RBR-557mbvy Intervention with access information via cell phone to increase the use of the HPV vaccine in people living with HIV/AID...

Date of registration: 10/31/2024 ^(mm/dd/yyyy)
Last approval date : 10/31/2024 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1314-2194

• Public title:

  en

  Intervention with access information via cell phone to increase the use of the HPV vaccine in people living with HIV/AIDS

  pt-br

  Intervenção com informações de acesso via celular para aumentar a utilização da vacina HPV em pessoas vivendo com HIV/AIDS

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 43282821.9.0000.0040
    Issuing authority: Plataforma Brasil
  • 4.677.610
    Issuing authority: Comitê de Ética em Pesquisa do Centro de Pesquisas Gonçalo Moniz - FIOCRUZ/BA

Sponsors

• Primary sponsor: Centro de Pesquisas Gonçalo Moniz - FIOCRUZ/ BA
• Secondary sponsor:
  • Institution: Centro de Pesquisas Gonçalo Moniz - FIOCRUZ/ BA
• Supporting source:
  • Institution: Centro de Pesquisas Gonçalo Moniz - FIOCRUZ/ BA

Health conditions

• Health conditions:

  en

  HIV infections

  pt-br

  Infecção por HIV

• General descriptors for health conditions:

  en

  B04.280.210.655.450 Human Papillomavirus Viruses

  pt-br

  B04.280.210.655.450 Papillomavirus Humano HPV

• Specific descriptors:

  en

  C01.221.250.875 HIV infections

  pt-br

  C01.221.250.875 Infecção por HIV

Interventions

• Interventions:

  en

  This is a two-arm, double-blind, randomized controlled study. In the experimental group: individuals living with HIV/AIDS will receive information about HPV and the HPV vaccine, prepared based on the Theory of Motivation for Protection (TMP) in a web intervention developed for mobile devices. In the control group: individuals living with HIV/AIDS will receive a synopsis of information from the page maintained by the Ministry of Health dedicated to informing the population about HPV and the HPV vaccine. The experimental and control intervention will be offered to a total sample with an estimated size of at least 396 participants in a randomized manner in a 1:1 ratio.

  pt-br

  Trata-se de um estudo randomizado controlado de dois braços, duplo-cego. No grupo experimental: os indivíduos vivendo com HIV/AIDS receberão informações sobre o HPV e a vacina HPV, elaboradas sob as bases da Teoria da Motivação para Proteção (TMP) numa intervenção web desenvolvida para dispositivos móveis. No grupo controle: os indivíduos vivendo com HIV/AIDS receberão uma sinopse de informações da página mantida pelo Ministério da Saúde dedicada a informar a população sobre o HPV e a vacina HPV. A intervenção experimental e a controle serão oferecidas a uma amostra total com tamanho estimado de pelo menos 396 participantes de forma aleatorizada na relação de 1:1.

• Descriptors:

  en

  N02.421.726.758.310.890.750 Vaccination coverage

  pt-br

  N02.421.726.758.310.890.750 Cobertura vacinal

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 01/06/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  396	-	18 Y	45 Y

• Inclusion criteria:

  en

  Women and men between the ages of 18–45 years; living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS); and who provided informed consent to participate

  pt-br

  Mulheres e homens com idades compreendidas entre os 18 e os 45 anos; que vivem com vírus da imunodeficiência humana (VIH)/síndrome de imunodeficiência adquirida (SID); e que forneceram consentimento informado para participar

• Exclusion criteria:

  en

  Women and men who had received any dose of human papillomavirus (HPV) vaccine

  pt-br

  Mulheres e homens que receberam qualquer dose da vacina contra o papilomavírus humano (HPV)

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Prevention	Parallel	2	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Expected outcome 1: It is expected to find a higher percentage of individuals intending to be vaccinated in the experimental group compared to the control group after the intervention, based on the finding of a difference greater than or equal to 10% in the percentage of participants who declared their intention to get vaccinated in the respective groups

  pt-br

  Desfecho esperado 1: Espera-se encontrar um percentual maior de indivíduos com intenção de se vacinar no grupo experimental comparado ao grupo controle após a intervenção, a partir da constatação de uma diferença maior ou igual a 10% no percentual de participantes que declararam intenção em se vacinar nos respectivos grupos

  en

  Outcome found 1: A significantly higher percentage of individuals intending to be vaccinated was observed in the experimental group (91%) compared to the control group (83%) after the intervention

  pt-br

  Desfecho encontrado 1: Foi observado um percentual significativamente maior de indivíduos com intenção de se vacinar no grupo experimental (91%) comparado ao grupo controle (83%) após a intervenção

• Secondary outcomes:

  en

  Outcome found 2: A significantly higher percentage of individuals starting vaccination (receiving at least one dose of vaccine) was observed in the experimental group (28%) compared to the control group (16%) after the intervention

  pt-br

  Desfecho encontrado 2: Foi observado um percentual significativamente maior de indivíduos iniciando a vacinação (recebendo pelo menos uma dose da vacina) no grupo experimental (28%) comparado ao grupo controle (16%) após a intervenção

  en

  Expected outcome 2: It is expected to find a higher percentage of initiation of vaccination (receipt of at least one dose of vaccine) in individuals in the experimental group compared to the control group after the intervention, based on the finding of a statistically significant difference in the percentage of participants who started vaccination in their respective groups

  pt-br

  Desfecho esperado 2: Espera-se encontrar um percentual de iniciação da vacinação (recebimento de pelo menos uma dose da vacina) maior nos indivíduos do grupo experimental comparado ao grupo controle após a intervenção, a partir da constatação de uma diferença estatisticamente significativa no percentual de participantes que iniciaram a vacinação nos respectivos grupos

Contacts

• Public contact
  • Full name: Kaliane Caldas Brito
  • • Address: Rua Waldemar Falcão 121
    • City: Salvador / Brazil
    • Zip code: 40296-710
  • Phone: +55-71-3176-2343
  • Email: kaliane.caldas@fiocruz.br
  • Affiliation: Instituto Gonçalo Moniz
   
• Scientific contact
  • Full name: Edson Duarte Moreira
  • • Address: Rua Waldemar Falcão 121
    • City: Salvador / Brazil
    • Zip code: 40296-710
  • Phone: +55-71-3176-2343
  • Email: edson.moreira@fiocruz.br
  • Affiliation: Instituto Gonçalo Moniz
   
• Site contact
  • Full name: Edson Duarte Moreira
  • • Address: Rua Waldemar Falcão 121
    • City: Salvador / Brazil
    • Zip code: 40296-710
  • Phone: +55-71-3176-2343
  • Email: edson.moreira@fiocruz.br
  • Affiliation: Instituto Gonçalo Moniz
   

Additional links:

• Download in ICTRP format