Diagnostic performance of an albuminuria point-of-care test in screening for chronic kidney disease among young people living with HIV in Uganda: a cross-sectional study.

OBJECTIVES: The main aim was to determine the diagnostic performance of an albuminuria point-of-care test (POC) for diagnosis of chronic kidney disease among young people living with HIV (YPLHIV) in Uganda. DESIGN: We conducted a cross-sectional study comparing the diagnostic performance of MicroalbuPHAN (Erba Lachema, Czech Republic), an albuminuria POC test against the laboratory-measured albumin and creatinine as the reference standard. SETTING: The study was set in seven HIV clinics in Kampala, Uganda that provide antiretroviral therapy to adults and children living with HIV. The study took place from April to August 2023. PARTICIPANTS: 497 YPLHIV aged 10-24 years who were diagnosed with HIV before 10 years of age were randomly selected from the HIV clinics. Pregnant YPLHIV were excluded. PROCEDURES: Participants provided a spot urine sample that was tested for albumin and creatinine using the POC and in the laboratory and proteinuria using urine dipstick. The sensitivity, specificity, negative and positive predictive values (NPV, PPV) of the POC versus the laboratory test were calculated, and factors associated with having a positive POC test were estimated using logistic regression. OUTCOME MEASURES: The primary outcome was a diagnosis of albuminuria defined as an albumin creatinine ratio above 30 mg/g. RESULTS: Of the 497 participants enrolled, 278 (55.9%) were female and 331 (66.8%) were aged 10-17 years. The POC test had a sensitivity of 74.5% (95% CI 70.6% to 78.4%) and specificity of 68.1% (95% CI 63.9% to 72.3%). The PPV was 21.5% (95% CI 17.8% to 25.1%) and the NPV was 95.8% (95% CI 94.0% to 97.6%), with an accuracy of 68.8%. There was strong evidence that a positive POC test was associated with having proteinuria (OR 2.82; 95% CI 1.89 to 4.22, p<0.001); body mass index <19.5 (OR 1.69 95% CI 1.17 to 2.45, p=0.005) and being male (OR 1.48; 95% CI 1.02 to 2.14, p=0.04). CONCLUSIONS: The albuminuria POC test had low sensitivity and specificity. However, it can be used to exclude kidney disease given its high NPV. It should be validated against the 24-hour urinary excretion rate to further determine its diagnostic performance.

Venues and methods to improve professional men's access to HIV self-testing and linkage to HIV prevention or treatment: a qualitative study.

BACKGROUND: HIV testing among men in sub-Saharan Africa is sub-optimal. Despite several strategies to improve access to underserved populations, evidence regarding engaging men in professional and formal occupations in HIV testing is limited. This study explored employed professional men's preferences for uptake of HIV self-testing, and linkage to HIV care, or prevention services. METHODS: This was an explorative-descriptive qualitative study where a sample of 33 men from six Ugandan urban centres. Participants were purposively selected guided by the International Standard Classification of Occupations to participate in in-depth interviews. The data were collected using an interview guide and the sample size was determined by data saturation. Eligibility criteria included fulltime formal employment for over a year at that organization. The data were analyzed manually using thematic content analysis. RESULTS: Three categories emerged: uptake of HIV self-tests, process of HIV self-testing and linkage to post-test services. The different modes of distribution of HIV self-test kits included secondary distribution, self-tests at typically male dominated spaces, delivery to workplaces and technology-based delivery. The process of HIV self-testing may be optimized by providing collection bins, and mHealth or mobile phone applications. Linkage to further care or prevention services may be enhanced using medical insurance providers, giving incentives and tele counselling. CONCLUSION: We recommend utilization of several channels for the uptake of HIV self-tests. These include distribution of test kits both to offices and men's leisure and recreation 'hot spots', Additionally, female partners, peers and established men's group including social media groups can play a role in improving the uptake of HIV self-testing. Mobile phones and digital technology can be applied in innovative ways for the return of test results and to strengthen linkage to care or prevention services. Partnership with medical insurers may be critical in engaging men in professional employment in HIV services.

The Effects of Workplace-Based HIV Self-testing on Uptake of Testing and Linkage to HIV Care or Prevention by Men in Uganda (WISe-Men): Protocol for a Cluster Randomized Trial.

BACKGROUND: HIV testing uptake remains low among men in sub-Saharan Africa. HIV self-testing (HIVST) at the workplace is a novel approach to increase the availability of, and access to, testing among men. However, both access and linkage to posttest services remain a challenge. OBJECTIVE: The aim of this protocol is to describe a cluster randomized trial (CRT)-Workplace-Based HIV Self-testing Among Men (WISe-Men)-to evaluate the effect of HIVST in workplace settings on the uptake of HIV testing services (HTS) and linkage to treatment and prevention services among men employed in private security services in Uganda. METHODS: This is a two-arm CRT involving men employed in private security services in two Ugandan districts. The participants in the intervention clusters will undergo workplace-based HIVST using OraQuick test kits. Those in the control clusters will receive routine HTS at their work premises. In addition to HTS, participants in both the intervention and control arms will undergo other tests and assessments, which include blood pressure assessment, blood glucose and BMI measurement, and rapid diagnostic testing for syphilis. The primary outcome is the uptake of HIV testing. The secondary outcomes include HIV status reporting, linkage into HIV care and confirmatory testing following HIVST, initiation of antiretroviral therapy following a confirmatory HIV test, the uptake of voluntary medical male circumcision, consistent condom use, and the uptake of pre-exposure prophylaxis by the most at-risk populations. RESULTS: Participant enrollment commenced in February 2020, and the trial is still recruiting study participants. Follow-up for currently enrolled participants is ongoing. Data collection and analysis is expected to be completed in December 2021. CONCLUSIONS: The WISe-Men trial will provide information regarding whether self-testing at worksites increases the uptake of HIV testing as well as the linkage to care and prevention services at male-dominated workplaces in Uganda. Additionally, the findings will help us propose strategies for improving men's engagement in HTS and ways to improve linkage to further care following a reactive or nonreactive HIVST result. TRIAL REGISTRATION: ClinicalTrials.gov NCT04164433; https://clinicaltrials.gov/ct2/show/NCT04164433. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25099.

Conducting an ongoing HIV clinical trial during the COVID-19 pandemic in Uganda: a qualitative study of research team and participants' experiences and lessons learnt.

OBJECTIVE: To explore the experiences and lessons learnt by the study team and participants of the Workplace-based HIV self-testing among Men trial during the COVID-19 pandemic in Uganda. DESIGN: An explorative qualitative study comprising two virtual focus group discussions (FGDs) with 12 trial team members and 32 in-depth participant interviews (N=44). Data were collected via telephone calls for in-depth interviews or Zoom for FGDs and manually analysed by inductive content analysis. SETTING: Fourteen private security companies in two Uganda districts. PARTICIPANTS: Members of the clinical trial study team, and men working in private security companies who undertook workplace-based HIV testing. RESULTS: The key themes for participants experiences were: 'challenges in accessing HIV treatment and care, and prevention services', 'misinformation' and 'difficulty participating in research activities'. The effects on HIV treatment and prevention resulted from; repercussions of the COVID-19 restrictions, participants fear of coinfection and negative experiences at health facilities. The difficulty in participating in research activities arose from: fear of infection with COVID-19 for the participants who tested HIV negative, transport difficulties, limited post-test psychosocial support and lack of support to initiate pre-exposure prophylaxis. The key study team reflections focused on the management of the clinical trial, effects of the local regulations and government policies and the need to adhere to ethical principles of research. CONCLUSIONS: Findings highlight the need to organise different forms of HIV support for persons living with HIV during a pandemic. Additionally, the national research regulators and ethics committees or review boards are strongly urged to develop policies and guidelines for the continuity of research and clinical trials in the event of future shocks. Furthermore, this study calls on the appropriate government agencies to ensure public and researchers' preparedness through continuing education and support. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT04164433; Pre-results.

Employers' and Employees' Perspectives of HIV Self-Testing at Male-Dominated Work Sites and Linkage to Posttest Services in Uganda.

This study explored men's views of workplace-based HIV self-testing and the barriers and facilitators of linkage to posttest services. Six focus group discussions and individual in-depth interviews were held with employers and employees in private security companies in Uganda (N = 70). Using content analysis, five categories emerged. The first category was the mitigation of potential harm, including reduction of stigma and discrimination, and the need for posttest support. The second category was a perceived need for on-site services where the men proposed on-site prevention services and HIV treatment and care. In the third category, which was strengthening linkage mechanisms, participants proposed expanded clinic hours, improved health facility efficiency, and provision of referral documentation. The fourth and fifth categories were organizational support and social support, respectively. There is need for employers and employees to work together for the success of workplace-based HIV initiatives.