Clinical trial NCT01173900: Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls
Official title: Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Cancer
Keywords: human papillomavirus
vaccine
school girls
Tanzania
acceptability
vaccine coverage
Cervical cancer prevention
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research, Tanzania
name: Ocean Road Cancer Institute, Tanzania
name: Institut Català d' Oncologia, Spain
name: Medical Research Council Social & Public Health Sciences Unit, UK
name: International Union Against Cancer, Switzerland
First posted: 2010-08-02
Enrollment: 5532
Sex: FEMALE
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* female pupil
* attends selected school
* born in 1998 if enrolled in school selected for age-based delivery
* attending standard (class) 6 if enrolled in school selected for class-based delivery

Exclusion Criteria:

* has not previously received HPV vaccine
* has not participated in previous HPV vaccine trials

Primary outcomes:
measure: Vaccine coverage by delivery strategy
timeFrame: Month 12
measure: Vaccine coverage (dose 2) by delivery strategy
timeFrame: Month 5
measure: Vaccine coverage (dose 1) by delivery strategy
timeFrame: Month 3
Secondary outcomes:
measure: Factors associated with refusal to vaccinate or to complete vaccination course
timeFrame: Month 12
measure: Identification of barriers to HPV vaccination
timeFrame: Month 14
measure: Estimation of the costs of introducing and scaling up HPV vaccines in schools
timeFrame: Month 10
Other outcomes:
Locations:
city: Mwanza
country: Tanzania
facility: National Institute for Medical Research
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Deborah :L Watson-Jones, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Richard J Hayes, DSC
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute for Medical Research
name: John Changalucha, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quentin W, Terris-Prestholt F, Changalucha J, Soteli S, Edmunds WJ, Hutubessy R, Ross DA, Kapiga S, Hayes R, Watson-Jones D. Costs of delivering human papillomavirus vaccination to schoolgirls in Mwanza Region, Tanzania. BMC Med. 2012 Nov 13;10:137. doi: 10.1186/1741-7015-10-137.
citation: Watson-Jones D, Baisley K, Ponsiano R, Lemme F, Remes P, Ross D, Kapiga S, Mayaud P, de Sanjose S, Wight D, Changalucha J, Hayes R. Human papillomavirus vaccination in Tanzanian schoolgirls: cluster-randomized trial comparing 2 vaccine-delivery strategies. J Infect Dis. 2012 Sep 1;206(5):678-86. doi: 10.1093/infdis/jis407. Epub 2012 Jun 18.