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临床试验/NCT05569070
NCT05569070进行中(未招募)不适用

Evaluation of Young United Parents

The Policy & Research Group2 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2022年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,400
试验地点
2
主要终点
Times having vaginal sex without a condom

研究概览

简要总结

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.

详细描述

The Policy & Research Group (PRG) will be rigorously evaluating an innovative intervention, Young United Parents! (YUP!), which is a website-based program designed to help young parents ages 15-22 avoid unplanned, repeat pregnancy and sexually transmitted infections (STIs), reach their personal goals, and thrive in all areas of life. The mobile-optimized website contains 50 articles and over 100 personal narrative videos of highly diverse young parents and experts. The YUP! intervention includes: 1) video and written content on six topics (sexual health and birth control; healthy relationships; self-care; reaching your goals; parenting; and pregnancy and birth); 2) access to near-peer mentors; 3) a goal-setting tool; 4) daily tips, reminders, and motivational messages; 5) links and referrals to support services; and 6) membership in the YUP! online community of young parents.

PRG will conduct an implementation evaluation and an impact evaluation of a structured version of YUP!, called Guided YUP!. Guided YUP! involves a two-month program experience during which participants are directed through a dashboard on the website to review between 15-35 minutes of particular website content each week. Participants will also be paired with a near-peer mentor who will schedule virtual interactions with them every two weeks, for a total of at least five interactions over the course of the two-month intervention period. All interactions will be held via the YUP! participant dashboard and are expected to last between 5-10 minutes. The aim of these interactions is for the near-peer mentor to offer support and guidance, using motivational interviewing techniques, as the participants go through the Guided YUP! program. Additionally, Guided YUP! participants will be asked to outline and complete at least one goal during the two-month intervention period, using the goal tool on the website. Guided YUP! participants will also receive automatically generated tips and affirmations through the website and have access to the YUP! online community to participate in, if desired.

PRG will assess the efficacy of Guided YUP! using a randomized controlled trial. The study will target young mothers ages 15-20 who are currently caring for their child(ren) and not pregnant or trying to become pregnant. The primary aim of the study will be to investigate the impact of the intervention on two self-reported sexual behaviors: 1) use of effective non-barrier contraception and 2) frequency of vaginal sex without condoms. In addition, the study will include exploratory investigations of the following self-reported sexual behaviors and theoretically relevant antecedents to these behaviors: 1) frequency of sexually transmitted infection (STI) testing; 2) frequency of completely unprotected vaginal sex; 3) incidence of pregnancy; 4) incidence of STIs; 5) condom, contraceptive, and STI knowledge; 6) condom negotiation, contraceptive use, and STI testing self-efficacy; 7) condom and contraceptive use outcome expectations; and 8) perceived pregnancy fatalism. Finally, the study will explore the impact of the intervention on measures that assess participants' perceptions of their healthy relationships, self-care and well-being, goal achievement, and parenting competence.

Outcomes will be assessed using self-reported, participant-level data gathered using a structured questionnaire administered at four time points: baseline (enrollment); post-intervention (two months after baseline); three months post-intervention (five months after the baseline); and twelve months post-intervention (fourteen months after the baseline).

Starting in October 2022 and continuing for 21 months, 1400 participants from around the United States will be enrolled virtually. The final two years of the grant will be used to collect follow-up data from study participants; conduct implementation and impact evaluation analysis, reporting, and dissemination efforts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
15 Years 至 20 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Guided Young United Parents! Website Intervention (Other)

Nutrition Website

Sham Comparator

The nutrition website is the control condition.

干预措施: Nutrition Website (Other)

结局指标

主要结局

Times having vaginal sex without a condom

时间窗: Assessed three months after the intervention period has ended

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

Use of effective non-barrier contraception

时间窗: Assessed three months after the intervention period has ended

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

次要结局

  • Goal setting self-efficacy(Assessed immediately post-intervention and three months after the intervention period has ended)
  • Perceived pregnancy fatalism(Assessed immediately post-intervention and three months after the intervention period has ended)
  • Times having vaginal sex without a condom(Assessed twelve months after the intervention period has ended)
  • Use of condoms during last vaginal sex(Assessed three and twelve months after the intervention period has ended)
  • Recent STI acquisition(Assessed three and twelve months after the intervention period has ended)
  • Condom negotiation self-efficacy(Assessed immediately post-intervention and three months after the intervention period has ended)
  • STI testing self-efficacy(Assessed immediately post-intervention and three months after the intervention period has ended)
  • Use of effective non-barrier contraception during last vaginal sex(Assessed three and twelve months after the intervention period has ended)
  • Completely unprotected during last vaginal sex(Assessed three and twelve months after the intervention period has ended)
  • Dual methods of protection during last vaginal sex(Assessed three and twelve months after the intervention period has ended)
  • Recent repeat unintended pregnancy(Assessed three and twelve months after the intervention period has ended)
  • 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)
  • Contraceptive use self-efficacy(Assessed immediately post-intervention and three months after the intervention period has ended)
  • Contraceptive use outcome expectations(Assessed immediately post-intervention and three months after the intervention period has ended)
  • Frequency of emergency contraception use(Assessed three and twelve months after the intervention period has ended)
  • Self-care self-efficacy(Assessed immediately post-intervention and three months after the intervention period has ended)
  • Times having completely unprotected during last vaginal sex(Assessed three and twelve months after the intervention period has ended)
  • Recent STI testing(Assessed three and twelve months after the intervention period has ended)
  • Recent repeat pregnancy(Assessed three and twelve months after the intervention period has ended)
  • Stigma(Assessed immediately post-intervention and three and twelve months after the intervention period has ended)
  • Social support(Assessed immediately post-intervention and three and twelve months after the intervention period has ended)
  • Condom use outcome expectations(Assessed immediately post-intervention and three months after the intervention period has ended)
  • Use of effective non-barrier contraception(Assessed twelve months after the intervention period has ended)
  • Consistent use of effective non-barrier contraception(Assessed three and twelve months after the intervention period has ended)
  • Dual methods of protection during recent vaginal sex(Assessed three and twelve months after the intervention period has ended)
  • Parenting competence(Assessed immediately post-intervention and three and twelve months after the intervention period has ended)
  • Well-being(Assessed immediately post-intervention and three and twelve months after the intervention period has ended)
  • Goal attainment(Assessed immediately post-intervention and three and twelve months after the intervention period has ended)

研究者

发起方
The Policy & Research Group
申办方类型
Other
责任方
Sponsor

研究点 (2)

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