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Evaluation of Peer Group Connection - Middle School (PGC-MS)

T

The Policy & Research Group

Status

Enrolling

Conditions

Teen Pregnancy Prevention

Treatments

Behavioral: Peer Group Connection - Middle School (PGC-MS)

Study type

Interventional

Funder types

Other

Identifiers

NCT06582641
1 TP2AH000083-01-00

Details and patient eligibility

About

The goal of this randomized trial is to learn if the Peer Group Connection - Middle School (PGC-MS) intervention delays initiation of sexual intercourse in middle school-aged youth. The primary research question it aims to answer is:

Sixteen months after being offered the intervention, does PGC-MS impact youth's initiation of sexual intercourse?

Researchers will compare participants randomized to receive PGC-MS (treatment group) to participants randomized to class-as-usual (which contains no sexual or reproductive health information (control group)).

Participants randomized to the treatment group will be offered PGC-MS over the course of their transition year into middle school (either 6th or 7th grade). Participants randomized to the control group will be offered class-as-usual.

Full description

This is an individual-level, randomized control trial to rigorously evaluate the impact of the Peer Group Connection - Middle School (PGC-MS) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at four time points: baseline (fall semester of 6th or 7th grade); post-intervention (spring semester of 6th or 7th grade); four months post-intervention (fall semester of 7th or 8th grade); and sixteen months post-intervention (fall semester of 8th or 9th grade).

Enrollment

1,400 estimated patients

Sex

All

Ages

11 to 14 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Be enrolled at a middle school participating in the study
  • Entering the middle school transition grade for the first time (6th or 7th grade depending on the middle school transition year) at a participating study school
  • Provide parental consent and student assent to participate in the study
  • Have the ability to complete a self-administered questionnaire in either English or Spanish in a classroom or group setting, unassisted, in 60 minutes or less.

Exclusion criteria

  • Repeating the middle school transition year (6th or 7th grade)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,400 participants in 2 patient groups

Peer Group Connection - Middle School (PGC-MS)
Experimental group
Treatment:
Behavioral: Peer Group Connection - Middle School (PGC-MS)
Class as usual
No Intervention group

Trial contacts and locations

1

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Central trial contact

Hilary Demby, MPH; Kelly Burgess, MPH

Data sourced from clinicaltrials.gov

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