The Feasibility and Preliminary Efficacy of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Medication Adherence of Patients With HIV Infection: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from one month percentage ART adherence at two months (by MEMScap)
研究概览
简要总结
A total of 40 HIV infected patients will be randomly assigned into intervention or control group. Participants in the intervention group will use an smart phone application for two months. Participants will receive reminder notifications and use the app to take and send videos of themselves taking the pill(s), uploaded videos will be centrally reviewed by a study nurse . Control group participants will receive standard care. Antiretroviral Therapy adherence will be measured by self-report, pill count, and smart bottle as well as the App. Participants' perceptions of app using experience will be recorded via face to face interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection diagnosis confirmed by western blot
- •Taking a once daily regimen of HIV medications
- •Able to take pills orally
- •Willing and able to give informed consent
排除标准
- •Inability to operate a smart phone
- •Active Tuberculosis infection requiring treatment during study (due to additional challenge posed to adherence that may confound the assessment of HIV adherence)
- •Substance use
- •Visual or hearing impairment
- •Cognitive impairment
研究组 & 干预措施
Intervention Group
干预措施: Mobile Interactive Supervised Therapy (MIST) (Behavioral)
Control Group
结局指标
主要结局
Change from one month percentage ART adherence at two months (by MEMScap)
时间窗: one-month follow-up and two-month follow-up visits
Change percentage ART adherence over the 2 month study period, as measured by MEMScaps, collected at the 1 and 2 month visits.
次要结局
- Variability in time (minutes) between prescribed pill time and actual dose taken(One-month follow-up visit, two-month follow-up visit(end of study visit))
- Percentage ART adherence (by pill count)(One-month follow-up visit, two-month follow-up visit(end of study visit))
- Participants' perceptions on using MIST intervention(two-month follow-up visit (end of the study visit))
- Percentage ART adherence (self-reported)(Baseline visit, one-month follow-up visit and two-month follow-up visits (end of study visit))