Teen Talk High School Refresher Rigorous Evaluation
NCT Number: NCT06574321
Acronym: TTHSR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy in Adolescence|Sexually Transmitted Diseases
Interventions: BEHAVIORAL: Teen Talk High School Refresher (TTHSR)
Sponsor: ETR Associates
Sex: ALL
Age: CHILD, ADULT
Enrollment: 1600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2027-12

Summary:
Unintended pregnancy rates among teenagers are higher in rural counties than urban or suburban counties. The Teen Talk High School Refresher (TTHSR) is a sexual health education "booster" program for older high school students attending school in rural communities that was designed to help address this health disparity. Though there is preliminary evidence of the program's effectiveness, it has not yet been rigorously evaluated with a randomized controlled trial.

TTHSR is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they transition from high school into adulthood, in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections. Because the California Health Youth Act mandates it in public schools, most students this age will have received prior SHE. TTHSR is a 5-hour "booster" intervention, delivered during late high school, intended to enhance the effectiveness of previous SHE.

The study's primary research question is:

What is the impact at 6-months post baseline of TTHSR relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days?

The study's secondary research questions are:

* What is the impact at 6-months post baseline of TTHSR relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy for self-advocating with healthcare providers, peers, and partners about their sexual health and sexuality?
* What is the impact at 6-months post-baseline of TTHSR relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy to find and access sexual health services?
* What is the impact at 12-months post-baseline of TTHSR relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days?

Primary Outcome Measures: No vaginal or anal sex, or use of condoms or effective birth control if having sex, in past 90 days, Vaginal sex: Single-item dichotomous measure assessing any consensual vaginal sex in the past 3 months. If yes, condom and birth control use measured with single-item categorical frequency of (a) condom use with consensual vaginal sex in past 3 months and (b) birth control use, other than condoms, with consensual vaginal sex in past 3 months. Categories: Every time, Almost every time, Most of the time, About half of the time, Less than half of the time, Just a few times, Never.

Anal sex: Single-item dichotomous measure assessing any consensual anal sex in the past 3 months. If yes, condom use measured with single-item categorical frequency of condom use with consensual anal sex in the past 3 months. Categories: Every time, Almost every time, Most of the time, About half of the time, Less than half of the time, Just a few times, Never., 6 months post-baseline
Secondary Outcome Measures: Improved self-efficacy for self-advocating with healthcare providers, peers, and partners about sexual health and sexuality, 13 items (adapted from established measures) with categorical responses assessing how sure or unsure/ confident or unconfident respondents are about advocating for their own sexual health and sexuality with healthcare providers and partners, and in situations of sexualized bullying with peers., 6 months post-baseline|Improved self-efficacy to find and access sexual health services, 4-item measure with categorical responses assessing how much respondents agree or disagree with statements about difficulty of accessing sexual health services and their confidence about doing so (adapted from measure reported in Manlove, J., Whitfield, B., Finocharo, J., \& Cook, E. (2021). Lessons learned from replicating a randomized control trial evaluation of an app-based sexual health program. International Journal of Environmental Research Public Health, 18(6), p. 3305.), 6 months post-baseline|No vaginal or anal sex, or use of condoms or effective birth control if having sex, in past 90 days, Vaginal sex: Single-item dichotomous measure assessing any consensual vaginal sex in the past 3 months. If yes, condom and birth control use measured with single-item categorical frequency of (a) condom use with consensual vaginal sex in past 3 months and (b) birth control use, other than condoms, with consensual vaginal sex in past 3 months. Categories: Every time, Almost every time, Most of the time, About half of the time, Less than half of the time, Just a few times, Never.

Anal sex: Single-item dichotomous measure assessing any consensual anal sex in the past 3 months. If yes, condom use measured with single-item categorical frequency of condom use with consensual anal sex in the past 3 months. Categories: Every time, Almost every time, Most of the time, About half of the time, Less than half of the time, Just a few times, Never., 12 months post-baseline