title: Community-Based Accompaniment with Supervised Antiretrovirals for HIV-Positive Adults in Peru: A Cluster-Randomized Trial.
abstract: We conducted a cluster-randomized trial to estimate effects of directly observed combination antiretroviral therapy (DOT-cART) on retention with viral suppression among HIV-positive adults in Peru. We randomly allocated facilities to receive the 12-month intervention plus the standard of care, including adherence support provided through accompaniment. In the intervention arm, health workers supervised doses, twice daily, and accompanied patients to appointments. Among 356 patients, intention-to-treat analyses showed no statistically significant benefit of DOT, relative to no-DOT, at 12 or 24 months (adjusted probability of primary outcome: 0.81 vs. 0.73 and 0.76 vs. 0.68, respectively). A statistically significant benefit of DOT was found in per-protocol and as-treated analyses at 12 months (0.83 for DOT vs. 0.73 for no DOT, p value: 0.02 per-protocol, 0.01 as-treated), but not 24 months. Rates of retention with viral suppression were high in both arms. Among adults receiving robust adherence support, the added effect of time-limited DOT, if any, is small-to-moderate.
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Megan M
authors.initials: MM
authors.lastname: McLaughlin
authors.affiliation: Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, MA, 02115, USA. molly_franke@hms.harvard.edu.
authors.forename: Molly F
authors.initials: MF
authors.lastname: Franke
authors.affiliation: Socios En Salud, Lima, Peru.
authors.forename: Maribel
authors.initials: M
authors.lastname: Muñoz
authors.affiliation: Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, MA, 02115, USA.
authors.forename: Adrianne K
authors.initials: AK
authors.lastname: Nelson
authors.affiliation: Socios En Salud, Lima, Peru.
authors.forename: Olga
authors.initials: O
authors.lastname: Saldaña
authors.affiliation: Socios En Salud, Lima, Peru.
authors.forename: Janeth Santa
authors.initials: JS
authors.lastname: Cruz
authors.affiliation: Socios En Salud, Lima, Peru.
authors.forename: Milagros
authors.initials: M
authors.lastname: Wong
authors.affiliation: Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Zibiao
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Socios En Salud, Lima, Peru.
authors.forename: Leonid
authors.initials: L
authors.lastname: Lecca
authors.affiliation: Peru Ministry of Health, Lima, Peru.|Universidad Nacional Mayor de San Marcos, Lima, Peru.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Ticona
authors.affiliation: Peru Ministry of Health, Lima, Peru.
authors.forename: Jorge
authors.initials: J
authors.lastname: Arevalo
authors.affiliation: Peru Ministry of Health, Lima, Peru.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Sanchez
authors.affiliation: Peru Ministry of Health, Lima, Peru.
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Sebastián
authors.affiliation: Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, MA, 02115, USA.|Socios En Salud, Lima, Peru.|Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Sonya
authors.initials: S
authors.lastname: Shin
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods* / Q000523:psychology; D001071:Appointments and Schedules; D003153:Community Health Services; D019033:Delivery of Health Care, Integrated / Q000458:organization & administration; D023801:Directly Observed Therapy; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000523:psychology / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010568:Peru; D000076522:Retention in Care; D012944:Social Support; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects*
keywords: Antiretroviral; Directly observed treatment; HIV; Treatment support