Abstract Tremendous efforts and resources have been expended by the global community to ensure that antiretroviral therapy (ART) is available and accessible to all that need it. Despite these, less than a half of HIV-infected patients requiring ART in sub-Saharan Africa are receiving it. Some of the most significant barriers to attaining universal access to ART in this region include large distances that patients have to travel to clinic, time spent in accessing care and a significant shortage of human resources. In order to address these challenges the WHO advocates alternative care models especially those that incorporate task-shifting to lower cadre health care workers and lay persons. Unfortunately, few such alternative care models have been identified and very little data exist on their long-term outcomes. We propose to develop and study an alternative care model that is established on the platform of a HIV-infected peer-group (ART Co-op) and facilitated by community health workers (CHWs). This model of care is intended to decentralize ART services and bring them closer to the patients. Specifically, we would like to: 1. Develop an acceptable model for extending HIV care and treatment into the community 2. Develop a sustainable model for extending HIV care and treatment into the community 3. Perform a pilot study comparing the outcomes of patients enrolled in the ART Co-ops program to those receiving standard of care 4. Determine the cost savings and cost effectiveness of ART Co-ops Our group is uniquely qualified to carry out this work given our access to a large HIV- treatment cohort (United States Agency for International Development-Academic Model Providing Access To Healthcare [USAID-AMPATH]) Partnership which has enrolled >140,000 HIV-infected patients (>77,000 initiated on ART), and our significant experience with both task shifting and community-based health care delivery. In conducting this study we hope to develop and test a model of HIV-care that will minimize the number of health care providers needed to deliver HIV care while maximizing patient outcomes including engagement and retention in care as well as durability of regimen. In addition we anticipate that such a model will be scalable to other settings in sub-Saharan Africa as the resources necessary for this model exist in most communities within the region.

Project Narrative One of the biggest challenges to attaining universal access to antiretroviral therapy (ART) in sub-Saharan Africa is the profound shortage of healthcare manpower, considering that the region is home to only 3% of the global healthcare workforce yet hosts >65% of the world's HIV-infected population. We propose to develop, implement and rigorously evaluate a novel model of ART care (that decongests healthcare facilities without compromising quality of care) that shifts part of the care and treatment tasks from the healthcare worker to HIV-infected patients, in the community, through a HIV-infected peer-group ('ART Co-operatives') platform. __SpecificAimsTextDelimiter__ Specific Aims Of the 10,600,000 HIV-infected patients requiring antiretroviral therapy (ART) in sub-Saharan Africa only 3,911,000 were receiving ART by the end of 2009. As this region commands only 3% of the global health care workforce, a significant barrier to meeting the goal of universal access (ART coverage of > 80% of those in need) to ART is the profound shortage of human resources in the region. WHO has advocated task shifting to lower cadre health care workers and lay individuals, including persons living with HIV/AIDS, in order to achieve universal access in resource constrained settings. However to date, there are limited data on the outcomes of patients receiving care within such alternative care delivery models. Our long term goal is the development and successful implementation of an HIV care system that can facilitate the achievement of universal access to and maximize retention in ART programs in sub-Saharan Africa. The objective of this proposal is to develop and assess a community-based ART delivery model established on the platform of a HIV-infected peer-group (ART Co-op) and facilitated by community health workers (CHWs). Our central hypothesis is that clinic outcomes will be similar between this community-based model and the standard of care. We base this hypothesis on our previous studies utilizing task-shifting to provide ART care as well as recent data from Mozambique on the use of community ART-Groups. Our group is uniquely qualified to carry out this work given our access to a large HIV-treatment cohort (United States Agency for International Development-Academic Model Providing Access To Healthcare [USAID-AMPATH] Partnership), and our significant experience with both task shifting and community-based health care delivery. Dr. Siika is the former director of the Primary Health Care Initiative at USAID-AMPATH, a program that has extensive experience in the use of CHWs. In addition, he is the principal investigator on a PEPFAR public health evaluation assessing home-based directly observed ART in severely immune suppressed patients. Dr. Wools-Kaloustian developed and evaluated an innovative care model using HIV- infected individuals to deliver ART within the community. Our aims are: SA1: To develop an acceptable model for extending HIV care and treatment into the community. H 1: Information gathered through focus groups and in-depth interviews will allow refinements in the ART Co- op model that will promote community and patient acceptance. SA2: To develop a sustainable model for extending HIV care and treatment into the community. H2: ART Co-ops can be assembled and managed with the assistance of CHWs. SA3: To perform a pilot study comparing the outcomes of patients enrolled in the ART Co-ops program to those receiving standard of care. H3a: Adherence to HIV-care visits (Co-op group meeting and/or clinic visits) and retention in care will be better in the ART Co-ops group. H3b: Adherence to ART will be equivalent between the groups. H3c: Durability of the ART regimen will be equivalent between the groups. H3d: Patient perceived quality of life will be better in the ART Co-ops group. SA4: To determine the cost savings and cost effectiveness of ART Co-ops. H 4a: ART Co-ops will generate cost savings to patients as well as the HIV care program. H 4b: ART Co-ops will be more cost effective than the standard of care when viewed from the program perspective.