跳至主要内容
临床试验/NCT03238313
NCT03238313已完成不适用

Evaluation of "Plan A" Video Intervention

The Policy & Research Group1 个研究点 分布在 1 个国家目标入组 1,770 人开始时间: 2016年6月15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
1,770
试验地点
1
主要终点
LARC Use

研究概览

简要总结

The purpose of the study is to determine if exposure to the "Plan A" video influences viewers' uptake of LARC, reduces unprotected sexual activity, and increases receipt of STI testing.

详细描述

The Policy & Research Group (PRG) is evaluating the "Plan A" video, which was designed to promote effective contraceptive use, use of dual methods of protection (condom use and prescription birth control use), and HIV/STI testing in African/American and Latina young women. The video is approximately 23 minutes in length and is shown immediately prior to a clinical appointment at a reproductive health center. By delivering the intervention prior to a clinic appointment, developers hope to reach high-risk teens at a teachable moment, when they can ask a health care provider about what they have learned. The primary focus of the study is to investigate the impact of the intervention on participants': 1) LARC use; 2) times having sex without a condom; and 3) STI testing. Secondary outcome measures include assessing the impact of the intervention on participants': 1) use of dual methods of protection during vaginal sex; and 2) use of other effective contraceptive methods. Finally, the evaluation will include exploratory analysis of participants': 1) perception of risk and/or severity for pregnancy and HIV/STI infection; (2) intention to use LARC; (3) intention to use other effective contraception methods; (4) provider communication self-efficacy; (5) condom negotiation self-efficacy; and (6) knowledge/awareness of contraception options/LARC.

The control (counterfactual) condition consists of a 17-minute video titled "The Toxic Life Cycle of a Cigarette". The control video, which discusses the effects of smoking, is shown in the same manner as the treatment video: immediately prior to a clinic appointment at a reproductive health center.

All eligible participants who provide the proper consent are randomized and enrolled into the study by a study coordinator who is an employee of the reproductive health clinic. Outcomes will be assessed using self-reported, participant-level data gathered (by way of a questionnaire) at three time points: baseline (enrollment, prior to watching the video); 3-month follow-up (3 months after baseline); and 9-month follow-up (9 months after baseline). The study is taking place at seven clinics within the Planned Parenthood Mar Monte system in California, all of which serve the target population.

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
None

入排标准

年龄范围
18 Years 至 19 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Be female
  • Be 18 or 19 years old
  • Self-identify as Latina and/or African-American
  • Be visiting a reproductive healthcare provider at the study site
  • Be deemed appropriate for the study by study staff/clinic staff with regards to physical and mental health and capacity
  • Consent to participate in the study

排除标准

  • Knowingly pregnant
  • Trying to become pregnant
  • Previously enrolled in the study
  • Enrolled in studies in the same geographic area that aim to prevent teen pregnancy

结局指标

主要结局

LARC Use

时间窗: Three months after intervention

Participant self-report on the use of Long Acting Reversible Contraception (LARC). Measured through one survey question which asks the participant to select all methods of prescription birth control currently being used.

STI Testing

时间窗: Three months after intervention

Participant self-report on if they have been tested for Sexually Transmitted Infections (STIs). Measured through two survey questions which ask the participant about whether they have ever been tested for STIs and if yes, whether they have been tested for STIs (other than HIV) in the past three months.

Times Having Sex Without a Condom

时间窗: Three months after intervention

Participant self-report on the number of times they have had vaginal, oral, or anal sex without a condom in the last three months. Measured through three survey questions which ask the participant how many times they have had vaginal, oral, and anal sex in the past three months.

次要结局

  • Use of Other Effective Contraception(Three months after intervention)
  • Dual Methods of Contraception(Three months after intervention)

研究者

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

研究点 (1)

Loading locations...

相似试验