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
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, The HPTN 071 (PopART) Study Team. 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 2014, 15: 57. PMID: 24524229, PMCID: PMC3929317, DOI: 10.1186/1745-6215-15-57.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAnti-HIV AgentsCircumcision, MaleClinical ProtocolsCost-Benefit AnalysisDrug Administration ScheduleFemaleHealth Care CostsHIV InfectionsHumansIncidenceMaleMass ScreeningPredictive Value of TestsPrevalenceResearch DesignSouth AfricaTime FactorsTreatment OutcomeYoung AdultZambiaConceptsImmediate antiretroviral treatmentAntiretroviral treatmentHIV incidenceHIV testingCombination HIV prevention packageHIV combination prevention interventionsHome-based HIV testingUniversal testingCombination prevention interventionsHIV prevention packageHPTN 071 (PopART) trialUniversal HIV testingHIV-negative menCluster-randomised trialCurrent national guidelinesStandard of careMedical male circumcisionPublic health problemThree-arm designPotential adverse effectsART initiationHPTN 071Testing HIVSecondary outcomesArm BHPTN 071 (PopART): A Cluster-Randomized Trial of the Population Impact of an HIV Combination Prevention Intervention Including Universal Testing and Treatment: Mathematical Model
Cori A, Ayles H, Beyers N, Schaap A, Floyd S, Sabapathy K, Eaton JW, Hauck K, Smith P, Griffith S, Moore A, Donnell D, Vermund SH, Fidler S, Hayes R, Fraser C, . HPTN 071 (PopART): A Cluster-Randomized Trial of the Population Impact of an HIV Combination Prevention Intervention Including Universal Testing and Treatment: Mathematical Model. PLOS ONE 2014, 9: e84511. PMID: 24454728, PMCID: PMC3893126, DOI: 10.1371/journal.pone.0084511.Peer-Reviewed Original ResearchConceptsAntiretroviral therapyArm AHIV incidenceHIV transmissionThree-arm cluster-randomized trialHIV combination prevention interventionsPopulation-level HIV incidenceCombination prevention interventionsCombination prevention packageHPTN 052 trialHPTN 071 (PopART) trialPopulation-level incidenceHIV-positive individualsHeterosexual HIV transmissionUptake of testingNational surveillance dataCluster-randomized trialImpact of treatmentLarge population clustersART retentionHPTN 071Primary endpointArm BPrevention packageControl arm