Clinical trial NCT04970485: Evaluation of the Talking Matters Teen Pregnancy Prevention Program
Official title: Evaluation of the Talking Matters Teen Pregnancy Prevention Program Through a Randomized Controlled Trial Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy in Adolescence
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2021-07-21
Enrollment: 321
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual randomized control trial
Primary purpose: PREVENTION

Brief 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, 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: Baseline up to 3 months post-baseline
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.
timeFrame: Baseline up to 6 months post-baseline
measure: 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.
timeFrame: Baseline up to 3 months post-baseline
measure: 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.
timeFrame: Baseline up to 6 months post-baseline
measure: 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.
timeFrame: Baseline up to 3 months post-baseline
measure: 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.
timeFrame: Baseline up to 6 months post-baseline
measure: Maintained condom use at last vaginal sex (yes/no) from baseline to follow up.
timeFrame: Baseline up to 3 months post-baseline
measure: Change in condom use at last vaginal sex (yes/no) from baseline to follow up.
timeFrame: Baseline up to 3 months post-baseline
measure: Maintained condom use at last vaginal sex (yes/no) from baseline to follow up.
timeFrame: Baseline up to 6 months post-baseline
measure: Change in condom use at last vaginal sex (yes/no) from baseline to follow up.
timeFrame: Baseline up to 6 months post-baseline
measure: Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up.
timeFrame: Baseline up to 5 weeks post-baseline
measure: Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up.
timeFrame: Baseline up to 3 months post-baseline
measure: Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up.
timeFrame: Baseline up to 6 months post-baseline
Secondary outcomes:
measure: Change in sexual and reproductive health knowledge from baseline to follow up.
timeFrame: Baseline up to 5 weeks post-baseline
measure: Change in sexual and reproductive health knowledge from baseline to follow up.
timeFrame: Baseline up to 3 months post-baseline
measure: Change in sexual and reproductive health knowledge from baseline to follow up.
timeFrame: Baseline up to 6 months post-baseline
measure: Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.
timeFrame: Baseline up to 5 weeks post-baseline
measure: Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.
timeFrame: Baseline up to 3 months post-baseline
measure: Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.
timeFrame: Baseline up to 6 months post-baseline
measure: Change in mental health literacy from baseline to follow up.
timeFrame: Baseline up to 5 weeks post-baseline
measure: Change in mental health literacy from baseline to follow up.
timeFrame: Baseline up to 3 months post-baseline
measure: Change in mental health literacy from baseline to follow up.
timeFrame: Baseline up to 6 months post-baseline
measure: Change in intentions to use condoms from baseline to follow up.
timeFrame: Baseline up to 5 weeks post-baseline
measure: Change in intentions to use condoms from baseline to follow up.
timeFrame: Baseline up to 3 months post-baseline
measure: Change in intentions to use condoms from baseline to follow up.
timeFrame: Baseline up to 6 months post-baseline
measure: Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up
timeFrame: Baseline up to 5 weeks post-baseline
measure: Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up
timeFrame: Baseline up to 3 months post-baseline
measure: Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up
timeFrame: Baseline up to 6 months post-baseline
measure: Change in self-efficacy for using condoms from baseline to follow up.
timeFrame: Baseline up to 5 weeks post-baseline
measure: Change in self-efficacy for using condoms from baseline to follow up.
timeFrame: Baseline up to 3 months post-baseline
measure: Change in self-efficacy for using condoms from baseline to follow up.
timeFrame: Baseline up to 6 months post-baseline
measure: Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up
timeFrame: Baseline up to 5 weeks post-baseline
measure: Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up
timeFrame: Baseline up to 3 months post-baseline
measure: Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up
timeFrame: Baseline up to 6 months post-baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Public Health Management Corporation
state: Pennsylvania
Study officials:
affiliation: Public Health Management Corporation
name: Archana B LaPollo, MPH
role: PRINCIPAL_INVESTIGATOR
References: