Study design and setting: This was a Cross-sectional study design. The study used TASO Mbale program data for the period between Jan 2018 and August 2021. The study was conducted in TASO Mbale center of Excellence, located in Mbale Hospital, Mbale Town/Municipality in Mbale District in Eastern Uganda. TASO Mbale is one of the 11 centers of TASO Organizations that provide prevention, care and treatment for people living with HIV/AIDS/TB. It has a population of over 7,285 active clients on ART. VL- testing as a model of monitoring treatment adherence was rolled out by MOH and adapted in 2015/2016 at TASO Mbale. Mbale city is approximately 210km from the Kampala city. It has two HCIVs and one regional referral hospital.
TASO Mbale, which is within Mbale city provides comprehensive HIV/AIDS prevention, care, and support to the population of Mbale, Sironko, Budaka, Kibuku, Kumi, Butaleja, Bulambuli, Manafwa, Butebu, Palisa, Bukedea, Kacumbala, Budadiri, Bududa, Tororo, Jinja among other places around Mbale.
Study population and sample selection: Figure 2 below shows a schematic flow chart showing how participants were enrolled for analysis. A total of 607 clients with VL >1000 copies/ml who were receiving treatment at TASO Mbale were retrieved for the period Jan 2018 to August 2021. Of which 450 clients were active and 157 were inactive (died or lost to follow-up). Four hundred forty two (442) of the active clients had undergone IAC whereas 8 clients did not undergo IAC at the time of follow-up visit. The 442 clients were considered for analysis.
Study Variables and measurement
Dependent variable; The study looked at the viral load outcomes of patients with suppressed and /or non-suppressed viral load among clients in TASO Mbale Centre.
The independent variables; are age -we considered adults 18years and above, sex-male and female, the WHO staging (stage 1, 2, 3 & 4). The intensive adherence counseling (IAC), the regimen-baseline and current regimen, nutritional status-green-well nourished, Red-severe malnutrition and yellow-moderate malnutrition, treatment supporter-present or absent and residence-Urban within Mbale city and Rural-outside Mbale municipality.
Inclusion and Exclusion
Inclusion criteria
All clients who had been on ART for at least 6 months, have had a viral load measure done with results in the system and VL ≥ 1000C/ml are active
Exclusion criteria
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Those not completing 3 sessions of EAC after first high viral load results
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Participants below the age of 18 years old
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Those living with HIV, not on Antiretroviral therapy
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The study also excluded all clients who are inactive (lost to follow up, dead, and transferred out)
Data source: Secondary data were retrieved from TASO Mbale treatment centre database. Data were retrieved from PLHIV on ART who had their viral load measured between Jan 2018 and August 2021. The retrieval was conducted in December 2022.
3.7 Data abstraction
The data were abstracted from the TASO Mbale program database regarding the PLHIV socio demographic and clinical, ART drug regimen, and virological characteristics. The abstraction was done December 2022 for the period; January 2018 through August 2021.
Data management and quality control: The data retrieved from TASO Mbale program database for the period Jan 2018 to August 2021 were extracted in spreadsheet format. Data cleaned, and sorted, then exported to STATA for analysis.The validity of the data was enhanced by a standardized record-keeping system of the TASO Mbale treatment centre database. These records are normally readily available and regularly updated by the Monitoring and Evaluation officers and data clerks during each Patient visit. Data recorded from the register at the treatment centre were found to be similar to the data in the database. The reliability of this study was ensured by consistently using the same data entered on the treatment centre database from the registers.
Data processing and analysis. The data were declared as survival time-data using stset command in STATA version 14.0 package (Stata-Corp. 2014. Stata Statistical Software: Release 14. College Station, TX: Stata-Corp LLC). The follow-up time in months was set as the failure time. Whereas the failure variable was referred to as VL non-suppression. The follow-up time in months was computed as the difference in dates of VL tests after IAC during the follow-up period. This was done to obtain the total time at risk and overall contribution of a patient time during the follow-up period.
Descriptive statistics were summarized using frequency and proportions for categorical variables, whereas continuous variables were summarized with a measure of central tendency with corresponding measures of dispersion. Incident rates were estimated for the events of viral load suppression and viral load non-suppression. Bivariate analysis was done for all covariates. Hazard ratios (CHRs) were estimated as a degree of association between viral non-suppression and client features, via a Cox proportional hazards regression. Variables with p-values less than 0.10 in the bivariate analysis were included in the multivariable analysis reporting adjusted hazard ratios (AHRs), whereas variables with a p-value ≤ 0.05 were measured as statistically significant determinants of viral non-suppression, with a 95% CI.
Ethical consideration. Ethical approval was sought from the Research Ethics Committee, REC Mbale Hospital. The study administrative clearances from both department of public health of Busitema University and TASO Mbale treatment centre. A wavier of consent was obtained from the IRB since the study was retrospective and will use the identified data for analysis. The Uganda National council for science and technology also provided approval. The data retrieved from TASO Mbale treatment centre was kept confidential and patients’ identity was not retrieved.