Cervical CancerNCT04154319
HPV Vaccination Among Daughters of Latina Immigrants
A study testing HPV Vaccination and Healthy Eating in people with Cervical Cancer and Healthy Diet, run by University of Alabama at Birmingham.
Trial summary
The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Healthy Diet
- What is being tested?
- HPV Vaccination and Healthy Eating
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2012to 10 Aug 2016
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Latina immigrant
- Resident of selected randomization unit (place of residence)
- 18 years of age and older
- At least one HPV unvaccinated daughter between the ages of 9 and 12
Who cannot join
- -
About this study
The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12.
Read the detailed description
Objective: Implementation and examination of the efficacy of a culturally relevant, community-based HPV vaccination intervention among daughters of Latina immigrants 9-12 years of age in Alabama.
Methods: Group-randomized controlled trial evaluating two interventions: 1) promotion of HPV vaccination and 2) promotion of healthy eating using "place of residence" as the unit of randomization. Between May 2013 and October 2017, forty locations with 317 mother-daughter dyads were enrolled.
- Conditions
- Cervical Cancer, Healthy Diet
- Being tested
- HPV Vaccination, Healthy Eating
- Keywords
- HPV vaccination, Healthy Eating, Latina immigrants
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV VaccinationBehavioural
Mothers assigned to this arm participated in educational/behavior change sessions to promote HPV vaccination among their unvaccinated 9-12 year old daughters
Healthy EatingBehavioural
Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels
| Study group | Role | What they receive |
|---|---|---|
| HPV Vaccination | Active comparator | Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters Receives: Behavioral: HPV Vaccination; Behavioral: Healthy Eating |
| Healthy Eating | Active comparator | Mothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation Receives: Behavioral: Healthy Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination among 9-12yo daughters of Latina immigrants
Daughters of mothers assigned to the HPV vaccination arm will more likely to complete the recommended HPV doses at 7-month follow-up than daughters of mothers assigned to the healthy eating arm.
Measured: 7 months
Healthy eating among Latina immigrants and their 9-12 yo daughters
Mothers and daughters assigned to the healthy eating arm will be more likely to eat fried food less than once per week, consume at least three portions of fruit/vegetables per day and have less than one sweetened beverage per day at 7-months than mothers and daughters assigned to the HPV vaccination arm
Measured: 7 months
Appropriate nutrition label interpretation among Latina immigrants mothers and 9-'12yo daughters
Mothers and daughters assigned to the healthy eating arm will be more likely to read nutrition labels sometimes/always and correctly interpret nutrition labels than mothers and daughters assigned to the HPV vaccination arm
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start15 Jun 2012
- Primary completion10 Aug 2016
- Study completion10 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group randomized trial
- Masking
- None (open label)
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Scarinci, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154319
- Sponsor's protocol ID
- IRB-120503007
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scarinci IC, Hansen B, Kim YI. A Cluster-Randomized Controlled Trial to Evaluate a Community-Based Healthy Eating and Nutrition Label Interpretation Intervention Among Latinx Immigrant Mothers and Their Daughters. J Community Health. 2021 Apr;46(2):313-323. doi: 10.1007/s10900-020-00885-x.
PubMed 32671515
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Vaccination Among Daughters of Latina Immigrants
- ClinicalTrials.gov ID
- NCT04154319
- Acronym / sponsor ID
- IRB-120503007
- Conditions
- Cervical Cancer, Healthy Diet
- Keywords
- HPV vaccination, Healthy Eating, Latina immigrants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Jun 2012 (actual)
- Primary completion
- 10 Aug 2016 (actual)
- Study completion
- 10 Aug 2016 (actual)
- First posted
- 6 Nov 2019 (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.
The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12.
Detailed description
Objective: Implementation and examination of the efficacy of a culturally relevant, community-based HPV vaccination intervention among daughters of Latina immigrants 9-12 years of age in Alabama.
Methods: Group-randomized controlled trial evaluating two interventions: 1) promotion of HPV vaccination and 2) promotion of healthy eating using "place of residence" as the unit of randomization. Between May 2013 and October 2017, forty locations with 317 mother-daughter dyads were enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group randomized trial
| Arm | Type | Receives |
|---|---|---|
| HPV Vaccination | Active comparator | Behavioral: HPV Vaccination, Behavioral: Healthy EatingMothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters |
| Healthy Eating | Active comparator | Behavioral: Healthy EatingMothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Latina immigrant
- Resident of selected randomization unit (place of residence)
- 18 years of age and older
- At least one HPV unvaccinated daughter between the ages of 9 and 12
Key exclusion criteria (1 listed)
- -
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 VaccinationMothers assigned to this arm participated in educational/behavior change sessions to promote HPV vaccination among their unvaccinated 9-12 year old daughters | Behavioural | HPV Vaccination |
| Healthy EatingMothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels | Behavioural | HPV Vaccination, Healthy Eating |
Primary outcome
HPV vaccination among 9-12yo daughters of Latina immigrants
Time frame: 7 months
Daughters of mothers assigned to the HPV vaccination arm will more likely to complete the recommended HPV doses at 7-month follow-up than daughters of mothers assigned to the healthy eating arm.
Healthy eating among Latina immigrants and their 9-12 yo daughters
Time frame: 7 months
Mothers and daughters assigned to the healthy eating arm will be more likely to eat fried food less than once per week, consume at least three portions of fruit/vegetables per day and have less than one sweetened beverage per day at 7-months than mothers and daughters assigned to the HPV vaccination arm
Appropriate nutrition label interpretation among Latina immigrants mothers and 9-'12yo daughters
Time frame: 7 months
Mothers and daughters assigned to the healthy eating arm will be more likely to read nutrition labels sometimes/always and correctly interpret nutrition labels than mothers and daughters assigned to the HPV vaccination arm
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 6 Nov 2019.
- Derived from this study: PubMed 32671515Scarinci IC, Hansen B, Kim YI. A Cluster-Randomized Controlled Trial to Evaluate a Community-Based Healthy Eating and Nutrition Label Interpretation Intervention Among Latinx Immigrant Mothers and Their Daughters. J Community Health. 2021 Apr;46(2):313-323. doi: 10.1007/s10900-020-00885-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Vaccination and Healthy Eating in people with Cervical Cancer and Healthy Diet, run by University of Alabama at Birmingham.
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 1 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 6 Nov 2019. 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?
HPV vaccination among 9-12yo daughters of Latina immigrants (time frame: 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154319, which also lists 1 linked publication.
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 6 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.