NCT02732730已完成4 期
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
HIV Prevention Trials Network3 个研究点 分布在 2 个国家目标入组 451 人开始时间: 2016年10月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 451
- 试验地点
- 3
- 主要终点
- Number of Participants With High Adherence at Six Months
研究概览
简要总结
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.
详细描述
A Phase IV randomized multi-site prospective study to assess PrEP acceptance and adherence among HIV-uninfected young women. All women who accept open-label daily oral PrEP will be randomized 1:1 to receive enhanced adherence counselling based on feedback from observed drug levels or standard adherence support. A subset of up to ~25 women per site (maximum 75), will participate in qualitative assessments of facilitators and barriers for PrEP acceptance, adherence and continuation.
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
- 16 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Young women who meet all of the following criteria are eligible for inclusion in this study:
- •Female at birth
- •Age 16-25 years
- •Per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening
- •Literate in one or more of the study languages
- •Willing and able to provide informed consent or assent (if parental consent is required per local regulations)
- •If parental consent is required per local regulations, parent/legal guardian willing and able to consent to all study procedures including HIV testing
- •Able and willing to provide adequate locator information, as defined in site Standard Operating Procedures (SOPs)
- •Have a score of 5 or greater on the Vaginal and Oral Intervention to Control the Epidemic (VOICE) risk score tool
- •Interest in PrEP (ascertained by selected questions from the HIV Prevention Readiness Measure (HPRM) and Prep Belief Measure (PBM) defined in the Study Specific Procedures [SSP] Manual)
- •Regular access to a mobile phone with SMS capacity
- •Agrees not to participate in other research studies involving drugs or medical devices for the next 12 months
- •Hepatitis B virus (HBV) seronegative and accepts HBV vaccination.
排除标准
- •Young women who meet any of the following criteria will be excluded from this study:
- •Planning to relocate in the next 12 months
- •Has a job or other obligations that would require long absences from the area (> 4 weeks at a time) for 12 months
- •Any health condition that may interfere with participation, including any debilitating or life-threatening conditions
- •Currently pregnant or planning to become pregnant in the next 12 months
- •Any reactive or positive HIV test at Screening or Enrollment, even if subsequent testing indicates that the person is HIV-uninfected
- •Renal dysfunction (Creatinine Clearance < 60 ml/min, Schwartz Equation)
- •Any reported PrEP use within the last 12 months
- •Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
- •Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial
- •Signs or symptoms of acute HIV infection (as described in the SSP Manual)
- •Current active and serious infections which could interfere with study participation, including active tuberculosis infection, osteomyelitis, and all infections requiring parenteral antibiotic therapy (other than STIs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly-controlled cardiac disease (e.g., symptoms of ischemia, congestive heart failure), or previously diagnosed malignancy expected to require further treatment.
- •Current use of ARV drugs for post-exposure prophylaxis (PEP) or completion of a PEP regimen within 4 weeks prior to Screening
- •History of pathological bone fracture not related to trauma
- •Known allergy/sensitivity to the study drug or its components
- •Receiving ongoing therapy with any of the following: investigational ARV agents, interferon or interleukin therapy, agents with substantial nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents
- •Any other condition that, based on the opinion of the site Investigator of Record (IoR) or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.
研究组 & 干预措施
Enhanced Adherence Support
Experimental
For those women who choose to accept PrEP (Truvada) and assigned to receive enhanced adherence support, the following adherence support package will be provided:
- Cognitive Behavioral Theory adherence support sessions
- Two-way SMS communications
- Optional monthly adherence support clubs
- Drug level counseling at Weeks 8 and 13
干预措施: Truvada (Drug)
Enhanced Adherence Support
Experimental
For those women who choose to accept PrEP (Truvada) and assigned to receive enhanced adherence support, the following adherence support package will be provided:
- Cognitive Behavioral Theory adherence support sessions
- Two-way SMS communications
- Optional monthly adherence support clubs
- Drug level counseling at Weeks 8 and 13
干预措施: Drug level counseling at Weeks 8 and 13 (Behavioral)
Standard Adherence Support
Active Comparator
For those women who choose to accept PrEP (Truvada) and assigned to receive standard adherence support, the following adherence support package will be provided:
- Cognitive Behavioral Theory adherence support sessions
- Two-way SMS communications
- Optional monthly adherence support clubs
干预措施: Truvada (Drug)
结局指标
主要结局
Number of Participants With High Adherence at Six Months
时间窗: at month 6 from start of the study
Number of Participants with High adherence defined as TFV-DP ≥700 fmol/punch
次要结局
- Number of Participants With High Adherence at Twelve Months(12 months from the start of the study)
研究者
研究点 (3)
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