HIV Clinical Trial
Official title:
Prevalence, Socio-demographic Correlates of Substance Use Disorders Among HIV-infected Adults in Cameroon, and Their Influence on Adherence to Antiretroviral Therapy and Immunological Feature: Study Protocol for a Retrospective Cohort Study
Background:
Data are scarce concerning injecting drug use (IDU) and alcohol consumption among
HIV-infected people on highly active antiretroviral treatment (HAART) in Cameroon. The aim
of this study is to determine the prevalence of alcohol consumption and IDU among
HIV-infected people on HAART; to determine sociodemographic factors associated with alcohol
abuse and IDU among people on HAART; and to determine impact of alcohol consumption and IDU
on adherence to HAART.
Methods/Design:
The investigators will conduct a cross sectional study at the Yaoundé Central Hospital in
Cameroon, from February to August 2015. Using a self-report questionnaire, the investigators
will include at least 1,000 HIV-infected adults (18 years or more) on HAART for at least one
month coming for HIV care. The investigators will exclude pregnant women. Data collection
will include sociodemographic and economic profile, alcohol consumption using Alcohol Use
Disorders Identification Test, injecting drug use, adherence to HAART using visual analog
scale and self-rate report. The investigators will perform sub-analysis for sex group and
area of habitation. A p value < 0.05 will be considered statistically significant.
Discussion:
There is a critical need of accurate estimates of the amplitude and the distribution of IDU
and alcohol consumption among HIV-infected adults, in order to inform health policies maker
for curbing burden of both injecting drug use and alcohol consumption among people living
with HIV.
1. Introduction
1.1. Background
In low and middle income countries, 28.6 million people were eligible for
antiretroviral therapy (ART) based on 2013 guidelines and only around 10 million were
currently on ART. Cameroon is a lower-middle-income country with a prevalence of human
immunodeficiency virus (HIV) infection in adults of 4.3% in 2011. In the same year,
coverage for antiretroviral therapy in adults and children was 49.6%, demonstrating the
immensity of the work to be done to achieve the goals of good ART coverage. The
considerable expansion of access to HIV treatment in the world has changed the epidemic
of HIV infection. The importance of ART is well established. Life expectancy of adults
receiving ART is approximately 80% of the normal life expectancy. The preventive effect
of ART is increasingly evident, even in cases where the HIV epidemic is concentrated.
There exists the link between alcohol consumption and infectious diseases, with the
deleterious effect of alcohol on disease progression. In Cameroon, in general
population, adult (15+ years) per capita alcohol consumption was 13.74 litters of pure
alcohol. Heavy episodic drinking is 8.4% and 2.1% respectively among males and females
in Cameroon in general population. Alcohol binge drinking was found in 11.6% of people
living with HIV on ART and in 20.6% of those who were interrupted their treatment.
Binge drinking was defined for male as consumption of 5 or more drinks, for female as
consumption of 4 or more drinks, in about 2 hours. Alcohol use disorders screened with
cutting down, annoyance by criticism, guilty feelings, eye-openers (cage) questionnaire
are present among 17% of adults HIV-infected in Cameroon.
In Cameroon, the prevalence of non-adherence to ART was 22.5% based on the Community
Programs for Clinical Research on AIDS index and 34.9% based on the Centre for
Adherence Support Evaluation index. Alcohol is one of the main factors of ART
interruption and ART non-adherence. The consumption of alcohol being on ART decrease
response to highly active ART, and decrease health related quality of life.
In general, health data, including HIV prevalence data, are less robust for key
populations than for general populations due to complexities in sampling (and lack of
size estimation data), legal concerns and issues of stigma and discrimination. To date,
studies on injecting drug user in Cameroon, and even in sub-Sahara Africa are scarce
among HIV-infected people. The estimation showed that in 2012 worldwide about 12.7
million people had recently injected drugs and that, of these, 13.1% was living with
HIV.
1.2. Study rationale
With this demonstrated burden so harmful of alcohol consumption and injecting drug use
(IDU) among people living with HIV, it is necessary to measure the weight of alcohol
consumption and IDU among HIV-infected adult on HAART; to understand why HIV-infected
people consume alcohol and use injecting drug being on HAART in Cameroon, sub-Saharan
Africa country; and to assess the impact of alcohol consumption and IDU on adherence to
ART.
2. Study objectives
The aim of this study is (1) to determine and describe the prevalence of alcohol
consumption and IDU among HIV-infected people on HAART; (2) to determine
sociodemographic factors associated with alcohol consumption and IDU among people on
HAART; (3) and to determine impact of alcohol consumption and IDU on adherence to
HAART.
3. Methods
3.1. Design
The investigators will use cross-sectional design. The recruitment of participants will
be conducted from January to June 2015. Socio-demographic data, adherence to ART,
alcohol consumption will be self-reported by the patients with a questionnaire, but
patient will can ask more clarifications if he/she not understood a question. The
investigators will follow STROBE guidelines for the report this study.
3.2. Setting
Cameroon is a sub-Saharan central Africa country, divided in ten region and with a
population of 19,406,100 inhabitants in 2011. The adult prevalence rate of HIV in the
country is 4.3%. In Yaoundé, capital of Cameroon, site of recruitment, the adult
prevalence rate of HIV infection is 6.4% (3.6% for men and 8.9% for women). Subjects
were recruited at Day Hospital in Yaoundé Central Hospital. It is the largest HIV
clinic in the country. This is an urban center in the heart of Yaoundé city.
3.3. Participants
The investigators will include in this study subjects who are aged 18 years or above
and who were on HAART for at least one month. The investigators will exclude pregnant
women. Informed consent will be a prerequisite for participating in the study, and will
be provided verbally.
3.4. Data collection
3.4.1. Sociodemographic profile
The investigators will collect age, gender, sexual orientation, last level of
education, monthly household income, area of habitation, number or person in household,
mode of healthcare payment, marital status, employment status, probable route of HIV
infection and when, and disclosure of HIV status.
3.4.2. Alcohol consumption
The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) to
identify subjects with at-risk, hazardous, or harmful drinking. AUDIT has a possible
range from 0 to 40. A score ≤ 7 is classified as no current problem (low risk
drinking), a score range between 8 - 15 is classified as probable current problem
drinking (risky or hazardous drinking), a score range between 16 - 19 is classified as
high risk or harmful drinking, and a score ≥ 20 as define harm and likely to be alcohol
dependent. The investigators prefer to use self-reported questionnaire vs. interview
questionnaire because it may produce more accurate answers, but patients who will not
well understand a question, could ask more clarifications. The investigators will
therefore use AUDIT screening instrument test to classify current drinkers as problem
or non-problem drinkers at cut-off ≥ 8. Sensitivity and specificity of AUDIT is
respectively 51%-97% and 78%-96%. The investigators will define as current drinkers,
all patients who had consumed alcohol in the last 12 months.
3.4.3. Adherence to antiretroviral therapy
The investigators will use several methods to measure adherence to ART: a linear visual
analogue scale (VAS) on the past month and self-rate of adherence to ART in the last
month using scale from '1 - very good' to '5 - very bad'.
3.4.4. Injecting drug use
Patients will report if Yes or No, they have already used an injectable drug. If yes,
they will give frequency and last time of use.
3.5. Statistical analysis
3.5.1. Sample size
The sample calculation was based on alcohol consumption, because there is no data for
IDU in Cameroon among HIV-infected people. The investigators assume that alcohol abuse
among adults HIV-infected is 17%. With a 95% confidence interval (95%CI), acceptable
difference of 5%; the minimal required sample size was 217 adult HIV-infected on ART.
The investigators have used Windows Program for Epidemiologist (WinPepi, version 11.43)
to estimate required sample size. Because the investigators will use self-reported
questionnaire, the investigators suppose 20% for missing data. Therefore, the minimal
required sample size will 272 for male and 272 for female because alcohol consumption
was different between both sex (14). The investigators hope to have a sample of about
1,000 patients to have a high powered study.
3.5.2. Statistical method
Data will be coded, entered, and analyzed using the Statistical Package for Social
Science version 20.0 for Windows (IBM Corp. Released 2011. IBM SPSS Statistics for
Windows, Version 20.0. Armonk, New York: IBM Corp.). The investigators will describe
continuous variables using means with standard deviations or using median with
interquartile range, and categorical variables using their frequencies and percentages.
For all tests, we will use 2-sided p-values with alpha < 0.05 level of significance.
The investigators used χ² test or equivalents for categorical variables, Student T test
for means, and Mann-Whitney U test for medians. Null hypothesis of no difference was
rejected if the 95% CI of odds ratio (OR) estimates excluded 1. All regression analyses
will be conducted with stepwise forward method with entry in model if p value ≤ 0.2.
Multiple imputation will be used to handle missing data, creating a new data set which
was the average of five data sets of imputed values. The investigators will only impute
socio-demographic data for regression analysis.
4. Ethical considerations
The study will be conducted in accordance with Helsinki Declaration. Prior to
enrolment, all eligible participants will provide verbal consent. Patients with alcohol
consumption, injecting drug use and/or non-adherence to ART will receive a counseling
to address this problem according WHO recommendations.
5. Discussion
The expansion of the use of ART helped make HIV infection as a chronic disease. One of the
major challenges to overcome is the effective use of ARVs to improve the outcome of people
living with HIV. Consumption of alcohol and injecting drug by patients on HAART may be
obstacles. The scientific evidence is already done for the first for its negative effect on
antiretroviral therapy in others people than Africa but very few studies on the IDU are
done, particularly in Africa. Even if there are data on alcohol consumption being on
antiretroviral therapy exist in Africa, very few studies have a large sample size. More and
to the best of our best knowledge, there are almost no studies on the prevalence of
injecting drug use among HIV infected people in Africa, particularly in Cameroon.
With this study, the gap in knowledge about injecting drugs and alcohol and their effects on
adherence to antiretroviral therapy may be addressed. This will guide future research. This
knowledge can also provide to clinicians and policy makers of health, a light on the
implementation of guidelines to improve the outcomes of people living with HIV in our
context.
One of the limitations that might emerge during the implementation of this study is the
presence of missing data, particularly related to data collection of the study by patients
themselves. It is nonetheless necessary to use this form of data collection, since we will
collect data on adherence to ARV treatment, on alcohol consumption, and on injecting drug
use. In general, people tend to underestimate their alcohol consumption and overestimate
adherence to treatment when a third party ask them a question about. In addition, the use of
drugs is prohibited by law. Some patients may therefore deny its consumption. This is why no
name or contact will be asked, no signature or written consent for participation in the
study will be required for this study. We will thus use verbal consent.
The final report of this study in the form of scientific paper will be published in
peer-reviewed journals. Findings will further be presented at conferences and submitted to
relevant health authorities.
;
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