@article{fdi:010054141,
  title = {{M}onitoring of {HIV} viral loads, {CD}4 cell counts, and clinical assessments versus clinical monitoring alone for antiretroviral therapy in rural district hospitals in {C}ameroon ({S}tratall {ANRS} 12110/{ESTHER}): a randomised non-inferiority trial},
  author = {{L}aurent, {C}hristian and {K}ouanfack, {C}. and {L}aborde-{B}alen, {G}. and {A}ghokeng {F}obang, {A}velin and {M}bougua, {J}. {B}. {T}. and {B}oyer, {S}. and {C}arrieri, {M}. {P}. and {M}ben, {J}. {M}. and {D}ontsop, {M}. and {K}aze, {S}. and {M}olinari, {N}. and {B}ourgeois, {A}. and {M}poudi-{N}gole, {E}. and {S}pire, {B}. and {K}oulla-{S}hiro, {S}. and {D}elaporte, {E}ric},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground {S}caling up of antiretroviral therapy in low-resource countries is done on the basis of decentralised, integrated {HIV} care in rural facilities; however, laboratory monitoring is generally unavailable. {W}e aimed to assess the effectiveness and safety of clinical monitoring alone ({CLIN}) in terms of non-inferiority to laboratory and clinical monitoring ({LAB}). {M}ethods {W}e did a randomised, open-label, non-inferiority trial in nine rural district hospitals in {C}ameroon. {E}ligible participants were adults (>= 18 years) infected with {HIV}-1 group {M} ({WHO} disease stage 3-4) who had not previously received antiretroviral therapy, and were followed-up for 2 years by health-care workers in routine activities. {W}e randomly assigned participants (1:1) to {CLIN} or {LAB} (counts of {HIV} viral load and {CD}4 cell every 6 months) groups with a computer-generated list. {T}he primary outcome was non-inferiority of {CLIN} to {LAB} in terms of increase in {CD}4 cell count with a non-inferiority margin of 25%. {W}e did all analyses in participants who attended at least one follow-up visit. {T}his trial is registered with {C}linical{T}rials.gov, number {NCT}00301561. {F}indings 238 (93%) of 256 participants assigned to {CLIN} and 221 (93%) of 237 assigned to {LAB} were eligible for analysis. {CLIN} was not non-inferior to {LAB}; the mean increase in {CD}4 cell count was 175 cells per mu {L} ({SD} 190, 95% {CI} 151-200) with {CLIN} and 206 (190,181-231) with {LAB} (difference 31 [-63 to 2] and non-inferiority margin -52 [-58 to -45]). {F}urthermore, in the predefined secondary outcome of treatment changes, 13 participants (6%) in the {LAB} group switched to second-line regimens whereas no participants in the {CLIN} group did so (p<0.0001). {B}y contrast, other predefined secondary outcomes were much the same in both groups viral suppression (<40 copies per m{L}; 465 [49%] of 952 measurements in {CLIN} vs 456 [52%] of 884 in {LAB}), {HIV} resistance (23 [10%] of 238 participants vs 22 [10%] of 219 participants), mortality (44 [18%] of 238 vs 32 [14%] of 221), disease progression (85 [36%] of 238 vs 64 [29%] of 221), adherence (672 [63%] of 1067 measurements vs 621 [61%] of 1011), loss to follow-up (21[9%] of 238 vs 17 [8%] of 221), and toxic effects (46 [19%] of 238 vs 56 [25%] of 221). {I}nterpretation {O}ur findings support {WHO}'s recommendation for laboratory monitoring of antiretroviral therapy. {H}owever, the small differences that we noted between the strategies suggest that clinical monitoring alone could be used, at least temporarily, to expand antiretroviral therapy in low-resource settings. {F}unding {F}rench {N}ational {A}gency for {R}esearch on {AIDS} ({ANRS}) and {E}nsemble pour une {S}olidarite {T}herapeutique {H}ospitaliere {E}n {R}eseau ({ESTHER}).},
  keywords = {},
  booktitle = {},
  journal = {{L}ancet {I}nfectious {D}iseases},
  volume = {11},
  numero = {11},
  pages = {825--833},
  ISSN = {1473-3099},
  year = {2011},
  DOI = {10.1016/s1473-3099(11)70168-2},
  URL = {https://www.documentation.ird.fr/hor/fdi:010054141},
}