Increase HPV Vaccination UptakeNCT02600884

Efficacy Trial of a Brief Parent-Based Adolescent Sexual Health Intervention

A study testing Families Talking Together Plus (FTT+HPV) and Brief motivational interviewing (BMI) in people with Increase HPV Vaccination Uptake and Delay Sexual Debut, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 11 years and olderHealthy volunteers can take part
Conditions the study is for: Increase HPV Vaccination Uptake, Delay Sexual Debut
What is being tested?: Families Talking Together Plus (FTT+HPV) and Brief motivational interviewing (BMI)
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,183 participants
Where: 1 siteUnited States
Study dates: Sep 2015to Apr 2019
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 11 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Parent: resides with a child 11-14 years old who attends a participating community center, after-school program, or Boys and Girls Club (BGC)
Parent: available for a face-to-face or small group session with the PI or student nurse within 2 months of consenting and assenting to participate in the study
Parent: can read, write, and speak English or Spanish
Child: between 11-14 years of age

Who cannot join

Parent: Without primary custody of child
Parent: Incarcerated
Parent: Unable to attend a face-to-face session within 2 months

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

The purpose of this research study is to evaluate a brief parent-based adolescent sexual health intervention called Families Talking Together Plus (FTT+). FTT+ is based on an established intervention called Families Talking Together (FTT) and will enhance FTT by adding modules on human papillomavirus (HPV). The goal of the study is to evaluate whether FTT will help parents increase sexual health communication, delay adolescent sexual debut, and increase HPV vaccination. FTT will be delivered to parents of minority youth and will be delivered by student nurses.

Conditions: Increase HPV Vaccination Uptake, Delay Sexual Debut
Being tested: Families Talking Together Plus (FTT+HPV), Brief motivational interviewing (BMI)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Families Talking Together Plus (FTT+HPV)Behavioural
Intervention parents will attend a 1-hour intervention session and receive program materials to use with youth at home and 2 booster phone calls post intervention. Content of the experimental intervention includes parent child sexual health communication and HPV vaccination navigation.
Brief motivational interviewing (BMI)Behavioural
Control parents will attend a 1-hour intervention session and receive program materials to use with youth at home and 2 booster phone calls post intervention. Content of the control intervention includes obesity prevention strategies using motivational interviewing.

Study groups in NCT02600884
Study group	Role	What they receive
Families Talking Together Plus (FTT+HPV)	Experimental	Parents in the experimental group will attend a 1-hour intervention session, receive program materials to use with youth at home, and receive 2 booster phone calls post-intervention. Content of the experimental intervention includes parent-child sexual health communication and HPV vaccination navigation. Receives: Behavioral: Families Talking Together Plus (FTT+HPV)
Brief motivational interviewing (BMI)	Active comparator	Parents in the brief motivational interviewing (BMI) group will attend a 1-hour intervention session, receive program materials to use with youth at home, and receive 2 booster phone calls post-intervention. Content of the control intervention includes obesity prevention strategies using motivational interviewing. Receives: Behavioral: Brief motivational interviewing (BMI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents
The FTT + HPV survey is a survey that has been developed by the investigator for this study. The survey is administered at baseline, 1, and 6 months using iPads and is available as Audio Computer-Assisted Self-Interviews in both English and Spanish.
Measured: 1 month
Change in parent child communication as assessed by the FTT + HPV survey administered to parents
Measured: 6 months
Change in intentions for sex as assessed by the FTT + HPV survey administered to youths
Measured: 1 month
Change in intentions for sex as assessed by the FTT + HPV survey administered to youths
Measured: 6 months

Secondary outcomes (16)

Change in parental monitoring as assessed by the FTT + HPV survey administered to parents
Measured: 1 month
Change in parental monitoring as assessed by the FTT + HPV survey administered to parents
Measured: 6 months
Change in parental involvement as Assessed by the FTT + HPV survey administered to parents
Measured: 1 month
Change in parental involvement as assessed by the FTT + HPV survey administered to parents
Measured: 6 months
Change in intentions for communication as assessed by the FTT + HPV survey administered to parents
Measured: 1 month
Change in intentions for communication as assessed by the FTT + HPV survey administered to parents
Measured: 6 months
Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents
Measured: 1 month
Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents
Measured: 6 months
Change in sexual activity as assessed by the FTT + HPV survey administered to youths
Measured: 1 month
Change in sexual activity as assessed by the FTT + HPV survey administered to youths
Measured: 6 months
Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths
Measured: 1 month
Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths
Measured: 6 months
Change in parental communication as assessed by the FTT + HPV survey administered to youths
Measured: 1 month
Change in parental communication as assessed by the FTT + HPV survey administered to youths
Measured: 6 months
Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths
Measured: 1 month
Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Apr 2019

First posted9 Nov 2015 (estimated)
Study startSep 2015
Primary completionNov 2018
Study completionApr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Increase HPV Vaccination UptakeStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe 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
Masking: None (open label)
Enrolment: 1,183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02600884
Sponsor's protocol ID: HSC-SN-15-0091
Status last verified: Oct 2023
First submitted: 5 Nov 2015
Last updated: 3 Nov 2023
Results posted: No
Data monitoring committee: No

Publications

Coleman DC, Frederick A, Cron S, Markham C, Guilamo-Ramos V, Santa Maria D. Impact of preparing nursing students to deliver a parent-based sexual health intervention on attitudes and intentions for sexual health education and parent communication counseling: a mixed methods study. BMC Nurs. 2023 Oct 10;22(1):375. doi: 10.1186/s12912-023-01531-2.
PubMed 37817237
Santa Maria D, Markham C, Misra SM, Coleman DC, Lyons M, Desormeaux C, Cron S, Guilamo-Ramos V. Effects of a randomized controlled trial of a brief, student-nurse led, parent-based sexual health intervention on parental protective factors and HPV vaccination uptake. BMC Public Health. 2021 Mar 24;21(1):585. doi: 10.1186/s12889-021-10534-0.
PubMed 33761920

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy Trial of a Brief Parent-Based Adolescent Sexual Health Intervention
ClinicalTrials.gov ID: NCT02600884
Acronym / sponsor ID: HSC-SN-15-0091
Conditions: Increase HPV Vaccination Uptake, Delay Sexual Debut
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,183 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: Sep 2015 (actual)
Primary completion: Nov 2018 (actual)
Study completion: Apr 2019 (actual)
First posted: 9 Nov 2015 (estimated)
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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Families Talking Together Plus (FTT+HPV)	Experimental	Behavioral: Families Talking Together Plus (FTT+HPV)Parents in the experimental group will attend a 1-hour intervention session, receive program materials to use with youth at home, and receive 2 booster phone calls post-intervention. Content of the experimental intervention includes parent-child sexual health communication and HPV vaccination navigation.
Brief motivational interviewing (BMI)	Active comparator	Behavioral: Brief motivational interviewing (BMI)Parents in the brief motivational interviewing (BMI) group will attend a 1-hour intervention session, receive program materials to use with youth at home, and receive 2 booster phone calls post-intervention. Content of the control intervention includes obesity prevention strategies using motivational interviewing.

Who may qualify

Ages: 11 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Parent: resides with a child 11-14 years old who attends a participating community center, after-school program, or Boys and Girls Club (BGC)
Parent: available for a face-to-face or small group session with the PI or student nurse within 2 months of consenting and assenting to participate in the study
Parent: can read, write, and speak English or Spanish
Child: between 11-14 years of age

Key exclusion criteria (3 listed)

Parent: Without primary custody of child
Parent: Incarcerated
Parent: Unable to attend a face-to-face session within 2 months

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
Families Talking Together Plus (FTT+HPV)Intervention parents will attend a 1-hour intervention session and receive program materials to use with youth at home and 2 booster phone calls post intervention. Content of the experimental intervention includes parent child sexual health communication and HPV vaccination navigation.	Behavioural	Families Talking Together Plus (FTT+HPV)
Brief motivational interviewing (BMI)Control parents will attend a 1-hour intervention session and receive program materials to use with youth at home and 2 booster phone calls post intervention. Content of the control intervention includes obesity prevention strategies using motivational interviewing.	Behavioural	Brief motivational interviewing (BMI)

Primary outcome

Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents
Time frame: 1 month
The FTT + HPV survey is a survey that has been developed by the investigator for this study. The survey is administered at baseline, 1, and 6 months using iPads and is available as Audio Computer-Assisted Self-Interviews in both English and Spanish.
Change in parent child communication as assessed by the FTT + HPV survey administered to parents
Time frame: 6 months
Change in intentions for sex as assessed by the FTT + HPV survey administered to youths
Time frame: 1 month
Change in intentions for sex as assessed by the FTT + HPV survey administered to youths
Time frame: 6 months

16 secondary outcomes

Change in parental monitoring as assessed by the FTT + HPV survey administered to parents
Time frame: 1 month
Change in parental monitoring as assessed by the FTT + HPV survey administered to parents
Time frame: 6 months
Change in parental involvement as Assessed by the FTT + HPV survey administered to parents
Time frame: 1 month
Change in parental involvement as assessed by the FTT + HPV survey administered to parents
Time frame: 6 months
Change in intentions for communication as assessed by the FTT + HPV survey administered to parents
Time frame: 1 month
Change in intentions for communication as assessed by the FTT + HPV survey administered to parents
Time frame: 6 months
Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents
Time frame: 1 month
Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents
Time frame: 6 months
Change in sexual activity as assessed by the FTT + HPV survey administered to youths
Time frame: 1 month
Change in sexual activity as assessed by the FTT + HPV survey administered to youths
Time frame: 6 months
Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths
Time frame: 1 month
Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths
Time frame: 6 months
Change in parental communication as assessed by the FTT + HPV survey administered to youths
Time frame: 1 month
Change in parental communication as assessed by the FTT + HPV survey administered to youths
Time frame: 6 months
Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths
Time frame: 1 month
Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths
Time frame: 6 months

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 3 Nov 2023.
Derived from this study: PubMed 37817237Coleman DC, Frederick A, Cron S, Markham C, Guilamo-Ramos V, Santa Maria D. Impact of preparing nursing students to deliver a parent-based sexual health intervention on attitudes and intentions for sexual health education and parent communication counseling: a mixed methods study. BMC Nurs. 2023 Oct 10;22(1):375. doi: 10.1186/s12912-023-01531-2.
Derived from this study: PubMed 33761920Santa Maria D, Markham C, Misra SM, Coleman DC, Lyons M, Desormeaux C, Cron S, Guilamo-Ramos V. Effects of a randomized controlled trial of a brief, student-nurse led, parent-based sexual health intervention on parental protective factors and HPV vaccination uptake. BMC Public Health. 2021 Mar 24;21(1):585. doi: 10.1186/s12889-021-10534-0.

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.

Diane Santa Maria, DrPH principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents (time frame: 1 month). The study lists 4 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 NCT02600884, which also lists 2 linked publications.

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 3 Nov 2023.