title: HIV-related stigma and universal testing and treatment for HIV prevention and care: design of an implementation science evaluation nested in the HPTN 071 (PopART) cluster-randomized trial in Zambia and South Africa.
abstract: BACKGROUND
  Stigma and discrimination related to HIV and key populations at high risk of HIV have the potential to impede the implementation of effective HIV prevention and treatment programmes at scale. Studies measuring the impact of stigma on these programmes are rare. We are conducting an implementation science study of HIV-related stigma in communities and health settings within a large, pragmatic cluster-randomized trial of a universal testing and treatment intervention for HIV prevention in Zambia and South Africa and will assess how stigma affects, and is affected by, implementation of this intervention.
  
  
  METHODS
  A mixed-method evaluation will be nested within HIV prevention trials network (HPTN) 071/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 anti-retroviral treatment to people living with HIV 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 HPTN 071/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 trial sites. We will collect quantitative data on indicators of HIV-related stigma over 3 years from large probability samples of community members, health workers and people living with HIV. We will collect qualitative data, including in-depth interviews and observations from members of these same groups sampled purposively. In analysis, we will: (1) compare HIV-related stigma measures between study arms, (2) link data on stigma to measures of the success of implementation of the PopART intervention and (3) explore changes in the dominant drivers and manifestations of stigma in study communities and the health system.
  
  
  CONCLUSIONS
  HIV-related stigma may impede the successful implementation of HIV prevention and treatment programmes. Using a novel study-design nested within a large, community randomized 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.
authors.affiliation: Department of Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK james.hargreaves@lshtm.ac.uk.
authors.forename: James R
authors.initials: JR
authors.lastname: Hargreaves
authors.affiliation: International Center for Research on Women, 1120 20th St NW, Suite 500 North, Washington, DC 20036, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Stangl
authors.affiliation: Department of Global Health and Development, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
authors.forename: Virginia
authors.initials: V
authors.lastname: Bond
authors.affiliation: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Lower Level Clinical Building, Fransie Van Zyl Street, Parow Valley, Cape Town, 7500, South Africa.
authors.forename: Graeme
authors.initials: G
authors.lastname: Hoddinott
authors.affiliation: Department of Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
authors.forename: Shari
authors.initials: S
authors.lastname: Krishnaratne
authors.affiliation: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Lower Level Clinical Building, Fransie Van Zyl Street, Parow Valley, Cape Town, 7500, South Africa.
authors.forename: Hlengani
authors.initials: H
authors.lastname: Mathema
authors.affiliation: Zambart, ZAMBART House, Ridgeway Campus, Lusaka, Zambia.
authors.forename: Maureen
authors.initials: M
authors.lastname: Moyo
authors.affiliation: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Lower Level Clinical Building, Fransie Van Zyl Street, Parow Valley, Cape Town, 7500, South Africa.
authors.forename: Lario
authors.initials: L
authors.lastname: Viljoen
authors.affiliation: International Center for Research on Women, 1120 20th St NW, Suite 500 North, Washington, DC 20036, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Brady
authors.affiliation: International Center for Research on Women, 1120 20th St NW, Suite 500 North, Washington, DC 20036, USA.
authors.forename: Kirsty
authors.initials: K
authors.lastname: Sievwright
authors.affiliation: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Lower Level Clinical Building, Fransie Van Zyl Street, Parow Valley, Cape Town, 7500, South Africa.
authors.forename: Lyn
authors.initials: L
authors.lastname: Horn
authors.affiliation: Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
authors.forename: Kalpana
authors.initials: K
authors.lastname: Sabapathy
authors.affiliation: Department of Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.|Zambart, ZAMBART House, Ridgeway Campus, Lusaka, Zambia.
authors.forename: Helen
authors.initials: H
authors.lastname: Ayles
authors.affiliation: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Lower Level Clinical Building, Fransie Van Zyl Street, Parow Valley, Cape Town, 7500, South Africa.
authors.forename: Nulda
authors.initials: N
authors.lastname: Beyers
authors.affiliation: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Lower Level Clinical Building, Fransie Van Zyl Street, Parow Valley, Cape Town, 7500, South Africa.
authors.forename: Peter
authors.initials: P
authors.lastname: Bock
authors.affiliation: 7Department of Medicine, Imperial College London, London SW7 2AZ, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Fidler
authors.affiliation: FHI 360, 359 Blackwell Street, Suite 200, Durham, NC 27701, USA.
authors.forename: Sam
authors.initials: S
authors.lastname: Griffith
authors.affiliation: Department of Global Health and Development, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Seeley
authors.affiliation: Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Hayes
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000517:prevention & control* / Q000628:therapy; D006801:Humans; D015994:Incidence; D008297:Male; D008403:Mass Screening / Q000379:methods*; D057545:Social Stigma; D013019:South Africa / Q000453:epidemiology; D055815:Young Adult; D015024:Zambia / Q000453:epidemiology
chemical_list: D019380:Anti-HIV Agents
keywords: AIDS; Africa; HIV; implementation science; key populations; stigma; treatment as prevention