Study design, area, and period
A comparative cross-sectional study was carried out at public health facilities of Hadiya Zone from July 1 – October 30, 2022. The zone is located 230 kilometres from Addis Ababa, the capital city of Ethiopia, and 194 kilometres from Hawassa, the capital of the Southern Nations, Nationalities, and People Region (SNNPR). There are one comprehensive and specialized hospital, four first-level hospitals, 59 government health centers, two non-governmental health centers, and 311 health posts in the zone. The total number of PLWHA in the zone was 2267, with 1201 and 1066 males and females, respectively.
The population of the study
The source population comprised all adult PLWHA enrolled in HAART centers of public health facilities in the Hadiya zone. Whereas the study population was made up of all randomly selected clients from the selected public health facilities. The study included all adults over the age of 15, and who had been on therapy for at least three months. Those clients who were severely ill at the time of data collection and those with inadequate or incomplete clinical records were excluded.
Sample size determination
The sample size for the two groups was estimated using Open Epi software version 2.3, taking into account the following parameters: power of 80%, confidence interval of 95%, a 1: 1 ratio of male to female on HAART, and mean(SD) of HRQoL( which was taken from related studies). After accounting for a 10% non-response rate, the maximum sample size for the study was 1,192(596 males and 596 females) (Table 1).
Table 1. Sample size determination for the study by using OpenEepi Version 2.3, 2022
Mean
|
SD
|
Difference
|
Power
|
95%CI
|
Ratio
|
NR
|
n1
|
n2
|
Total
|
Ref
|
Male
|
Female
|
Male
|
Female
|
81.2
|
77
|
14.9
|
17.4
|
4.2
|
80
|
1.96
|
1:1
|
10
|
234
|
234
|
515
|
[35]
|
4.11
|
3.96
|
0.85
|
0.91
|
0.15
|
80
|
1.96
|
1:1
|
10
|
541
|
541
|
1192
|
[31][31][31]
|
3.5
|
3.0
|
1.1
|
1.0
|
0.5
|
80
|
1.96
|
1:1
|
10
|
70
|
70
|
154
|
[30]
|
Where, SD: standard deviation, n1, and n2: estimated sample size for males and females respectively before adding NR (non-response rate)
Sampling procedure
From a total of five hospitals and twenty HAART centers in the Hadiya zone, two public hospitals and ten HAART centers were selected by simple random sampling (Lottery method). A sampling frame was formed from a list of PLHIV who had an appointment during the two-the study period. Based on the number of patients on follow-up, the sample size was distributed proportionally throughout the health facilities. Study participants were selected based on their unique ART numbers using computer-generated random numbers (Figure 1).
Fig 1. Schematic presentation of sampling procedures followed to get clients on HAART in Southern Ethiopia, 2022
Data collection tools, methods, and personnel
A pretested interviewer-administered structured questionnaire and data abstraction checklist were used to collect data. A face-to-face interview was carried out to collect data on Socio-demographic (age, educational level, marital status, ethnicity, religion, occupation, and residence), behavioural (HIV serostatus disclosure, physical activity, smoking, and alcohol intake) and family-related (family support, current living status and serostatus of the family members) characteristics. Clinical information such as WHO clinical stages, CD4 count(recent and baseline), haemoglobin level, adherence to HAART, TB/HIV co-infection, current illness reported side effects, duration of stay on HAART, and the type of HAART regimen were collected by reviewing records of the HAART registration book and individual follow-up form.
HRQoL was assessed using the WHOQOL-HIV BREF[36]. For each item, a five-point Likert scale was used, with 1 and 5 representing the lowest (negative) and the highest (positive) perceptions respectively. For example, an item in the positive feeling facet asks “How much do you enjoy life?” and the available responses are 1 (not at all), 2 (a little) 3 (a moderate amount), 4 (very much), and 5 (an extreme amount). The six domains used to assess overall HRQoL were: physical health, psychological well-being, social relationships, environmental health, level of independence, and spiritual health. Two items focus on an individual's overall perception of quality of life, and overall perception of health were used to examine the general QoL (Table 2). The proposed reference period for each experience in each QOL category was two weeks[37](S1File).
Table 2. HRQoL domains with their respective facets and number of items, 2022
Domains
|
No. of items
|
List of Items
|
Number of questions
|
Domain I= Physical
|
4
|
1. Pain and discomfort
|
4
|
2. Energy and fatigue
|
4
|
3. Sleep and rest
|
4
|
50. Symptoms of PLWHA*
|
4
|
Domain II=Psychological
|
5
|
4. Positive feelings
|
4
|
5. Thinking, learning, memory, and concentration
|
4
|
6. Self-esteem
|
4
|
7. Bodily image and appearance
|
4
|
8. Negative feelings
|
4
|
Domain III Level of Independence
|
4
|
9. Mobility
|
4
|
10. Activities of daily living
|
4
|
11. Dependence on medication or treatments
|
4
|
12. Work capacity
|
4
|
Domain IV Social Relationships
|
4
|
13 Personal relationships
|
4
|
14 Social support
|
4
|
15 Sexual activity
|
4
|
51 Social Inclusion
|
4
|
Domain V Environment
|
8
|
16. Physical safety and security
|
4
|
17. Home environment
|
4
|
18. Financial resources
|
4
|
19. Health and social care: accessibility and quality
|
4
|
20. Opportunities for acquiring new information and skills
|
4
|
21. Participation in and opportunities for recreation/ leisure activities
|
4
|
22. Physical environment
|
4
|
23. Transport
|
4
|
Domain VI Spirituality/Religion/ Personal Beliefs
|
5
|
24. SRPB
|
4
|
52. Forgiveness and Blame
|
4
|
53. Concerns about the Future
|
4
|
54. Death and Dying
|
4
|
|
|
The overall quality of life and general health perceptions
|
4
|
* Facets highlighted in bold were specific to the PLWHA, and as such have been added to the original WHOQOL Instrument.
To assess the level of depression and stigma, the Beck Depression Inventory, Second Edition (BDI-II) [38] and Berger's HIV stigma scale (BHSS) [39] were used, which have been well-validated in most African countries. Alcohol consumption was assessed using the FAST alcohol screening test measurement scale[40][41][41]. WHO criteria for controlling and monitoring the tobacco epidemic tool was used to assess the status of smoking[41][42][42]. Anthropometric data (weight and height) were used to assess clients' nutritional status. Weight was measured using a standard beam balance, in light clothing and bare feet. The beam balance was reset to zero scale before each measurement and the readings were recorded to the nearest 0.1 kg. A standard scale was used to measure height. Participants were told to remove their shoes, stand tall, and position themselves on the Frankfurt plane with their feet together and knees straight. The readings were recorded to the nearest 0.1 cm by touching the heels, buttocks, shoulder blades, and back of the head (occiput) against the stadiometer vertical stand.
Data quality management
Properly designed data collection instruments were provided after translation into the local language, Hadiyissa. The data collectors and supervisors were provided with intensive training that lasts two days on the objective of the study, the way of data collection, and how to deal with difficulties that may arise at the time of the data collection. A pre-test was done on 5% of the sample size (30 males and 30 females) at Worabe Comprehensive and specialized hospital one week before the actual data collection. Necessary corrections were made based on the result to avoid any confusion and for better completion of the questionnaires. The internal consistency of the WHOQOL-HIV-BREF instrument was measured and determined by using a Cronbach’s alpha. As a result, the Cronbach's alpha coefficients for physical, spiritual, independence, environmental, and social domains were 0.81, 0.83, 0.86, 0.88, and 0.84, respectively, and were all good enough. In addition the internal consistency for Bergen's scale, and the Beck Depression Inventory-Second Edition (BDI-II) were assessed and their Cronbach’s alpha value was 0.79 and 0.82 respectively. Throughout the data collection period, the principal investigator and supervisors gave on-site supervision. Every day, each questionnaire was checked for completeness, and the appropriate feedback was given to the data collectors. To minimize social desirability bias, study participants were interviewed privately.
Measurement of variables of the study
Outcome variable measurement
The outcome variable for the study was HRQoL which was measured by using (WHOQOL-HIV BREF)[36]. The domain scores were scaled upward, with a higher score representing a higher QoL. The mean score of items within each domain was used to compute each domain score.First, facet scores were developed by using summative scaling by taking the average of each item (Table 3).
Table 3: Calculation of the facet score for each item in all the six domains of HRQoL among PLWHA, 2022
Items
|
Calculating the facet score
|
1. Pain and discomfort
|
Pain = (f1.1 + f1.2 + f1.3 + f1.4)/4
|
2. Energy and fatigue
|
Energy = (f2.1 + f2.2 + f2.3 + f2.4)/4
|
3. Sleep and rest
|
Sleep = (f3.1 + f3.2 + f3.3 + f3.4)/4
|
50. Symptoms of PLWHA*
|
Symptom = (f50.1 + f50.2+ f50.3 + f50.4)/4
|
4. Positive feelings
|
Pfeel= (f4.1 + f4.2 + f4.3 + f4.4)/4
|
5. Thinking, learning, memory, and concentration
|
Cog = (f5.1 + f5.2 + f5.3 + f5.4)/4
|
6. Self-esteem
|
Esteem = (f6.1 + f6.2 + f6.3 + f6.4)/4
|
7. Bodily image and appearance
|
Body = (f7.1 + f7.2 + f7.3 + f7.4)/4 .
|
8. Negative feelings
|
Nfeel = (f8.1 + f8.2 + f8.3 + f8.4)/4 .
|
9. Mobility
|
Mobil = (f9.1 + f9.2 + f9.3 + f9.4)/4 .
|
10. Activities of daily living
|
Adl = (f10.1 + f10.2 + f10.3 + f10.4)/4 .
|
11. Dependence on medication or treatments
|
Depend = (f11.1 + f11.2 + f11.3 + f11.4)/4
|
12. Work capacity
|
Work = (f12.1 + f12.2 + f12.3 + f12.4)/4
|
13 Personal relationships
|
relation = (f13.1 + f13.2 + f13.3 + f13.4)/4
|
14 Social support
|
Support = (f14.1 + f14.2 + f14.3 + f14.4)/4
|
15 Sexual activity
|
sex = (f15.1 + f15.2 + f15.3 + f15.4)/4
|
51 Social Inclusion
|
Inclusi= (f51.1 + f51.2 + f51.3 + f51.4)/4
|
16. Physical safety and security
|
Safe = (f16.1 + f16.2 + f16.3 + f16.4)/4
|
17. Home environment
|
Home = (f17.1 + f17.2 + f17.3 + f17.4)/4
|
18. Financial resources
|
Finance = (f18.1 + f18.2 + f18.3 + f18.4)/4
|
19. Health and social care: accessibility and quality
|
Care = (f19.1 + f19.2 + f19.3 + f19.4)/4
|
20. Opportunities for acquiring new information and skills
|
Info = (f20.1 + f20.2 + f20.3 + f20.4)/4
|
21. Participation in and opportunities for recreation/ leisure activities
|
Leisure = (f21.1 + f21.2 + f21.3 + f21.4)/4
|
22. Physical environment
|
Enviro = (f22.1 + f22.2 + f22.3 + f22.4)/4
|
23. Transport
|
Trans = (f23.1 + f23.2 + f23.3 + f23.4)/4
|
24. Spirituality, Religion, and Personal Beliefs
|
Srpb = (f24.1 + f24.2 + f24.3 + f24.4)/4
|
52. Forgiveness and Blame
|
Forgive = (f52.1 + f52.2 + f52.3 + f52.4)/4
|
53. Concerns about the Future
|
Future = (f53.1 + f53.2 + f53.3 + f53.4)/4
|
54. Death and Dying
|
Death = (f54.1 + f54.2 + f54.3 + f54.4)/4
|
The overall QoL and general health perceptions
|
General = (g.1 + g.2 + g.3 + g.4)/4
|
The next step was to construct domain scores by taking the mean of the facet scores estimated in the previous stage.The mean scores were then multiplied by four to create a domain score comparable to the WHOQOL-100 scores and resulting in a range of four to twenty. HRQoL was dichotomized as poor or good by using the mean of each domain as a cut-off point. Individuals who scored below the mean in each of the six domains will be labeled as having a poor QoL.
Domain1 = (pain + energy + sleep + symptom) / 4 * 4
Domain2 = (pfeel + cog + esteem + body + nfeel)/5 * 4
Domain3 = (mobil + adl + depend + work)/4 * 4
Domain4 = (relatio + support + sex + inclusi)/4 * 4
Domain5 = (safe + home + finance + care + info + leisure + enviro + rans)/8*4
Domain6 = (forgive + future + death + srpb)/4 *4
|
Explanatory variables
Psychosocial Support from Family Members: It is family or friend support for the PLHIV in terms of psychological, financial, or adherence aid[31][31][31].
Perceived stigma: Berger’s HIV stigma scale(HSS-40) was used to assess how PLWHA feel about four dimensions of stigma: (a) personalized stigma (or acted stigma), (b) concerns about disclosing one's own HIV serostatus, (c) negative self-image (self-stigma), and (d) concerns about public attitudes towards PLWHA. There were 40 items on the scale, each having a 4-point Likert-type response as strongly disagree (=1), disagree (=2), agree (=3), and strongly agree (=4). The scores were scaled in a positive direction, suggesting that the higher the score, the more stigma there is. The composite index of the total stigma score varies from 40 to 160. Low, middle, and high-level stigma were defined as values between the 25th and 50th (40-80), 50th and 75th (81-120), and greater than the 75th percentiles (121-160), respectively [77, 78].
Level of depression: The BDI-II was used to determine the severity of depression. It had 21 questions with a scale of 0 to 3, meaning the lowest possible total score is 0 and the greatest possible total for the entire test is 63. BDI-II: a score of 0–10 indicates no depression/normal, whereas a score of more than 11 indicates depression [38].
Nutritional status: Was assessed by computing Body Mass Index (BMI) using weight and height measurements, and typical cut-off points of <18.5 kg/m2 considered underweight, 18.5–24.9 kg/m2 considered normal, and greater than or equal to 25 kg/m2 considered overweight.
Psychosocial support outside family members. It is support for the PLHIV outside family members like governmental or non-governmental organizations, religious-based organizations, and community-based organizations in terms of psychological, financial, material, or spiritual support.
Current smoking status: Smokers and non-smokers were classified based on WHO criteria for controlling and monitoring the tobacco epidemic [41][42][42]. A smoker is someone who uses tobacco products on a daily or occasional basis, whereas a non-smoker is someone who does not use tobacco products at all. Non-smokers include ex-smokers, never-smokers, and ex-occasional smokers.
Alcohol consumption: Alcohol consumption was assessed using the FAST alcohol screening test measurement scale which has 4 questions and a 5-point Likert scale. For the 1st, 2nd, and 3rd questions, 0 to 4 Likert scales were used as (0 = never, 1 = Less than monthly, 2 = monthly, 3 = weekly, 4 = daily or almost daily). However, for the 4th question, we used 0 for No, 2 for Yes (on one occasion), and 3 for Yes (on more than one occasion) and categorized it into two categories. The [40][41][41]. A composite index was formed with a minimum and a maximum score of 0 and 16 respectively. Finally, it was dichotomized as non-hazardous drinkers (<3), and hazardous drinkers(≥ 3) [40][41][41].
Data analysis
The data were entered into EpiData version 3.1 and then exported to SPSS version 23 for analysis. The WHO-HRQoL-HIV-BREF instrument was rigorously followed to compute the facet and domain scores[36, 37]. The original 40-item Berger HIV-stigma scale will be conducted via exploratory factor analysis (EFA) utilizing the original 4-component structure (Personalized Stigma, Disclosure Concerns, Negative Self-Image, and Public Attitudes) [39]. The factor loading (lambda) was fixed at 0.6 in the EFA to guide item retention and shorten the scale. We then removed items with factor loadings <0.6 and items deemed redundant by our expert panel to produce the abridged scale. Descriptive statistics namely frequency, percentage, mean and standard deviation were computed. Chi-square testing was done to see if there was any significant difference in the outcome of interest and covariates across males and females. Accordingly, a statistically significant difference in HRQoL was observed between the two groups (χ2=21.57, p <0.001), and therefore, three models were fitted separately for the whole study participants, males, and females. To identify predictors of good HRQoL, bivariable logistic regression analysis was carried out at first, and factors that showed association at p-value<0.25 were entered into a multivariable logistic regression model. The reason we chose logistic regression over linear regression was that our data did not meet the fundamental assumptions of linear regression, like normality and constant variance of residuals[42]. In such instances, logistic regression is a reliable choice for modeling by transforming the continuous variable to binary outcomes. The adjusted odds ratio with the corresponding 95% confidence interval was reported and significant predictors were declared at p-value<0.05. A Variance Inflation Factor (VIF) was used to test for multicollinearity across the covariates and found none (i.e. the VIF ranged from 1.02 to 2.27 with a mean of 1.19). Finally, the goodness of fit of the final model was checked using Hosmer and Lemeshow statistics.
Ethical consideration and consent to participate
Ethical clearance was obtained from the institutional review board (IRB) of Wachamo University, through the Office of Research, and Community Service Vice President with a reference number WCU /321/22. Permission was also obtained from each district Health office and respective health facilities with HAART centers. Respondents were well informed about the objective and purpose of the study and written informed consent was obtained from each respondent of age 18 years. Those under the age of 18 gave their consent through their parents or guardians. A unique ID number was assigned to keep the information confidential. Furthermore, respondents were told that the information they gave would be utilized solely for research purposes and would not be given to anybody outside of the study team. Personal protective equipment was provided for data collectors because the study is taking place in the midst of a global pandemic, COVID-19.