How 'place' matters for addressing the HIV epidemic: evidence from the HPTN 071 (PopART) cluster-randomised controlled trial in Zambia and South Africa.


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
06 Apr 2021
Historique:
received: 29 04 2020
accepted: 16 03 2021
entrez: 7 4 2021
pubmed: 8 4 2021
medline: 22 6 2021
Statut: epublish

Résumé

In a cluster-randomised trial (CRT) of combination HIV prevention (HPTN 071 (PopART)) in 12 Zambian communities and nine South African communities, carried out from 2012 to 2018, the intervention arm A that offered HIV treatment irrespective of CD4 count did not have a significant impact on population level HIV incidence. Intervention arm B, where HIV incidence was reduced by 30%, followed national guidelines that mid trial (2016) changed from starting HIV treatment according to a CD4 threshold of 500 to universal treatment. Using social science data on the 21 communities, we consider how place (community context) might have influenced the primary outcome result. A social science component documented longitudinally the context of trial communities. Data were collected through rapid qualitative assessment, interviews, group discussions and observations. There were a total of 1547 participants and 1127 observations. Using these data, literature and a series of qualitative analysis steps, we identified key community characteristics of relevance to HIV and triangulated these with HIV community level incidence. Two interdependent social factors were relevant to communities' capability to manage HIV: stability/instability and responsiveness/resistance. Key components of stability were social cohesion; limited social change; a vibrant local economy; better health, education and recreational services; strong institutional presence; established middle-class residents; predictable mobility; and less poverty and crime. Key components of responsiveness were community leadership being open to change, stronger history of HIV initiatives, willingness to take up HIV services, less HIV-related stigma and a supported and enterprising youth population. There was a clear pattern of social factors across arms. Intervention arm A communities were notably more resistant and unstable. Intervention arm B communities were overall more responsive and stable. In the specific case of the dissonant primary outcome results from the HPTN 071 (PopART) trial, the chance allocation of less stable, less responsive communities to arm A compared to arm B may explain some of the apparently smaller impact of the intervention in arm A. Stability and responsiveness appear to be two key social factors that may be relevant to secular trends in HIV incidence. We advocate for a systematic approach, using these factors as a framework, to community context in CRTs and monitoring HIV prevention efforts. ClinicalTrials.gov NCT01900977 . Registered on July 17, 2013.

Sections du résumé

BACKGROUND BACKGROUND
In a cluster-randomised trial (CRT) of combination HIV prevention (HPTN 071 (PopART)) in 12 Zambian communities and nine South African communities, carried out from 2012 to 2018, the intervention arm A that offered HIV treatment irrespective of CD4 count did not have a significant impact on population level HIV incidence. Intervention arm B, where HIV incidence was reduced by 30%, followed national guidelines that mid trial (2016) changed from starting HIV treatment according to a CD4 threshold of 500 to universal treatment. Using social science data on the 21 communities, we consider how place (community context) might have influenced the primary outcome result.
METHODS METHODS
A social science component documented longitudinally the context of trial communities. Data were collected through rapid qualitative assessment, interviews, group discussions and observations. There were a total of 1547 participants and 1127 observations. Using these data, literature and a series of qualitative analysis steps, we identified key community characteristics of relevance to HIV and triangulated these with HIV community level incidence.
RESULTS RESULTS
Two interdependent social factors were relevant to communities' capability to manage HIV: stability/instability and responsiveness/resistance. Key components of stability were social cohesion; limited social change; a vibrant local economy; better health, education and recreational services; strong institutional presence; established middle-class residents; predictable mobility; and less poverty and crime. Key components of responsiveness were community leadership being open to change, stronger history of HIV initiatives, willingness to take up HIV services, less HIV-related stigma and a supported and enterprising youth population. There was a clear pattern of social factors across arms. Intervention arm A communities were notably more resistant and unstable. Intervention arm B communities were overall more responsive and stable.
CONCLUSIONS CONCLUSIONS
In the specific case of the dissonant primary outcome results from the HPTN 071 (PopART) trial, the chance allocation of less stable, less responsive communities to arm A compared to arm B may explain some of the apparently smaller impact of the intervention in arm A. Stability and responsiveness appear to be two key social factors that may be relevant to secular trends in HIV incidence. We advocate for a systematic approach, using these factors as a framework, to community context in CRTs and monitoring HIV prevention efforts.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov NCT01900977 . Registered on July 17, 2013.

Identifiants

pubmed: 33823907
doi: 10.1186/s13063-021-05198-5
pii: 10.1186/s13063-021-05198-5
pmc: PMC8025534
doi:

Banques de données

ClinicalTrials.gov
['NCT01900977']

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

251

Subventions

Organisme : Department for International Development
ID : 00
Organisme : U.S. President's Emergency Plan for AIDS Relief
ID : 00
Organisme : National Institute of Allergy and Infectious Diseases
ID : UMq-AI068617
Organisme : NIAID NIH HHS
ID : U01 AI068617
Pays : United States
Organisme : Bill and Melinda Gates Foundation
ID : 00
Organisme : Medical Research Council
ID : MR/R010161/1
Pays : United Kingdom
Organisme : NIAID NIH HHS
ID : UM1 AI068617
Pays : United States

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Auteurs

Virginia Bond (V)

Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, WC1H 9SH, UK. Virginia.Bond@lshtm.ac.uk.
Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia. Virginia.Bond@lshtm.ac.uk.

Graeme Hoddinott (G)

Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 241, Cape Town, 8000, South Africa.

Lario Viljoen (L)

Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 241, Cape Town, 8000, South Africa.

Fredrick Ngwenya (F)

Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.

Melvin Simuyaba (M)

Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.

Bwalya Chiti (B)

Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.

Rhoda Ndubani (R)

Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.

Nozizwe Makola (N)

Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 241, Cape Town, 8000, South Africa.

Deborah Donnell (D)

Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., P.O. Box 19024, Seattle, WA, 98109-1024, USA.

Ab Schaap (A)

Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.
Department of Infectious Disease Epidemiology, Faculty of Epidemiology and Population Health, LSHTM, Keppel Street, London, WC17HT, UK.

Sian Floyd (S)

Department of Infectious Disease Epidemiology, Faculty of Epidemiology and Population Health, LSHTM, Keppel Street, London, WC17HT, UK.

James Hargreaves (J)

Centre for Evaluation, Faculty of Public Health and Policy, LSHTM, Keppel Street, London, WC17HT, UK.

Kwame Shanaube (K)

Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.

Sarah Fidler (S)

National Institute for Health Research Biomedical Research Centre, Imperial College, South Kensington, London, SW7 2BU, UK.

Peter Bock (P)

Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, P.O. Box 241, Cape Town, 8000, South Africa.

Helen Ayles (H)

Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.
Department of Clinical Research, Faculty of Infectious and Tropical Diseases, LSHTM, Keppel Street, London, WC17HT, UK.

Richard Hayes (R)

Department of Infectious Disease Epidemiology, Faculty of Epidemiology and Population Health, LSHTM, Keppel Street, London, WC17HT, UK.

Musonda Simwinga (M)

Zambart, School of Public Health, University of Zambia, Ridgeway Campus, P.O. Box 50697, Lusaka, Zambia.

Janet Seeley (J)

Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, WC1H 9SH, UK.
Africa Health Research Institute, Nelson R. Mandela Medical School, 719 Umbilo Rd, Durban, 4001, South Africa.

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