Study design
A comparative cross-sectional study design was used to assess the level of viral suppression and associated factors among HIV-infected adolescents among OTZ and regular ART programs. Addis Ababa, Ethiopia 2021.
Study setting and period
The research was conducted at Saint Paul’s Hospital Millennium Medical College, Black Lion Hospital, and Zewditu Memorial Hospital, all of which have been implementing regular ART (RART) programs and practicing the Operation Triple Zero (OTZ) program since 2018. The OTZ program is also being provided at Yekatit 12 and Alert Hospitals. Out of the facilities providing OTZ program services, Black Lion Hospital, Zewditu Memorial Hospital, and Saint Paul’s Hospital Millennium Medical College (SPH) have the largest proportion of ART clients. Black Lion Referral Hospital is the largest teaching hospital in Ethiopia, while Zewditu Memorial Hospital is a specialized hospital that provides maternal and child health services and offers the largest number of ART services. Saint Paul’s Hospital Millennium Medical College, the second largest hospital in Ethiopia, is also a well-known HIV/AIDS treating, preventing, and controlling setting. All of these hospitals are located in Addis Ababa, the capital city of Ethiopia. Finally, the study period was conducted from July 1st to 30th, 2021.
The inclusion criteria were as follows
all HIV-positive adolescents who were on antiretroviral therapy (ART) and were being followed up in the Operation Triple Zero (OTZ) program. In addition, they should have attended the adolescent ART clinic for at least six months. Only adolescents between the ages of 10 and 19 years old will be included.
The exclusion criteria were adolescents who had been on ART for less than six months and had been enrolled in the OTZ clinic for less than six months. Additionally, those who are less than 10 years or over 19 years old will also be excluded from the study.
Sample size determination
The determination of the sample size for the research study was computed using Epi Info Version 7.2.1.0 software, utilizing a comparative cross-sectional study design. To achieve this, several assumptions were considered, which included a 95% confidence level, 80% power, 5% margin of error, the ratio of exposed to unexposed (1:1) and percent of an outcome in unexposed to be 81% and percent of an outcome among exposed 91% (percent of the outcome in exposed and unexposed was taken from a previous report [21]. Being included in the OTZ program was considered an exposure. We got 416 from the assumptions and added a 5% non-response rate to a get final sample size of 446, with equal distribution between OTZ and regular ART centers.
Sampling technique/procedures
From a total of five centers providing both OTZ and RART, a multistage (two-stage) sampling method was employed to include three study centers, namely, Black Lion Hospitals (BLH), Zewuditu Memorial Hospital (ZMH), and Saint Paul Hospital Millennium Medical College (SPHMMC). These centers were selected randomly to control any selection bias. Thereafter, proportional-to-size, allocation was computed to include participants from each selected hospital. All participants receiving services at the OTZ centers and regular ART centers were assigned equal proportions. Finally, each participant in each center was selected using a simple random sampling technique (lottery method).
Consequently, there were a total of 922 adolescents living with HIV clients in the three selected hospitals, with 325 (n1), 285 (n2), and 312 (n3) from Zewditu Memorial Hospital (ZMH), Saint Paul’s Hospital Millennium Medical College (SPHMCC), and Tikur Ambessa Hospital (TAH), respectively. The total required sample size for the project was 446 (n), with 223 allocated to the OTZ centers and the remaining 223 allocated to the regular ART centers. Participants from OTZ and regular ART were allocated equally (n) for each institution (Fig. 1).
Operation triple zero (OTZ) = 223.
Regular ART (RART) = 223.
Accordingly: \(ZMH\left({n}_{1}\right)=\frac{n}{N}\times {N}_{1}\)this is equal to\(n=\frac{446}{922}\times 325=157\)
Subsequently, participants for OTZ and regular ART are allocated equally n1 ÷ 2 = n1,
\(\frac{157}{2}=79\) Seventy-nine OTZ clients and 79 regular ART clients will be selected.
The next is the same procedure:
$$\eqalign{\,SPHMMC(N2) & = \frac{n}{N} \times N2\\& = \frac{{446}}{{922}} \times 285 = 138\,then\,\frac{{138}}{2} = 69}$$
$$BLRH(n3) = \frac{n}{N} \times N3 = \frac{{446}}{{922}} \times 312 = 151\,then\,\frac{{151}}{2} = 76$$
Dependent variables
Viral suppression.
Independent variable
The independent variables used to assess the prevalence and associated factors of viral suppression for HIV-infected adolescents are classified as follows:
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i.
Demographic characteristics of age, sex, religion, ethnicity, income, schooling.
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ii.
Behavioral factors alcohol consumption, chat chewing, sexual behaviors, cigarette smoking.
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iii.
Clinical care/factors of appointment viral load status, adherence.
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iv.
Psychosocial factors- stigma, discrimination, peer support, parental alive/died.
Operational definition of terms
Virological suppression: Virologic suppression is achieved when the HIV plasma viral load is less than 1,000 copies/ml based on one viral load measurement after six months on ART [23, 24]. Adherence: Adherence is assessed by pill count and child/caretaker’s self-report. Good adherence is considered when the patient misses less than or equal to 2 of 30 prescribed doses. Fair adherence is considered when the patient misses 3–5 of 30 prescribed doses. Poor adherence is considered when the patient misses less than 6 of 30 prescribed doses [25, 26]. Operation triple zero (OTZ) is a program of comprehensive HIV treatment to achieve “three zeroes”: zero missed appointments, zero missed drugs/medications, and zero viral loads (VLl) [21]. Discrimination in HIV is the act of treating people living with HIV differently than those without HIV. It can take various forms, such as refusal of health care, social isolation, verbal abuse, or rejection [27]. Moderate drinking is up to 1 drink per day for women and up to 2 drinks per day for men. One drink is a 12-ounce bottle of beer, a 5-ounce glass of wine, or a shot of liquor [28]. In this study, smoking was defined as smoking one stick of cigarette at least once per day.
Viral load determination procedures
Approximately 10ml of whole blood was taken and divided into two EDTA tubes, with 2ml transferred to another tube and left at room temperature for 24 h. The remaining 8ml of blood was centrifuged at 5000 rpm for 5 min, resulting in 0.35ml of plasma which was then divided into six 1.8ml Thermo Scientific NunC tubes. These six plasma samples were stored under three different temperature conditions: two at room temperature, two at 2–8 °C, and two at -20 °C. One aliquot with a volume of 0.4ml was diluted in different concentration ratios (1:2, 1:3, and 1:5) as per standard. The results obtained from the diluted samples were adjusted using dilution correction factors before conducting data analysis. All diluted plasma samples were tested within six hours of collection. The remaining 1.5ml aliquot was subjected to a four-cycle freeze-thaw experiment. The real-time HIV-1 viral load assay was performed using the M2000 SP/RT platform by Abbott Molecular, following the manufacturer’s instructions [29].
Data collection tools and procedures
Three data collectors were hired in the respective hospitals for data collection. For data collection tools and procedures, a pretest was conducted using a self-administered questionnaire assisted by family or guardians, and a standard checklist was used to review charts. The questionnaire drew on components from different literature sources, in addition to using the OTZ register book. It aimed to gather a range of demographic, behavioral, clinical, and psychosocial variables to help measure associated factors and the viral suppression rate among HIV-infected adolescents at ART and OTZ centers.
Data quality
To maintain data quality, the questionnaires were initially translated into the local Amharic language and then retranslated back into English by different translators for consistency. Data collectors received training on confidentiality maintenance, data privacy, patient information collection, and patient chart review. The questionnaire was pretested on a sample of 5% of the total size in other hospitals. All completed questionnaires were checked for completeness, accuracy, and consistency, and any necessary corrections were made promptly. The principal investigator supervised all data collection activities.
Data entry and analysis
For data entry and analysis, EPI-INFO version 7.2.1.0 and SPSS version 20 were used. To describe the demographics of ART clients, descriptive statistics methods such as frequencies, percentages, and mean/standard deviation were applied to the data from both programs separately. The prevalence rate of viral load (VL) suppression was calculated separately for each program, and a t-test was used to check the mean difference in viral suppression. In the initial model, bivariate analysis was conducted to identify variables that were associated with the outcome variable at p = 0.20, and these variables were included in the final model. The final model used multivariate binary and multiple logistic regression to identify factors associated with viral suppression. Adjusted odds ratios with a p-value of less than or equal to 0.05 and 95% confidence intervals were considered significant in declaring association.
Ethical considerations and consent to participate
A letter was primarily received from SPHMMC, Department of Public Health. In addition, the proposal was submitted for review, and further ethical approval was given by SPHMMC- Institutional Review Board with letter number PM23/278. Next, ethical approval from the IRB of each study setting of this project was received. Written assent was obtained from each study participant and/or family and/or guardian after explaining the objective of the study. Participation of the respondents was volunteer-based based and kept any privacy issues confidential. Cultures and norms were respected properly. Each participant can be withdrawn at any time during the interview process. No names were used when the questionnaires were serial numbers only for the purpose of confidentiality. Finally, we approve that this research was done according to the Declaration of Helsinki Ethical Principles.