NCT05767138

Brief Summary

Although screening for pre-cancerous cervical lesions and human papilloma virus (HPV) vaccination are accepted and effective means to prevent cervical cancer, women in Mali have limited access to these interventions. In addition, cervical cancer prevention by HPV vaccination has been controversial in some settings. To reduce cervical cancer prevalence and increase HPV vaccine uptake, it is important to understand the level of knowledge about cervical cancer screening and practices related to vaccination in at-risk populations. In this study, the level of knowledge about HPV and cervical cancer and attitudes towards vaccination were assessed among 301 participants (male and female, adults and adolescents) in a house-to-house survey in two urban neighborhoods in Bamako, Mali. The survey was combined with a brief educational session on HPV. Prior to the education session, overall knowledge of HPV infection and cervical cancer was very low: only 8% knew that HPV is a sexually transmitted infection (STI). Less than 20% of women had ever consulted a gynecologist and less than 3% had ever had cervical cancer screening. After hearing a description of HPV vaccine, more than 80% would accept HPV vaccination; fathers and husbands were identified as primary decisions makers and local clinics or the home as preferred sites for vaccination. This study provides information on STI knowledge and vaccine acceptance in Bamako, Mali in 2012, prior to the introduction of HPV vaccination.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

October 26, 2022

Last Update Submit

March 1, 2023

Conditions

Keywords

MaliBamakoSurvey

Outcome Measures

Primary Outcomes (1)

  • Participants' acceptance of the vaccine

    Number of participants willing to be vaccinated against HPV and their vaccination preferences after educational sessions

    immediately after the intervention

Secondary Outcomes (1)

  • Knowledge of STIs, HPV, and Cervical Cancer

    immediately after the intervention

Study Arms (1)

Bamako Participants

301 male and female participants. Teenagers and adults. Living in two urban regions of Bamako.

Behavioral: HPV Vaccine Acceptance Survey

Interventions

Bamako Participants

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants were recruited between May and June 2011 in Mèkin-Sikoro and Djikoroni, two peri-urban communities of Bamako that have been site for previous population surveys. Adolescents were eligible if aged 12-17 years and living in the household, and if a guardian was available to provide consent. Adults (male and female) were eligible if aged \>18 years and living in the household. A total of 301 participants participated (150 living in households in Djikoroni, 151 living in Me´kin-Sikoro)

You may qualify if:

  • years of age, with guardian consent
  • years or older
  • Male or Female
  • Living in Mèkin-Sikoro and Djikoroni

You may not qualify if:

  • years of age, without guardian consent
  • \<12 years of age
  • Living outside Mèkin-Sikoro and Djikoroni

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Anne De Groot, MD

    GAIA Vaccine Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

March 14, 2023

Study Start

March 1, 2011

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share