Engineering CD4 Testing Capacity in Lusaka, Zambia Final Report SP.783 Engineering Capacity in Community-Based Healthcare October 26, 2005 Team 1: HIV/AIDS Diagnostics and Monitoring Team Members Pragnya Yogesh Alekal (MIT) Nedialka Douptcheva (HSPH) Jeff Hsu (MIT) Victoria Fan (MIT) Alexis White (HSPH)Executive Summary The purpose of this report is to provide an assessment of our research on obstacles to CD4 Count Testing (CD4C) in Lusaka, Zambia and lay out our recommendations for improvement. The Government of Zambia, with funding from Global initiatives like PEPFAR and the Global Fund, hopes to scale up HIV treatment through comprehensive prevention, treatment and care programs that include the provision of Anti Retroviral Therapy (ART) to 100% of the population. The responsibility for this initiative falls largely on the Center for Disease Research in Zambia (CIDRZ). CIDRZ is a Zambian-based non-governmental organization (NGO) charged with the monumental task of coordinating and implementing the Zambian ART scale-up program. They currently operate 18 government health clinics, where HIV testing, counseling, prenatal care, and ARTs are available to all patients free of charge. However, Zambia’s aim of 100% provision of ARTs hinges on its CD4C capability. CD4Cs are the current yardstick to measure when an HIV patient should begin treatment, and efficacy of treatment once begun. The WHO treatment guidelines require that an HIV-positive person receive a CD4 count before treatment is initiated, in the absence of obvious clinical signs of Stage IV AIDS. Therefore, distribution of ARTs heavily depend on CD4Cs. Our research on Lusaka, the capital of Zambia, yielded two key obstacles to CD4C capability: (1) Lack of CD4C Facilities: Lusaka has only four facilities with CD4C capability1. Only one of these, the CIDRZ-Kalingalinga diagnostic lab, provides treatment free of charge. The other facilities include a military hospital not accessible to civilians and two facilities that charge approximately $21 per test (well beyond the means of the average Zambian) and require an appointment outside of the government health system (where free ARVs are distributed). (2) Extensive Turn-around Time: “Turn-around Time” is calculated as the difference between time of collection of blood sample and time when results are 1 Information from Peter Mack and students in the UNZA seminar (???) 2communicated to the patient. At Kalingalinga, CIDRZ currently reports a 1-2 week turn-around time. We would like to focus on decreasing turn-around time for CD4Cs. In this report, we will evaluate the reasons for extensive turn-around time and possible solutions. Most importantly, we propose to send a team of MIT students to study the existing system over Summer 2006. We intend to solicit funding from the MIT Public Service Center. Primary area of focus will be a systems analysis of CD4C process surrounding Kalingalinga. Ultimately, we hope that the on-site assessment and the implementation of the solutions proposed by the MIT team will reduce the turn-around time to at least one-day. 31.0 Problem Statement Although HIV/AIDS is the number one cause of death in Zambia and Africa, the disease can be chronic, rather than fatal, for patients who initiate and receive anti-retroviral therapy (ART). According to WHO treatment guidelines, CD4 enumeration technologies are crucial to initiate and monitor ART for patients who do not exhibit signs of Stage IV AIDS. Of the four CD4 facilities in Lusaka, Zambia, the Center for Infectious Disease Research in Zambia (CIDRZ) runs a diagnostic lab in the Kalingalinga clinic that offers free CD4 testing to 18 government clinics, with an average turn-around time of 1 to 2 weeks. Current delays in delivering diagnostic results to patients delay initiation of ART, thereby increasing patient mortality risk. To reduce this testing delay to under a day, we propose to improve the logistical and technological aspects of the testing process, beginning from sample collection, transport, tracking, and testing to maximize the CD4 testing capacity and turnover in Lusaka while minimizing cost. 42.0 Background on HIV/AIDS and Current Situation in Lusaka, Zambia 2.1 HIV/AIDS in Zambia Zambia is one of the countries in Africa most affected by the HIV/AIDS pandemic. At the end of 2003 about 920,000 adults and children were living with HIV and AIDS. Currently there are an estimated 800,000 AIDS orphans in Zambia2 and 470,000 women of child-bearing age are now HIV positive, leaving the potential increase for future HIV-positive births or yet-unborn orphans to be massive.3 Young women are particularly vulnerable, with 11 per cent of women in the 15-24 age group infected, compared to three per cent of men in the same age group. According to UNAIDS, an estimated sixteen per cent of the adult population in the country is living with HIV. Prevalence is about twice as high in urban areas as in rural areas. 2.2 Government Commitment In 2004, in response to the escalating epidemic, the government of Zambia created a plan to roll out a national HIV/AIDS programs. One of the key elements of the program became access to ARVs and the government took actions to improve the availability of ARVs in the country. Thus in September 2004, in line with WTO/TRIPS regulations, the government declared HIV/AIDS a national emergency in a bid to start manufacturing generic AIDS drugs.4 The declaration, which extends from August 2004 to July 2009, allowed for the government to issue licenses to local firms to begin to manufacture generic AIDS drugs. Consequently, the government awarded a locally based pharmaceutical company, Pharco Limited, a license to manufacture a generic antiretroviral drug combination. 2 3 WHO website http://www.who.int/3by5/en/cp_zmb.pdf, Accessed on September 20, 2005. 4 Reuters, “Zambia Declares AIDS Emergency to Produce ARVs”, 3 September 2004. Accessed at http://www.accessmed-msf.org/prod/publications.asp?scntid=12112004174478&contenttype=PARA& on September 20, 2005. 5 UNAIDS Zambia webiste: http://www.unaids.org/en/Regions_Countries/Countries/zambia.asp. Accessed 7 March 2006.In June 2005, the Zambian government declared its commitment to provide antiretroviral drugs (ARVs) for all people in Zambia who need treatment.5 The program plans to provide free ARVs in public health institutions. 200,000 people require ARVs and the immediate target is to put 100,000 people on