Intervention
TB, HIV infection, cough
HIV INFECTION, DISEASE
A study fieldworker was allocated to be present at each intervention clinic on working days. Fieldworkers received trial-specific training that included approaching and obtaining individual written consent from participants, safe collection and labeling of sputum specimens, and the maintenance of patient confidentiality. We used 3 methods to identify potential participants: fieldworkers presented at approximately 2 hourly intervals in intervention clinic waiting rooms during which they introduced the study and its purpose, and requested attendees who thought they were in a high-risk group to privately contact the fieldworker at any time during their clinic visit; they reviewed patient files to assess potential eligibility of participants; and other healthcare workers in intervention clinics were requested to refer potentially eligible patients to fieldworkers for enrolment and sputum collection.Adults, ≥18 years of age, with at least one of the following were eligible: documented HIV infection in the clinical record irrespective of ART treatment or CD4 count; self-report of a close contact with a person with TB in the workplace or at home or elsewhere in the prior year; or self-report of TB disease—including receipt of TB treatment—in the prior 2 years. We excluded individuals taking TB treatment at the time of the study visit, as well as those who had a trial specimen collected in the previous 6 months. Consented participants had a brief interview, and confirmation of HIV seropositivity was abstracted from medical records, with the most recent CD4 count, if available. Irrespective of the presence of symptoms, every participant had a supervised sputum specimen taken in a standardized manner according to an operating procedure on which fieldworkers rceived training at the beginning and also oversight throughout the trial. Specimens were taken either outside the clinic or in a well-ventilated sputum collection booth. After an oral water rinse, fieldworkers collected ≥3 ml of sputum in a prelabelled specimen container. Participants unable to produce a mucoid sputum specimen immediately were encouraged to make repeated cough efforts and then spit whatever was in their mouth into the specimen container and to repeat this process 3 times. Specimens were couriered by routine transport systems to NHLS mycobacterial culture laboratories (in eThekwini, Cape Town, Tshwane, and Johannesburg) with automated liquid culture capacity.At each laboratory, after homogenization and decontamination with In control clinics, no changes in TB symptom screening or collection of specimens for TB testing occurred. Patients attending these clinics continued to have specimens collected if they reported TB symptoms. All control clinics’ sputum specimens were delivered by routine courier to the nearest NHLS laboratory to be tested using Ultra. TB screening and sample collection processes were observed and evaluated at least twice at each control clinic over the duration of the intervention phase. Clinics that scored poorly on 2 occasions on a standardized evaluation by study staff were brought to the attention of the Provincial TB Manager by the study team.