Study contexts
This study was carried out in the Gedeo zone in the Southern Nations, Nationalities, and Peoples regions (SNNPRs). The area is situated 360 km south of Addis Ababa, the capital of Ethiopia, and 86 km south of Hawassa, the headquarters of the SNNPRs. The zone houses three main hospitals, one teaching and reference hospital, nine public health institutions comprising 141 health posts, and twenty-one private clinics. Some of the healthcare facilities, including five health centers and four hospitals, offer chronic HIV care services (CHCCs) funded by the CDC organization. During the study period, 3597 adult PLHIVs were registered in these public health institutions; 412 sought care from the ART clinics in public hospitals, and 2395 enrolled in clinics across all public health institutions. Antiretroviral treatment (ART) is accessible to PLWHs regardless of their CD4 level or clinical stage. Following a confirmed diagnosis, clinical assessment, and client readiness evaluation, rapid ART initiation should occur. Adults with advanced HIV or a CD4 count of ≤ 350 cells/mm3 must commence antiretroviral therapy (ART) promptly [10, 16].
Study design and period
An unmatched case-control study was done between December 29th, 2017 and January 22nd, 2019.
Source and study population
The study’s source population comprised confirmed PLWHs aged 18 and above who had previously been enrolled in chronic HIV care clinics in the Gedeo zone. These individuals had either returned to regular follow-up care or had registered for the first time and took part in a one-year survey to establish a database [10, 17]. The study population included PLWHs who met the conventional criteria for defining cases (LLPA performers) or controls (non-LLPA performers, such as MLPA and HLP performers), as well as the study’s inclusion and exclusion criteria for each comparison group [9].
Outcome ascertainment
The study determined that moderate and vigorous intensity levels were at 4.0 and 8.0 for work, 4.0 for transportation, and 8.0 for recreational activities according to WHO criteria. The guidelines recommend at least 150 min of moderate-intensity physical activity, 75 min of vigorous-intensity exercise, or a combination of both each week, totaling 600 MET minutes to maintain health. The MET values and duration from TPA were classified as low, moderate, and high based on WHO’s comparative purpose criteria. Using these criteria, cases and controls among PLWHs were identified. Cases met the LLPA criteria, while controls included those classified as HLPA or MLPA [18].
Case finding
Case identification
In this study, a case refers to a confirmed HIV + individual who took part in a previous survey and is now classified as an LLPA performer based on the study’s eligibility criteria, which were derived from prior databases [10, 17]. The study’s criteria for defining a case included the WHO’s previous recommendation for comparison [9]. This guideline defines a case or LLPA performer as a low-intensity, low-effort activity that does not greatly elevate heart rate or cause sweating and does not meet the standards for MLPA or HLPA categories. The study’s criteria for defining a case included the WHO’s former recommendation for comparison [9]. According to this guideline, a case or LLPA performer is a low-intensity, effort-intensive activity that does not significantly increase heart rate or sweat and does not meet MLPA or HLPA category standards.
Case inclusion and exclusion criteria
This study involved PLWHS aged 18 or older, with or without antiretroviral treatment, who were registered in ART clinics of governmental healthcare institutions for an extended period or for the first time, and had previously participated in a survey and met the former case definition criterion of the WHO [10, 17]. It excluded PLWHs with missing or incomplete data from prior survey databases, which had a major influence on overall outcomes and risk variables.
Control identification
The study utilized the same criteria to select control subjects, which comprised HIV-positive individuals who had previously taken part in a survey and were included in a database. These individuals were now categorized as non-participants in LLPA (light or low-intensity physical activity) but regular participants in MLPA (moderate-intensity physical activity), HLPA (high-intensity physical activity), or both. According to WHO guidelines, HLPA involves vigorous-intensity activities on at least three days per week, totaling 1500 MET-minutes, or walking and engaging in moderate- to vigorous-intensity activities for seven days or more, achieving 3000 MET-minutes per week. Meanwhile, MLPA consists of vigorous-intensity activities on three or more days, lasting at least 20 min per day, as well as moderate-intensity activities or walking on five or more days, achieving a minimum of 600 MET-minutes per week [9].
Control inclusion and exclusion criteria
The study used a cumulative case-control strategy [19], and applied the same eligibility criteria to select both controls and cases from the same sources. This included PLWHs who met the control definition criteria set by the WHO. However, the study excluded individuals of the same age group who had missing or incomplete data in previous survey databases.
Sample size determination
The study’s sample size was determined using OpenEpi version 3 and several values, such as the confidence level, power, ratio of controls to cases, proportion of controls exposed, and important predictors of physical activity from previous Ethiopian research [15, 20]. After accounting for a 10% non-response rate, the total sample size was determined to be 576, utilizing the predictor factor of sex in Tegene et al. (2022) study [20]. However, to increase the power of the study, all participants who met the case and control eligibility requirements were included, resulting in a sample size of 633. This decision was based on the fact that the sample size calculated using the above assumptions was smaller than the sample size used in the previous survey. An additional file shows this in more detail [see Additional file 1. Sample size determination].
Sampling procedure
The study enrolled participants from public healthcare organizations in the Gedeo zone based on factors such as patient size, quality of chronic HIV/AIDS medical care, and degree of service provision. Healthcare facilities were categorized based on the amount of care they provide, including hospitals and health centers. Through lottery methods, two hospitals (Yirga-Cheffe Primary Hospital and Dilla University Referral Hospital) and two healthcare centers (Dilla and Wonago Health centers) were randomly chosen. A survey was conducted to evaluate the movement of HIV patients to ART clinics at specific institutions using a proportionate allocation to sample size (PPS) approach to estimate the target sample size for each institution and then calculate the overall sample size for one year. Recruitment of PLWHs using systematic sampling procedures was undertaken until the required sample size for the survey was met [10, 17]. Lastly, the study used historical survey data and WHO guidelines to build an independent sample frame, and then used a cumulative case-control strategy and random sampling and lottery procedures to select and enroll cases and controls [19].
Data collection methods and materials
The study, conducted in chronic HIV care clinics, involved four teams for data collection. Each team consisted of five data collectors and a supervisor, all of whom received training to ensure accurate data collection. Prior to the main study, a pretest was carried out on 5% of participants at an Ethiopian Kebado health center, which was not part of the study, to identify any issues with the questionnaire flow, language, interview duration, and other potential challenges [10, 17].
The WHO/NCD STEPS instrument 3.2 [21], validated in Ethiopian contexts [11], was utilized to assess NCD risk factors, along with a checklist to gather data from medical records. The questionnaire included demographic and behavioral data on respondents’ socioeconomic status, cigarette and alcohol consumption, and other healthy lifestyle-related information. A sixteen-item questionnaire was used to evaluate physical activity levels at work, during recreational activities, and when traveling. An additional file shows this in more detail [see Additional file 2. Instruments used] PLWHs were categorized into three groups based on their physical activity level: low, moderate, and high.(see Additional file 2 ).
The study also examined the prevalence of overweight, obesity, and elevated blood pressure using physical measurements such as height, weight, hip and waist circumferences, and blood pressure. Blood samples were collected from the antecubital fossa vein and stored at + 4 °C. The serum or plasma was then transported to Dilla University Hospital for biochemical analysis. Abnormal biochemical data was defined using the updated Adult Treatment Panel Three (ATP III) criteria cut-off reference [18].
Data processing and analysis
The lead author collected the final hard copy data and entered it into Epidata v3.1 templates and then transferred it to SPSS v22 for analysis. Descriptive statistics, such as percentage, mean, and standard deviation, were computed to analyze biochemical and physical risk variables. The outcome variable was divided into two groups: cases and controls. The study employed bivariable binary logistic regression to find possible LLPA predictors. Variables with p-value < 0.25 were investigated further using multivariable logistic regression. The connection was statistically significant (P-value < 0.05) and analyzed using adjusted odds ratio, 95% confidence intervals, and P-value. Variance inflation factors (VIF) were used to assess multicollinearity, and the model’s fit was evaluated using a model summary, Omnibus test, Hosmer-Lemeshow goodness of fit test, and classification table. Quantitative exposure factors were categorized, and important explanatory variables were identified. The study employed various methods to handle missing data at each stage, ensuring no data was missing in the study.I’m sorry, I cannot fulfill that request.
Variables and criteria used to operationalize
Socio-economic and demographic characteristics: The study analyzed socioeconomic and demographic factors, including age, education, and employment, to calculate a wealth index based on eleven household variables. The index was divided into four quintiles: lowest, medium, fourth, and fifth [16]. HIV/AIDS-related factors include antiretroviral therapy state, type of regimen, opportunistic infections, duration since diagnosis, duration on ART, functional status, current Tuberculosis state, and WHO staging (stage III and >/=III).Lifestyle and behavioral risk factors include smoking status, alcohol consumption status, daily Khat chew state, serving fruit/vegetables daily, oil type, and self-reported salt consumption. Smoking status, alcohol consumption status, and Khat chew state are also important factors to consider. Consuming too much, too much, just the right amount, or too little salt can impact overall health. Total Physical Activity (TPA) is the sum of all physical activities in healthy adult populations, including Work, Transportation, and Recreation, and can be measured using Metabolic Equivalents (MET) or percentages. MET: is the ratio of a person’s working metabolic rate relative to the resting metabolic rate. One MET is defined as the energy cost of sitting quietly, and is equivalent to a caloric consumption of 1 kcal/kg/hour. Moderate MET values were obtained for the Work, Transportation, and Recreational Activities Related domains. High-level physical activity (HLPA): involves at least three days of vigorous-intensity activity per week, achieving 1500 MET-minutes, or seven or more days of walking, moderate- or vigorous-intensity activities, achieving 3000 MET-minutes per week. Moderate-level physical activity (MLPA): is defined as three or more days of vigorous-intensity activity of at least 20 min per day, five or more days of moderate-intensity activity or walking for at least 30 min per day, or five or more days of a combination of walking, moderate- or vigorous-intensity activities achieving at least 600 MET-minutes per week. Low-level physical activity (LLPA): A person who does not meet HLPA or MLPA requirements. Not meeting WHO recommendations on physical activity for health: The percentage of respondents not meeting WHO recommendations on physical activity for health, which includes doing less than 150 min of moderate-intensity physical activity per week or equivalent. Total physical activity- mean: The mean minutes of total physical activity on average per day.; Domain specific physical activity- mean: Mean minutes spent in work-, transport- and recreation-related physical activity on average per day.; No physical activity by domain: Percentage of respondents classified as doing no work-, transport- or recreational related physical activity.; Composition of total physical activity: Percentage of work, transport and recreational activity contributing to total activity. The instrument questions for the above criteria cover work activities; travel to and from places, and recreational activities.No vigorous physical activity: The percentage of respondents who are not engaged in vigorous physical activity. The instrument inquiries included work activity and recreational activities; Sedentary practices; Minutes spent on average each day engaging in sedentary activities. The instrument question was Sedentary Behavior [9].
Anthropometric measurement related factors: elevated blood pressure, BMI, and waist circumference are related factors in anthropometric measurements, affecting BP, BMI, and WC measured based on the revised ATP criteria [16, 18]. Clinical history related factors: In order to analyze chronic illnesses in the last 12 months, inquire about the patient’s clinical history, including blood pressure, sugar, cholesterol, and cardiovascular history. Biochemical measurement; Elevated fasting plasma glucose (FBG>/=110 mg/dl), triglyceride (TGL>/=150 mg/dl), low high density lipoprotein (HDL_c < 40 mg/dl) and 50 mg/dl), total cholesterol (TC >/= 200 mg/dl), and low low density lipoprotein (LDL>/=150 mg/dl) were measured based on the revised ATP criteria. In general, using expectation and prior knowledge analysis approaches, the missing at random (MAR) assumptions were applied to manage missing interval/ratio and categorical data, respectively. However, no approaches were employed to investigate subgroup analysis [16, 18].
Data quality control
The study followed established data quality control procedures at all stages, starting from the design phase. On-site training was provided to data collectors and supervisors to standardize processes. Quality control samples and instrument pre-testing were conducted at non-selected health facilities. Standard operating procedures were adhered to from sample collection to result reporting, with laboratory personnel handling all tasks. Additionally, direct supervisors and lead investigators monitored and followed up on each stage of the study to ensure its quality.
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