Evaluation of the Talking Matters Teen Pregnancy Prevention Program

NCT04970485 | Completed

• 1 other identifier: 2003
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy in Adolescence

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline up to 6 months post-baseline

• Maintained condom use at last vaginal sex (yes/no) from baseline to follow up.

  Baseline up to 3 months post-baseline

• Change in condom use at last vaginal sex (yes/no) from baseline to follow up.

  Baseline up to 3 months post-baseline

• Maintained condom use at last vaginal sex (yes/no) from baseline to follow up.

  Baseline up to 6 months post-baseline

• Change in condom use at last vaginal sex (yes/no) from baseline to follow up.

  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)

  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)

  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)

  Baseline up to 6 months post-baseline

Secondary Outcomes (21)

• Change in sexual and reproductive health knowledge from baseline to follow up.

  Baseline up to 5 weeks post-baseline

• Change in sexual and reproductive health knowledge from baseline to follow up.

  Baseline up to 3 months post-baseline

• Change in sexual and reproductive health knowledge from baseline to follow up.

  Baseline up to 6 months post-baseline

• Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.

  Baseline up to 5 weeks post-baseline

• Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.

  Baseline up to 3 months post-baseline

Study Arms (2)

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.

Behavioral: Talking Matters

Control Group

NO INTERVENTION

Business as usual

Interventions

Talking Matters BEHAVIORAL

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.

Also known as: We Get to Choose, Let's Talk Real Talk

Talking Matters intervention

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Identifies as Black or African American
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Public Health Management Corporation: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Public Health Management Corporation

Philadelphia, Pennsylvania, 19102, United States

Location

Study Officials

• Archana B LaPollo, MPH

  Public Health Management Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Project Director

Model Details: Individual randomized control trial

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: July 21, 2021
• Study Start: July 15, 2020
• Primary Completion: September 15, 2022
• Study Completion: December 31, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)