A Mixed Methods Process Evaluation of a Randomised Controlled Trial (META Trial) to Evaluate the Use of Metformin in HIV-Positive Persons With Pre-Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Qualitative interview, focus group, and brief questionnaire findings
研究概览
简要总结
The aim of this study is to conduct a mixed methods process evaluation of the META trial. Semi-structured interviews, focus groups, and brief questionnaires will be conducted with a purposive sample of participants (patients and healthcare providers) who were involved in the trial to explore the feasibility, acceptability and perceived effectiveness of the trial intervention.
详细描述
The META trial was a phase II randomised double-blind placebo-controlled trial that is being conducted in Dar es Salaam, Tanzania to evaluate the use of metformin in HIV-positive persons on antiretroviral therapy (ART) with pre-diabetes.
This study aims to explore the feasibility, acceptability and perceived effectiveness of the META trial intervention by conducting qualitative interviews, focus groups, and brief questionnaires with a purposive sample of participants (patients and healthcare providers) in Tanzania who are involved in the META trial.
Data collection will commence during June-July 2025 with a purposive sample of patients and health care professionals who were involved in the trial (n=50-60).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who participated in the META Trial
- •Participants who have the capacity to provide written informed consent
排除标准
- 未提供
结局指标
主要结局
Qualitative interview, focus group, and brief questionnaire findings
时间窗: 8 weeks
The primary outcome will the findings of in-depth semi-structured qualitative interviews, focus groups, and brief questionnaires with a purposive sample of patients and HCPs who participated in the META trial (n=50-60).
次要结局
未报告次要终点