Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Vaccine-Preventable Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

Immunologic Factors

Single dose of the 4-valent HPV vaccine (Gardasil®; Merck \& Co.) offered to all eligible boys aged 14 to 18 years in the 13 intervention communities. Girls aged 14 years are offered 2 doses of Gardasil® through the Tanzanian national HPV vaccine programme

Girls aged 14 years are offered 2 doses of Gardasil® through the Tanzanian national HPV vaccine programme

Single dose 4-valent HPV vaccine in males. Gardasil®, manufactured by MSD, consists of a licensed prophylactic virus-like particle (VLP) vaccine that protects against 4 HPV genotypes (HPV 6, 11, 16, 18).

Gardasil® HPV vaccine

Add-Vacc is an unblinded cluster-randomised trial (CRT) with two arms: (i) the national HPV vaccination programme (girls aged \~14 years, control arm) and (ii) the national programme plus single-dose male HPV vaccination given to a multi-year cohort of boys (intervention arm). The CRT will be conducted in 26 communities/clusters (13 per arm) in northern Tanzania. Boys aged 14 to 18 years in the intervention arm will receive one dose of the 4-valent HPV vaccine (Gardasil®) that protects against HPV 6, 11, 16, and 18. Population genital HPV prevalence in 18 to 21-year-olds will be compared between intervention clusters (female and male vaccination) and control clusters (female vaccination only) at 3 years after the intervention. Blood sampling for immune responses and adverse event data collection will be performed in a subset of 200 male subjects in selected intervention clusters.

Cluster randomised trial with 26 communities (13 per arm)

Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania

Prevalence of 4-valent vaccine HPV genotype DNA (HPV 6, 11, 16 or 18) in males and females aged 18 to 21 years in intervention clusters and control clusters 36 months post-male vaccination

Proportion seroconverting to, and geometric mean antibody titres (GMTs) for, HPV vaccine genotypes, and safety and tolerability (local and systemic adverse events), measured in a subset of 200 vaccinated boys

The proportion of females, and of males, aged 18 to 21 years in the control arm with detectable genital 4-valent HPV vaccine genotype DNA at baseline and at M36.

The proportion of females aged 16 years who received 1 dose of HPV vaccine (uptake) and who complete 2 doses (coverage) by arm at baseline and M36

Self-reported acceptability of and barriers to receiving male vaccination by community members and to delivering male HPV vaccination by health care workers (HCW)

Incremental cost-effectiveness ratio for single dose male vaccination plus existing female vaccination programme compared to female vaccination only

Mwanza Intervention Trials Unit, National Institute for Medical Research

York Biomedical Research Institute, Hull York Medical School, University of York

Cancer Epidemiology Research Programme Institut Català d' Oncologia

Karolinska Institute Department of Laboratory Medicine

Department of Pathology University of Cambridge

London School of Hygiene and Tropical Medicine

Neoplasms

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All girls attending standard 6 in schools selected for class-based vaccine delivery

All girls born in 1998 attending schools selected for age-based delivery

Deborah :L Watson-Jones, MD, PhD

Richard J Hayes, DSC

John Changalucha, BSc

The aims of this study are:

1. To determine feasibility of a school-based human papillomavirus (HPV) vaccination programme in Tanzania.
2. To measure the uptake and acceptability of two different vaccination strategies in rural and urban schools.
3. To examine the characteristics of accepters/refusers of vaccination and to identify reasons for acceptance, refusal or non-completion.
4. To measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

Vaccines against human papillomavirus infection, the primary cause of cervical cancer, are an attractive cervical cancer prevention strategy for resource poor settings which lack the infrastructure for establishing and maintaining complex screening programmes.Feasibility and costs of setting up and sustaining an HPV vaccination programme will depend on whether it can be added onto an existing health programme within schools, if one exists, or whether it has to be established as a separate health intervention. Other factors will also affect vaccine coverage. For example, uptake and overall effectiveness will be critically dependent on parental and community acceptability of a vaccine that prevents a sexually transmitted infection and how the vaccine is promoted and delivered by health-care providers will influence its uptake and acceptability.

This study will determine feasibility, uptake and acceptability of different delivery strategies of school-based HPV vaccination in Tanzania, examine factors related to acceptance or refusal of vaccination and measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

Three doses of quadrivalent human papillomavirus (HPV) vaccine, (Gardasil®; Merck \& Co) given at 0, 2 and 6 months, will be provided to 5000 primary school girls at 134 randomly selected schools in Mwanza Region in Tanzania. Selected schools will be randomly assigned to one of two delivery strategies (age-based or class-based) and coverage and acceptability of these vaccine delivery strategies will be compared. Qualitative research will be conducted before, during and after vaccination to examine barriers to vaccination and reasons for failure to complete vaccination as well as general community perceptions. To determine factors associated with refusal a case control study will be conducted on a 1:1 sample of 350 vaccine refusers and 350 accepters. The costs of introducing and scaling up HPV vaccines in schools will be estimated using established costing methods.

Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

Vaccine coverage will be estimated for each dose given and for those completing the full course of vaccination and compared by delivery strategy.

A case control study to determine factors associated with refusal will be conducted on a 1:1 sample of 350 vaccine refusers and 350 accepters.

Qualitative research will be conducted to examine barriers to vaccination and reasons for failure to complete vaccination.

Full financial and economic costs from the provider's perspective will be collected for the intervention. Total costs of a district vaccination programme and cost per urban school and rural school reached (if urban/rural differences are identified) and cost per fully-vaccinated girl will be estimated for the two alternative delivery strategies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania	NCT04953130	HPV Infection Vaccine Prevent...	Gardasil® HPV v...	14 Years - 18 Years	London School of Hygiene and Tropical Medicine
Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls	NCT01173900	Cervical Cancer	Gardasil® HPV v...	9 Years -	London School of Hygiene and Tropical Medicine
Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania	NCT04953130	HPV Infection Vaccine Prevent...	Gardasil® HPV v...	14 Years - 18 Years	London School of Hygiene and Tropical Medicine

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