds desired services for adolescent health education, screening, counseling, and referrals. In addition, this intervention has strategic community engagement to identify out of school girls with limited access to existing integrated health services available in schools, community sensitization activities, and training for healthcare workers.

06

What researchers measure

Primary outcomes

  1. Number/proportion of adolescent girls vaccinated for HPV

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

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

  2. Number/proportion of adolescent girls intending to get HPV vaccine

    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.

    Time frame: Endline (after ~6 months intervention)

Secondary outcomes

  1. Number/proportion of participants with HPV knowledge

    This measure will be captured through a survey by several knowledge related items, including a standardized composite measure.

    Time frame: Endline (after ~6 months intervention)

  2. Number/proportion of participants with positive attitudes towards integrated services

    This outcome reflects several indicators related to attitudes related to accessing integrated adolescent health services, including HPV vaccination

    Time frame: Endline (after ~6 months intervention)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06915844
Lead sponsor
Jhpiego
Responsible party
Sponsor
First posted
Apr 8, 2025
Start date
May 22, 2025
Primary completion
Nov 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 13, 2025

Study contacts

Pooja Sripad, PhD, MPH
principal investigator · Jhpiego

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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