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临床试验/NCT02128087
NCT02128087已完成不适用

Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders

RAND4 个研究点 分布在 2 个国家目标入组 330 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
330
试验地点
4
主要终点
Medication adherence rates using electronically monitored adherence (MEMS cap) data

研究概览

简要总结

In this project the investigators develop and test a short message service (SMS) intervention based on the Information Motivation and Behavior skills (IMB) model. Reminding Adolescents To Adhere (RATA) prompts youths at two clinics in Uganda to take their medications and offers social support via weekly text messages. The investigators propose to adapt their previous successful SMS-intervention to the specific needs of youths and to evaluate the relative effectiveness of one-way versus two-way text messages (where two-way messages allow youths to respond to messages and we hypothesize that this may increase perceived social support that may be important for youth populations). We will also test the effectiveness of SMS messages over the longer-term (2 years), for which currently no information is available.

详细描述

The primary goal of the proposed study is to develop and test SMS-based text messages for improving medication adherence among HIV-positive youths in a resource-limited setting. The study will be conducted in three phases: Phase 1 will consist of qualitative interviews with patients, clinic providers and directors, and community leaders and will elicit information on barriers to treatment and adherence patterns and cognitive obstacles to adherence that may be addressed by RATA. A second focus of this phase will be to investigate the familiarity with and attitude towards SMS messages among adolescents, and their attitudes towards different aspects of these messages. Parameters of the messages that will be probed include their frequency, content, and form using Figure 1 as a guiding principle for this exploratory phase. Phase 2 will use the findings from Phase 1 to develop and implement RATA in a randomized controlled trial (RCT). A sample of 330 clients aged 15-24 who are in HIV care and show signs of problems with adherence will be recruited and randomized into one of three equal-sized intervention arms: a control group that will receive usual care, or one of two treatment groups in which participants will receive usual care and additionally will receive either two-way SMS messages or one-way SMS messages. All RATA participants will be followed for two years. Assessments will be conducted at baseline and every 6 months over the course of 24 months. Medication event monitoring system (MEMS)-caps measured medication adherence will be the primary outcome measure, while viral load (for a subset of clients) CD4 count, self-reported adherence and pharmacy refill data as well as retention in care constitute secondary outcomes. Phase 3 will be used to analyze the collected data, conduct qualitative interviews with providers, clinic administrators, and study participants to learn about implementation difficulties and areas of improvement, and to share preliminary results and project implementation insights with these key players. This stage allows evaluating the feasibility and sustainability of the intervention for potential scale-up, for which we will also conduct a relative cost-effectiveness analysis of two- versus one-way messages. RATA will be extended to the control group in Year 5 if findings from phase 2 suggest its success at improving outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age 15-24
  • have been in HIV care at the clinic for at least three months
  • are currently taking HIV-related medication (ART or co-trimoxazole)
  • have demonstrated adherence problems (defined as having missed at least one medication dose per week on average)
  • either own a phone or have regular access to one
  • intend to stay at the clinic for the study period
  • are not in boarding school (where phones are forbidden)

排除标准

  • does not speak or understand either English or Luganda

结局指标

主要结局

Medication adherence rates using electronically monitored adherence (MEMS cap) data

时间窗: 24 months after enrollment

Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing. MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the primary outcome variable of adherence (# of actual bottle openings / # of prescribed bottle openings).

次要结局

  • Clinic Attendance(Continuous over 24 months)
  • Self-reported adherence(At baseline, 6, 12, 18 and 24 months)
  • Pharmacy Refill Adherence(Months 6, 12, 18 and 24)
  • Fraction of clients displaying adherence of 90% or more(At 6, 12, 18 and 24 months)
  • Viral load assays(At month 12)
  • Cluster of differentiation 4 (CD4) count(Occasionally over 24 months)
  • Indicator for treatment interruptions of more than 48 hours(At 6, 12, 18 and 24 months)

研究者

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

Sebastian Linnemayr

Economist

RAND

研究点 (4)

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