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临床试验/NCT03394391
NCT03394391已完成不适用

A Single-blind, Randomized, Parallel Design Study to Assess the Effectiveness of SMS Reminders in Improving ART Adherence Among Adolescents Living With HIV in Nigeria (STARTA Trial-Adolescents)

Dr. Olumide ABIODUN5 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2018年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
212
试验地点
5
主要终点
ART Adherence at 20 Weeks as Determined by Viral Load Count

研究概览

简要总结

The non-maintenance of ART adherence is a major barrier to the achievement of optimal treatment outcomes among adolescents living with HIV. ART adherence is a challenge among adolescents living with HIV because of lack of appropriate information, their unique emotional state and lifestyles but the most commonly quoted challenge to adherence is forgetting to take antiretroviral drugs. There is evidence to suggest that short message service (SMS) reminder- interventions may enhance drug compliance among adolescents living with other chronic diseases such as asthma and diabetes. Available literature underscores the need for randomized controlled trials (RCTs) of effective interventions to promote ART adherence among adolescents with HIV.

The aim of this study is to evaluate the feasibility, acceptability, and efficacy of interactive and tailored SMS reminders on ART adherence among adolescents (15-19 years) living with HIV in Ogun State, Nigeria. The study hypothesizes that the use of personal mobile phones and SMS reminders for the improvement of ART adherence among adolescents living with HIV are feasible, acceptable, and effective.

A single-blind, parallel-design (ratio 1:1), and multi-center RCT of 230 adolescent living with HIV who are non-adherent to medications will be conducted over a one-year period in Southwest Nigeria. All the participants will receive routine adherence counseling during clinic visits and one SMS reminder each for follow-up appointments 48 hours and 24 hours before the follow-up visit date. The intervention group will also receive daily ART adherence reminder SMS. Participants will be assessed at baseline and during follow-up visits at 4, 8, 12, 16 and 20 weeks after the baseline. Baseline assessment of participants will include socio-demographic characteristics; HIV/AIDS risk behaviour assessment, Alcohol and Drug abuse assessment, Client Satisfaction Survey, ART adherence assessment, CD4count and viral load assessments. ART adherence and client satisfaction will be assessed at each follow-up visit while CD4count and viral load assessments will be done at baseline and at 20th week.

It is possible that tailored SMS reminders will mitigate the barrier of forgetfulness in ART-adherence and lead to improved drug compliance, viral suppression, and quality of life among adolescents living with HIV.

详细描述

BACKGROUND In Nigeria, approximately 3.2 million people were living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) in Nigeria. Nigeria has about 196,000 adolescents (10-19 years) living with HIV with an estimated 17,000 new infections and 11,000 AIDS-related deaths per year in the age group. Adolescents aged 15 to 19 years constitute 8.8% of Nigeria's over 173 million people and have an HIV prevalence rate of 2.9%.

Non-adherence to antiretroviral therapy (ART) increases the risk of non-suppression of HIV, secondary HIV transmission, and development of drug resistance; it has a negative impact on treatment outcomes, leads to decreased survival and worsened quality of life. Adolescents on ART have lower viral suppression rates (49%) when compared with both adults and younger children (72.8% and 57%) and this is one of the most frequent causes of lower adherence to ART.

The non-maintained ART adherence is a major barrier to the achievement of optimal treatment outcomes among adolescents living with HIV. ART adherence is a challenge among adolescents living with HIV because of lack of appropriate information, their unique emotional state and lifestyles. Religious, cultural, social and health services related factors have also been recognized as a source of non-adherence to ART treatment. Other known barriers to ART adherence include difficult dosing schedule, side effects, food restrictions and pill burden but the most commonly quoted challenge to adherence is forgetting to take antiretroviral drugs. Many strategies, including directly observed drug use, adherence counselling, telephone calls and reminder devices adopted to enhance ART adherence have turned out to be time-consuming, costly and intrusive.

With over 148 million active mobile lines, short message service (SMS) has become a common means of communication in Nigeria. SMS is used commonly by teenagers, including those who are economically disadvantaged. SMS has been applied in a variety of healthcare setting because of its low-cost and convenient technology and has proved to be an effective tool for behavioural change interventions. There is evidence to suggest that SMS interventions may enhance drug compliance among adolescents living with other chronic diseases such as asthma and diabetes. An RCT showed that text-messaging system increased adherence to medication among adolescents by about 7%. While studies have evaluated the effectiveness of SMS reminders on ART adherence among PLHIV in some low-resource settings, to the best of our knowledge studies that evaluated SMS reminders for adolescents living with HIV have not yet been published. Indeed, a Cochrane systematic review of randomized controlled trials (RCTs) that assessed the effectiveness of SMS for improving ART adherence among people living with HIV infection identified the need of RCTs for this intervention among adolescents.

Mobile technology communicates interventions to people in real-time and in their natural habitat. A review of the literature on SMS interventions for behavioural change in health care settings identified key characteristics for success such as interactivity and tailored messages.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

The investigators, data manager, research assistants, counselors and other project staff will be blinded throughout the study. An independent medical internet technology firm will be contracted to randomize participants and to send the required SMS to the participants. After scientific review has been completed and data collection has been completed, at the point of analysis, a list of participants' unique identifiers in two groups will be sent to the data analysts without specifying which the investigation or control group is. The blinding of the clinical database will finally be removed after final data analysis has been completed.

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • HIV seropositivity
  • Being on ART for at least three month
  • Age 15 to 19 years as at last birthday
  • Use of personal mobile phone
  • Poor adherence to ART

排除标准

  • Adolescents who are too ill to require hospital admission will be excluded from the study.

结局指标

主要结局

ART Adherence at 20 Weeks as Determined by Viral Load Count

时间窗: 20 week [End of study]

Viral load count is measured in copies per ml. The minimum value is 0. There is no maximum value. The higher values reflect poor adherence

ART Adherence at 20 Weeks as Determined by VAS, Viral Load

时间窗: 20week [End of study]

ART adherence is assessed by different well-validated methods. In this study, ART adherence will be measured, primarily, using the self-report visual analog scale. The scale is well-validated, self-report of the level of ART adherence with a range from 0 to 100%. While higher values indicate better levels of adherence, patients with adherence levels of 95% and above are regarded as ART-adherent while those with values less than 95% are not adherent to ART medications. Viral load is the number of copies of viral RNA detected in participants' blood. Participants with viral load \</=20 copies per ml are regarded to have optimal viral suppression indicative of optimal adherence to medications.

ART Adherence at 20 Weeks as Determined by Pill Counts, ACTG Adherence Questionnaire, and VAS Scores

时间窗: 20week [End of study]

AIDS Clinical Trials Group Scale scores range from 0 to 1. The higher scores reflect better ART adherence Pill count scores also range from 0 to 1 and the higher scores also reflect better adherence. Visual analog scale \[VAS\] adherence ranges between 0 and 100%. Higher scores reflect better ART adherence

ART Adherence at 20 Weeks as Determined by Log of Viral Load Count

时间窗: 20week [End of study]

log of viral load count is log 10 transformation of the viral load values

次要结局

  • Patient Satisfaction Score at 20 Weeks(End of Study (20weeks))
  • Number of Participants With Mental Distress Determined by General Health Questionnaire 12 at 20 Weeks(End of study (20weeks))

研究者

发起方
Dr. Olumide ABIODUN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Olumide ABIODUN

Senior Lecturer and Honorary Consultant

Babcock University

研究点 (5)

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