Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- PrEP Adherence
研究概览
简要总结
The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.
详细描述
Women enrolled in the study will be randomized to standard of care adherence support (brief counseling) and either WhatsApp groups or weekly two-way SMS messages. Two months after PrEP initiation, tenofovir drug levels will be measured to determine if participants have achieved high adherence based on their initial randomization. Women with high adherence (i.e., TFV-DP >/=500 fmol/punch from dried blood spots [DBS]) will continue with the adherence support to which they were initially randomized. Participants with low adherence (i.e., TFV-DP <500 fmol/punch from DBS) will continue initial randomization (WhatsApp or two-way SMS) plus be randomized to more one of two more intensive adherence support interventions - continued monthly visits with adherence and problem-focused counseling at months 3-8 or quarterly visits between months 3-9 with feedback about adherence based on drug levels at months 3 and 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female at birth
- •Age 18-25 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
- •Able and willing to provide adequate locator information
- •Regular access to a mobile phone with SMS and WhatsApp capacity
- •Agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation
排除标准
- •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
- •A reactive or positive HIV test at Enrollment
- •Any reported PrEP use within the last 6 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
- •Positive pregnancy test
研究组 & 干预措施
WhatsApp Group
Participants will be assigned to participate in a WhatsApp Group
干预措施: WhatsApp Group (Behavioral)
2-way SMS
Participants will be assigned to receive weekly 2-way SMS initiated by the study team
干预措施: 2-way SMS (Behavioral)
2-way SMS and monthly counseling sessions
Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions
干预措施: 2-way SMS (Behavioral)
2-way SMS and monthly counseling sessions
Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions
干预措施: Monthly counseling sessions (Behavioral)
2-way SMS and drug level feedback
Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback
干预措施: 2-way SMS (Behavioral)
2-way SMS and drug level feedback
Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback
干预措施: Drug level feedback (Behavioral)
WhatsApp Group and monthly counseling sessions
Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
干预措施: WhatsApp Group (Behavioral)
WhatsApp Group and monthly counseling sessions
Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
干预措施: Monthly counseling sessions (Behavioral)
WhatsApp Group and drug level feedback
Participants will be assigned to participate in a WhatsApp Group and drug level feedback
干预措施: WhatsApp Group (Behavioral)
WhatsApp Group and drug level feedback
Participants will be assigned to participate in a WhatsApp Group and drug level feedback
干预措施: Drug level feedback (Behavioral)
结局指标
主要结局
PrEP Adherence
时间窗: 9 months
Evaluation of the proportion of young women who adhere well to PrEP in each of the original intervention arms.
次要结局
- Intervention satisfaction(12 months)
- Correlates of PrEP adherence(12 months)
- PrEP discontinuation(12 months)
- PrEP persistence(12 months)
- PrEP decision making(12 months)
- Probability of High PrEP Adherence at Nine Months(9 months)
- PrEP Discontinuation(9 months)
研究者
Connie Celum
Prof of Medicine & Global Health, Adjunct Prof of Epidemiology
University of Washington