@article{fdi:010072498, title = {{U}niversal test and treat and the {HIV} epidemic in rural {S}outh {A}frica : a phase 4, open-label, community cluster randomised trial}, author = {{I}wuji, {C}. {C}. and {O}rne-{G}liemann, {J}. and {L}armarange, {J}oseph and {B}alestre, {E}. and {T}hiebaut, {R}. and {T}anser, {F}. and {O}kesola, {N}. and {M}akowa, {T}. and {D}reyer, {J}. and {H}erbst, {K}. and {M}c{G}rath, {N}. and {B}arnighausen, {T}. and {B}oyer, {S}. and {D}e {O}liveira, {T}. and {R}ekacewicz, {C}. and {B}azin, {B}. and {N}ewell, {M}. {L}. and {P}illay, {D}. and {D}abis, {F}. and {ANRS} 12249 {T}as{P} {S}tudy {G}roup}, editor = {}, language = {{ENG}}, abstract = {{B}ackground {U}niversal antiretroviral therapy ({ART}), as per the 2015 {WHO} recommendations, might reduce population {HIV} incidence. {W}e investigated the effect of universal test and treat on {HIV} acquisition at population level in a high prevalence rural region of {S}outh {A}frica. {M}ethods {W}e did a phase 4, open-label, cluster randomised trial of 22 communities in rural {K}wa{Z}ulu-{N}atal, {S}outh {A}frica. {W}e included individuals residing in the communities who were aged 16 years or older. {T}he clusters were composed of aggregated local areas (neighbourhoods) that had been identified in a previous study in the {H}labisa subdistrict. {T}he study statisticians randomly assigned clusters (1:1) with {M}ap{I}nfo {P}ro (version 11.0) to either the control or intervention communities, stratified on the basis of antenatal {HIV} prevalence. {W}e offered residents repeated rapid {HIV} testing during home-based visits every 6 months for about 4 years in four clusters, 3 years in six clusters, and 2 years in 12 clusters (58 cluster-years) and referred {HIV}-positive participants to trial clinics for {ART} (fixed-dose combination of tenofovir, emtricitabine, and efavirenz) regardless of {CD}4 cell count (intervention) or according to national guidelines (initially <= 350 cells per mu {L} and <500 cells per mu {L} from {J}anuary, 2015; control). {P}articipants and investigators were not masked to treatment allocation. {W}e used dried blood spots once every 6 months provided by participants who were {HIV} negative at baseline to estimate the primary outcome of {HIV} incidence with cluster-adjusted {P}oisson generalised estimated equations in the intention-to-treat population after 58 cluster-years of follow-up. {T}his study is registered with {C}linical{T}rials. gov, number {NCT}01509508, and the {S}outh {A}frican {N}ational {C}linical {T}rials {R}egister, number {DOH}-27-0512-3974. {F}indings {B}etween {M}arch 9, 2012, and {J}une 30, 2016, we contacted 26 518 (93%) of 28 419 eligible individuals. {O}f 17 808 (67%) individuals with a first negative dried blood spot test, 14 223 (80%) had subsequent dried blood spot tests, of whom 503 seroconverted after follow-up of 22 891 person-years. {E}stimated {HIV} incidence was 2.11 per 100 person-years (95% {CI} 1.84-2.39) in the intervention group and 2.27 per 100 person-years (2.00-2.54) in the control group (adjusted hazard ratio 1.01, 95% {CI} 0.87-1.17; p=0.89). {W}e documented one case of suicidal attempt in a woman following {HIV} seroconversion. 128 patients on {ART} had 189 life-threatening or grade 4 clinical events: 69 (4%) of 1652 in the control group and 59 (4%) of 1367 in the intervention group (p=0.83). {I}nterpretation {T}he absence of a lowering of {HIV} incidence in universal test and treat clusters most likely resulted from poor linkage to care. {P}olicy change to {HIV} universal test and treat without innovation to improve health access is unlikely to reduce {HIV} incidence.}, keywords = {{AFRIQUE} {DU} {SUD}}, booktitle = {}, journal = {{L}ancet {HIV}}, volume = {5}, numero = {3}, pages = {{E}116--{E}125}, ISSN = {2352-3018}, year = {2018}, DOI = {10.1016/s2352-3018(17)30205-9}, URL = {https://www.documentation.ird.fr/hor/fdi:010072498}, }