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临床试验/NCT02544841
NCT02544841已完成不适用

Evaluation of Safer Sex Intervention (SSI)

The Policy & Research Group0 个研究点目标入组 319 人开始时间: 2012年2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
319
主要终点
Two questionnaire items measuring consistency of condom use

研究概览

简要总结

The purpose of the study is to determine the impact of the offer to participate in Safer Sex Intervention (SSI) (treatment) relative to the offer to participate in Female Sexual Health (control) on three self-reported sexual behaviors (condom use, other contraceptive use, and frequency of sex) six months after the end of treatment.

详细描述

The Policy & Research Group (PRG) will be evaluating the Safer Sex Intervention (SSI). The Safer Sex Intervention is based in Social Cognitive Theory, the Transtheoretical Model of Behavior Change, and motivational interviewing. Coupled with skill-building exercises, the intervention is intended to increase knowledge related to risk and safe-sex behaviors, to increase awareness of risk and need for behavior change, to help build self-efficacy to engage in safe-sex behaviors, and, ultimately, to motivate participants to engage in and maintain safe sex practices. The intervention is meant to be delivered in four, one-on-one sessions over the course of six months. Each session is to be conducted in a private setting by a female health educator trained in motivational interviewing and Safer Sex Intervention. The initial or primary intervention session should take approximately 30 to 50 minutes. Subsequent "booster sessions" delivered 1, 3, and 6 months following the initial session are to take 10 to 30 minutes. Booster sessions are intended to sustain any resulting behavior change. The control (counterfactual) condition, Female Sexual Health, was developed specifically for use in this study; it consists of a 30-minute PowerPoint presentation, intended to be delivered in one face-to-face session that provides information about reproductive anatomy and STIs. After the presentation, participants receive free condoms. This is the only session for the control condition; there are no booster sessions. Though there were some variations in consent requirements across sites, there were no differences in the recruitment process between the treatment and control groups. All eligible individuals who provided the proper consent to participate were randomized and enrolled into the study at the time they attended their first scheduled study session. Data were collected via self-administered questionnaires that were scheduled at baseline and six months post treatment (12 months after baseline). The study took place in New Orleans, Louisiana, at five clinics that served young women between the ages of 14 and 19.

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
14 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Between the ages of 14-19 Had engaged in sex with a male in the three months prior to enrollment Provide parental consent (if under age 18) and participant assent to participate in the study.

排除标准

  • Not have previously participated in any of the following pregnancy/HIV prevention programs:
  • 4 Real Health
  • Becoming a Responsible Teen (BART)
  • Healthy Living
  • Staying Mature and Responsible Towards Sex (SMARTS)
  • Sisters Informing Healthy Living and Empowering (SIHLE)
  • Project AIM
  • Making Proud Choices
  • Be Proud Be Responsible
  • Focus on Your Future

结局指标

主要结局

Two questionnaire items measuring consistency of condom use

时间窗: 6 months after the end of intervention

The risk outcome is operationalized as the proportion of times in the past three months a person reports having any type of sex without using a condom. The measure is calculated from the following items on the Outcome Questionnaire administered 6 months after the program ends: * In total, how many times have you had any type of sex in the past 3 months? * Now, think about the number of times that you had any type of sex in the past 3 months. How many of those times did you use condoms? The resulting variable is a continuous proportion with values that range from 0 to 1, where 0 indicates that a person has not engaged in sex without a condom in the past three months, and 1 indicates that the person has engaged in sex without a condom 100% of the times they had sex in the past three months.

次要结局

  • Two questionnaire items measuring consistency of contraceptive use(6 months after end of intervention)
  • One questionnaire item measuring frequency of sexual activity(6 months after end of intervention)

研究者

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

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