METHODS: Adults (≥ 18 years) diagnosed with HIV after 2013 in a regional observational cohort were included. Fine and Gray competing risk regression examined predictors of ART initiation (≥ 3 antiretroviral medications), accounting for those lost to follow-up or deceased before treatment considered as competing risks.
RESULTS: Among 14,968 participants, most were male (70.1%), with a median age of 36 years (interquartile range [IQR]: 28-44). At HIV diagnosis, median CD4 count was 208 cells/µL (IQR: 69-395), and median viral load was 86,296 copies/mL (IQR: 13,186-392,000). Over 85% of participants had initiated ART during the study period. Median time from HIV diagnosis to ART initiation differed across years of HIV diagnosis: 51 days (2013-2015), 28 days (2016-2019), and 26 days (≥ 2020). Factors associated with shorter time to ART initiation were higher country income-level (upper-middle: sub-distribution hazard ratio [SHR] = 1.34, 95% CI: 1.28, 1.40; high: SHR = 1.35, 95% CI: 1.28, 1.43; vs. lower-middle); HIV transmission via male-to-male contact (SHR = 1.06, 95% CI: 1.02, 1.11) or injection drug use (SHR = 1.23, 95% CI: 1.09, 1.38; vs. heterosexual contact); and later years of HIV diagnosis (2016-2019: SHR = 1.33, 95% CI: 1.28, 1.38; ≥ 2020: SHR = 1.40, 95% CI: 1.33, 1.48; vs. 2013-2015). Those with higher CD4 counts had longer time to ART start (350-499 cells/µL: SHR = 0.76, 95% CI: 0.67, 0.86; > 500 cells/µL: SHR = 0.55, 95% CI: 0.49, 0.61; vs. CD4
Objective: To examine the effects of a quality improvement intervention comprising information and communications technology and contact with nonphysician personnel on the care and cardiometabolic risk factors of patients with type 2 diabetes in 8 Asia-Pacific countries.
Design, Setting, and Participants: This 12-month multinational open-label randomized clinical trial was conducted from June 28, 2012, to April 28, 2016, at 50 primary care or hospital-based diabetes centers in 8 Asia-Pacific countries (India, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam). Six countries were low and middle income, and 2 countries were high income. The study was conducted in 2 phases; phase 1 enrolled 7537 participants, and phase 2 enrolled 13 297 participants. Participants in both phases were randomized on a 1:1 ratio to intervention or control groups. Data were analyzed by intention to treat and per protocol from July 3, 2019, to July 21, 2020.
Interventions: In both phases, the intervention group received 3 care components: a nurse-led Joint Asia Diabetes Evaluation (JADE) technology-guided structured evaluation, automated personalized reports to encourage patient empowerment, and 2 or more telephone or face-to-face contacts by nurses to increase patient engagement. In phase 1, the control group received the JADE technology-guided structured evaluation and automated personalized reports. In phase 2, the control group received the JADE technology-guided structured evaluation only.
Main Outcomes and Measures: The primary outcome was the incidence of a composite of diabetes-associated end points, including cardiovascular disease, chronic kidney disease, visual impairment or eye surgery, lower extremity amputation or foot ulcers requiring hospitalization, all-site cancers, and death. The secondary outcomes were the attainment of 2 or more primary diabetes-associated targets (glycated hemoglobin A1c <7.0%, blood pressure <130/80 mm Hg, and low-density lipoprotein cholesterol <100 mg/dL) and/or 2 or more key performance indices (reduction in glycated hemoglobin A1c≥0.5%, reduction in systolic blood pressure ≥5 mm Hg, reduction in low-density lipoprotein cholesterol ≥19 mg/dL, and reduction in body weight ≥3.0%).
Results: A total of 20 834 patients with type 2 diabetes were randomized in phases 1 and 2. In phase 1, 7537 participants (mean [SD] age, 60.0 [11.3] years; 3914 men [51.9%]; 4855 patients [64.4%] from low- and middle-income countries) were randomized, with 3732 patients allocated to the intervention group and 3805 patients allocated to the control group. In phase 2, 13 297 participants (mean [SD] age, 54.0 [11.1] years; 7754 men [58.3%]; 13 297 patients [100%] from low- and middle-income countries) were randomized, with 6645 patients allocated to the intervention group and 6652 patients allocated to the control group. In phase 1, compared with the control group, the intervention group had a similar risk of experiencing any of the primary outcomes (odds ratio [OR], 0.94; 95% CI, 0.74-1.21) but had an increased likelihood of attaining 2 or more primary targets (OR, 1.34; 95% CI, 1.21-1.49) and 2 or more key performance indices (OR, 1.18; 95% CI, 1.04-1.34). In phase 2, the intervention group also had a similar risk of experiencing any of the primary outcomes (OR, 1.02; 95% CI, 0.83-1.25) and had a greater likelihood of attaining 2 or more primary targets (OR, 1.25; 95% CI, 1.14-1.37) and 2 or more key performance indices (OR, 1.50; 95% CI, 1.33-1.68) compared with the control group. For attainment of 2 or more primary targets, larger effects were observed among patients in low- and middle-income countries (OR, 1.50; 95% CI, 1.29-1.74) compared with high-income countries (OR, 1.20; 95% CI, 1.03-1.39) (P = .04).
Conclusions and Relevance: In this 12-month clinical trial, the use of information and communications technology and nurses to empower and engage patients did not change the number of clinical events but did reduce cardiometabolic risk factors among patients with type 2 diabetes, especially those in low- and middle-income countries in the Asia-Pacific region.
Trial Registration: ClinicalTrials.gov Identifier: NCT01631084.