Table 1 Primary, secondary, and exploratory endpoints
Primary endpoint |
 • Mean HbA1c 12 months after enrolment |
Secondary endpoints |
 • 10-year risk for a fatal or non-fatal cardiovascular event estimated using the WHO cardiovascular disease risk prediction tool [33] 6 and 12 months after enrolment  • Mean HbA1c 6 months after enrolment  • Mean fasting blood glucose (FBG) 6 and 12 months after enrolment  • Proportion of participants with an HbA1c < 8% 6 and 12 months after enrolment  • Proportion of participants with an FBG < 7 mmol/l 6 and 12 months after enrolment  • CVD risk factors, such as BMI, abdominal circumference, blood lipid status, physical activity using the validated International Physical Activity Questionnaire Short Form (IPAQ-SF) [34], dietary habits using a shortened unquantified food frequency questionnaire adapted from an assessment tool for obesity used in South Africa [35], and alcohol and tobacco use 6 and 12 months after enrolment  • Linkage to care: proportion of participants not taking treatment at enrolment who have initiated pharmacological antidiabetic treatment 6 and 12 months after enrolment  • Engagement in care: proportion of participants who are engaged in care, defined as reporting intake of antidiabetic medication as per prescription of a healthcare provider (VHW or healthcare professional) 6 and 12 months after enrolment or reaching treatment targets without intake of medication  • Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 6 and 12 months after enrolment  • Self-reported adherence to antidiabetic treatment 6 and 12 months after enrolment |
Exploratory endpoints |
 • Quality of life using the EQ-5D-5L instrument [36] and diabetes distress using the five item version of the "Problem Area in Diabetes" (PAID-5) Scale [37, 38] after 6 and 12 months and health beliefs using the Beliefs about Medicines Questionnaire adapted for people living with T2D [39, 40] after 12 months  • Self-reported access to care and access to medication  • Number of consultations at a health facility and with the VHW within 6 and 12 months after diagnosis  • Trajectory of participants between facility-based and community-based care in the intervention villages (i.e. number of participants accepting community-based care at baseline, number of people switching to facility-based care and back to community-based care during the study period)  • Proportion of participants with T2D who stop drug treatment or interrupt drug treatment for more than 3 weeks or require a switch of drug treatment due to (perceived) adverse events (AEs) within 6 and 12 months after enrolment  • Proportion of participants who are reaching treatment targets (FBG < 7 mmol/l) and are reporting no intake of antidiabetic medication in the 2 weeks prior to assessment after 6 and 12 months  • Proportion of participants accessing lipid-lowering medication 6 and 12 months after enrolment  • Participants’, VHWs’, and involved healthcare professionals’ perception of the risks, benefits, and problems of community-based management of uncomplicated T2D by VHWs  • Causes for the stop or interruption of treatment or switch to health facility-based treatment after initiation by VHWs in the community  • Health system costs and individual costs for participants for the management of their condition within the first 6 and 12 months after diagnosis  • 10-year CVD risk estimated using the Globorisk score [41] and Framingham Risk Score [42] 6 and 12 months after enrolment  • Type and dosage of antidiabetic and lipid-lowering medications prescribed by VHWs or healthcare professionals 6 and 12 months after enrolment |