跳至主要内容
临床试验/NCT05463692
NCT05463692Enrolling By Invitation不适用

CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 830 人开始时间: 2023年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
830
试验地点
2
主要终点
Annualized Sexually Transmitted Infections (STIs)

研究概览

简要总结

Pre-exposure prophylaxis (PrEP) is an important biomedical human immunodeficiency virus (HIV) prevention tool and may particularly benefit black, cis and trans-gender women, who are at an increased risk for HIV and Sexually Transmitted Infections (STIs). The purpose of this study is to use a population-based approach to create a cohort of cis and trans-gender women at risk for future HIV acquisition to better understand the factors associated with the risk of STIs and HIV diagnosis and predictors of PrEP use.

详细描述

To better understand contextual factors among people who identify as women in Alabama that predict STI/HIV infection and PrEP use, we will refine an existing evidence-based mobile health app (HealthMpowerment or HMP) to optimally engage and retain a digital cohort of women at-risk for HIV infection (i.e. prior infection in the past 3 months with gonorrhea or syphilis). Using a sampling strategy based on geospatial analysis of HIV-risk, we will enroll and follow our cohort longitudinally to assess factors associated with incident STI/HIV infection as well as utilization of PrEP through iterative self-collected STI/HIV testing and survey assessments.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self identify as a Cis-gender or Trans-gender woman
  • Age 18 - 89
  • Reported STI in past 3 months by the Alabama Department of Public Health (ADPH)
  • Gonorrhea and Syphilis negative
  • HIV negative at screening encounter
  • Live in Alabama
  • Have access to a private smart phone

排除标准

  • Live outside of Alabama
  • Positive diagnosis for HIV, Gonorrhea, or Syphilis

结局指标

主要结局

Annualized Sexually Transmitted Infections (STIs)

时间窗: From time of enrollment through study completion at 24 months

We will calculate incidence of gonorrhea and new positive cases of syphilis.

次要结局

  • Pre-Exposure Prophylaxis (PrEP) uptake(From time of enrollment through study completion at 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lynn T. Matthews

Professor

University of Alabama at Birmingham

研究点 (2)

Loading locations...

相似试验