Study area, design, and period
The study was conducted in the ART clinics of east and west Wollega zone health institutions, Oromia region, west Ethiopia; Nekemte town which is the capital of east Wollega is located 328 km where as Gimbi town which is the capital of west Wollega is 438 Km western to Addis Ababa [14].
The area is well known by its coffee production. The economy of the people is based on subsistence farming and livestock rearing. The climatic condition of the area is ‘woinadega’ (semi-desert) and it is found at 2080 m above sea level.
A facility based retrospective cross-sectional study was conducted by reviewing patient information sheets and physician diagnostic cards to assess reasons for HAART regimen change. The study was conducted from April 28, 2017 to May 30, 2017.
Source and study population
All HIV/AIDS positive patients who were greater than 18 years and on HAART in east and west Wollega zone health institutions ART Clinic from April 28, 2007 to April 28, 2017 were the source population. All HIV/AIDS positive patients greater than 18 years who had undergone HAART regimen change in east and west Wollega zone health institutions ART Clinic in between April 28, 2007 to April 28, 2017 were the study population.
Inclusion and exclusion criteria
Inclusion criteria:
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✓ Patients on follow up in the ART clinic who had undergone HAART regimen change until the study period.
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✓ Patients on follow up in the ART clinic who were on second line regimen when the study was undergone.
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✓ HIV/AIDS patients who were greater than18 years.
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✓ Patients receiving HAART regimen for at least 6 months at the beginning of the study period
Exclusion criteria:
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✓ Patient information cards with incomplete information (Patient information card which had no one or more of information like information on demographics, WHO clinical stage, CD4 count, initiation regimen and changed regimen, duration of initial therapy, and causes for regimen change).
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✓ Patients with less than 6 months on HAART regimen.
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✓ Patients who didn’t switch HAART regimen.
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✓ Under eighteen year old HIV/AIDS patients.
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✓ Deceased patients
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✓ Transfer out patients
Sample population
A total of 243 patients who had undergone HAART regimen change in the ART clinics of east and west Wollega zone health institutions from April 28, 2007 to April 28, 2017 were included in the study while patients below 18 years were excluded from the study. Patient information cards that showed a change in the initial treatment regimen were assessed and analyzed, to identify the common reasons that resulted in a change from the initial treatment regimen.
Study variables
Independent variables
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✓ Socio-demographic characteristics: age at initiation, sex, marital status, educational status.
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✓ Disease related variables: baseline WHO stage, base line CD4, and baseline weight.
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✓ ART related variables: types of initial regimen
Dependent variables
Data procedure and management
Data collection procedure
Data abstraction form was developed based on the objectives of the study. It contained socio-demographic, clinical information and ART information such as, CD4 count, WHO stage, initial regimen, date on which treatment was started, date of ARV drug switch, duration of initial ARV therapy before first switch, regimen switched to, and causes for regimen change. The types of toxicity and treatment failure reasons were included. If there was ARV drug switch for the second and third time it was recorded in a similar manner. For data collection four 10th grade completed students were recruited. One pharmacist and one druggist from each health institutions were also recruited as supervisors.
Data collectors recruitment and training
Data collectors were recruited and trained methods of data collection prior to the start of actual data collection.
Data quality assurance/control
Training was provided for supervisors and data collectors and they were standardized. Data abstraction form was pre-tested on randomly selected patient information cards to identify any drawbacks in Shambu hospital which is found in Horro Gudru Wollega zone before the actual survey and improvements were made. The principal investigator supervised the data collection. Every questionnaire was checked for completeness and logical consistency.
Data processing and analysis
The data were coded and entered in to a computer using statistical Package for the Social Sciences (SPSS) software for windows version 20 and the analysis was performed after the data were cleaned, edited and processed. Distribution of Patients such as percentages and their number by socio demographic characteristics and other relevant variables in the study were described using descriptive analysis.
Ethical considerations
An official letter was written by department of pharmacy, college of public health and medical sciences, Wollega University to zonal and woreda health offices of east and west Wollega zone Administration to get permission. After permission to conduct the study was obtained, data has been collected in one of refilling rooms at ART Clinic by safe keeping of records.
Only numerical identifications were used as a reference, confidentiality and anonymity of subject was maintained by not recording and identifying details, such as name or any other personal details. No disclosure of any name of the patients, the healthcare provider or drug product was made in relation to the finding.
Operational definitions
ABC based regimen: regimen containing abacavir as one of the NRTI backbones and may have different NNRI or PI bases.
Antiretroviral drug switch/change: it is the change of one or two ARV drugs from the initial drug regimens.
AZT based regimen: regimen containing zidovudine as one of the NRTI backbones and may have different NNRI or PI bases.
Co morbidity: is defined as the occurrence of one or more additional disorders which are on drug therapy with HIV/AIDS simultaneously (TB, diabetes, hypertension).
d4T based regimen: regimen containing Stavudine as one of the NRTI backbones and may have different NNRI or PI bases.
TDF based regimen: regimen containing Tenofovir as one of the NRTI backbones and may have different NNRI or PI bases.
Toxicity: is defined as the occurrence of adverse events such as diarrhea, nausea, vomiting, anemia, rash, fatigue, peripheral neuropathy, lipodystrophy, metabolic disturbances, CNS abnormalities or any other unwanted effect related to HAART.
Transfer out: Patients who changed their follow up to other health institution.