Objective: Number of People Living with Human Immune-deficiency Virus in Ghana is over 300,000 and unmet need for antiretroviral therapy is approximately 60%. This study sought to determine the quality of antiretroviral therapy services in selected ART sites in Ghana using the input-process-outcome approach. Methods: This is a descriptive cross-sectional case study that employed modified normative evaluation to assess quality of antiretroviral therapy services in the Oti and Volta regions of Ghana among People Living with HIV (n = 384) and healthcare providers (n = 16). The study was conducted from 11 March to 9 May 2019. Results: Resources for managing HIV clients were largely available with the exception of viral load machines, reagents for CD4 counts, and antifungals such as Fluconazole and Cotrimoxazole. Patients enrolled on antiretroviral therapy within 2 weeks was 71% and clients retained in care within 2 weeks of enrolment was 90%. Approximately 26% of enrolled clients recorded viral load suppression; 33% of People Living with HIV who were not insured with the National Health Insurance Scheme paid for some antiretrovirals and cotrimoxazole. Adherence to ART and Cotrimoxazole were 95% and 88%, respectively, using pill count on their last three visits. Time spent with clinical team was among the worst rated (mean = 2.98, standard deviation = 0.54) quality indicators by patients contrary to interpersonal relationship with health provider which was among the best rated (mean = 3.25, standard deviation = 0.41) indicators. Conclusion: Observed quality care gaps could potentially reverse gains made in HIV prevention and control in Ghana if not addressed timely; an important value addition of this study is the novel application of input-process-outcome approach in the context of antiretroviral therapy services in Ghana. There is also the need for policy dialogue on inclusion of medications for prophylaxis in antiretroviral therapy on the National Health Insurance Scheme to promote adherence and retention.
This is a descriptive cross-sectional case study that employed modified normative evaluation based on Donabedian’s model of healthcare quality. 1 The modified normative evaluation is an evaluation procedure where standards as per Ghana’s guidelines for HIV management are compared with the prevailing situation in the various study sites. The modified normative evaluation emphasizes context-specific evaluation approach as against a one-size-fits-all. 26 In this study, the approach was used to assess quality of HIV care in the selected ART sites using patient clinical records according to Ghana’s guidelines for HIV management. For the purpose of this paper, only the input and process indicators of healthcare quality are reported. The study was conducted in Ho, Hohoe and Jasikan districts in the Volta and Oti regions. Volta and Oti regions are 2 of the 16 administrative regions in Ghana. Per the 2010 population and housing census, the population of Jasikan, Hohoe and Ho Municipal were 59,181; 262,046 and 271,881 respectively. 27 Three HIV Sentinel sites offering ART services as at June, 2019 were purposively selected from the three administrative districts. The three purposively selected ART sites were Jasikan District Hospital (rural), Hohoe Municipal Hospital (peri-urban) and Ho Teaching Hospital (urban). All these facilities are national sentinel sites for HIV management with fully functioning ART clinics. The target population size is the of clinical records of 1,500 PLHIV from the three ART sites at the time of conducting this study. Thus, Ho Teaching Hospital (N = 745), Hohoe Municipal Hospital (N = 450), and Jasikan District Hospital (N = 305). This ART site is hosted in a 240-bed capacity tertiary hospital under the Ministry of Health. It serves as the regional referral health facility in its catchment area including neighbouring Republic of Togo. The hospital records are averagely 160 daily attendance. Healthcare services provided include outpatient/inpatient services, dental, eye, family planning, mental health, maternal and child health, surgical, physiotherapy, radiography, herbal Medicine, pharmacy, internal medicine, laboratory, ART clinic and mortuary services. This ART site is hosted in a 178-bed secondary referral hospital under the Ghana Health Service (GHS). Average daily attendance is 150. Services provided in this secondary hospital include outpatient/admissions, pharmacy, laboratory, dental, physiotherapy, medical imaging, antenatal, maternity, surgical, ART, eye and mortuary services. This ART site is hosted in a 53-bed secondary hospital also under the GHS. Average daily out-patient attendance is 165. Services provided include outpatient/admissions, pharmacy, laboratory, pharmacy, X-ray, antenatal, maternity, ART, eye and other specialized services. Target study population was all registered PLHIV above the age of 18 years enrolled in ART for at least six (6) months. Sample size for the clinical records review was 384 from all the three ART sites. The sample size was calculated using the formula: n = Z²PQ/d² where: n = sample size; Z = statistic for a 95% Confidence Interval; P = expected outcome; Q = complement of P and d = precision (fixed at 5%). Based on findings from a study conducted in Nigeria, 28 it was found that approximately 49% of PLHIV rated quality of service delivery as excellent. Thus, an expected outcome of 49% rated satisfaction was used for the sample size determination. At the time of conducting this study there was no known data on similar studies in Ghana hence reliance on evidence in Olowookere et al. 28 with the following assumed parameters: P (expected outcome = 0.487); Q (1 P = 1- 0.487 = 0.513); n = Z²PQ/d²; (1.96) 2 x 0.487 x 0.513/ (0.05); 2 = 383.84 ≈ 384. Final selection of the sample was done using multi-stage sampling to allocate sample sizes to the ART sites. Percentage share of PLHIV in the Ho Teaching Hospital, Hohoe Municipal Hospital and Jasikan District are 50%, 30% and 20% respectively. Based on these proportions, the sample size allocation through quota system was as follows: Ho Teaching Hospital (50/100*384 = 191), Hohoe Municipal Hospital (30/100*384 = 115), and Jasikan District Hospital (20/100*384 = 79). Subsequently, clinical record reviews were conducted on all the 384 sampled PLHIV in each of the ART sites. Healthcare providers (n = 16) directly involved in the care of PLHIV were also purposively sampled and engaged through interviews to ascertain the providers’ perspectives on the quality of ART services. PLHIV enrolled in ART for at least 6 months, age 18 years or more, access care in the three ART sentinel sites and voluntarily agreed to participate in the study. The study excluded PLHIV who were lost to follow-up for over a year; those who were transferred in or out of selected ART sites, and those who visited the clinic for the first time on the day of data collection. Patients with Tuberculosis co-morbidities were equally excluded. A modified normative evaluation tool based on an adapted Donabedian’s input–process–outcome model of health care quality. 28 Ghana’s guideline for HIV management informed data collection instrument items for the process and outcome quality indicators. Inventory data extraction tool designed according to the national resource requirement for the management of HIV in Ghana was used to assess input quality indicators. Adherence to ARVs was measured by dividing the number of people enrolled in ART and consistently took their ARVs without default (through pill count) over the total number of enrolled patients and multiplied by 100. The authors, however, acknowledge the limitations of using pill counts as a proxy for ARVs adherence. Pill count is highly subject to bias and might not account for missed doses due to falls and stock piling at home. 29 Face validity was done by giving data collection tools/extraction forms to independent reviewers in the field of HIV to determine whether questions measured the indicators of interest as per Donabedian 1 validated test items for measuring medical technical quality. Tools were also pre-tested in a comparable health facility in the Volta region to address ambiguity in questions and typographical errors to enhance internal validity. Also, all tool items were developed based on the study objectives alongside strict monitoring during the data collection, entry, cleaning and analysis. Data collection in all the three ART sites lasted approximately 3 months from 11 March to 9 May 2019. In terms of the input quality indicators, availability of resources was assessed through inventory data extraction according to the national resource requirement for the management of HIV in Ghana. Health staff who were in-charge of various resources such as head of Pharmacy, Laboratory, Medical Superintendent and Health Services Administrators were interviewed for secondary data verification. Data collection technique entailed review of patient management records using data extraction tools. The steps were as follows: first, patient folder numbers (i.e manual folders or electronic folders through e-tracker) were used to retrieve medical records for data extraction on adherence to national guidelines and outcome of care. In addition, availability of resources was checked with requirements of the Ghana National AIDS and Sexually Transmitted Infections (STIs) Control Programme (NACP). Data on outcome indicators of quality care were from clients’ clinical records and client satisfaction survey tools administered on site. Field data were coded, cleaned and analysis done with SPSS-IBM Version 22. Descriptive Statistics were generated including Chi-square and Fisher’s Exact tests to ascertain associations between variables as appropriate. Summary statistics were generated for continuous variables, percentages and frequency distributions were generated for categorical variables. In addition, after an orthogonal unrotated Principal Component Analysis (PCA), 8 out of the 32 items were retained for final analysis. Subsequently, summary statistics (means and standard deviations) were used to ascertain the average responses of patients on the Likert-type scale items. Test for statistical significance was set at 95% confidence level. Normality testing of data was done in GraphPad Prism to check for distribution, skewness and kurtosis before analysis. Visual inspection of data was done on SPSS-IBM to check for missing data and normality. Data from the semi-structured interviews with health staff was captured, cleaned and coded using SPSS -IBM Version 22. Analysis strategy was mainly descriptive statistics to demonstrate staff perspectives on the quality of ART services in the three ART sites. Since the variables of interest were mainly quantitative measures in nature, the data collection approach was quantitative. Input indicators: Proxies for input indicators were centred on resource availability. For the purposes of this study the input factors were: resource availability including antiretroviral medicines, laboratory reagents, equipment, trained healthcare providers and logistics. Process indicators: On the other hand, process quality indicators were determined based on adherence to national guidelines for HIV diagnostic and treatment and Donabedian’s model for service quality. 1 These indicators were reviewed by clinicians working on the HIV control programme as well as those providing HIV care in the facilities to promote institutional relevance of the tool. Medication adherence as operationalized in this study ranged from treatment initiation to maintenance of a particular therapeutic medication regimen to control viral replication and improving immune system function. Discontinuity or cessation of part or all of the treatment in instances of missing doses, drug holidays, overdosing or under-dosing is referred to as non-adherence. Outcome indicators: Outcome quality indicators were measured using technical and functional quality proxies. The technical quality measures were patients’ adherence to medication and clinical improvement in functional status based on objective documentation in the clients’ clinical folders. Functional outcome quality care dimensions were client satisfaction scores on dimensions of healthcare quality. Total of 32 client perceived service quality indicators were developed based on national guidelines for HIV care and adapted Donabedian’s structure-process-outcome model of health care quality. After principal component analysis (PCA), the 32 factors were further scaled down to eight (8), comprising of patient satisfaction with general services; technical quality; interpersonal relations; communication; financial accessibility; time spent with clinical team; accessibility and convenience and other patient satisfaction factors. Five-point Likert-type scale used to measure satisfaction levels ranging from 1 = ‘Very dissatisfied’ – 5 ‘Very satisfied’. This study was granted ethical approval by the Ghana Health Service (GHS) Ethical Review Committee (ERC) (clearance number: GHS-ERC009/08/19). Administrative approvals were also sought from the respective health facility heads. To promote anonymity of the study sites, codes used in place of participants’ names to guarantee their privacy and confidentiality. Collated data was kept on a password protected computer and kept with the Principal Investigator. Participation in the study was voluntary and participants were told to discontinue from the study anytime they so wish without consequences. Only participants who voluntarily signed the informed consent form were allowed to participate in the study. Participation in the study was voluntary and were told to discontinue from the study anytime they so wish without consequences. Only participants who voluntarily signed the informed consent form were allowed to participate in the study. Written informed consent was obtained from all subjects. In the case of minors (persons below 18 years), written informed consent from legally authorized representatives (locus parentis) was obtained before they were included in the study. Please see Supplementary File 1 for Consent Forms for the various study respondents.