Community-Based Accompaniment with Supervised Antiretrovirals for HIV-Positive Adults in Peru: A Cluster-Randomized Trial

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, inclu...

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Autores principales: Megan McLaughlin, Molly F. Franke, Maribel Muñoz, Adrianne Katrina Nelson, Olga Saldaña, Janeth Santa Cruz, Milagros Wong, Zibiao Zhang, Leonid Lecca, Eduardo Ticona, Jorge Arévalo, Eduardo Sánchez, J.L. Sebastián, Sonya Shin
Formato: Artículo
Lenguaje:inglés
Publicado: 2017
Materias:
Medicine
Cart
Human immunodeficiency virus (HIV)
Randomized controlled trial
Public health
Health psychology
Cluster (spacecraft)
Cluster randomised controlled trial
Internal medicine
Antiretroviral therapy
Intervention (counseling)
Viral load
Physical therapy
Immunology
Psychiatry
Computer science
Nursing
Mechanical engineering
Programming language
Engineering
Retention in Care
Adult
Appointments and Schedules
Community Health Services
Female
Humans
Male
Middle Aged
Peru
Social Support
HIV Infections drug therapy
HIV Infections psychology
HIV Infections virology
Treatment Outcome
Delivery of Health Care, Integrated organization & administration
Viral Load drug effects
Antiretroviral Therapy, Highly Active methods
Antiretroviral Therapy, Highly Active psychology
Directly Observed Therapy
Health Sciences Medicine Infectious Diseases HIV/AIDS Research and Interventions
Health Sciences Medicine Epidemiology HIV, Drug Use, Sexual Risk
Life Sciences Immunology and Microbiology Virology HIV Research and Treatment
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Sumario: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.

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