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临床试验/NCT03330522
NCT03330522已完成不适用

Reducing HIV Risk in Urban Women: Soap Opera Videos on Video-Capable Cell Phones

Northeastern University2 个研究点 分布在 1 个国家目标入组 295 人开始时间: 2008年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
295
试验地点
2
主要终点
Change in unprotected sex risk with high risk partners from baseline to 6 months post-intervention

研究概览

简要总结

Background: Love, Sex, and Choices (LSC) is a soap opera video series created to reduce HIV sex risk in women.

Methods: LSC was compared to text messages in a randomized trial in 238 high-risk mostly Black young urban women. 117 received 12-weekly LSC videos, 121 received 12-weekly HIV prevention messages on smartphones. Changes in unprotected sex with high risk partners were compared by mixed models.

详细描述

This randomized controlled trial (RCT) aims to evaluate "Love, Sex, & Choices" (LSC), a video-based intervention to reduce human immunodeficiency virus (HIV) sex risk behaviors in young adult urban women. Consisting of 12-weekly soap opera videos lasting up to 20 minutes each, messages about reducing HIV sexual risk are communicated through the drama and context of relationships, a strength of the soap opera modality. Based on true stories analyzed from focus groups, viewers can identify with the heroines in the videos who suffer tragedy and heartbreak and transform their behavior through a new awareness of their value as women, their choices, and their potential. Women watch a new video sequel weekly for 12 weeks on smartphones. A control group receives text/audio messages concerning HIV risk reduction. If successful, the public health impact is that women at risk for HIV will be able to access video interventions to reduce HIV risk on personal mobile devices.

Prior to this work, a 43-minute soap opera video, "A Story about Toni, Mike, and Valerie" had been produced and pilot tested by the Principal Investigator (PI) on handheld computers (RO3 NR009349). Findings had indicated the video was highly appealing and there was a statistically significant short-term reduction in stereotypical gender views about the need to engage in unprotected sex in the video intervention arm that was not observed in the control arm.

The current RCT seeks to test the effect of the LSC series on sex risk behavior as compared to a control receiving HIV prevention text messages. Analysis and story development had been guided by Sex Script Theory and the Theory of Power as Knowing Participation in Change; as well as, content analysis of focus groups with urban young adult African American and Latina women. Consistent with the theories and focus group analyses, the new LSC series elaborates on the original story weaving in the stories of four women. In both the RO3 pilot study and the related National Library of Medicine funded study (1 G08 LM008349-01), the use of small handheld computers to watch the video was found to be enjoyable and promoted a sense of privacy. Based on these promising findings concerning the experience of viewing videos on small handheld devices, the popularity of cell phones in this age group, and that the use of cell phones to watch videos is growing as cell phone technology, multimedia, and Internet connections improve, the present study seeks to deliver the weekly series of videos on smartphones.

There are several advantages of viewing videos on smartphones, in particular the freedom to watch the intervention videos often and in privacy. This study is also consistent with several NINR objectives stated in its strategic plan. These are: to apply findings concerning the social and cultural context of health behavior to health promotion, to develop and test interactive web-based and wireless technologies to eliminate health disparities, and to refine methods in the delivery of health promotion. The overall aim of this study is to conduct a RCT to determine whether the 12-week series of theory-based urban soap operas will reduce HIV sexual risk behavior. The specific aims of this study are:

Aim1. Complete final editing phase of LSC, a series of 12, 20-minute soap opera videos, and 12 HIV health promotion text/audio messages that will be released weekly and viewed on smartphones.

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
18 Years 至 29 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women 18-29 years old
  • Unprotected vaginal or anal sex with at least one man that they perceive as engaging in risky behavior OR
  • Unprotected vaginal or anal sex with more than 1 man regardless of perceived partner risk
  • Can understand written and spoken English

排除标准

  • Women younger than 18 years old
  • Women older than 29 years old
  • Cannot understand written or spoken English
  • Previously participated in the study

结局指标

主要结局

Change in unprotected sex risk with high risk partners from baseline to 6 months post-intervention

时间窗: change in sex risk behavior from baseline to 6 months

Sex risk is measured by the Vaginal Episode Equivalent (VEE) score (Susser, Desvarieux, \& Wittkowski, 1998) with high risk partners. The VEE is the sum of all unprotected vaginal anal sex acts weighted by the relative HIV transmission risk (vaginal 1 and anal 2). A high risk partner is defined as the likelihood the male partner had sex with another woman, sex with men, or injected drugs in the past 3 months. Partner risk could range from 0 to 9; main or non-main partners with scores \> 0 were considered to engage in risk behavior. Multiple partners were considered high-risk. An HIV positive partner is high risk.There is a four-point response metric, from "Definitely not" (0) to "Definitely did" (3). Only women having unprotected sex with a partner they perceived to have risk \> 0 by this system were included into the study. For a given visit, unprotected vaginal and anal sex with all high risk partners in the previous 3 months were calculated at baseline and at 3 and 6 months.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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