NCT05569070

Brief Summary

The purpose of the study is to determine the impact of the offer to participate in the Young United Parents! (YUP!) intervention relative to the control condition on use of effective non-barrier contraception and frequency of vaginal sex without condoms three months after the intervention period has concluded.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Oct 2022Sep 2026

First Submitted

Initial submission to the registry

October 3, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

October 3, 2022

Last Update Submit

April 21, 2026

Conditions

Keywords

Teen Pregnancy Prevention

Outcome Measures

Primary Outcomes (2)

  • Use of effective non-barrier contraception

    Participant self-report on whether (or not) they are currently using effective non-barrier contraception (IUD, implant, oral contraceptive pill, injection, patch, or ring)

    Assessed three months after the intervention period has ended

  • Times having vaginal sex without a condom

    Participant self-report on the number of times having vaginal sex without using a condom during the past three months

    Assessed three months after the intervention period has ended

Secondary Outcomes (30)

  • Contraceptive knowledge

    Assessed immediately post-intervention and three months after the intervention period has ended

  • Condom knowledge

    Assessed immediately post-intervention and three months after the intervention period has ended

  • STI knowledge

    Assessed immediately post-intervention and three months after the intervention period has ended

  • Condom negotiation self-efficacy

    Assessed immediately post-intervention and three months after the intervention period has ended

  • Contraceptive use self-efficacy

    Assessed immediately post-intervention and three months after the intervention period has ended

  • +25 more secondary outcomes

Study Arms (2)

Guided Young United Parents! (YUP!) Website Intervention

EXPERIMENTAL

The Guided YUP! website intervention is the treatment condition, which will involve two months of directed use of the YUP! website.

Other: Guided Young United Parents! Website Intervention

Nutrition Website

SHAM COMPARATOR

The nutrition website is the control condition.

Other: Nutrition Website

Interventions

Participants assigned to Guided YUP! will receive two months of structured use of the YUP! website intervention, which involves weekly review of written and video content, meetings with near-peer mentors, use of the goal tool, interaction with the online community, and receipt of tips and affirmations.

Guided Young United Parents! (YUP!) Website Intervention

Participants assigned to the Nutrition Website will be provided with the link to the MyPlate website, which is maintained by the U.S. Department of Agriculture. At the enrollment session, participants will be given brief instruction during the enrollment session about features available on the website that may be interesting to them and encouraged to engage in any of the website or app features at whatever level they are comfortable with. No further direction will be provided to them after the enrollment session.

Nutrition Website

Eligibility Criteria

Age15 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Biological female aged 15-20
  • Has given birth to a child they currently provide care for
  • Reports having penile-vaginal sex at least one time in past three months
  • Fluent in English (able to read and comprehend the online intervention materials, which are available only in English)
  • Owns or has regular access to a personal device (smartphone, laptop, tablet) with internet access
  • United States resident
  • Provides informed assent or consent for study participation

You may not qualify if:

  • Currently pregnant
  • Currently trying to become pregnant
  • Previously registered to use the YUP! website
  • Enrolled in an ongoing PRG-run TPP study
  • Identified as fraudulent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Policy & Research Group

New Orleans, Louisiana, 70118, United States

Location

Study Officials

  • Eric Jenner, PhD

    The Policy & Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 6, 2022

Study Start

October 10, 2022

Primary Completion

December 29, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.

Shared Documents
SAP
Time Frame
The individual participant dataset will become available twelve months after the study has concluded.

Locations