HPVNCT05767138
STI Knowledge and HPV Vaccine Acceptance in Bamako, Mali in 2012
An observational study of HPV and HPV-Related Cervical Carcinoma, run by Global Alliance to Immunize Against AIDS Vaccine Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- HPV, HPV-Related Cervical Carcinoma
- What is being tested?
- HPV Vaccine Acceptance Survey
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 301 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- 12-17 years of age, with guardian consent
- 18 years or older
- Male or Female
- Living in Mèkin-Sikoro and Djikoroni
Who cannot join
- 12-17 years of age, without guardian consent
- <12 years of age
- Living outside Mèkin-Sikoro and Djikoroni
About this study
Official title: Knowledge, Attitudes, Practices and Willingness to Vaccinate in Preparation for the Introduction of HPV Vaccines in Bamako, Mali
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.
- Conditions
- HPV, HPV-Related Cervical Carcinoma
- Being tested
- HPV Vaccine Acceptance Survey
- Keywords
- Mali, Bamako, Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Vaccine Acceptance SurveyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Bamako Participants | 301 male and female participants. Teenagers and adults. Living in two urban regions of Bamako. Receives: Behavioral: HPV Vaccine Acceptance Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' acceptance of the vaccine
Number of participants willing to be vaccinated against HPV and their vaccination preferences after educational sessions
Measured: immediately after the intervention
Secondary outcomes (1)
Knowledge of STIs, HPV, and Cervical Cancer
Knowledge Question asked before and after educational session
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study startMar 2011
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Alliance to Immunize Against AIDS Vaccine Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Anne De Groot, MD, Principal investigator, GAIA Vaccine Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767138
- Sponsor's protocol ID
- HPV Vaccine Survey
- Status last verified
- Mar 2023
- First submitted
- 26 Oct 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Attitudes, Practices and Willingness to Vaccinate in Preparation for the Introduction of HPV Vaccines in Bamako, Mali
- ClinicalTrials.gov ID
- NCT05767138
- Acronym / sponsor ID
- HPV Vaccine Survey
- Conditions
- HPV, HPV-Related Cervical Carcinoma
- Keywords
- Mali, Bamako, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Global Alliance to Immunize Against AIDS Vaccine FoundationUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2011 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bamako Participants | – | Behavioral: HPV Vaccine Acceptance Survey301 male and female participants. Teenagers and adults. Living in two urban regions of Bamako. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 12-17 years of age, with guardian consent
- 18 years or older
- Male or Female
- Living in Mèkin-Sikoro and Djikoroni
Key exclusion criteria (3 listed)
- 12-17 years of age, without guardian consent
- <12 years of age
- Living outside Mèkin-Sikoro and Djikoroni
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV Vaccine Acceptance Survey | Behavioural | Bamako Participants |
Primary outcome
Participants' acceptance of the vaccine
Time frame: immediately after the intervention
Number of participants willing to be vaccinated against HPV and their vaccination preferences after educational sessions
1 secondary outcome
Knowledge of STIs, HPV, and Cervical Cancer
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne De Groot, MD principal investigator
GAIA Vaccine Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of HPV and HPV-Related Cervical Carcinoma, run by Global Alliance to Immunize Against AIDS Vaccine Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' acceptance of the vaccine (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.