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临床试验/PACTR202006754762723
PACTR202006754762723已完成未知

EMPOWER: An evaluation of a combination HIV prevention intervention that includes oral PrEP for adolescent girls and young women in South Africa and Tanzania

Wits Health Consortium0 个研究点目标入组 500 人开始时间: 2020年5月4日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
500

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
13 Year(s) 至 18 Year(s)(—)
性别
Female

入选标准

  • 1. AGYW (born female) at substantial risk for HIV infection who are confirmed age 16 - 24 years ( inclusive)
  • 2. HIV seronegative
  • 3. Interested in HIV prevention methods, including oral PrEP
  • 4. Sexually active per participant report, defined as having vaginal intercourse at least once in the past 30 days
  • 5. Willing and able to provide adequate locator information and
  • 6. Willing and able to provide informed consent or assent ( if parental consent is required per local regulations) and
  • 7. Regular access to mobile phone with SMS capability

排除标准

  • Not planning to be in the study area during the follow-up period or has obligations that would require long absences (>8 weeks at a time) from the study area;
  • HIV seropositive;
  • Women identified at screening as being at immediate risk of harm (either from self or others);
  • Signs or symptoms of acute HIV infection;
  • Currently pregnant;
  • Renal dysfunction (creatinine clearance <60ml/min, Schwartz equation);
  • Receiving on-going therapy with agents with substantial nephrotoxic potential; or
  • Hepatitis B seropositive.
  • Currently enrolled or planning to enrol in another HIV prevention research study;
  • Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial; or
  • Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

研究者

发起方
Wits Health Consortium

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