Randomized controlled trial of trained patient-nominated treatment supporters providing partial directly observed antiretroviral therapy

Abstract

Background-Directly observed therapy (DOT) for antiretroviral therapy (ART) may improve adherence, but there are limited data on its clinical effectiveness.

Directly observed antiretroviral therapy: a systematic review and meta-analysis of randomised clinical trials

“…13,26,[29][30][31][32] When we examined study reporting of methodological features in full-text studies and where authors provided information (n=7), we found moderate reporting of important methodological issues. Six studies reported sequence generation, 13,[22][23][24][25]28 three reported allocation concealment, 13,24,25 none reported masking of study analysts, and four reported results as a full intention-totreat analysis. 13,22,27,28 Five studies reported less than 20% of participants lost to follow-up.…”

“…Six studies reported sequence generation, 13,[22][23][24][25]28 three reported allocation concealment, 13,24,25 none reported masking of study analysts, and four reported results as a full intention-totreat analysis. 13,22,27,28 Five studies reported less than 20% of participants lost to follow-up. 13,23,24,27,28 The method of implementation of directly observed therapy varied across studies.…”

“…13,22,27,28 Five studies reported less than 20% of participants lost to follow-up. 13,23,24,27,28 The method of implementation of directly observed therapy varied across studies. Two studies used full directly observed therapy (observation of every single dose), 23,31 and the remainder had a partial regimen whereby only a proportion of doses was observed.…”

“…A further seven studies were included from article bibliographies and conference abstracts, and 78 were excluded because they did not meet our inclusion criteria (one because the author did not respond so we failed to secure suffi cient data 21 ). Overall, 12 studies were included for analysis (table 1): six from the USA, 22,23,27,[30][31][32] fi ve from Africa (Mozambique, 24 Kenya, 25 Nigeria, 26 and South Africa 13,29 ), and one multicentre study from the USA and South Africa. 28 All full-text papers and abstracts were published in English.…”

Social Determinants of HIV Health Care: A Tale of Two Cities

“…Pill counts (Achieng et al 2011) and pharmacy refill monitoring have been shown to be reliable and inexpensive but not consistent across all settings. Directly observed ART has also been examined with mixed results but overall is costly and labor intensive (Nachega et al 2010;Hart et al 2010), as is therapeutic drug monitoring via plasma or hair sampling (van Zyl et al 2011). …”