Background Stigma and discrimination related to HIV and populations at high risk of HIV have the potential to impede the implementation of effective HIV prevention and treatment programmes. We will conduct an implementation science study of HIV-related stigma in communities and health settings within a large, pragmatic cluster-randomised trial of a universal testing and treatment intervention for HIV prevention in Zambia and South Africa and assess how stigma affects, and is affected by, implementation of this intervention.

Methods A mixed-method evaluation will be nested within HPTN071/PopART (Clinical Trials registration number NCT01900977), a three-arm trial comparing universal door-to-door delivery of HIV testing and referral to prevention and treatment services, accompanied by either an immediate offer of antiretroviral treatment to people living with HIV (PLHIV) regardless of clinical status, or an offer of treatment in-line with national guidelines, with a standard-of-care control arm. The primary outcome of HPTN071/PopART is HIV incidence measured among a cohort of 52,500 individuals in 21 study clusters. Our evaluation will include integrated quantitative and qualitative data collection and analysis in all sites. We will collect quantitative data on indicators of HIV-related stigma over three years from large probability samples of community members, health workers, and PLHIV, and qualitative data, including in-depth interviews and observations from members of these same groups sampled purposively. In analysis we will: (i) compare HIV-related stigma measures between study arms, (ii) link data on stigma to measures of the success of implementation of the intervention, (iii) explore changes in the drivers and manifestations of stigma in study communities and the health system.

Discussion Using a novel study-design nested within a large, pragmatic trial we will evaluate the extent to which HIV-related stigma affects and is affected by the implementation of a comprehensive combination HIV prevention intervention including a universal test and treatment approach.

Disclosure of interest statement HPTN 071 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) under Cooperative Agreements UM1-AI068619, UM1-AI068617, and UM1-AI068613, with funding from the US President’s Emergency Plan for AIDS Relief (PEPFAR). Additional funding is provided by the International Initiative for Impact Evaluation (3ie) with support from the Bill and Melinda Gates Foundation, as well as by NIAID, the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH), all part of NIH. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAID, NIMH, NIDA, PEPFAR, 3ie, or the Bill and Melinda Gates Foundation. We have no conflicts of interest to declare.