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临床试验/NCT02965014
NCT02965014终止不适用

Young Women-Focused HIV Prevention: Seek & Test in North Carolina (NC) Clinics

RTI International8 个研究点 分布在 1 个国家目标入组 652 人开始时间: 2017年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
652
试验地点
8
主要终点
Condomless Sex

研究概览

简要总结

This three-arm cross-over randomized trial will develop, test, and compare the efficacy of two delivery formats of the Young Women's CoOp (YWC), which is designed to provide risk reduction and empowerment skills, as well as linkages to healthcare services for women who use substances. The current study will develop a revised version of the YWC and evaluate the relative efficacy of a face-to-face (face-to-face YWC), mobile Health application (mHealth YWC) delivery format, and HIV counseling and testing (HCT) as a control to reduce risky sexual behaviors and reduce substance use among young (18-25) African American women who use substances and are sexually active and have not recently been tested for HIV in three NC counties.

详细描述

The purpose of this study is to use the seek, test, treat, and retain framework to develop and test the efficacy of a clinic-based, age-appropriate, woman-focused HIV risk-reduction intervention to reduce sexual risk among up to 700 young sexually active African American women aged 18 to 25 who use drugs in three North Carolina counties. The researchers will test the delivery of the woman-focused intervention conducted in two formats, face-to-face YWC and mHealth YWC, using a three-arm cross-over randomized design in which counties are randomized to (1) HCT as the control, (2) face-to-face YWC; and (3) mHealth YWC that will be delivered on tablets using an interactive app. The researchers will fulfill the purpose of this study through the following aims: (Aim 1) To develop a new YWC intervention and recruitment strategies using formative methods to engage young African American women who use substances and have not recently been tested for HIV, clinic staff, and stakeholders to ensure age appropriateness, to identify barriers to reaching these young women and the challenges in conducting the intervention in the clinics, and to develop the mHealth YWC; (Aim 2) To test the efficacy of two formats of the woman-focused intervention program (face-to-face YWC and mHealth YWC) relative to HCT with up to 700 young women aged 18 to 25 in three North Carolina county health departments for primary outcomes at 6-, and 12-month follow-up assessments; (Aim 3) To estimate the total costs of implementing the face-to-face YWC and mHealth YWC interventions, and to assess the resource components that drive these costs; and (Aim 4) To examine the extent to which the face-to-face YWC and mHealth YWC are perceived by collaborating health clinic staff and participants as being acceptable and sustainable.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Identify as female
  • Identify as Black or African American
  • 18-25 years of age
  • Have used alcohol or drugs in greater quantity or for a longer period of time than intended within the past 30 days

排除标准

  • Participants may not be non-Black/African American

结局指标

主要结局

Condomless Sex

时间窗: 12-month follow-up

Self-reported frequency of condomless sex

Frequency of Substance Use

时间窗: 12-month follow-up

Frequency of using illicit drugs and alcohol

次要结局

  • Reduced Alcohol and Illicit Drug Use for a Subsample of Participants(12-month follow-up)
  • Reduced Violence and Victimization for a Subsample of Participants(12-month follow-up)
  • Increased Sexual Negotiation(12-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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