Altmetric

HPTN 071 (PopART): Rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment - a study protocol for a cluster randomised trial

Title: HPTN 071 (PopART): Rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment - a study protocol for a cluster randomised trial
Authors: Hayes, R
Ayles, H
Beyers, N
Sabapathy, K
Floyd, S
Shanaube, K
Bock, P
Griffith, S
Moore, A
Watson-Jones, D
Fraser, C
Vermund, SH
Fidler, S
Item Type: Journal Article
Abstract: Background: Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. Mathematical modelling and the HIV Prevention Trials Network (HPTN) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment (ART) should substantially reduce incidence and may eliminate HIV as a public health problem. We describe the rationale and design of a trial to evaluate this hypothesis. Methods/Design: A rigorously-designed trial of universal testing and treatment (UTT) interventions is needed because: i) it is unknown whether these interventions can be delivered to scale with adequate uptake; ii) there are many uncertainties in the models such that the population-level impact of these interventions is unknown; and ii) there are potential adverse effects including sexual risk disinhibition, HIV-related stigma, over-burdening of health systems, poor adherence, toxicity, and drug resistance. In the HPTN 071 (PopART) trial, 21 communities in Zambia and South Africa (total population 1.2 m) will be randomly allocated to three arms. Arm A will receive the full PopART combination HIV prevention package including annual home-based HIV testing, promotion of medical male circumcision for HIV-negative men, and offer of immediate ART for those testing HIV-positive; Arm B will receive the full package except that ART initiation will follow current national guidelines; Arm C will receive standard of care. A Population Cohort of 2,500 adults will be randomly selected in each community and followed for 3 years to measure the primary outcome of HIV incidence. Based on model projections, the trial will be well-powered to detect predicted effects on HIV incidence and secondary outcomes. Discussion: Trial results, combined with modelling and cost data, will provide short-term and long-term estimates of cost-effectiveness of UTT interventions. Importantly, the three-arm design will enable assessment of how much could be achieved by optimal delivery of current policies and the costs and benefits of extending this to UTT.
Issue Date: 13-Feb-2014
Date of Acceptance: 3-Feb-2014
URI: http://hdl.handle.net/10044/1/49795
DOI: https://dx.doi.org/10.1186/1745-6215-15-57
ISSN: 1745-6215
Publisher: BioMed Central
Journal / Book Title: Trials
Volume: 15
Issue: 1
Copyright Statement: © 2014 Hayes et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Sponsor/Funder: Medical Research Council (MRC)
Funder's Grant Number: MR/K010174/1B
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
SIMPLEX-VIRUS TYPE-2
ANTIRETROVIRAL THERAPY
MALE CIRCUMCISION
SEXUAL TRANSMISSION
RURAL TANZANIA
SOUTH-AFRICA
VIRAL LOAD
INFECTION
RISK
STRATEGY
Adolescent
Adult
Anti-HIV Agents
Circumcision, Male
Clinical Protocols
Cost-Benefit Analysis
Drug Administration Schedule
Female
HIV Infections
Health Care Costs
Humans
Incidence
Male
Mass Screening
Predictive Value of Tests
Prevalence
Research Design
South Africa
Time Factors
Treatment Outcome
Young Adult
Zambia
HPTN 071 (PopART) Study Team
1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Cardiovascular System & Hematology
General & Internal Medicine
Publication Status: Published
Article Number: ARTN 57
Appears in Collections:Department of Medicine
Faculty of Medicine
Epidemiology, Public Health and Primary Care



Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Creative Commonsx