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临床试验/NCT03029962
NCT03029962已完成不适用

Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls

Center for Innovative Public Health Research2 个研究点 分布在 1 个国家目标入组 948 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
948
试验地点
2
主要终点
Number of participants who abstained from penile-vaginal sex

研究概览

简要总结

The purpose of this study is to finalize and rigorously evaluate Girl2Girl, a novel text messaging-based teenage pregnancy prevention (TPP) program designed specifically for LGB women ages 14-18 years, nation-wide. The guiding theoretical model is the Information-Motivation-Behavioral Skills (IMB) Model, which has been used extensively and is associated with increases in TPP behavior.

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. The investigators will test the intervention in a randomized control trial (RCT) of 840 LGB teenage women randomly assigned to either the intervention (n = 420) or control (n = 420) arms. Our primary efficacy outcome measures, measured at 12-months post-intervention, will be: (a) abstinence from penile-vaginal sex; (b) condom use during penile-vaginal sex, (c) use of other birth control methods during penile-vaginal sex, and (d) pregnancy.

If effective, Girl2Girl has promise to be quickly and cost-effectively implemented to scale to help to curb the spread of teenage pregnancy among women who identify as LGB.

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);
  • be cisgender (i.e., be assigned a female sex at birth and endorse a female gender identity);
  • be aged 14-18;
  • in high school or equivalent (including those who did not finish school/dropped out);
  • be English speaking;
  • be exclusive owners of a cell phone with an unlimited text messaging plan;
  • have used text messaging for at least six months;
  • intend to have the same cell number for the next six months; and,
  • be able to provide informed assent, including an acceptable score for "capacity to consent" and the self-safety assessment.

排除标准

  • not having the capacity to assent
  • not passing the self-safety assessment
  • previously participating in another study activity (with the exception of the baseline and intervention end survey pilot tests)
  • knowing someone who is already enrolled in the program
  • non-cisgender

结局指标

主要结局

Number of participants who abstained from penile-vaginal sex

时间窗: Post-intervention (about 20 weeks after randomization)

The relative difference of abstinence (not engaging in vaginal sex) in the intervention versus control group at 12-months post-intervention

Number of participants who used other birth control methods

时间窗: Post-intervention (about 20 weeks after randomization)

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 12-months post-intervention

Number of protected penile-vaginal sex acts

时间窗: Post-intervention (about 20 weeks after randomization)

The relative difference of protected penile-vaginal sex acts in the intervention versus control group at 12-months post-intervention

次要结局

  • Number of participants who used other birth control methods(immediate post-intervention end, 3-, 6-, 9-months post-intervention)
  • Number of penile-vaginal sex acts during which a condom was used(immediate post-intervention end, 3-, 6-, 9-months post-intervention)
  • Number of participants who abstained from penile-vaginal sex(immediate post-intervention end, 3-, 6-, 9-months post-intervention)
  • Pregnancy(Across the 12 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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