Integrating Mobile Phone-Based Intervention With Test and Treat Strategy to Improve Clinic Attendance for Antiretroviral Pills Pick Up Among HIV Positive Individuals in Nepal: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- Clinic attendance for pills pick up
研究概览
简要总结
Antiretroviral therapy (ART) has been a game changer in the context of HIV-epidemic. From 2005 to 2015, HIV-related deaths have fallen by 45% thanks to ART. However, ART's success heavily depends on HIV-positive individuals' high adherence to it. This includes clinic attendance for various purposes. It is necessary among HIV-positive individuals for their antiretroviral (ARV) pills pick up, monitoring of their treatment outcomes, and treatment of their opportunistic infections. Among them, ARV pills pick up is the major reason for the ART clinic attendance. Improving clinic attendance for pills pick up remains one of the key challenges to ART programs. The World Health Organization (WHO) recommends more than 90% on-time ARV pills pick up as per the early warning indicators of HIV-drug resistance. Among six Asian countries, none of the 1048 clinics under the study could meet the WHO target. Among HIV-positive individuals, clinic attendance for pills pick can be improved by using mobile phones. Those who receive mobile phone reminders are two times more likely to attend their clinics regularly than those who did not receive such reminders. Nepal belongs to a low-income country and is facing a similar problem, too. In 2015, approximately 39,000 people were estimated to be living with HIV and ART coverage was limited to only 31.5%. In the same year, only 32% of the HIV-positive individuals attended their clinics regularly for ARV pills pick up. Like other countries, one of the potential strategies is to use mobile phones effectively in Nepal. Mobile phones have been very widely used in Nepal. In 2016, Nepal had 27.9 million mobile phone users, against the population of 26.5 million. Under such a context, mobile phone reminders can be effective to improve clinic attendance among HIV-positive individuals. However, the effectiveness of such interventions barely remains examined by using a randomized controlled trial. This study evaluates the effectiveness of mobile phone reminder intervention on improving clinic attendance for ARV pills pick up and medication adherence among HIV-positive individuals on ART following the implementation of test and treat strategy in Nepal.
详细描述
Background Antiretroviral therapy (ART) has been a game changer in the context of HIV-epidemic. From 2005 to 2015, HIV-related deaths have fallen by 45% thanks to ART. In addition, ART has produced a two-fold positive impact on the lives of HIV-positive populations. First, it has increased the life expectancy and improved the quality of life of HIV-positive individuals. Second, it has prevented new infections in the population.
However, ART's success heavily depends on HIV-positive individuals' high adherence to it. This includes clinic attendance for various purposes. It is necessary among HIV-positive individuals for their antiretroviral (ARV) pills pick up, monitoring of their treatment outcomes, and treatment of their opportunistic infections. Among them, ARV pills pick up is the major reason for the ART clinic attendance.
Three negative consequences may occur when HIV-positive individuals miss their clinic attendances. First, it can directly impair their medication adherence. Second, HIV-drug resistance and treatment failure could rise. Finally, mortality may increase among HIV-positive individuals. In addition, missed clinic attendances increase economic burden to the health system. However, both in high-and low-income countries, significant proportions of HIV-positive individuals miss their scheduled clinic attendances for ARV pills pick up.
Improving clinic attendance for pills pick up remains one of the key challenges to ART programs. The World Health Organization (WHO) recommends more than 90% on-time ARV pills pick up as per the early warning indicators of HIV-drug resistance. However, in 2012, worldwide, more than 30% of the ART clinics did not meet WHO target of timely ARV pills pick up.
Achieving WHO's pills pick up target is more challenging in low-income countries. For instance, in the Sub-Saharan Africa, 59 to 83% of the ART clinics could not achieve the WHO target of on-time pills pick up. Similarly, among six Asian countries, none of the 1048 clinics under the study could meet the WHO target.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study will be a double blinded RCT. HIV-positive individuals will be blinded to allocation group. Further, those who deliver the intervention will be blinded to the allocation. Intervention and control groups will receive similar intervention strategies. Only the content of the interventions will be different. Therefore, it is difficult for HIV-positive individuals to tell if they are receiving intervention or control. The outcome assessor will be masked to the allocation of each HIV-positive individual by using trial identity numbers. Only the principal researcher will have complete access to all the information.
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
- •Eligibility criteria
- •be 18 years or over;
- •own a mobile phone;
- •started treatment following test and treat strategy; and
- •under the first line ART regimen
排除标准
- •HIV-positive individuals will be excluded if they have severe physical and mental illnesses.
研究组 & 干预措施
Intervention
HIV-positive individuals will receive the standard HIV care following the national ART guidelines. In addition, the intervention group will receive mobile phone calls. A mobile phone reminder will be made two days prior to their scheduled appointment for pills pick up. Trained research assistants will remind them of their scheduled clinic appointment of pills pick up. If the first call is missed, the second call will be made within the same day, if the second call is also missed, the final call will be made next day. The intervention will be delivered over the period of six months. Outcome assessors will not be involved in the phone calls.
干预措施: Mobile phone reminder (Behavioral)
Control
Control group will also receive the standard HIV care following the national ART guidelines and phone calls educating them on healthy living. Phone calls will be made once a month.
干预措施: Mobile phone reminder (Behavioral)
结局指标
主要结局
Clinic attendance for pills pick up
时间窗: six months.
Clinic attendance adherence rate will be used to assess the clinic attendance. The rate will be based on the rate of total days adhered to the total scheduled days. An attendance will be called 'adhered', when they maintained an attendance in less than or equals to two days among scheduled days. Information on clinic attendance will be obtained from HIV-positive individuals' treatment and care files. Clinic attendance will be measured over the period of six months after the intervention. Dichotomous measure will be used to assess the clinic attendance for pills pick up. A 100% adherence rate will be used to define regular clinic attendance and missing any appointment(s) will be categorized as inconsistent clinic attendance.
次要结局
- Delay in pills pick up(Six months.)
- Medication adherence(Six months.)
研究者
Rakesh Ayer
Mr.
Tokyo University