Clinical trial NCT06580080: Evaluation of Are You Ready?
Official title: Evaluation of Are You Ready?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Teen Pregnancy Prevention
Lead sponsor: The Policy & Research Group
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: Mathematica Policy Research, Inc.
name: Reproductive Health National Training Center
name: Institute of Women & Ethnic Studies
First posted: 2024-08-30
Enrollment: 1850
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomized trial is to learn if the Are You Ready? (AYR) intervention has a positive impact on the sexual and mental health behaviors of sexually active youth between the ages of 14 and 21 years old who are at risk for or involved in the juvenile justice and/or child welfare systems. The primary research questions it aims to answer are:

* Three months after being offered the intervention, does AYR impact youth's receipt of sexually transmitted infection testing in the past three months?
* Three months after being offered the intervention, does AYR impact youth's use of coping skills?
* Nine months after being offered the intervention, does AYR impact youth's frequency of having vaginal and anal sex without condoms in the past three months?

Researchers will compare participants randomized to receive AYR (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group).

Participants randomized to the treatment group will be offered AYR as a virtual or in-person, 2.5 hour group session. Participants randomized to the control group will be offered a virtually delivered control condition.

Detailed description: This is an individual-level, randomized control trial to rigorously evaluate the impact of the Are You Ready? (AYR) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at three time points: baseline (enrollment); three months post-intervention (four months after baseline); and nine months post-intervention (ten months after baseline).

Eligibility criteria: Inclusion Criteria:

* At risk for or involved in the juvenile justice and/or child welfare systems
* Has had vaginal or anal sex in the past 3 months
* Comfortable reading, speaking, and writing in English

Exclusion Criteria:

- Has received other known sexual and reproductive health evidence-based interventions implemented in their local area.

Primary outcomes:
measure: Receipt of sexually transmitted infection (STI) testing in the past three months
timeFrame: Assessed three months after the intervention period has ended (four months post-baseline)
measure: Use of coping skills
timeFrame: Assessed three months after the intervention period has ended (four months post-baseline)
measure: Times having vaginal and anal sex without condoms in the past three months
timeFrame: Assessed nine months after the intervention period has ended (ten months post-baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: The Policy & Research Group
state: Louisiana
Study officials:
affiliation: The Policy & Research Group
name: Sarah Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
References: