Effect of a clinical decision support system on early action on immunological treatment failure in patients with HIV in Kenya: a cluster randomised controlled trial.

BACKGROUND: A clinical decision support system (CDSS) is a computer program that applies a set of rules to data stored in electronic health records to offer actionable recommendations. We aimed to establish whether a CDSS that supports detection of immunological treatment failure among patients with HIV taking antiretroviral therapy (ART) would improve appropriate and timely action. METHODS: We did this prospective, cluster randomised controlled trial in adults and children (aged ≥18 months) who were eligible for, and receiving, ART at HIV clinics in Siaya County, western Kenya. Health facilities were randomly assigned (1:1), via block randomisation (block size of two) with a computer-generated random number sequence, to use electronic health records either alone (control) or with CDSS (intervention). Facilities were matched by type and by number of patients enrolled in HIV care. The primary outcome measure was the difference between groups in the proportion of patients who experienced immunological treatment failure and had a documented clinical action. We used generalised linear mixed models with random effects to analyse clustered data. This trial is registered with ClinicalTrials.gov, number NCT01634802. FINDINGS: Between Sept 1, 2012, and Jan 31, 2014, 13 clinics, comprising 41,062 patients, were randomly assigned to the control group (n=6) or the intervention group (n=7). Data collection at each site took 12 months. Among patients eligible for ART, 10,358 (99%) of 10,478 patients were receiving ART at control sites and 10,991 (99%) of 11,028 patients were receiving ART at intervention sites. Of these patients, 1125 (11%) in the control group and 1342 (12%) in the intervention group had immunological treatment failure, of whom 332 (30%) and 727 (54%), respectively, received appropriate action. The likelihood of clinicians taking appropriate action on treatment failure was higher with CDSS alerts than with no decision support system (adjusted odds ratio 3·18, 95% CI 1·02-9·87). INTERPRETATION: CDSS significantly improved the likelihood of appropriate and timely action on immunological treatment failure. We expect our findings will be generalisable to virological monitoring of patients with HIV receiving ART once countries implement the 2015 WHO recommendation to scale up viral load monitoring. FUNDING: US President's Emergency Plan for AIDS Relief (PEPFAR), through the US Centers for Disease Control and Prevention.

Using information and communications technology in a national population-based survey: the Kenya AIDS Indicator Survey 2012.

BACKGROUND: With improvements in technology, electronic data capture (EDC) for large surveys is feasible. EDC offers benefits over traditional paper-based data collection, including more accurate data, greater completeness of data, and decreased data cleaning burden. METHODS: The second Kenya AIDS Indicator Survey (KAIS 2012) was a population-based survey of persons aged 18 months to 64 years. A software application was designed to capture the interview, specimen collection, and home-based testing and counseling data. The application included: interview translations for local languages; options for single, multiple, and fill-in responses; and automated participant eligibility determination. Data quality checks were programmed to automate skip patterns and prohibit outlier responses. A data sharing architecture was developed to transmit the data in real-time from the field to a central server over a virtual private network. RESULTS: KAIS 2012 was conducted between October 2012 and February 2013. Overall, 68,202 records for the interviews, specimen collection, and home-based testing and counseling were entered into the application. Challenges arose during implementation, including poor connectivity and a systems malfunction that created duplicate records, which prevented timely data transmission to the central server. Data cleaning was minimal given the data quality control measures. CONCLUSIONS: KAIS 2012 demonstrated the feasibility of using EDC in a population-based survey. The benefits of EDC were apparent in data quality and minimal time needed for data cleaning. Several important lessons were learned, such as the time and monetary investment required before survey implementation, the importance of continuous application testing, and contingency plans for data transmission due to connectivity challenges.

The Kenya AIDS Indicator Survey 2012: rationale, methods, description of participants, and response rates.

BACKGROUND: Cross-sectional population-based surveys are essential surveillance tools for tracking changes in HIV epidemics. In 2007, Kenya implemented the first AIDS Indicator Survey [Kenya AIDS Indicator Survey (KAIS) 2007)], a nationally representative, population-based survey that collected demographic and behavioral data and blood specimens from individuals aged 15-64 years. Kenya's second AIDS Indicator Survey (KAIS 2012) was conducted to monitor changes in the epidemic, evaluate HIV prevention, care, and treatment initiatives, and plan for an efficient and effective response to the HIV epidemic. METHODS: KAIS 2012 was a cross-sectional 2-stage cluster sampling design, household-based HIV serologic survey that collected information on households as well as demographic and behavioral data from Kenyans aged 18 months to 64 years. Participants also provided blood samples for HIV serology and other related tests at the National HIV Reference Laboratory. RESULTS: Among 9300 households sampled, 9189 (98.8%) were eligible for the survey. Of the eligible households, 8035 (87.4%) completed household-level questionnaires. Of 16,383 eligible individuals aged 15-64 years and emancipated minors aged less than 15 years in these households, 13,720 (83.7%) completed interviews; 11,626 (84.7%) of the interviewees provided a blood specimen. Of 6302 eligible children aged 18 months to 14 years, 4340 (68.9%) provided a blood specimen. Of the 2094 eligible children aged 10-14 years, 1661 (79.3%) completed interviews. CONCLUSIONS: KAIS 2012 provided representative data to inform a strategic response to the HIV epidemic in the country.