Implementation of REDCap mobile app in an oral HIV clinical study.

BACKGROUND: In Peru, HIV cases are highly concentrated among men who have sex with men (MSM). Despite the availability of anti-retroviral therapy, people living with HIV (PWH) have higher levels of oral diseases. Alcohol use disorder (AUD) is significantly present among PWH. Our overarching goal was to generate foundational evidence on the association of AUD and oral health in MSM with HIV and enhance research capacity for future intersectional research on AUD, oral health and HIV. Our specific aim was to implement an on-site electronic data collection system through the use of a REDCap Mobile App in a low-middle income country (LMIC) setting. METHODS: Five validated surveys were utilized to gather data on demographics, medical history, HIV status, alcohol use, HIV stigma, perceived oral health status, and dietary supplement use. These surveys were developed in REDCap and deployed with the REDCap Mobile App, which was installed on ten iPads across two medical HIV clinics in Lima, Peru. REDCap app as well as the protocol for data collection were calibrated with feedback from trial participants and clinical research staff to improve clinical efficiency and participant experience. RESULTS: The mean age of participants (n = 398) was 35.94 ± 9.13y, of which 98.5% identified as male, and 85.7% identified as homosexual. 78.1% of participants binge drank, and 12.3% reported being heavy drinkers. After pilot testing, significant modifications to the structure and layout of the surveys were performed to improve efficiency and flow. The app was successfully deployed to replace cumbersome paper records and collected data was directly stored in a REDCap database. CONCLUSIONS: The REDCap Mobile App was successfully used due to its ability to: (a) capture and store data offline, (b) timely translate between multiple languages on the mobile app interface, and (c) provide user-friendly interface with low associated costs and ample support. TRIAL REGISTRATION: 1R56DE029639-01.

Acute retroviral syndrome is associated with lower CD4 + T cell nadir and delayed viral suppression, which are blunted by immediate antiretroviral therapy initiation.

OBJECTIVES: To describe the prevalence of acute retroviral syndrome (ARS) and associated findings during primary HIV, and explore the relationship of ARS to clinical, virological, and immunological outcomes within a longitudinal screen, retest and treat study that minimized ascertainment bias. DESIGN: We evaluated ARS symptoms and signs among 216 persons with acute and early incident HIV within the Sabes study of timing of antiretroviral therapy (ART) initiation during primary HIV in Peru. METHODS: We evaluated patient reported symptoms and signs during primary HIV and used logistic regression and generalized linear models to evaluate associations with CD4 + and CD8 + T cell counts, HIV viral load, and a panel of 23 soluble markers of immune activation. RESULTS: Sixty-one percent of participants had at least one ARS finding and 35% had at least 3. More ARS findings were reported in those enrolled within a month of estimated date of detectable infection (EDDI). Having more ARS signs/symptoms was associated with increased risk of CD4 + cell decrease below 350 cells/ml within the first 24 weeks, failure to suppress HIV viral load, and was most strongly associated with elevated IP-10. Immediate ART blunted effects on symptoms, CD4 + cell count and viral load, as associations were strongest in the arm that started ART after 24 weeks. Detrimental associations of ARS with CD4 + counts, and CD4 + /CD8 + ratio were not maintained at 2 or 4 years. CONCLUSIONS: ARS has marked associations with short-term immunologic function and virologic suppression, which were mitigated in participants randomized to initiate ART immediately during primary infection.