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Introduction: The practice of creating large databases has become increasingly common by combining research participants' data into larger repositories. Funders now require that data sharing be considered in newly funded research project, unless there are justifiable reasons not to do so. Access to genomic data brings along a host of ethical concerns as well as fairness and equity in the conduct of collaborative research between researchers from high- income and low-and middle-income countries., Materials and Methods: This systematic review protocol will be developed in line with PRISMA -guidelines which refers to Open Science Framework, registered in PROSPERO (https://www.crd.york.ac.uk/prospero/) record CRD42022297984 and published in a peer reviewed journal. Data sources will include PubMed, google scholar, EMBASE, Web of science and MEDLINE. Both published and grey literature will be searched. Subject matter experts including bioethicists, principal investigators of genomic research projects and research administrators will be contacted. After de-duplication, titles and abstracts will be screened for eligibility. Data extraction will be undertaken using a piloted form designed in EPPI-Reviewer software before conducting risk of bias assessments by a pair of reviewers, acting independently. Any discrepancies will be resolved by consensus. Analysis will be done using a structured narrative synthesis and where feasible metanalysis. This review will attempt to highlight the context of data sharing practices in the global North-South and South-South collaborative human genomic research in low- and middle-income countries. This review will enhance the body of evidence on ethical, legal and social implications of data sharing in international collaborative genomic research setting criteria for data sharing. The full report will be shared with relevant stakeholders including universities, civil society, funders, and departments of genomic research to ensure an adequate reach in low-and middle-income countries (LMICs)., Competing Interests: The authors have declared that no competing interest exists., (Copyright: © 2023 Ekusai-Sebatta et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: The prevalence of HIV in Uganda is 7.3%, and yet nearly 40% of people living with HIV are unaware of their status. The current HIV testing policy which is strictly blood-based poses several challenges including: a need for high level laboratory skills, stringent waste disposal needs, and painful sample collection. It is envisaged that introduction of a rapid, painless HIV oral fluid test as a potential alternative is likely to increase the number of people testing. The aim of this study was to determine the diagnostic accuracy and acceptability of rapid HIV oral testing among adults attending Kisenyi Health Centre IV in Kampala., Methods and Findings: We conducted a cross-sectional study among 440 adults recruited consecutively at Kisenyi Health Centre IV from January to March 2016. The diagnostic accuracy of the HIV oral test was assessed by comparing to the national HIV serial testing algorithm. We also assessed for acceptability among patients and health care workers (HCWs) by triangulating responses from a structured questionnaire, three focus group discussions and seven key informant interviews. Acceptability was defined as willingness to take the test at the time of the study and intention for future use of the test if it was availed. The prevalence of HIV infection among study participants was 14.8%. The HIV oral fluid test was highly accurate with sensitivity of 100% (95% CI; 94.5-100.0), specificity of 100% (95% CI; 99.0-100.0), positive predictive value (PPV) of 100% (95% CI; 94.5-100.0) and negative predictive value (NPV) of 100% (95% CI; 99.0-100.0). Acceptability of HIV oral testing was also high at 87.0% (95% CI; 83.6-89.9). Participants preferred HIV oral testing because it was: pain free (91%, n = 399) and did not require blood draw (82%, n = 360)., Conclusion: The HIV oral fluid test has high diagnostic accuracy and acceptability. HIV oral testing is a suitable addition to the national HIV testing strategies with the potential of increasing access to HIV testing services in Uganda.

Background: WHO recommends regular viral load (VL) monitoring of patients on antiretroviral therapy (ART) for timely detection of virological failure, prevention of acquired HIV drug resistance (HIVDR) and avoiding unnecessary switching to second-line ART. However, the cost and complexity of routine VL testing remains prohibitive in most resource limited settings (RLS). We evaluated a simple, low-cost, qualitative viral-failure assay (VFA) on dried blood spots (DBS) in three clinical settings in Uganda., Methods: We conducted a cross-sectional diagnostic accuracy study in three HIV/AIDS treatment centres at the Joint Clinical Research Centre in Uganda. The VFA employs semi-quantitative detection of HIV-1 RNA amplified from the LTR gene. We used paired dry blood spot (DBS) and plasma with the COBASAmpliPrep/COBASTaqMan, Roche version 2 (VLref) as the reference assay. We used the VFA at two thresholds of viral load, (>5,000 or >1,000 copies/ml)., Results: 496 paired VFA and VLref results were available for comparative analysis. Overall, VFA demonstrated 78.4% sensitivity, (95% CI: 69.7%-87.1%), 93% specificity (95% CI: 89.7%-96.4%), 89.3% accuracy (95% CI: 85%-92%) and an agreement kappa = 0.72 as compared to the VLref. The predictive values of positivity and negativity among patients on ART for >12 months were 72.7% and 99.3%, respectively., Conclusions: VFA allowed 89% of correct classification of VF. Only 11% of the patients were misclassified with the potential of unnecessary or late switch to second-line ART. Our findings present an opportunity to roll out simple and affordable VL monitoring for HIV-1 treatment in RLS.

Objective: Clinical and immunological data about HIV in older adults from low and middle income countries is scarce. We aimed to describe differences between younger and older adults with HIV starting antiretroviral therapy in two low-income African countries., Setting: HIV clinics in Uganda and Zimbabwe., Design: Secondary exploratory cross-sectional analysis of the DART randomized controlled trial., Outcome Measures: Clinical and laboratory characteristics were compared between adults aged 18-49 years (younger) and ≥ 50 years (older), using two exploratory multivariable logistic regression models, one with HIV viral load (measured in a subset pre-ART) and one without., Results: A total of 3316 eligible participants enrolled in DART were available for analysis; 219 (7%) were ≥ 50 years and 1160 (35%) were male. Across the two adjusted regression models, older adults had significantly higher systolic blood pressure, lower creatinine clearance and were consistently less likely to be females compared to younger adults with HIV. Paradoxically, the models separately suggested that older adults had statistically significant (but not clinically important) higher CD4+ cell counts and higher plasma HIV-1 viral copies at initiation. Crude associations between older age and higher baseline hemoglobin, body mass index, diastolic blood pressure and lower WHO clinical stage were not sustained in the adjusted analysis., Conclusions: Our study found clinical and immunological differences between younger and older adults, in a cohort of Africans starting antiretroviral therapy. Further investigations should explore how these differences could be used to ensure equity in service delivery and affect outcomes of antiretroviral therapy.

Objective: The HIV/AIDS epidemic has evolved with an increasing burden in older adults. We assessed for knowledge about aging and HIV/AIDS, among clinicians in Kampala district, Uganda., Methods: A cross-sectional survey of 301 clinicians complemented by 9 key-informant interviews between May and October 2011. Data was analyzed by multivariable logistic regression for potential determinants of clinician knowledge about HIV/AIDS in older adults, estimating their adjusted Odds Ratios (aOR) and 95% confidence intervals (95% CI) using Stata 11.2 software., Results: Two-hundred and sixty-two questionnaires (87.7%) were returned. Respondents had a median age of 30 years (IQR 27-34) and 57.8% were general medical doctors. The mean knowledge score was 49% (range 8.8%-79.4%). Questions related to co-morbidities in HIV/AIDS (non-AIDS related cancers and systemic diseases) and chronic antiretroviral treatment toxicities (metabolic disorders) accounted for significantly lower scores (mean, 41.7%, 95% CI: 39.3%-44%) compared to HIV/AIDS epidemiology and prevention (mean, 65.7%, 95% CI: 63.7%-67.7%). Determinants of clinician knowledge in the multivariable analysis included (category, aOR, 95% CI): clinician age (30-39 years; 3.28∶1.65-9.75), number of persons with HIV/AIDS seen in the past year (less than 50; 0.34∶0.14-0.86) and clinical profession (clinical nurse practitioner; 0.31∶0.11-0.83). Having diploma level education had a marginal association with lower knowledge about HIV and aging (p = 0.09)., Conclusion: Our study identified gaps and determinants of knowledge about HIV/AIDS in older adults among clinicians in Kampala district, Uganda. Clinicians in low and middle income countries could benefit from targeted training in chronic care for older adults with HIV/AIDS and long-term complications of antiretroviral treatment.