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临床试验/NCT04809155
NCT04809155Unknown不适用

A Reproductive Health Program for A Select Population

Center for Innovative Public Health Research2 个研究点 分布在 1 个国家目标入组 574 人开始时间: 2020年7月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
574
试验地点
2
主要终点
Number of Condom protected penile-vaginal Sex Acts

研究概览

简要总结

This is a pilot effectiveness study of Girl2Girl, a text messaging-based pregnancy prevention program for cisgender sexual minority adolescents.

详细描述

An estimated one in four teen women will become pregnant by the time she is 20 years of age. That said, significant disparity in rates exist for lesbian, gay, bisexual and other sexual minority women (LGB) versus non-LGB teen women: Research suggests that lesbian and bisexual teen women are between two and four times more likely to report having been pregnant than teen women who identified as exclusively heterosexual. Despite this compelling evidence that lesbian and bisexual adolescent women are at risk for teen pregnancy, programs tailored to the unique needs of adolescent LGB women are nonexistent. Evidence-based teen pregnancy prevention (TPP) programs targeting LGB teen women are urgently needed.

The Girl2Girl intervention text messaging-based TPP program designed specifically for LGB women ages 14-18 years, nation-wide. This is an extension of a previous randomized controlled trial. Here, the cohort was recruited using an effectiveness strategy: Girls were allowed to register and enroll themselves without needing to talk to research staff. All eligible and interested youth were allowed to enroll; no diversity targets were applied.

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
14 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Endorse a non-heterosexual sexual identity (i.e., lesbian/gay, bisexual, queer, questioning, unsure) on the screener;
  • Be cisgender (i.e., be assigned a female sex at birth and endorse a female gender identity) on the screener;
  • Be aged 14-18;
  • Be English speaking;
  • Be able to provide informed assent, including the self-directed self-safety assessment.

排除标准

  • Not passing the self-directed self-safety assessment
  • Knowing someone who is already enrolled in the program (added part-way through the recruitment period)
  • Non-cisgender identity in the screener

结局指标

主要结局

Number of Condom protected penile-vaginal Sex Acts

时间窗: 3-months post-intervention

The relative difference of protected penile-vaginal sex acts in the intervention versus control group at 3-months post-intervention

Number of Participants Who Used Other Birth Control Methods

时间窗: 3-months post-intervention

The relative difference of teens who used birth control methods other than condoms (e.g., the pill, the patch) in the intervention versus control group at 3-months post-intervention

次要结局

  • Testing for HIV and other sexually transmitted infections (STIs)(3-months post intervention)
  • Intentions to use condoms(3-months post intervention)
  • Intentions to Use Birth Control Other Than Condoms(3-months post intervention)
  • Pregnancy(3-months post intervention)

研究者

发起方
Center for Innovative Public Health Research
申办方类型
Other
责任方
Sponsor

研究点 (2)

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