HIV Infections Clinical Trial
Official title:
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)
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.
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.
PROJECT OBJECTIVES Objective 1: To evaluate the efficacy of interactive and tailored SMS
reminders on ART adherence among adolescents (15-19 years) living with HIV in Southwest,
Nigeria.
Objective 2: To assess the feasibility and acceptability of using personal mobile phones and
interactive and tailored SMS reminders for the improvement of ART adherence among adolescents
living with HIV in Southwest, Nigeria.
Objective 3: To identify the predictors of ART non-adherence among adolescents (15-19 years)
living with HIV in Southwest, Nigeria.
STUDY HYPOTHESES
1. Interactive and tailored SMS reminders are efficacious in the improvement of ART
adherence among adolescents (15-19) years living with HIV.
2. The use of personal mobile phones for the improvement of ART adherence among adolescents
living with HIV is feasible and acceptable.
3. ART adherence among adolescents is predicted by demographic, socioeconomic, and
psychosocial factors.
METHODOLOGY Study design and procedure This study is designed to have 80% power to detect a
difference of 20%. When the proportion of adolescents who are adherent to ART was taken as
49% (5), a sample size of 104 per group was obtained. The study will recruit 230 participants
from the ART clinics in Southwest Nigeria into a randomized controlled trial (RCT).
Convenience sampling method by which participants will be recruited on routine clinic visits
across five (5) high patient-density ART sites will be used.
For the purpose of this study, we defined poor adherence as self-reported < 95% adherence in
the preceding one month using a validated visual analogue scale. Self-reported 95% adherence
level is an ideal cut-off point because self-reported measures tend to exaggerate adherence
and such high adherence level will minimize the occurrence of false-negatives.
Initial eligibility screening and recruitment will be carried out by the primary caregivers
using a checklist. Potential participants who meet the first four criteria will be presented
with a visual analogue scale (VAS) labelled 0 to 100% at intervals of 5%. Eligible and
willing participants will then be referred to the research assistants for a comprehensive
informed consent process.
Baseline activities
At the baseline, the research assistants will give the volunteer participants a detailed
explanation of the study, including its aim, duration, intervention and possible benefits.
All the volunteers will be required to give a signed informed consent in a private room.
Adolescents aged 15 to 19 years are thought to be relatively mature. According to a brief of
AIDS regulations and Laws in Nigeria, children who are deemed mature in this context are
capable of giving informed consent. Besides, based on evidence from South Africa and Lesotho,
the WHO recommended that the legal age of consent for HIV testing and treatment should be 12
years. The consenting volunteers will then be allocated unique identifiers that they will
maintain throughout the course of the study. The contact details of the lead investigator
will be made available to the participants so that he can be reached directly for any reason
that is related to the study. Baseline data will be obtained in a private room by trained
research assistants using structured interviewer-administered paper-based questionnaires over
a period of about 40 minutes. The questionnaire will assess:
1. socio-demographic variables.
2. HIV/AIDS risk behaviour assessment: This will be done using the AIDS Risk Behavior
Assessment (ARBA); a validated, adolescent-specific tool for the assessment of sexual
behaviour, drug and alcohol use, and HIV-associated needle use. It assesses sexual
behaviour over the previous 30 days and the previous three months.
3. Alcohol and Drug abuse assessment: The Alcohol Use Disorders Identification Test (AUDIT)
will be used to assess alcohol abuse. AUDIT, which was developed in 1982 by the World
Health Organization, is a simple tool that is used to screen for and to identify people
who are at risk of alcohol problems. The drug abuse screening test (DAST-20, adolescent
version) will be used to screen for drug abuse. DAST is a validated scale that was
designed to provide a brief, self-reported instrument for population screening, clinical
case finding, and treatment evaluation research. It yields a quantitative index of the
drug abuse consequences.
4. Client Satisfaction Survey: A 22-item adaptation of the SERVQUAL tool will be used for
this purpose. First published in 1988, the SERVQUAL is a multi-dimensional tool that
assesses patients expected and perceived quality of services across five domains. Its
use currently dominates research and industry for the assessment of quality of services
and is well-validated in HIV service quality assessment.
5. Adherence assessment: This will be done using the validated visual analogue scale
(described above), monthly pill count, pharmacy records and the AIDS Clinical Trials
Group (ACTG) adherence questionnaire. The research assistants will carry out pill counts
and obtain the pharmacy records. Adherence assessment will be carried out at baseline
and at every follow-up visit.
Ten millilitres (10 ml) of blood samples will also be taken by laboratory scientists to
measure the volunteers' CD4 cell count and HIV viral load. Sampling collection, handling and
disposal will follow the standards and guidelines outlined by the WHO and PEPFAR. The
participants' capability to operate mobile phones will be enhanced. The research assistants
will work with participants to select from a list the most preferred SMS that will serve as a
daily reminder of ART adherence. Each participant will select an SMS format that will serve
as a reminder for follow-up visit reminders. In addition, the participants will also choose
the preferred language and time for SMS reminders. The messages will be designed in such a
way that they are sensitive and protect the privacy of the participants. The participants
will be able to contact the lead investigator if they wish to change their chosen messages or
if the services to their mobile phones are disrupted.
Data Analysis The research assistants will code and enter the data obtained into Microsoft
excel software in the CSV format. The data will be exported to the STATA version 15/SE for
analyses. The data manager will fully review 5% (one in every twenty) questionnaire for
errors. The data manager in conjunction with the investigators will be responsible for
baseline, interim and final data analysis. The investigators, data manager, research
assistants, counsellors and other project staff will be blinded throughout the study. After
the 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.
Statistical Methods Intention-to-treat analysis will be carried out. Baseline characteristics
will be compared using the chi-square test, rank-sum test, and independent t-test as
appropriate. The independent t-test will be used to compare the means of ART adherence
between the investigation and control groups after each follow-up visit in order to test if
the intervention has any effect. The incidence proportion, incidence rate, relative risk,
risk difference, and odds ratio will be used to measure the effect. Survival analysis will
also be carried out to adjust for censoring (competing risk and loss to follow-up). Multiple
regression analyses will be used to control for possible confounders. Subgroup analysis will
also be undertaken in order to generate further hypotheses.
The acceptability of the SMS will be accessed by the responses given by participants. The
proportion of participants who find the method acceptable will be determined.
The feasibility will be determined using the proportion of participants who are deemed to
have completed the study (participate fully).
The study will also assess client satisfaction and the possible effect of adherence on the
mental health status of adolescents. Correlation and linear regression analyses will be used
to determine the association between adherence (percent) and mental health status (GHQ 12
measure).
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