Study Area
The investigation was carried out in five public ART health facilities in the Ethiopian Amhara region's Debre Berhan regio-Politian city. The distances are 130 km to Addis Ababa, the capital, and 695 km to Bahir Dar, a regional center. The study was conducted in three of the city's five ART health facility sub-cities, which total 39 kebeles. The total population of Debre Berhan City is 209,011, according to the 2016 Ethiopian calendar population projection. Of them, 98,934 were men and 110,077 were women. Twelve health posts, eight health centers, and two hospitals are located in the city. As of June 2023, 3,623 ART customers were enrolled in six ART health facilities under the sub-city, according to the DHIS2 report. Four HFs employ nine case managers and three adherence support staff. Due to inadequate documentation, one private hospital and two health centers that were not ART sites were removed from the study.
Study Design and Period
An institutional-based retrospective follow up study was conducted from July 2018- June 2023.
Population
The source population for this study was all HIV-positive individuals who tested positive for the virus after six months of antiretroviral therapy (ART) and who enrolled in the EAC program in Debre Berhan regio-Politian city, Ethiopia. The study population consisted of HIV-positive individuals who tested positive for the virus at least once and who had at least one repeat result following an Enhanced Adherence counseling session between July 2018 and June 2023 in the designated health facilities. The study subjects were those HIV-positive individuals who were randomly selected and who had viral loads > 1000 copies/ml and at least one repeat result following an Enhanced Adherence counseling session between July 2018 and June 2023 in the designated Health facilities.
Eligibility criteria
Inclusion and exclusion Criteria
All ART- clients whose documented viral load was more than 1000 copies/ml were enrolled in the EAC. In contrast, patients who were lost to follow-up, transferred before finishing all EAC, or had no second virus load result were not included in this research.
Sample size Determination
Sample size determination by using first objective
Sample size was determined by using single population proportion formula by considering the following assumption.
Where:
Z = Standard normal distribution value at 95% CI, which is 1.96;
P = 40.9% (P = 0.409) the proportion of viral load suppression after EAC from study done in Public Hospitals of Hawassa City Administration, Ethiopia (1).
d = the margin of error, taken as 5%.
Accordingly, the sample size were calculated as,
n= (1.96)2 0.409(1-0.409)/ (0.05)2 = 371 by adding 10% for none response, the total sample size is 409 (Table 1)
Table 1
Sample size calculation for the second objective of the study
Factors | Ratio (Unexposed : exposed) | % in Unexposed group | Adjust Odds ratio | % in exposed group | sample size | Reference |
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Initial CD4 count | 1.4 | 41% | 0.149 | 9.40% | 74 | (1) |
Adherence | 1.33 | 42% | 0.504 | 26.70% | 337 | (1) |
Education | 2.54 | 37.5% | 0.317 | 16% | 190 | (4) |
Duration on ART | 0.55 | 26.9% | 2.315 | 46% | 241 | (4) |
Finally, the sample size for the second objective found to be less than the first objective and the sample size of the first objective, 409
Sampling Technique and Procedure
There are five public ART HFs within the Debre Berhan Town Zonal Health Department; all of these public health facilities were included in the study. Total number of cohort clients who meet the requirements for inclusion Clients who had finished their EAC between July 2018 and June 2023 were gathered from the viral load registration books of the five public health facilities, and the necessary sample size was distributed among them in a proportionate manner. Lastly, use the basic random sampling technique of RAND BETWEEN excel to select the sample at random from the viral load registration book of each of the five public health facilities (Fig. 1).
Study Variables
Dependent Variables
Independent Variables
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Socio-demographic and Related characteristics; Age, sex, Educational status, Marital status, Occupation, Residence
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Nutrition status; Normal, Under nutrition
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Treatment and Related characteristics; ART adherence, Type of ART Regimen, daily drug dosage, EAC sessions, ART duration, Other medication
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Clinical and Related characteristics; WHO clinical stage, CD4 count and opportunistic infections
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Psychosocial, Mental and Behavioral Related Characteristics; Mental disorder, Alcohol drinking, Khat Chewig
Operational Definition
Viral load suppression
refers to a viral load below the detection threshold using viral assays. Less than or equal to 1000 copies/mL after 3–6 month of EAC (14).
High Viral load
refers to when viral load result is greater than 1000 copies/mL(14).
Virological Failure
is experienced when VL is above 1000 copies/ml based on two consecutive VL measurements within 3–6 months. A PLHIV who has Virological failure will receive adherence support following the first VL test(46).
Good adherence
equal to or greater than 95% adherence i.e., missing only 1 out of 30 doses or missing 2 from the 60 doses implies good adherence(14).
Fair adherence
85–94% adherence, i.e., missing 2–4 doses out of 30 doses or 4 to 9 doses from 60 doses(14).
Poor adherence
less than 85% adherence, i.e. missing > 5 doses out of 30 doses or > 10 doses from 60 doses implies poor adherence(14).
A mental disorder is characterized by a clinically significant disturbance in an individual’s cognition, emotional regulation, or behavior(47).
Nutritional status for Adolescent
Normal BMI for age greater than or equal to -2 SD and + 1SD and Under Nutrition BMI for age < -3 SD(48).
Nutritional status for Adult
Normal BMI for adult 18.5–25 and undernutrition less than 18.5(48).
Data Collection Methods.
Using a pretested structured checklist, the data was gathered from the following sources: the client's chart, the EMR ART Smart Care, the viral load registration book, the increased adherence counseling page, and the laboratory request. As a result, every chart that included comprehensive data regarding clients receiving ART was examined. The data that was most current to the commencement date of increased adherence counseling sessions were deemed baseline data if clinical parameters and laboratory findings (CD4 count and WHO clinical stage) were not found at that time. Five certified BSc degree nurses were chosen to gather data, and two ART data managers with extensive expertise served as supervisors and also engaged in the process. Chart abstraction and sociodemographic and clinical characteristics were both included in the data collection form. The most recent and comprehensive data for incomplete charts were also obtained by using various registers, follow-up forms, and laboratory findings. Expert content reviews and internal consistency checks were used to verify the authenticity and reliability of the tests.
Data quality management, process and analysis
Designing appropriate data gathering materials ensured the quality of the collected data. A one-day instruction on the goal of the study, data extraction, and recording from the client's chart and registration books was given to supervisors and data collectors. A supervisor was tasked with making sure no data was overlooked throughout the data gathering phase. The primary investigator of the study was in charge of all overall operations. Ten percent of participants were chosen at random from the Debresina Health Center to take a pretest. Any challenges were redesigned after the pretest in light of the experience gained from it. The tools are validated for every data extraction sheet during the development of Kobo data variables, and data entry, frequency, and cross-tabulation are performed for outliers and missing data thereafter. The Kobo Collect Toolbox was used to gather the data, which was then exported to Excel for analysis using Stata version 14 and validated for completeness. Based on the characteristics of the variables, descriptive statistics were performed, and the results were displayed in a table and graph. To determine whether there was a rough correlation between the independent and outcome variables, bi-variable logistic regression analysis was carried out. Candidates for multivariable analysis were variables with a p-value of less than 0.25 in the bivariable analysis. Following EAC sessions, the percentage of viral load suppression was displayed. The independent predictors of viral suppression and associated factors among HIV patients undergoing therapy were identified using a multivariable logistic regression model. Statistical significance was defined as P-values less than 0.05. Variables with a standard error (SE) or variance inflation factor (VIF less than 10) greater than two were eliminated from the analysis and those without a collinearity effect were added to a binary logistic regression model to examine its relationship with the outcome variables. The Hosmer-Lem show test (> 0.05) or goodness of fit test (estat gof) were used to assess the model's fitness. The model's value was 0.28.