Pregnancy in AdolescenceNCT04970485
Evaluation of the Talking Matters Teen Pregnancy Prevention Program
A study testing Talking Matters in people with Pregnancy in Adolescence, run by Public Health Management Corporation at 1 site in United States.
Trial summary
A culturally tailored program that creates a safe, open space to increase knowledge, self-efficacy, skills, and comfort related to sexual and reproductive health, including HIV/STI and teen pregnancy prevention, mental health, and substance use risk reduction behavior, and strengthens protective factors… Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy in Adolescence
- What is being tested?
- Talking Matters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 31 Dec 2023
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Identifies as Black or African American
- 14 to 19 years old at baseline
- Lives in Philadelphia, PA
- English-speaking
- Able to or will be able to obtain access to the internet through a phone, tablet, or computer
Who cannot join
- Does not identify as Black or African American
- Less than 14 years old or 20 years or older at baseline
- Does not live in Philadelphia, PA
- Unable to speak or understand English
- Unable to access internet through a phone, tablet, or computer
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health Management Corporation
Philadelphia, Pennsylvania, 19102
About this study
Official title: Evaluation of the Talking Matters Teen Pregnancy Prevention Program Through a Randomized Controlled Trial Design
A culturally tailored program that creates a safe, open space to increase knowledge, self-efficacy, skills, and comfort related to sexual and reproductive health, including HIV/STI and teen pregnancy prevention, mental health, and substance use risk reduction behavior, and strengthens protective factors, decision-making skills, and connections to trusted adults may help participants chart a path toward optimal health. To address a significant gap in evidence-based, culturally-tailored sexual and reproductive health services for Black and African American adolescents, Public Health Management Corporation (PHMC) is conducting a rigorous evaluation of an innovative group-level, two pronged intervention called Talking Matters using an individual randomized control trial (RCT) design. Due to social distancing guidelines during COVID-19 at the start of the study, all Talking Matters activities, including recruitment, screening, consent, intervention implementation, and data collection, will be conduct virtually and remotely.
Developed and piloted over the past two years through FY2018 Phase I New and Innovative Strategies (Tier 2) to Prevent Teen Pregnancy and Promote Healthy Adolescence funding from the Office of Population Affairs (OPA), Talking Matters is a promising group-level, two-pronged intervention tailored for urban Black and African American 14 to 19 year old adolescents who are recruited from school- and community-based settings in Philadelphia, PA. Grounded in Social Cognitive Theory, the Transtheoretical Model, and Self-Determination Theory, and using evidence-based Motivational Interviewing strategies, the primary goals of Talking Matters are to reduce adolescents' risk for teen and unplanned pregnancy, sexually transmitted infections (STIs) and HIV, and to strengthen protective factors improve optimal health.
The two prongs of Talking Matters include (1) an adolescent-focused five-session, group-level intervention called We Get to Choose (WGTC) and (2) an adult-focused three-session, group-level training called Let's Talk Real Talk (LTRT). An opportunity to connect WGTC participants to trusted adults who completed LTRT is provided during one facilitated session conducted each quarter. Adult participants of the LTRT training are not human subjects of the Talking Matters study.
- Conditions
- Pregnancy in Adolescence
- Being tested
- Talking Matters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talking MattersBehavioural
Also called We Get to Choose, Let's Talk Real Talk
Group-level, facilitator-led behavioral intervention for 14-19 year old Black and African American adolescents with an intergenerational component to reduce teen pregnancy, strengthen protective factors to improve optimal health, and increase access to trusted adults.
| Study group | Role | What they receive |
|---|---|---|
| Talking Matters intervention | Experimental | Talking Matters is a group-level, two-pronged intervention for Black and African American 14 to 19 year old adolescents recruited from school- and community-based settings in Philadelphia, PA. Goals are to reduce teens' risk for unplanned pregnancy, sexually transmitted infections, and HIV, and to strengthen protective factors to improve health. The two prongs include (1) an adolescent-focused five-session, group-level intervention called We Get to Choose (WGTC) covering sexual and reproductive health (SRH) knowledge and skills, decision making and self-worth, healthy relationships, substance use and mental health; and (2) an adult-focused three-session, group-level training called Let's Talk Real Talk (LTRT) to build SRH knowledge and skills to communicate with teens about SRH. An opportunity to connect WGTC participants to trusted adults who completed LTRT is provided during one facilitated session conducted each quarter. LTRT participants are not human subjects of the study. Receives: Behavioral: Talking Matters |
| Control Group | No intervention | Business as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of oral, vaginal, and/or anal sex episodes without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up.
Measured: Baseline up to 3 months post-baseline
Change in the number of oral, vaginal, and/or anal sex episodes without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up.
Measured: Baseline up to 6 months post-baseline
Change in the number of vaginal sex episodes without any form of contraception (including condoms) in the past 60 days (2 months) from baseline to follow up.
Measured: Baseline up to 3 months post-baseline
Change in the number of vaginal sex episodes without any form of contraception (including condoms) in the past 60 days (2 months) from baseline to follow up.
Measured: Baseline up to 6 months post-baseline
Change in the number of partners with whom participants had oral, vaginal, and/or anal sex without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up.
Measured: Baseline up to 3 months post-baseline
Change in the number of partners with whom participants had oral, vaginal, and/or anal sex without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up.
Measured: Baseline up to 6 months post-baseline
Maintained condom use at last vaginal sex (yes/no) from baseline to follow up.
Measured: Baseline up to 3 months post-baseline
Change in condom use at last vaginal sex (yes/no) from baseline to follow up.
Measured: Baseline up to 3 months post-baseline
Maintained condom use at last vaginal sex (yes/no) from baseline to follow up.
Measured: Baseline up to 6 months post-baseline
Change in condom use at last vaginal sex (yes/no) from baseline to follow up.
Measured: Baseline up to 6 months post-baseline
Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up.
Abbreviated Sexual communication self-efficacy scales from The sexual communication self-efficacy scale and Canadian Sexual Health Indicators Survey-Pilot Test And Validation Phase: Final Technical Report.
Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada, 2012. (16 of 20 items used)
Measured: Baseline up to 5 weeks post-baseline
Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up.
Abbreviated Sexual communication self-efficacy scales from The sexual communication self-efficacy scale and Canadian Sexual Health Indicators Survey-Pilot Test And Validation Phase: Final Technical Report.
Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada, 2012. (16 of 20 items used)
Measured: Baseline up to 3 months post-baseline
Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up.
Abbreviated Sexual communication self-efficacy scales from The sexual communication self-efficacy scale and Canadian Sexual Health Indicators Survey-Pilot Test And Validation Phase: Final Technical Report.
Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada, 2012. (16 of 20 items used)
Measured: Baseline up to 6 months post-baseline
Secondary outcomes (21)
Change in sexual and reproductive health knowledge from baseline to follow up.
As measured by the number of correct items reported on a 22-item questionnaire comprising modified items from Sexual Transmitted Diseases Knowledge Questionnaire (Jaworski, B. C., \& Carey, M. P. (2007). Development and psychometric evaluation of a self-administered questionnaire to measure knowledge of sexually transmitted diseases. AIDS and Behavior, 11(4), 557-574); items from Anderman, E. M., Cupp, P. K., Lane, D. R., Zimmerman, R., Gray, D. L., \& O'Connell, A. (2011). Classroom goal structures and HIV and pregnancy prevention education in rural high school health classrooms. Journal of Research on Adolescence, 21(4), 904-922; Section 7 from Cleland, J. (2001). Illustrative questionnaire for interview-surveys with young people. Asking Young People About Sexual and Reproductive Behaviors. Illustrative Core Instruments, Geneva: World Health Organization.
Measured: Baseline up to 5 weeks post-baseline
Change in sexual and reproductive health knowledge from baseline to follow up.
As measured by the number of correct items reported on a 22-item questionnaire comprising modified items from Sexual Transmitted Diseases Knowledge Questionnaire (Jaworski, B. C., \& Carey, M. P. (2007). Development and psychometric evaluation of a self-administered questionnaire to measure knowledge of sexually transmitted diseases. AIDS and Behavior, 11(4), 557-574); items from Anderman, E. M., Cupp, P. K., Lane, D. R., Zimmerman, R., Gray, D. L., \& O'Connell, A. (2011). Classroom goal structures and HIV and pregnancy prevention education in rural high school health classrooms. Journal of Research on Adolescence, 21(4), 904-922; Section 7 from Cleland, J. (2001). Illustrative questionnaire for interview-surveys with young people. Asking Young People About Sexual and Reproductive Behaviors. Illustrative Core Instruments, Geneva: World Health Organization.
Measured: Baseline up to 3 months post-baseline
Change in sexual and reproductive health knowledge from baseline to follow up.
As measured by the number of correct items reported on a 22-item questionnaire comprising modified items from Sexual Transmitted Diseases Knowledge Questionnaire (Jaworski, B. C., \& Carey, M. P. (2007). Development and psychometric evaluation of a self-administered questionnaire to measure knowledge of sexually transmitted diseases. AIDS and Behavior, 11(4), 557-574); items from Anderman, E. M., Cupp, P. K., Lane, D. R., Zimmerman, R., Gray, D. L., \& O'Connell, A. (2011). Classroom goal structures and HIV and pregnancy prevention education in rural high school health classrooms. Journal of Research on Adolescence, 21(4), 904-922; Section 7 from Cleland, J. (2001). Illustrative questionnaire for interview-surveys with young people. Asking Young People About Sexual and Reproductive Behaviors. Illustrative Core Instruments, Geneva: World Health Organization.
Measured: Baseline up to 6 months post-baseline
Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.
Abbreviated Healthy Relationship Knowledge, Expectations, and Attitudes domain from the Health Marriage and Relationship Education Models and Measures Project.(Scott, M.E., Moore, K.A., Fish, H., Benedetti, A., \& Erikson, S. (2015). Healthy marriage and relationship education: Recommended outcome measures for adolescents. OPRE Report #2015-65a. Prepared by Child Trends. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.)
Measured: Baseline up to 5 weeks post-baseline
Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.
Abbreviated Healthy Relationship Knowledge, Expectations, and Attitudes domain from the Health Marriage and Relationship Education Models and Measures Project.(Scott, M.E., Moore, K.A., Fish, H., Benedetti, A., \& Erikson, S. (2015). Healthy marriage and relationship education: Recommended outcome measures for adolescents. OPRE Report #2015-65a. Prepared by Child Trends. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.)
Measured: Baseline up to 3 months post-baseline
Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.
Abbreviated Healthy Relationship Knowledge, Expectations, and Attitudes domain from the Health Marriage and Relationship Education Models and Measures Project.(Scott, M.E., Moore, K.A., Fish, H., Benedetti, A., \& Erikson, S. (2015). Healthy marriage and relationship education: Recommended outcome measures for adolescents. OPRE Report #2015-65a. Prepared by Child Trends. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.)
Measured: Baseline up to 6 months post-baseline
Change in mental health literacy from baseline to follow up.
18 items scored from 1 to 4 (higher score=higher knowledge) from O'Connor, M., \& Casey, L. (2015). The Mental Health Literacy Scale (MHLS): A new scale-based measure of mental health literacy. Psychiatry research, 229(1-2), 511-516. and Self efficacy for stress management from Hansen, W. B., \& McNeal Jr, R. B. (1997). How DARE works: An examination of program effects on mediating variables. Health education \& behavior, 24(2), 165-176.
Measured: Baseline up to 5 weeks post-baseline
Change in mental health literacy from baseline to follow up.
18 items scored from 1 to 4 (higher score=higher knowledge) from O'Connor, M., \& Casey, L. (2015). The Mental Health Literacy Scale (MHLS): A new scale-based measure of mental health literacy. Psychiatry research, 229(1-2), 511-516. and Self efficacy for stress management from Hansen, W. B., \& McNeal Jr, R. B. (1997). How DARE works: An examination of program effects on mediating variables. Health education \& behavior, 24(2), 165-176.
Measured: Baseline up to 3 months post-baseline
Change in mental health literacy from baseline to follow up.
18 items scored from 1 to 4 (higher score=higher knowledge) from O'Connor, M., \& Casey, L. (2015). The Mental Health Literacy Scale (MHLS): A new scale-based measure of mental health literacy. Psychiatry research, 229(1-2), 511-516. and Self efficacy for stress management from Hansen, W. B., \& McNeal Jr, R. B. (1997). How DARE works: An examination of program effects on mediating variables. Health education \& behavior, 24(2), 165-176.
Measured: Baseline up to 6 months post-baseline
Change in intentions to use condoms from baseline to follow up.
Sakeah, J. K. (2017). Determinants of Condom use intentions among University students in Ghana (Doctoral dissertation, Lethbridge, Alta: University of Lethbridge, Faculty of Health Sciences).
Measured: Baseline up to 5 weeks post-baseline
Change in intentions to use condoms from baseline to follow up.
Sakeah, J. K. (2017). Determinants of Condom use intentions among University students in Ghana (Doctoral dissertation, Lethbridge, Alta: University of Lethbridge, Faculty of Health Sciences).
Measured: Baseline up to 3 months post-baseline
Change in intentions to use condoms from baseline to follow up.
Sakeah, J. K. (2017). Determinants of Condom use intentions among University students in Ghana (Doctoral dissertation, Lethbridge, Alta: University of Lethbridge, Faculty of Health Sciences).
Measured: Baseline up to 6 months post-baseline
Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up
Modified Parent-Teen Communication About Premarital Sex from Jaccard, J., Dittus, P. J., \& Gordon, V. V. (2000). Parent-teen communication about premarital sex: Factors associated with the extent of communication. Journal of Adolescent Research, 15(2), 187-208.
Measured: Baseline up to 5 weeks post-baseline
Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up
Modified Parent-Teen Communication About Premarital Sex from Jaccard, J., Dittus, P. J., \& Gordon, V. V. (2000). Parent-teen communication about premarital sex: Factors associated with the extent of communication. Journal of Adolescent Research, 15(2), 187-208.
Measured: Baseline up to 3 months post-baseline
Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up
Modified Parent-Teen Communication About Premarital Sex from Jaccard, J., Dittus, P. J., \& Gordon, V. V. (2000). Parent-teen communication about premarital sex: Factors associated with the extent of communication. Journal of Adolescent Research, 15(2), 187-208.
Measured: Baseline up to 6 months post-baseline
Change in self-efficacy for using condoms from baseline to follow up.
Abbreviated condom use self-efficacy scale from Asante, K. O., \& Doku, P. N. (2010). Cultural adaptation of the condom use self efficacy scale (CUSES) in Ghana. BMC public health, 10(1), 1-7. (12 of 14 items used)
Measured: Baseline up to 5 weeks post-baseline
Change in self-efficacy for using condoms from baseline to follow up.
Abbreviated condom use self-efficacy scale from Asante, K. O., \& Doku, P. N. (2010). Cultural adaptation of the condom use self efficacy scale (CUSES) in Ghana. BMC public health, 10(1), 1-7. (12 of 14 items used)
Measured: Baseline up to 3 months post-baseline
Change in self-efficacy for using condoms from baseline to follow up.
Abbreviated condom use self-efficacy scale from Asante, K. O., \& Doku, P. N. (2010). Cultural adaptation of the condom use self efficacy scale (CUSES) in Ghana. BMC public health, 10(1), 1-7. (12 of 14 items used)
Measured: Baseline up to 6 months post-baseline
Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up
Abbreviated Making Decisions in Everyday life instrument. from Mincemoyer, C., Perkins, D. F., \& Munyua, C. (2005). Measuring the impact of youth development programs: A national on-line youth life skills evaluation system. In The Forum for Family and Consumer Issues (Vol. 10, No. 2).
Measured: Baseline up to 5 weeks post-baseline
Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up
Abbreviated Making Decisions in Everyday life instrument. from Mincemoyer, C., Perkins, D. F., \& Munyua, C. (2005). Measuring the impact of youth development programs: A national on-line youth life skills evaluation system. In The Forum for Family and Consumer Issues (Vol. 10, No. 2).
Measured: Baseline up to 3 months post-baseline
Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up
Abbreviated Making Decisions in Everyday life instrument. from Mincemoyer, C., Perkins, D. F., \& Munyua, C. (2005). Measuring the impact of youth development programs: A national on-line youth life skills evaluation system. In The Forum for Family and Consumer Issues (Vol. 10, No. 2).
Measured: Baseline up to 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start15 Jul 2020
- Primary completion15 Sep 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in AdolescenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual randomized control trial
- Masking
- None (open label)
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Management Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Archana LaPollo, Public Health Management Corporation
- Investigators
- Archana B LaPollo, MPH, Principal investigator, Public Health Management Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970485
- Sponsor's protocol ID
- 2003
- Status last verified
- Apr 2024
- First submitted
- 11 Jan 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Talking Matters Teen Pregnancy Prevention Program Through a Randomized Controlled Trial Design
- ClinicalTrials.gov ID
- NCT04970485
- Acronym / sponsor ID
- 2003
- Conditions
- Pregnancy in Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Public Health Management CorporationUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Jul 2021 (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.
A culturally tailored program that creates a safe, open space to increase knowledge, self-efficacy, skills, and comfort related to sexual and reproductive health, including HIV/STI and teen pregnancy prevention, mental health, and substance use risk reduction behavior, and strengthens protective factors, decision-making skills, and connections to trusted adults may help participants chart a path toward optimal health. To address a significant gap in evidence-based, culturally-tailored sexual and reproductive health services for Black and African American adolescents, Public Health Management Corporation (PHMC) is conducting a rigorous evaluation of an innovative group-level, two pronged intervention called Talking Matters using an individual randomized control trial (RCT) design. Due to social distancing guidelines during COVID-19 at the start of the study, all Talking Matters activities, including recruitment, screening, consent, intervention implementation, and data collection, will be conduct virtually and remotely.
Developed and piloted over the past two years through FY2018 Phase I New and Innovative Strategies (Tier 2) to Prevent Teen Pregnancy and Promote Healthy Adolescence funding from the Office of Population Affairs (OPA), Talking Matters is a promising group-level, two-pronged intervention tailored for urban Black and African American 14 to 19 year old adolescents who are recruited from school- and community-based settings in Philadelphia, PA. Grounded in Social Cognitive Theory, the Transtheoretical Model, and Self-Determination Theory, and using evidence-based Motivational Interviewing strategies, the primary goals of Talking Matters are to reduce adolescents' risk for teen and unplanned pregnancy, sexually transmitted infections (STIs) and HIV, and to strengthen protective factors improve optimal health.
The two prongs of Talking Matters include (1) an adolescent-focused five-session, group-level intervention called We Get to Choose (WGTC) and (2) an adult-focused three-session, group-level training called Let's Talk Real Talk (LTRT). An opportunity to connect WGTC participants to trusted adults who completed LTRT is provided during one facilitated session conducted each quarter. Adult participants of the LTRT training are not human subjects of the Talking Matters study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individual randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Talking Matters intervention | Experimental | Behavioral: Talking MattersTalking Matters is a group-level, two-pronged intervention for Black and African American 14 to 19 year old adolescents recruited from school- and community-based settings in Philadelphia, PA. Goals are to reduce teens' risk for unplanned pregnancy, sexually transmitted infections, and HIV, and to strengthen protective factors to improve health. The two prongs include (1) an adolescent-focused five-session, group-level intervention called We Get to Choose (WGTC) covering sexual and reproductive health (SRH) knowledge and skills, decision making and self-worth, healthy relationships, substance use and mental health; and (2) an adult-focused three-session, group-level training called Let's Talk Real Talk (LTRT) to build SRH knowledge and skills to communicate with teens about SRH. An opportunity to connect WGTC participants to trusted adults who completed LTRT is provided during one facilitated session conducted each quarter. LTRT participants are not human subjects of the study. |
| Control Group | No intervention | –Business as usual |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Identifies as Black or African American
- 14 to 19 years old at baseline
- Lives in Philadelphia, PA
- English-speaking
- Able to or will be able to obtain access to the internet through a phone, tablet, or computer
Key exclusion criteria (5 listed)
- Does not identify as Black or African American
- Less than 14 years old or 20 years or older at baseline
- Does not live in Philadelphia, PA
- Unable to speak or understand English
- Unable to access internet through a phone, tablet, or computer
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 |
|---|---|---|
| Talking MattersAlso: We Get to Choose, Let's Talk Real TalkGroup-level, facilitator-led behavioral intervention for 14-19 year old Black and African American adolescents with an intergenerational component to reduce teen pregnancy, strengthen protective factors to improve optimal health, and increase access to trusted adults. | Behavioural | Talking Matters intervention |
Primary outcome
Change in the number of oral, vaginal, and/or anal sex episodes without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Change in the number of oral, vaginal, and/or anal sex episodes without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Change in the number of vaginal sex episodes without any form of contraception (including condoms) in the past 60 days (2 months) from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Change in the number of vaginal sex episodes without any form of contraception (including condoms) in the past 60 days (2 months) from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Change in the number of partners with whom participants had oral, vaginal, and/or anal sex without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Change in the number of partners with whom participants had oral, vaginal, and/or anal sex without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Maintained condom use at last vaginal sex (yes/no) from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Change in condom use at last vaginal sex (yes/no) from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Maintained condom use at last vaginal sex (yes/no) from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Change in condom use at last vaginal sex (yes/no) from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up.
Time frame: Baseline up to 5 weeks post-baseline
Abbreviated Sexual communication self-efficacy scales from The sexual communication self-efficacy scale and Canadian Sexual Health Indicators Survey-Pilot Test And Validation Phase: Final Technical Report. Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada, 2012. (16 of 20 items used)
Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Abbreviated Sexual communication self-efficacy scales from The sexual communication self-efficacy scale and Canadian Sexual Health Indicators Survey-Pilot Test And Validation Phase: Final Technical Report. Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada, 2012. (16 of 20 items used)
Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Abbreviated Sexual communication self-efficacy scales from The sexual communication self-efficacy scale and Canadian Sexual Health Indicators Survey-Pilot Test And Validation Phase: Final Technical Report. Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada, 2012. (16 of 20 items used)
21 secondary outcomes
Change in sexual and reproductive health knowledge from baseline to follow up.
Time frame: Baseline up to 5 weeks post-baseline
Change in sexual and reproductive health knowledge from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Change in sexual and reproductive health knowledge from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.
Time frame: Baseline up to 5 weeks post-baseline
Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Change in mental health literacy from baseline to follow up.
Time frame: Baseline up to 5 weeks post-baseline
Change in mental health literacy from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Change in mental health literacy from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Change in intentions to use condoms from baseline to follow up.
Time frame: Baseline up to 5 weeks post-baseline
Change in intentions to use condoms from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Change in intentions to use condoms from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up
Time frame: Baseline up to 5 weeks post-baseline
Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up
Time frame: Baseline up to 3 months post-baseline
Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up
Time frame: Baseline up to 6 months post-baseline
Change in self-efficacy for using condoms from baseline to follow up.
Time frame: Baseline up to 5 weeks post-baseline
Change in self-efficacy for using condoms from baseline to follow up.
Time frame: Baseline up to 3 months post-baseline
Change in self-efficacy for using condoms from baseline to follow up.
Time frame: Baseline up to 6 months post-baseline
Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up
Time frame: Baseline up to 5 weeks post-baseline
Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up
Time frame: Baseline up to 3 months post-baseline
Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up
Time frame: Baseline up to 6 months post-baseline
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 2 Apr 2024.
- 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.
Archana B LaPollo, MPH principal investigator
Public Health Management Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talking Matters in people with Pregnancy in Adolescence, run by Public Health Management Corporation at 1 site in United States.
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 5 inclusion and 5 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 2 Apr 2024. 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 the number of oral, vaginal, and/or anal sex episodes without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up. (time frame: Baseline up to 3 months post-baseline). The study lists 13 primary outcomes in all. 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 2 Apr 2024.