Infant Diagnosis This activity links to NIMR, CLSI, APHL, ASCP, RPSO, BMC, ZACP ART-TRACK 1 PARTNERS, DoD, CT, HBC,TB/HIV, PMI, AMREF, SCMS,FHI

This activity works to assist the MOHSW with the development of a National Infant Diagnosis Program as part of a Comprehensive Paediatric HIV Care and Treatment Initiative. HIV disease progression during infancy is extremely rapid where over a third of children succumb to HIV by 12 months of age and one-half die by 24 months. Early diagnosis of HIV is therefore critical and is now possible in limited resource settings through use of dried blood spot (DBS) sampling and DNA PCR testing. Timely diagnosis of HIV infection in young infants and children enables timely initiation of treatment and fosters better treatment outcomes, reduces morbidity and mortality and promotes optimal growth and development. The appropriate use of HIV rapid tests and ELISA tests and the RNA PCR can also be used to facilitate the identification and subsequent management of HIV exposed and infected infants and children. The primary focus of identifcation of the exposed infant is the initiation of life saving prophylaxis and institution of preventive measures where the infant is not infected.

In Africa, children constitute up to 15% of the population that needs ART but in the majority of countries in the region only 5% or less are currently on treatment. (WHO). Tanzania is beginning to address this challenge. The Tanzanian Ministry of Health and Social Welfare (MOHSW) has committed itself to ensuring that 20% of those on antiretroviral treatment will be infants and children. This target has not yet been achieved, although significant progress has been made. The MOHSW through the Global Fund has already started the procurement process for DNA PCR equipment to be placed at the Referral Laboratories of Muhimbili National Hospital, Mbeya Referral Hospital and Kilimanjaro Christian Medical Centre Laboratory. Columbia University has already placed equipment at the Bugando Medical Centre Laboratory. Zanzibar which has an HIV prevalence rate of 1% and a catchment population of less than two million will utilize the referral laboratory at Muhimbili National Hospital.

The identification of HIV-exposed and infected children relies on the children identified as part of PMCT activities and followed in postnatal child health. Steps to do this are being taken, for example, by identifying HIV exposure on a child's health card. However, much more needs to be done for effective linkages to be established between the testing sites, the laboratories that perform DNA PCR, the PMTCT programs and the Paediatric Care and Treatment Programs. This Infant Diagnosis Program will work to establish these linkages between the partners involved in diagnosis, care and treatment of infants exposed and infected with HIV.

This activity will assist the MOHSW in developing national implementation guidelines in consultation with all stakeholders. The guidelines will cover all the programmatic areas associated with the identification and recruitment of infants and children into Paediatric HIV Care and Treatment Programs. These areas are the PMTCT service area, Counselling and Testing, Laboratory Testing and Quality Assurance, Reproductive and Child Health Services, Care and Treatment service provision, the home-based care activities, monitoring and evaluation activities, data collection for starategic information and reagent and equipment procurement.

The core activities for this funding include the coordination of partner initiatives, development and adoption of national guidelines, development of training curriculum, training of trainers, development of appropriate data capture tools and monitoring and evaluation of the implementation of program. The following tasks will be undertaken to accomplish the objectives: a) Work with the MOHSW, CDC, USAID, DOD, NACP and other partners/stakeholders in infant HIV diagnosis, care and treatment to plan the review of existing policies, strategies and guidelines in view of lessons learnt and gaps b) Support the process for the development of appropriate data capture tools and tools for monitoring and evaluation c) Strengthen the nascent technical working group on infant HIV diagnosis to review policies, strategies and guidelines d) Establish a stakeholders/partners forum for infant HIV diagnosis linked to the care and treatment program for continued experiential exchange, collaboration of efforts and networking e) Organize technical stakeholders like heads of schools of Medical Laboratory Training institutions, MOHSW (Training Directorate and Diagnostic Services), CDC, USAID, DOD,

NIMR, EGPAF, and others to develop/adapt existing HIV/AIDS laboratory-training curricula to include infant HIV diagnosis f)In collaboration with MOHSW, USG and partners develop a plan for the structured deployment of training sessions to provide maximal geographical coverage through the zonal approach g) Conduct and evaluate training programs for laboratory staff in HIV/AIDS infant diagnosis and review training program based on evaluation findings h) Maintain and share with stakeholders a database of institutions and persons skilled in laboratory diagnosis of infant HIV infection i) Train TOTs and support the MOHSW and partners to implement the strategy for improving quality of laboratory services through supportive supervision j) Ensure collaboration with schools of Medical Laboratory Sciences (SMLS ) that offer pre-service certificate and diploma training of laboratory personnel in Tanzania to improve the quality of the training programs for new laboratory technologists and microbiologists k) Support the procurement and maintenance of the necessary laboratory equipment, test kits and supplies, as required, to support the proposed laboratory-training program in HIV infant diagnosis l) Develop and institutionalize a national quality assurance program.

The key stakeholders in this program are identified as the PMTCT , Counselling and testing , Care and Treatment, Laboratory Infrastructure, Strategic Information, Health Management Information Systems programs, the Clinton Foundation, SCMS, RPSO and others. This activity will coordinate stakeholders and provide a forum for policy and guideline formulation where all will work to: improve linkages and systematize referrals between programs that service mothers and children; educate and mobilize communities about pediatric HIV; link community and facility services for referrals, follow up, and adherence support to families; and maximize opportunities to identify exposed and infected infants and children at multiple entry points (MCH/RCH, PMTCT, CTCs, HBC and OVC programs) in order to provide or refer for necessary care and treatment. An active monitoring system will be developed to follow-up HIV exposed children with an HIV positive rapid test or EIA performed before 18 months of age.

Columbia University, International Center for AIDS Care and Treatment Program (ICAP) has begun a pilot program in the Lake Zone. This program will serve as a learning ground for the National Infant Diagnosis Implementation Strategy .

The CDC Atlanta-based Laboratory support team will support the field staff to develop systems including implementation of the Laboratory Quality System for infant diagnosis , HIV/AIDS testing and laboratory monitoring of care and treatment to ensure that all ART sites access high quality laboratory services.

This activity links to activities HLAB MOHSW7758, 7779 NIMR, CDCBase7834, CLSI 7696, APHL7682, AIHA7676, ASCP7681, RPSO7792, BMC 7685, ZACP 8224, DoD 7746; Track 1 ART CU7697/7698, EGPAF7705/7706, HARVARD7719/7722, AIDSRelief7692/7694, DoD7747, Blood Safety; CT NACP7776, TB/HIV7781, PMI, SCMS8233, FHI7712; SI NACP7773, MOHSW7761

The government of Tanzania is committed to improving access to antiretroviral therapy (ART) for its citizens. It has developed a National Care and Treatment Plan (NCTP) 2003-2008 for this expansion, and is now scaling-up to provide care in 200 private, public, referral, district, regional and faith based hospitals throughout the country. The success of the program is dependent on the ability to reliably diagnose and qualify HIV-positive patients for therapy and to monitor treatment efficacy and safety.

The purpose of this funding is to progressively build an indigenous, sustainable capacity of laboratory technicians and non laboratory health care workers to perform rapid HIV testing accurately and reliably, gain knowledge on quality assurance for HIV rapid testing and provide supportive supervision to the testing sites. AMREF will work with MOHSW and partners to develop a national HIV testing training plan, collaborate with HHS/CDC Atlanta, HHS/CDC Tanzania, Muhimbili University Colleges of Health Sciences (MUCHS), NIMR and national/zonal referral hospitals in Tanzania Mainland and Zanzibar and other institutions to adapt existing HIV training package developed by WHO/CDC and tailor them to the local situation. The training package were pre-tested in Tanzania in 2005 in the training of 108 laboratory technicians and non laboratory based healthcare workers from the five zones of Tanzania. AMREF will use lessons learnt to work in collaboration with other partners and develop a national rapid HIV testing roll out strategy. AMREF will assist with logistics during trainings and meetings, collaborate with and support staff from Diagnostic Services and Training directorate of the MOHSW Tanzania Mainland and Zanzibar to conduct supervisory visits to all training venues and follow up visits/supportive supervision to trainees at the facilities to monitor and evaluate the impact of the training. AMREF will procure and maintain necessary laboratory equipment, test kits and supplies as required to support proposed TOT laboratory training program in HIV rapid testing.

The roll out of rapid HIV testing entails having a larger group of people involved in testing in order to meet national care and treatment as well as PEPFAR goals. This will necessitates HIV testing being undertaken by non-laboratory health care workers involved in voluntary counseling and testing (VCT), prevention of mother to child HIV transmission (PMTCT), Tuberculosis and HIV (TB/HIV) co-infection , Home Based Care personnel to perform rapid HIV testing in the United Republic of Tanzania. There is acceptance by the Ministry of Health and Social Welfare for non laboratory health care workers to perform rapid HIV testing upon meeting the prerequisite of training and certification by MOHSW or designated institution on using the National testing algorithm. Therefore it is necessary to train the non laboratory based healthcare workers on how to correctly perform rapid HIV testing, to ensure the quality of testing and certify them. Using the MOHSW decentralization processes AMREF will conduct five zonal Trainer training (TOT) sessions consisting of 20 participants each, who will subsequently conduct the training in their respective zones in a cascading fashion. The total number of trainers per zone will be 20, making a national total of 100. Each zone will train a total of 100 participants from PMTCT, HBC, CTC, CT and TB/HIV program areas. The overall target is 600 people trained including the trainers.

Plus up funds will cover the printing and distribution of the guidelines and job aids, the training of 300 health care workers, using the training of trainers approach, hire training facilities and accommodation, transport staff, and the pay allowances at the government rate for trainees. AMREF will procure filter papers for specimen collection, reagents, consumables and any additional small equipment needed for the training.