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

Simple item page
dc.contributor.authorHayes, Richard
dc.contributor.authorAyles, Helen
dc.contributor.authorBeyers, Nulda
dc.contributor.authorSabapathy, Kalpana
dc.contributor.authorFloyd, Sian
dc.contributor.authorShanaube, Kwame
dc.contributor.authorBock, Peter
dc.contributor.authorGriffith, Sam
dc.contributor.authorMoore, Ayana
dc.contributor.authorWatson-Jones, Deborah
dc.contributor.authorFraser, Christophe
dc.contributor.authorVermund, Sten H.
dc.contributor.authorFidler, Sarah
dc.contributor.authorThe HPTN 071 (PopART) Study Team
dc.date.accessioned2014-05-29T07:49:34Z
dc.date.available2014-05-29T07:49:34Z
dc.date.issued2014-02
dc.date.updated2014-02-20T00:09:21Z
dc.descriptionPlease site as follows:en_ZA
dc.descriptionHayes, R. et al. 2014. 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. Trials, 15(1):57, doi:10.1186/1745-6215-15-57.en_ZA
dc.descriptionThe original publication is available athttp://www.trialsjournal.com/content/15/1/57en_ZA
dc.description.abstractAbstract 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. Trial registration ClinicalTrials.gov NCT01900977.en_ZA
dc.description.sponsorshipNational Institute of Allergies and Infectious Diseases (NIAID)en_ZA
dc.description.sponsorshipInternational Initiative for Impact Evaluationen_ZA
dc.description.sponsorshipNational Institute on Drug Abuse (NIDA)en_ZA
dc.description.sponsorshipNational Institute of Mental Health (NIMH)en_ZA
dc.description.sponsorshipBill and Melinda Gates Foundationen_ZA
dc.description.versionPublishers' Versionen_ZA
dc.format.extent17 p. : ill., col. maps
dc.identifier.citationHayes, R. et al. 2014. 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. Trials, 15(1):57, doi:10.1186/1745-6215-15-57.en_ZA
dc.identifier.issn1745-6215 (online)
dc.identifier.otherdoi:10.1186/1745-6215-15-57
dc.identifier.urihttp://hdl.handle.net/10019.1/86850
dc.language.isoen_ZAen_ZA
dc.language.rfc3066enen_ZA
dc.publisherBioMed Centralen_ZA
dc.rights.holderRichard Hayes et al.; licensee BioMed Central Ltd.en_ZA
dc.subjectAIDS (Disease) -- Patients -- Diagnosis -- Africa, Sub-Saharanen_ZA
dc.subjectHIV Prevention Trials Network (HPTN)en_ZA
dc.subjectHighly active antiretroviral therapy -- Africa, Sub-Saharanen_ZA
dc.subjectHIV-infected persons -- Africa, Sub-Saharan -- Clinical trialsen_ZA
dc.subjectHIV infections -- Prevention -- Africa, Sub-Saharanen_ZA
dc.titleHPTN 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 trialen_ZA
dc.typeArticleen_ZA
Files
Original bundle
Now showing 1 - 2 of 2
Thumbnail Image
Name:
1745-6215-15-57.xml
Size:
171.73 KB
Format:
Extensible Markup Language
Description:
Download
Thumbnail Image
Name:
1745-6215-15-57.pdf
Size:
2.53 MB
Format:
Adobe Portable Document Format
Description:
Publisher's Version
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
1.95 KB
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Research Articles (Desmond Tutu TB Centre)