Primary and secondary outcome analyses
TB, death
REGRESSION, EVENTS, SECONDARY
Summary statistics of the enrolled index patients will be presented stratified by arm and study site. Analysis of the primary outcome of the number of child contacts less than of 15 years of age in Ethiopia and less than 5 years of age in South Africa who initiate TPT per index patient diagnosed will be stratified by country. Cluster-level ratios will be compared between arms using an unpaired t-test which has been shown to be robust for a relatively small number of clusters [Secondary outcomes to be compared between arms will be the number of child contacts identified (using index patient’s clinic-based contact tracing report, the child contact management file, and the community-level file maintained by the community health team) per index patient, and the proportions of these who are screened, initiated on TPT and who complete TPT. As done for the primary outcome, cluster-level summaries for secondary outcomes will also be compared between arms. Count outcomes will be compared using Poisson regression, and cluster-level proportions (after a log-transformation, if necessary) will be compared using a We will provide summary statistics of TPT completion rates and losses to follow-up discontinuation (due to incident TB, side effects, transfer out, other reasons, or death) stratified by study arm and site. TPT completion will be defined as three monthly follow-up visits over a 4-month period (3HP or 3HR) or six monthly visits over a 9-month period (6H). Loss to follow-up will be defined as no return visit within three months of the child’s last recorded visit. Other reported outcomes will include new HIV diagnoses among children who are referred for ART initiation. All outcomes will be summarized by the study arm, and formal statistical tests will be conducted if the number of events observed allows. All data will be abstracted by study staff from index patient and child contact management files.Acceptability of the intervention will be assessed as the proportion of child contacts who are identified and whose families agrees for them to be screened by community-based clinic staff (community health worker, professional nurse, type of provider dependent on the setting) in their home. We will also summarize reasons for the refusal of a household visit in the intervention arm using proportions among those approached. Fidelity to guidelines will be summarized as the proportion of TB contacts initiated on the correct TPT regimen by age and HIV status, and the proportion of TPT initiations with the correct dose for weight to measure guideline fidelity of community-based TB preventive care.Process outcomes to be reported will include drug shortages and stockouts, stockouts of supplies needed for pediatric specimen collection, stockouts of TB and contact file and registers, other materials needed for the intervention (scale, etc.), staffing within the TB clinic and community health teams, use of community health teams to do contact tracing in control clinics, changes in key personnel including community health workers and TB nurses, and time the TB nurse and/or community health worker is pulled away from TB activities.All analyses will be conducted using STATA software (StataCorp. 2021) [