HPTN 071 (PopART) community-randomised trial design, PopART intervention, and TREATS study design
TB, sweats, weight loss, cough
The HPTN 071 (PopART) community-randomised trial was conducted during 2013 to 2018. All communities were urban or peri-urban, 12 were in Zambia and 9 were in the Western Cape Province of South Africa, with a total population of around 1 million individuals and estimated adult HIV prevalence of around 15%. In the HPTN 071 (PopART) trial, the 21 communities were matched into 7 triplets based on geographical area and estimated HIV prevalence [The PopART intervention was delivered by community HIV care providers (CHiPs) for 4 years (2014 to 2017), primarily through a door-to-door approach, with CHiPs aiming to reach all households and all community members who were aged ≥15 years approximately annually. HIV testing was offered to all who participated in the intervention, apart from individuals who self-reported they were HIV–positive. Systematic screening for TB was done for everyone who reported they were not currently on TB treatment, based on TB symptoms. Two sputum samples were requested from individuals who reported any among a cough for ≥2 weeks, unintentional weight loss ≥1.5 kg in the last month, current night sweats, or that a member of their household was currently on TB treatment. CHiPs took the sputum samples to the health clinic, where TB diagnostic testing followed national guidelines; in South African communities Xpert-MTB/RIF was used, and in Zambian communities Xpert-MTB/RIF was used for people living with HIV (PLWH) and smear microscopy was used for all other individuals. CHiPs made at least 1 follow-up visit to individuals who had TB symptoms or were a household contact of a TB patient at the time of the annual visit, to provide TB diagnostic test results and support for starting TB treatment (if required). They also made regular follow-up visits to individuals who were known to be HIV–positive, to support linkage to HIV care and retention on ART. Alongside this, routine TB service provision at the health clinic was strengthened in various ways, in collaboration with each country’s Department of Health or Ministry of Health. This strengthening included additional provision of machines for Xpert-MTB/RIF testing, additional Xpert-MTB/RIF cartridges and reagents, support to staff doing laboratory testing, and support to strengthen recordkeeping for TB registers. TB preventive therapy was recommended for PLWH and individuals aged <5 years old who were a household contact of a TB patient, according to national guidelines, but uptake of such therapy was low during the period of the PopART intervention delivery.The TREATS study was conducted in the same 21 communities as the HPTN 071 (PopART) trial and was designed as a follow-up study to the HPTN 071 (PopART) trial. The TREATS study was designed to measure the impact of the PopART intervention on TB outcomes, including TB prevalence, and was conducted during 2017 to 2022. The primary comparison of TB prevalence was between arms A and B combined (PopART intervention) versus arm C (standard-of-care). Arms A and B were combined because the TB screening and universal HIV testing components of the PopART intervention were the same throughout the HPTN 071 (PopART) trial, and universal ART was offered in arm B from mid-2016 (when universal ART became national guidelines).