Cultural adaptation and psychometric evaluation of the Kinyarwanda version of the diabetes-39 (D-39) questionnaire.

BACKGROUND: In recent years, more importance is being given to the assessment of quality of life (QoL) among diabetic patients as a measure of their health and the goal of all health interventions. Other studies have reported a high prevalence of diabetes-related effects on; however, there is a knowledge gap in the region of Sub-Saharan Africa, as is the case for Rwanda, where the prevalence of diabetes is expected to rise over the next decade. The aim of this study is to report on the translation and cultural adaptation of the Diabetes-39 (D-39) questionnaire into the Kinyarwanda and its psychometric properties among diabetic patients in Rwanda. METHODS: The D-39 questionnaire-a five-scale, disease-specific QoL questionnaire-was translated from English to Kinyarwanda, then back-translated to English. A consensus meeting discussed discrepancies and agreed on changes. Interviews were conducted with 26 participants before producing a final version. For the psychometric evaluation, the adapted version was administered to 309 patients with diabetes mellitus. Participants either came from a separate cluster-randomised controlled trial or were recruited ad hoc for this study. The evaluation included testing internal consistency, known group validity, and construct validity. RESULTS: Participants' mean age was 51 ± 12.7 years with a predominance of women (64%) in the sample. All five scales of the questionnaire showed a good internal consistency, with composite reliability of above 0.7. The five-factor model of the questionnaire was fitted to the 39 items. Although the fit was not exact, there was a satisfactory approximate fit (CFI = 0.93, TLI = 0.92, RMSEA = 0.05). There was a good discriminant validity except for the "social burden" and "anxiety and worry" scales (inter-factor correlation = 0.80). CONCLUSIONS: Diabetes-39 is a questionnaire developed in English that was adapted and translated into Kinyarwanda. The Kinyarwanda version of D-39 is a reliable and valid instrument to measure QoL among diabetic patients in Rwanda. The questionnaire can be helpful in research and clinical practice improving health outcomes for patients with diabetes in Rwanda and other Kinyarwanda-competent areas in the sub-region. However, certain cross-cultural differences should be considered.

Cultural adaptation and psychometric evaluation of the Kinyarwanda version of the problem areas in diabetes (PAID) questionnaire.

BACKGROUND: High prevalence rates in diabetes-related distress have been observed in several studies; however, in the region of Sub-Saharan Africa evidence is lacking as is, for example, the case for Rwanda, where diabetes prevalence is expected to increase over the next decade. The aim of this study is to report on the translation and cultural adaption of the problem areas in diabetes (PAID) questionnaire into Kinyarwanda and its psychometric properties. METHODS: The questionnaire was translated following a standard procedure. Interviews were conducted with 29 participants before producing a final version. For the psychometric evaluation, a sample of 266 patients with diabetes mellitus, aged 21-64 years old were examined. Participants either came from a separate cluster-randomised controlled trial or were recruited ad-hoc for this study. The evaluation included testing internal consistency, known groups validity, and construct validity. A series of confirmatory factor analysis were conducted investigating seven previously established factorial structures. An exploratory factor analysis (EFA) was also carried out to examine the structure further. RESULTS: The full scale showed good internal reliability (Cronbach's α = 0.88). A four-factor solution previously tested in Spain with subdimensions of emotional, treatment, food-related and social-support problems demonstrated adequate approximate fit (RMSEA = 0.056; CFI = 0.951; TLI = 0.943). The EFA revealed a four-factor structure; however, two of these factors were not as homogeneous and easily interpretable as those of the Spanish model. CONCLUSIONS: The psychometric properties of the Kinyarwanda version of PAID are acceptable. The questionnaire can be helpful in research and clinical practice in Rwanda, however certain cross-cultural differences should be taken into account.

Retention in care and virological failure among adult HIV+ patients on second-line ART in Rwanda: a national representative study.

BACKGROUND: Currently, there is limited evidence on the effectiveness of second-line antiretroviral therapy (ART) in sub-Saharan Africa. To address this challenge, outcomes of second-line protease inhibitor (PI) based ART in Rwanda were assessed. METHODS: A two-stage cluster sampling design was undertaken. 49 of 340 health facilities linked to the open-source electronic medical record (EMR) system of Rwanda were randomly sampled. Data sampling criteria included adult HIV positive patients with documented change from first to second-line ART regimen. Retention in care and treatment failure (viral load above 1000 copies/mL) were evaluated using multivariable Cox proportional hazards and logistic regression models. RESULTS: A total of 1688 patients (60% females) initiated second-line ART PI-based regimen by 31st December 2016 with a median follow-up time of 26 months (IQR 24-36). Overall, 92.5% of patients were retained in care; 83% achieved VL ≤ 1000 copies/ml, 2.8% were lost to care and 2.2% died. Defaulting from care was associated with more recent initiation of ART- PI based regimen, CD4 cell count ≤500 cells/mm3 at initiation of second line ART and viral load > 1000 copies/ml at last measurement. Viral failure was associated with younger age, WHO stage III&IV at ART initiation, CD4 cell count ≤500 cells/mm3 at switch, atazanavir based second-line ART and receiving care at a health center compared to hospital settings. CONCLUSIONS: A high proportion of patients on second-line ART are doing relatively well in Rwanda and retained in care with low viral failure rates. However, enhanced understandings of adherence and adherence interventions for less healthy individuals are required. Routine viral load measurement and tracing of loss to follow-up is fundamental in resource limited settings, especially among less healthy patients.

Quality of life among adult patients living with diabetes in Rwanda: a cross-sectional study in outpatient clinics.

OBJECTIVES: To report on the disease-related quality of life of patients living with diabetes mellitus in Rwanda and identify its predictors. DESIGN: Cross-sectional study, part of the baseline assessment of a cluster-randomised controlled trial. SETTING: Outpatient clinics for non-communicable diseases of nine hospitals across Rwanda. PARTICIPANTS: Between January and August 2019, 206 patients were recruited as part of the clinical trial. Eligible participants were those aged 21-80 years and with a diagnosis of diabetes mellitus for at least 6 months. Illiterate patients, those with severe hearing or visual impairments, those with severe mental health conditions, terminally ill, and those pregnant or in the postpartum period were excluded PRIMARY AND SECONDARY OUTCOME MEASURES: Disease-specific quality of life was measured with the Kinyarwanda version of the Diabetes-39 (D-39) questionnaire. A glycated haemoglobin (HbA1c) test was performed on all patients. Sociodemographic and clinical data were collected, including medical history, disease-related complications and comorbidities. RESULTS: The worst affected dimensions of the D-39 were 'anxiety and worry' (mean=51.63, SD=25.51), 'sexual functioning' (mean=44.58, SD=37.02), and 'energy and mobility' (mean=42.71, SD=20.69). Duration of the disease and HbA1c values were not correlated with any of the D-39 dimensions. A moderating effect was identified between use of insulin and achieving a target HbA1c of 7% in the 'diabetes control' scale. The most frequent comorbidity was hypertension (49.0% of participants), which had a greater negative effect on the 'diabetes control' and 'social burden' scales in women. Higher education was a predictor of less impact on the 'social burden' and 'energy and mobility' scales. CONCLUSIONS: Several variables were identified as predictors for the five dimensions of quality of life that were studied, providing opportunities for tailored preventive programmes. Further prospective studies are needed to determine causal relationships. TRIAL REGISTRATION NUMBER: NCT03376607.

The Need for a Practical Approach to Evaluate the Effectiveness of COVID-19 Vaccines for Low- and Middle-Income Countries.

The global demand for coronavirus disease 2019 (COVID-19) vaccines currently far outweighs the available global supply and manufacturing capacity. As a result, securing doses of vaccines for low- and middle-income countries has been challenging, particularly for African countries. Clinical trial investigation for COVID-19 vaccines has been rare in Africa, with the only randomized clinical trials (RCTs) for COVID-19 vaccines having been conducted in South Africa. In addition to addressing the current inequities in the vaccine roll-out for low- and middle-income countries, there is a need to monitor the real-world effectiveness of COVID-19 vaccines in these regions. Although RCTs are the superior method for evaluating vaccine efficacy, the feasibility of conducting RCTs to monitor COVID-19 vaccine effectiveness during mass vaccine campaigns will likely be low. There is still a need to evaluate the effectiveness of mass COVID-19 vaccine distribution in a practical manner. We discuss how target trial emulation, the application of trial design principles from RCTs to the analysis of observational data, can be used as a practical, cost-effective way to evaluate real-world effectiveness for COVID-19 vaccines. There are several study design considerations that need to be made in the analyses of observational data, such as uncontrolled confounders and selection biases. Target trial emulation accounts for these considerations to improve the analyses of observational data. The framework of target trial emulation provides a practical way to monitor the effectiveness of mass vaccine campaigns for COVID-19 using observational data.

Prevalence and incidence of HIV among female sex workers and their clients: modelling the potential effects of intervention in Rwanda.

BACKGROUND: Rwanda has identified several targeted HIV prevention strategies, such as promotion of condom use and provision of antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) for female sex workers (FSWs). Given this country's limited resources, understanding how the HIV epidemic will be affected by these strategies is crucial. METHODS: We developed a Markov model to estimate the effects of targeted strategies to FSWs on the HIV prevalence/incidence in Rwanda from 2017 to 2027. Our model consists of the six states: HIV-; HIV+ undiagnosed/diagnosed pre-ART; HIV+ diagnosed with/without ART; and death. We considered three populations: FSWs, sex clients and the general population. For the period 2017-2027, the HIV epidemic among each of these population was estimated using Rwanda's demographic, sexual risk behaviour and HIV-associated morbidity and mortality data. RESULTS: Between 2017 and 2027, with no changes in the current condom and ART use, the overall number of people living with HIV is expected to increase from 344,971 to 402,451. HIV incidence will also decrease from 1.36 to 1.20 100 person-years. By 2027, a 30% improvement in consistent condom use among FSWs will result in absolute reduction of HIV prevalence among FSWs, sex clients and the general population by 7.86%, 5.97% and 0.17%, respectively. While recurring HIV testing and improving the ART coverage mildly reduced the prevalence/incidence among FSWs and sex clients, worsening the two (shown by our worst-case scenario) will result in an increase in the HIV prevalence/incidence among FSWs and sex clients. Introduction of PrEP to FSWs in 2019 will reduce the HIV incidence among FSWs by 1.28%. CONCLUSIONS: Continued efforts toward improving condom and ART use will be critical for Rwanda to continue their HIV epidemic control. Implementing a targeted intervention strategy in PrEP for FSWs will reduce the HIV epidemic in this high-risk population.

Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial.

INTRODUCTION: In Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients' health behaviours and HBCPs' work satisfaction. METHODS AND ANALYSIS: This is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs' programme; (2) HBCPs' programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs' programme. Under each hospital, administrative areas implementing the HBCPs' programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs' programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT03376607; Pre-results.

Combating non-communicable diseases: potentials and challenges for community health workers in a digital age, a narrative review of the literature.

The use of community health workers (CHWs) has been explored as a viable option to provide home health education, counselling and basic health care, notwithstanding their challenges in training and retention. In this manuscript, we review the evidence and discuss how the digitalization affects the CHWs programmes for tackling non-communicable diseases (NCDs) in low- and middle-income countries (LMICs). We conducted a review of literature covering two databases: PubMED and Embase. A total of 97 articles were abstracted for full text review of which 26 are included in the analysis. Existing theories were used to construct a conceptual framework for understanding how digitalization affects the prospects of CHW programmes for NCDs. The results are divided into two themes: (1) the benefits of digitalization and (2) the challenges to the prospects of digitalization. We also conducted supplemental search in non-peer reviewed literature to identify and map the digital platforms currently in use in CHW programmes. We identified three benefits and three challenges of digitalization. Firstly, it will help improve the access and quality of services, notwithstanding its higher establishment and maintenance costs. Secondly, it will add efficiency in training and personnel management. Thirdly, it will leverage the use of data generated across grass-roots platforms to further research and evaluation. The challenges posed are related to funding, health literacy of CHWs and systemic challenges related to motivating CHWs. Several dozens of digital platforms were mapped, including mobile-based networking devices (used for behavioural change communication), Web-applications (used for contact tracking, reminder system, adherence tracing, data collection and decision support), videoconference (used for decision support) and mobile applications (used for reminder system, supervision, patients' management, hearing screening and tele-consultation). The digitalization efforts of CHW programmes are afflicted by many challenges, yet the rapid technological penetration and acceptability coupled with the gradual fall in costs constitute encouraging signals for the LMICs. Both CHWs interventions and digital technologies are not inexpensive, but they may provide better value for the money when applied at the right place and time.

Household survey of HIV incidence in Rwanda: a national observational cohort study.

BACKGROUND: In Rwanda, HIV prevalence among adults aged 15-49 years has been stable at 3% since 2005. The aim of this study was to characterise HIV incidence across Rwanda. METHODS: We did a nationally representative, prospective HIV incidence survey for the period of 2013-14, which used two-stage sampling. We randomly selected 492 villages in the first sampling stage and 14 households per village in the second stage. Participants completed a questionnaire and 14 140 people were tested for HIV. 13 728 participants were HIV negative, and were enrolled in the incidence cohort. Participants were retested and surveyed again after 12 months. Weights were calculated as the inverse of the probability to select the villages and the households. FINDINGS: The study period was from Nov 5, 2013, to Nov 15, 2014. Among 14 222 respondents from 6792 households, 14 140 were tested for HIV and 13 728 were HIV negative. Of 12 593 people who participated in the endpoint data collection activities, 5965 (47·4%) were men and the mean age was 30 years (SD 10·8). 11 237 (89·2%) participants lived in rural areas, 4826 (38·3%) were single, and 7140 (56·7%) were married or cohabitating. During the year, 35 participants had seroconversion, including 13 men and 22 women, resulting in an overall incidence of 0·27 per 100 person-years (95% CI 0·18-0·35). Incidence was 0·21 per 100 person-years (0·10-0·32) in men and 0·32 per 100 person-years (0·19-0·45) in women. Our findings suggested multiple breakouts, with multiple seroconversions occurring in three villages and two households. Incidence was higher in adults aged 36-45 years (0·37 per 100 person-years, 0·12-0·62; adjusted hazard ratio [aHR] 4·49, 95% CI 1·30-14·70) relative to those aged 16-25, higher in western province (0·57 per 100 person-years, 0·31-0·87; aHR 5·90, 1·33-25·28) relative to the northern province, and higher in urban areas (0·65 per 100 person-years, 0·23-1·07; aHR 3·10, 1·28-6·99) than in rural areas. INTERPRETATION: The incidence of HIV in Rwanda was higher than that previously estimated from models, with outbreaks seeming to contribute to the ongoing epidemic. Characterisation of incident infections can help the national HIV programmes to plan for preventive interventions tailored to the most at risk populations. FUNDING: Global Fund to Fight HIV, Tuberculosis and Malaria, WHO Rwanda, UNAIDS Rwanda, and the Government of Rwanda.

A Randomized Switch From Nevirapine-Based Antiretroviral Therapy to Single Tablet Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in Virologically Suppressed Human Immunodeficiency Virus-1-Infected Rwandans.

Background. Many human immunodeficiency virus (HIV)-infected patients remain on nevirapine-based antiretroviral therapy (ART) despite safety and efficacy concerns. Switching to a rilpivirine-based regimen is an alternative, but there is little experience with rilpivirine in sub-Saharan Africa where induction of rilpivirine metabolism by nevirapine, HIV subtype, and dietary differences could potentially impact efficacy. Methods. We conducted an open-label noninferiority study of virologically suppressed (HIV-1 ribonucleic acid [RNA] < 50 copies/mL) HIV-1-infected Rwandan adults taking nevirapine plus 2 nucleos(t)ide reverse-transcriptase inhibitors. One hundred fifty participants were randomized 2:1 to switch to coformulated rilpivirine-emtricitabine-tenofovir disoproxil fumarate (referenced as the Switch Arm) or continue current therapy. The primary efficacy endpoint was HIV-1 RNA < 200 copies/mL at week 24 assessed by the US Food and Drug Administration Snapshot algorithm with a noninferiority margin of 12%. Results. Between April and September 2014, 184 patients were screened, and 150 patients were enrolled; 99 patients switched to rilpivirine-emtricitabine-tenofovir, and 51 patients continued their nevirapine-based ART. The mean age was 42 years and 43% of participants were women. At week 24, virologic suppression (HIV-1 RNA level <200 copies/mL) was maintained in 93% and 92% in the Switch Arm versus the continuation arm, respectively. The Switch Arm was noninferior to continued nevirapine-based ART (efficacy difference 0.8%; 95% confidence interval, -7.5% to +12.0%). Both regimens were generally safe and well tolerated, although 2 deaths, neither attributed to study medications, occurred in participants in the Switch Arm. Conclusions. A switch from nevirapine-based ART to rilpivirine-emtricitabine-tenofovir disoproxil fumarate had similar virologic efficacy to continued nevirapine-based ART after 24 weeks with few adverse events.