We propose a cluster-randomized trial to assess the impact of community-based DOT-HAART on HIV-positive individuals and community members in Lima, Peru. We will enroll individuals living in extreme poverty who are starting either first-line HAART or salvage therapy due to virologic failure. Those residing in intervention clusters will receive 12 months of DOT-HAART.
We aim to 1) assess the proportion with suppressed HIV viral load at 18 and 24 months after starting HAART among those receiving community-based DOT-HAART versus the control group;2) compare social capital among community members in DOT-HAART versus control communities;and 3) assess the cost-effectiveness of community-based DOT-HAART. Innovative aspects of this proposal include 1) a targeted intervention for the most vulnerable subgroup of individuals starting HAART (i.e. those living in extreme poverty);2) a community- based DOT-HAART intervention designed specifically to achieve long-term efficacy;3) cost- effectiveness analysis;and 4) assessment of the intervention effect on community-level social capital. These study components will inform how best to design and implement DOT-HAART strategies in Peru and other resource-poor settings. By offering a practical, efficacious and cost-effective model of DOT-HAART for resource-poor settings, the findings of this study could improve global efforts to achieve excellent long-term clinical outcomes among individuals on HAART.

Public Health Relevance

Given the limited resources and magnitude of human immunodeficiency virus (HIV) treatment scale-up in resource-poor countries, cost-effective, efficacious adherence interventions for resource-poor settings are urgently needed. Despite accumulating evidence that directly observed therapy of highly active antiretroviral therapy (DOT- HAART) is effective, how best to apply DOT-HAART in resource-poor settings remains unanswered. Development of DOT-HAART interventions with long-term efficacy, refinement of target populations, and evaluation of cost-effectiveness are all scientific research priorities that are urgently needed to inform efforts to implement DOT-HAART in settings with limited resources.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH083550-03
Application #
8071140
Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
Program Officer
Stirratt, Michael J
Project Start
2009-07-17
Project End
2014-02-28
Budget Start
2011-05-01
Budget End
2012-02-29
Support Year
3
Fiscal Year
2011
Total Cost
$647,161
Indirect Cost
Name
Brigham and Women's Hospital
Department
Type
DUNS #
030811269
City
Boston
State
MA
Country
United States
Zip Code
02115
McLaughlin, Megan M; Franke, Molly F; Muñoz, Maribel et al. (2018) Community-Based Accompaniment with Supervised Antiretrovirals for HIV-Positive Adults in Peru: A Cluster-Randomized Trial. AIDS Behav 22:287-296
Gongvatana, Assawin; Harezlak, Jaroslaw; Buchthal, Steven et al. (2013) Progressive cerebral injury in the setting of chronic HIV infection and antiretroviral therapy. J Neurovirol 19:209-18
Harezlak, Jarek; Buchthal, Steven; Taylor, Michael et al. (2011) Persistence of HIV-associated cognitive impairment, inflammation, and neuronal injury in era of highly active antiretroviral treatment. AIDS 25:625-33