Regional PMTCT Services Hospital Level

This is a continuing activity from FY06. JHU TSEHAI has been working with JHPIEGO in providing site level support for hospital-based PMTCT programs at 20 sites in Addis Ababa, SNNPR, Gambella, and Benshangul regions in FY06.

The funding level for FY07 has increased from the FY06 amount, in part because JHU has taken additional PMTCT responsibilities including training of staff in PMTCT service areas, formerly carried out by JHPIEGO, and in part because JHU will expand services from 20 to 30 hospitals, and in part in response to recommendations from the OGAC PMTCT TA visit held in July 2006.

Their major areas of emphasis include the use of the maternal child health (MCH) platform to identify HIV-infected women and families, providing PMTCT interventions, and engaging HIV-infected patients in care and treatment. This expertise will enhance activities in Ethiopia as they expand to include PMTCT training and direct implementation of PMTCT services in COP07.

At the national level, JHU will continue to provide technical input and guidance to the MOH and Regional Health Bureaus (RHB), supporting initiatives to expand PMTCT beyond single-dose NVP where appropriate, enhancing PMTCT-plus training, and supporting links between PMTCT programs, ART programs, and pediatric services.

At the facility level, hospital-based PMTCT programs were initiated by the MOH and have been supported by JHPIEGO, while JHU supported site-level PMTCT activities, in collaboration with the MOH and RHB. In COP07, JHU will add PMTCT training activities to its portfolio, expanding its activities to include training, supervision, and implementation of PMTCT programs by increasing the coverage from 20 sites in FY06 to 30 sites in FY07. In FY07, JHU will increase the quality and uptake of PMTCT services and ensure that women enrolled in PMTCT are rapidly staged and referred for care and treatment services when needed. The PMTCT intervention package will include: - Assessment of new sites, followed by development of site-specific work plans. his includes evaluation of each site's capacity to provide more advanced ART regimens, with the idea that sites should move beyond single-dose Nevirapine PMTCT regimens when sufficient capacity exists. - Immediate assessment of HIV-infected pregnant women for ART eligibility, routine CD4 testing, and provision of appropriate clinical services, including ART when indicated. - Promotion of a family-centered care model in which women are encouraged to bring their children, partners, and other family members to the facility for counseling, education, testing and care and treatment if needed. - Support for appropriate post-natal follow up of mothers and infants that will include close follow-up of infants, nutritional counseling and support, provision of prophylactic cotrimoxazole, and ongoing assessment of eligibility for ART. - Tracking the supplies management required for PMTCT services. - Referral linkages between PMTCT and TB, STI, FP, and ART clinics. - Access to appropriate pre-natal care, including nutritional counseling and multivitamins. - Facilitation of access to IPT and bed nets in coordination with the Global Fund and other partners. - Access to nutritional education, support and "therapeutic feeding" for pregnant and breast-feeding women in the 6-months post-partum period. - Promotion of safer infant feeding, especially exclusive breastfeeding with rapid cessation when replacement feeding is not acceptable, feasible, affordable, sustainable and safe ("AFASS"). - Quality assurance by supporting staff to implement performance standards and the JHPIEGO-supported Standard-based Management Program. - Implementation of peer educator programs and support groups at selected sites, designed to maximize adherence to care and treatment among pregnant HIV-infected women, and to strengthen their links to support groups and community resources. - Provision of PMTCT-Plus training to multi-disciplinary teams at the facility level. JHU Clinical Advisors will provide ongoing clinical mentoring and supervision, in partnership with RHB in the respective regions. - Ongoing development and distribution of provider job aids and patient education materials related to PMTCT-plus.

- Routine monitoring of PMTCT-plus programs, reporting of their progress against targets and enhancement of patient tracking to enable assessment of linkages within facilities (from PMTCT to ART clinics, for example) and to evaluate the uptake of services by family members. - Support for the availability and correct usage of PMTCT registers and forms, timely and complete transmission of monthly reports to regional and central levels, and appropriate use of collected data to support quality care and ongoing performance improvements.

Added July 2007 Reprogramming: Optimizing Infant Feeding practices to reduce risk of MTCT and Seconding a physician at HAPCO to facilitate implementation of the national PMTCT program. In addition to implementing package of PMTCT services, JHU will focus on optimizing breastfeeding practices to undertake Public education through radio and production of IEC/BCC materials to improve the uptake of PMTCT services in Oromia, Harari and Somali regions. In COP07, JHU will implement the following activities: • Assess and improve current breastfeeding counseling practices • Target pregnant women in the antenatal period to counsel on infant feeding • Collaborate with partners on revising and updating current infant feeding guidelines and manuals • Assess and support factors that promote optimal breastfeeding such as maintaining breast health and appropriate breastfeeding (positioning, attachment, etc.), ensuring maternal health and nutrition status, and family support. • Train mother to mother groups to ensure ongoing support for optimal infant feeding • Provide mother to mother groups for ongoing support meetings for exclusive breastfeeding

Model Center for Maternal and Family ART/Care

This is a new activity in COP07. To improve delivery of PMTCT and ART services and to facilitate the care of all family members of HIV infected persons, JHU with the assistance and collaboration of JHPIEGO proposes to develop a model Maternal and Family HIV Center of Excellence within Gandhi Hospital to pilot delivery of ART care through maternal health services. Gandhi, located in Addis Ababa, is a specialized hospital that has been providing high quality maternal care for many years. Despite its long standing reputation, Gandhi hospital has not functioned to its full potential due to severe shortage in material and human resources. Nevertheless, Gandhi has provided excellent ANC and PMTCT care. With the growing HIV problem in Ethiopia, Gandhi has opened a successful model VCT center in the past year and currently serves pregnant women, their male partners and children. In an effort to increase its capacity, Gandhi has built a new VCT center and has hired both a full-time GP to care for HIV patients and a pediatrician who will be called upon to follow "HIV exposed" infants. Currently great efforts are been made to further develop Gandhi hospital as a model center which will provide integrated PMTCT, VCT and direct delivery of ART services to eligible patients.

To expand these activities, Gandhi will take the lead in introducing the new PMTCT guidelines which support opt-out HIV counseling and testing and aggressive referral of family members. In the ANC setting, the opt-out approach will include group education and rapid testing by trained non-health professional counselors. Positive women will be encouraged to have their partners or husbands and children tested. JHU will support an innovative approach at Gandhi: family focused HIV testing and care utilizing PMTCT as the entry point.

The clinicians at Gandhi will also be the first to start HIV+ pregnant women on ART within the same clinic. Evidence from Ethiopia has shown that referring a pregnant woman from PMTCT to an ART clinic in the hopes that she will receive timely ART is not an efficient system. Although pregnant women in Ethiopia who meet clinical staging or CD4 criteria for treatment are eligible for ART, in reality most women who are found to have HIV infection during pregnancy do not receive evaluation or ART until after delivery. One identified barrier is a 6-8 week waiting time from time of referral to initial appointment in ART programs. Other pregnant women are never properly screened for therapy or are referred back to PMTCT programs due to clinician inexperience treating pregnant woman with ART. Referrals may also over-burden ART providers further contributing to burn out and attrition rate of ART practitioners.

JHU proposes to optimize delivery of ART to pregnant women who meet criteria for treatment. In Ethiopia in 2003, HIV prevalence rates in antenatal care clinics (ANC) ranged from 2.2% to 30.2% and an estimated 35,000 infants were born with HIV. Based on data from the Nigat Project, approximately 30% of HIV-infected pregnant women have CD4 counts <200/mm3. Pregnant women with advanced clinical AIDS or with CD4 counts <200/mm3 are known to be of greater risk for transmitting infection to their infants than those with less immune compromise and are at greater risk of serious morbidity or death. Maternal illness and death have been shown to adversely affect neonatal/infant health and survival, even among those infants who are HIV-uninfected. Women with more advanced HIV require ART with ongoing combination antiretroviral therapy for their own health. Use of SD-NVP in the setting of lower CD4 counts has been associated with increased risk of development of NVP resistance, which may potentially impact circulating rates of NNRTI resistance in the community and reduce future maternal treatment options.

As part of the training programs of the center of excellence, JHU will begin and continue to train ANC providers and OB/GYN in the management of ART in pregnant women, clinical staging and CD4 interpretation. JHU will implement the new Ethiopia PMTCT guidelines which include a broader number of ARV prophylaxis options ranging from full ART to AZT and NVP to single dose NVP where facilities do not allow for a more complex regimen. This transition in regimens will require intensive training of personnel and measures to ensure accessibility of HIV medications for pregnant women. The target number of pregnant women reached through this activity will be part of the overall JHU PMTCT targets under activity number 10632.

JHU feels that the continuum of care for positive pregnant women starts at the ANC visit,

followed by HIV counseling testing and appropriate ARVs throughout pregnancy with the goal of reducing HIV transmission to the infant. Postnatal care will include the transition of the HIV exposed infant to pediatric clinic and mother to adult ART clinic.

Furthermore, improvement in maternal health with ART can be expected to result in healthier infants and reduced neonatal/infant mortality. For these reasons, delivery of ART to HIV-infected pregnant women who meet criteria for treatment should be prioritized. In addition, general obstetrical antenatal practices will be strengthened, with a focus on those most relevant to PMTCT (e.g., malaria prophylaxis/ITN in endemic areas; syphilis screening; prevention/treatment of anemia; antenatal discussion of postnatal family planning).

The model center will provide general postpartum and newborn/infant care, including provision of family planning methods, counseling/monitoring of infant feeding options, growth monitoring, and immunizations for children. After 18 months, care for the mother and family will be transferred to the nearest ART clinic. Pediatricians will be trained in infant diagnosis and will provide infant management. The center will co-manage the male fathers and partners of the HIV+ women. Treatment of the family as a unit has been shown to improve the chance of keeping the household together which will, in turn, minimize mother and infant morbidity and mortality.

Care and treatment burden sharing among a greater range of the medical specialties will be one of the great strength of this center and a marker of quality comprehensive care for the entire family unit. This model will also be applied to Black Lion Hospital in parallel to Gandhi in order to introduce this into a teaching hospital. It is expected that this will also positively impact the trained health provider retention crisis and human resource shortage challenges plaguing ART provision services.

Quality of services will be guaranteed with the establishment of reliable consultative linkages to internal medicine and infectious disease services at Tikur Ambassa or Zewditu, for the management of complicated or advanced cases. JHU plans to facilitate the transfer of knowledge through international subject matter expert exchanges, supportive supervision and mentoring, distance learning, scheduled in-services training in the field of HIV+ pregnant mother management. The center will be a training and demonstration center for initiation of ART services in MCH clinics. This new activity for COP 07 will be scale up in coming years by the university partners.

Proposed General Activities: 1. Baseline assessment: number of pregnant HIV-infected women seen in ANC clinics and referred to ART clinics; number of pregnant women seen in ART clinics; 2. Training of ANC providers to do clinical staging and perform and interpret CD4 counts; 3. training of ANC/L&D physicians in ART management/follow-up; 4. Introduce counseling and testing at labor and delivery.

Strengthening STI Service for MARP

In FY06, prevention and control of STI was implemented by PEPFAR Ethiopia in collaboration with the MOH and WHO. Major accomplishments during this period include support to the revision of STI guidelines, development of STI training materials, training of providers and production of job-aids.

During COP07 JHU TSEHAI will support expanded access to STI prevention and treatment services and improved STI service quality at 40 JHU TSEHAI supported ART sites in its working regions (Addis Ababa, SNNPR,Gambella and Benshangul). Prevention of STI among the general population, most vulnerable groups, and people living with HIV/AIDS is a critical activity in preventing new HIV infections and slowing the pace of the epidemic. At the regional level JHU TSEHAI will work with RHB to facilitate and coordinate linkages between STI and HIV/AIDS services, and to strengthen external referral linkages between hospitals, health centers, and CSO, FBO and PLWHA Support Groups and Associations. Regional linkages will be supported so that patients not responsive to syndromic symptom management at health center level are referred for hospital care.

At the facility level JHU TSEHAI will support STI service provision at 31 public and private hospitals in AA, SNNPR, Gambella and Benshagul. Although people will seek STI investigation at the health center nearest them, there are many who seek all aspects of primary care at hospital level, as they live in urban areas. HIV+ persons receiving palliative care and/or ART at hospitals are also at risk for STI and require focused STI services at these facilities. Specific activities will include: (1) In collaboration with respective RHB, conduct need assessments at all supported hospitals, followed by joint action planning with facility staff to improve STI services and appropriate linkages (counseling and testing, care and treatment, ANC, etc.); (2) Provision of on-site technical assistance to improve STI diagnosis and treatment following national syndromic management guidelines; (3) JHU TSEHAI will conduct training for 220 providers (physicians, nurses etc) on STI prevention, diagnosis, and treatment, with a focus on links between STI and HIV infection, as per national guidelines; (4) Training of facility-based peer educators on STI prevention and treatment for PLWHA and their partners, as well as community education regarding the STI symptoms and the need to seek care; (5) Linkage with Global Fund and USG-funded partners to ensure adequate supplies of STI drugs at all facilities; (6) Linkages to HIV counseling and testing (CT) services, promoting a provider-initiated, opt-out approach, for all STI patients, and linkages to care and treatment services for those who are HIV+ (7) STI education focused on risk reduction, screening, and treatment for patients enrolled in HIV/AIDS care and treatment at hospitals, including PMTCT services; (8) Condom provision and education on usage, to patients enrolled in care and treatment, with a special focus on most at-risk patients/populations. STI services will also be integrated into antenatal and PMTCT services to ensure that all pregnant women are STI educated, receive treatment if necessary and are given STI prevention education during pregnancy (according to national STI management and antenatal care guidelines); (9) Linkages to community-based organizations that promote risk reduction and HIV/STI prevention and early/complete treatment in communities surrounding JHU TSEHAI supported ART sites; and (10) Supportive supervision and mentoring of clinical providers on STI services and STI/HIV linkages by I-TECH Clinical Advisors.

Palliative Care and Nutrition Support at Hospitals

In this continuing COP 07 activity, one activity from COP06 is merged with a new activity (# 5618 and # 1058). This activity is programmatically linked to: access to home water treatment and basic hygiene counseling (# 6630), increasing access to palliative care at hospitals (# 1062), promote positive living and self reliance for HIV/AIDS affected beneficiaries of urban nutrition support program (# 1061), HIV/TB at hospital level (# 5772), Regional PMTCT services- hospital level (# 5641), model center for maternal and family ART/care (# 1069), technical support for ART scale-up (# 5664).

In FY06 JHU introduced a basic palliative care approach to the 20 ART facilities it supports. This included initial assessment of the palliative care activities conducted at sites, development of site level training in cooperation with the national leadership, and supervision of palliative care activities. Training and supervision focused on identification of pain and discomfort among HIV patients, ensuring cotrimoxazole prophylaxis, TB screening and targeted elements of the preventive care package such as multivitamin provision, nutrition assessments and prevention for positives. The program was introduced to hospitals in Addis Ababa, SNNPR, Benshangul Gumuz, and Gambella (Operational Zone 3).

In FY07, JHU will support palliative care activities at 40 hospitals providing HIV/AIDS care and treatment, via a multi-disciplinary, family-focused approach to provision of the preventive care package for both adults and children. This approach will incorporate best practices for the health maintenance and prevention of opportunistic infections for PLWHA to slow disease progression and reduce morbidity and mortality.

JHU will assist hospitals in Operational Zone 3 to provide the preventive care package, complementing Global Fund, MOH, and other PEPFAR Ethiopia funded activities when possible. JHU will focus on provision of the preventive care package which for adults includes: active TB screening, cotrimoxazole prophylaxis, symptom management, micronutrient (multivitamin) and nutrition supplements and counseling, insecticide mosquito nets (linkage), positive living strategies, HIV counseling and testing of family members and contacts, and supporting safe water usage through the provision of safe water vessels at all JHU-supported hospitals. The preventive care package for children includes: prevention of serious illnesses like PCP, TB and malaria; prevention and treatment of diarrhea; nutrition and micronutrient supplement; and linkage to national childhood immunization programs. OVC will be prioritized for palliative care and linked to other OVC care programs to receive a continuum of care.

JHU will work closely with other university partners to ensure complementary of activities with, for example, UCSD on the implementation of national pain management guidelines. More details on the delivery of these aspects of the preventive care package are outlined below.

JHU support to facilities will be continued or expanded as follows: (1) strengthen the internal and external linkages required to identify HIV+ individuals and provide them with access to care (internal linkages include referrals to the HIV/AIDS/ART clinic from ANC, TB clinic, under-5 clinics, inpatient wards, OPD, and VCT, and external linkages include referrals to and from community-based resources providing counseling, adherence support, home-based care, and financial/livelihood and nutritional support; (2) provide on-site implementation assistance, including staff support, implementation of referral systems and forms, and support for monthly HIV/AIDS team meetings to enhance these linkages; (3) provide training on palliative care and the preventive care package to multi-disciplinary teams; (4) provide clinical mentoring and supervision to multi-disciplinary teams related to the care of PLWHA -- including those who do not qualify for or choose not to be on treatment -- in partnership with RHB in the respective regions; (5) continue to develop and distribute provider job aids and patient education materials related to palliative care and positive living ; (6) identify and sensitize community-based groups on palliative care and the importance of adherence to both care and treatment for PLWHA and the palliative care services available at facility-level; (7) improve nutrition assessment at health facilities; (8) promote intervention (pharmacologic/opioids and non-pharmacologic) to ease distressing pain or symptoms; (9) continue patient management after hospital discharge if pain or symptoms are chronic; and (10) link

patient with community resources after discharge.

JHU will ensure that all supported sites have reliable stocks of cotrimoxazole tablets and syrups, and will provide emergency supplies when absolutely necessary to ensure quality and continuity of care. Similarly, TB screening and isoniazid prophylaxis will be promoted and provided for HIV+ adults and children. (See also the activity section on TB/HIV activities.) Supportive supervision and the institution of standard operating procedures will improve the use of cotrimoxazole and INH prophylaxis. Attention will be given to the issue of HIV/malaria co-infection, and the routine provision of impregnated bednets, at minimum, to pregnant patients in HIV/AIDS and PMTCT programs in collaboration with Global Fund.

Health education and behavior change communication for HIV+ individuals will be provided by facility and lay staff, complementing Global Fund and other USG-funded activities. Health education, counseling, and support will encourage positive living to forestall disease progression, promote prevention among positives to prevent further HIV transmission, and strengthen adherence to both.

In FY07, JHU will take the lead among PEPFAR Ethiopia's US university partners in nutrition support activities of HIV/AIDS hospital programs. JHU will support or expand nutritional activities to: (1) assist in development of guidelines for nutrition assessment; (2) improve dietary and nutrition assessment at the point of care; (3) improve nutrition counseling; (4) assess and address micronutrient supplement needs and examine and address therapeutic and supplemental feeding needs; (5) integrate therapeutic food-by-prescription with ART and PMTCT programs; (6) support therapeutic "feeding-by-prescription" of patients who qualify in at least 5 hospitals based upon criteria agreed upon by PEPFAR Ethiopia (e.g. all HIV+ pregnant women in PMTCT, HIV+ lactating women in their first six months postpartum, and malnourished PLWHA); (7) evaluate therapeutic and supplementary feeding programs with adaptation of WHO criteria for eligibility and exit criteria for programs; (8) support dietary assessment and supplementation of micronutrients to pregnant and lactating women and children; (9) assess and recommend effective ways to improve dietary intake in patients with weight loss due to appetite loss and inadequate intake; (10) integrate infant feeding counseling and maternal nutrition in PMTCT programs; (11) assess effect of ART in chronically malnourished populations; (12) develop capacity and skill of hospital staff in nutritional assessment; (13) examine the use of lay counselors such as PLWHA to assist with nutritional counseling so that clinic staff is not overburdened; and (14) share information regarding nutritional assessment guidelines and experiences gained through pilot implementation programs with the other university partners.

This activity also relates to activities in Counseling and Testing (#5728), ART (#5664), Palliative Care (#5618), and PMTCT (#5641)

An integrated TB/HIV program is an essential component of the comprehensive HIV care preventive package. This program aims to support the strengthening of linkages between TB and HIV services in the hospitals in the four regions of Addis Ababa, SNNPR, Benshangul Gumuz, and Gambella.

JHU will continue to support and expand activities initiated in COP06, and as such, will support TB/HIV activities in 20 ART facilities in Operation Zone 3 and expand up to 40 ART sites in FY07. Working with Columbia and other US Universities, JHU will continue to introduce and implement a package of key interventions, including: 1) expansion of provider initiated HIV CT for TB patients, 2) referrals of HIV/TB patients for HIV related care including CTX and ART, 3) TB screening in HIV care and treatment settings, and 4) INH preventive therapy (IPT) for HIV+ patients in whom active disease has been safely ruled out. These activities, which were initiated in FY06, will continue to be closely coordinated with the National TB and HIV control programs and RHB in the areas covered by JHU.

JHU will continue to work closely with the RHB in each region to strengthen: 1) TB/HIV working groups at the regional level, 2) strategies to provide supportive supervision for TB/HIV activities, 3) monitoring and evaluation of TB/HIV activities, 4) programs to improve prevention and diagnosis of MDR-TB, 5) the human resource both in quality and quantity.

In FY06, JHU initiated support to strengthen TB diagnostics among HIV+ patients through improvement of smear microscopy services, quality assurance of laboratory networks and support for regional referral. JHU laboratory personnel assisted in the review of new smear microscopy guidelines and will be responsible for dissemination of this information to JHU supported TB/HIV sites. JHU will continue to support improved smear microscopy but will also expand this laboratory support to labs providing culture and sensitivity testing at the regional and federal level. The goal will be to increase ease of referral, information feedback to the patient and efforts to assess situation of MDR-TB. Targeted evaluation regarding TB sensitivities will be implemented among cases that present as re-infection or relapse.

In FY06, JHU identified St. Peter's Specialized TB Hospital as a model center for TB/HIV activities. St. Peter's Hospital, located in Addis Ababa is a federal institution specializing in TB. It has a bed capacity of 200 and serves 1000 inpatients annually, of whom 60-70% of the in-patients are co-infected with HIV. This center will continue to serve to: 1) adapt existing TB/HIV training materials and provide both didactic and on-the- job training at the regional level, 2) evaluate the success of the TB/HIV interventions, 3) develop a multidisciplinary care model in the hospital setting, and 4) adapt and implement TB infection control strategies for the hospital setting.

In FY07, along with continuing to support all activities initiated in FY06, JHU will increase the number of ART and TB/HIV clinics support in accordance with the MOH road map for ART and TB/HIV expansion activities and targets. JHU will increase supportive supervision and mentoring activities from 20 to 40 sites. To accomplish these expanded goals, JHU will invest in the needed personnel nationally and regionally to support TB/HIV activities directly. JHU will continue to support the RHB through regional meetings technical assistance to federal and regional TB/ HIV teams.

Additionally, JHU will initiate family-focused care within the TB/HIV clinics to increase TB screening and treatment for family members of HIV/ TB patients. This effort will specifically target pediatric screening and diagnosis of TB in co-infected persons. JHU will work with Columbia University and the MOH to assess the training needs and curricula related to family- focused TB/HIV activities, including PIHCT guidelines for children. With Columbia as the lead, current didactic materials will be modified to reflect these needs. JHU will implement training so that all site level personnel are aware and able to practice the MOH TB/HIV guidelines.

JHU will support quarterly TB/HIV meetings for planning and implementation purposes.

Duplication of materials, including guidelines will be performed. JHU will assist with the strengthening of inter and intra-facility referral for TB /HIV activities. MOH guided referral forms and data collection will be supported and enhanced at site level. JHU will assist at site level with data collection, filling in of data forms and accurate reporting to the MOH.

Within the ART clinics, JHU will assess needs and support access to the full complement of clinical and/or diagnostic services needed to rule-in or rule-out TB; including X-ray and FNA services. Once capacity has been significantly improved so that all active sites are capable of ruling out active TB, JHU will support site level expansion of IPT to TB exposed HIV patients. JHU will assist the CDC-Ethiopia, Atlanta and WHO to continue an evaluation of IPT at JHU supported ART clinics.

To better support expansion of TB activities at St. Peter's out and in patient departments, renovations will be required to expand laboratory and care services. Laboratory training will be initiated and improved at site level.

Finally, in an effort to better understand the impact of these interventions of the lives of the TB/HIV infected patients, JHU will lead targeted evaluations. Potential targeted evaluations include: (1) An initial assessment of the current clinical screening techniques at all newly supported sites. After which, a standard clinical screening form will be introduced and implemented to improve accuracy of identifying patients with TB infection or exposure among HIV+ patients. (2) To better document treatment outcomes among HIV/ TB patients, a selected group of patients will be identified and charts tracked to distinguish between re-treatment, re-infection, and treatment default versus actual TB therapy failure. This will be accomplished with improved screening, recording and case follow-up from local TB health centers. Laboratory support for this targeted evaluation will be required.

Based on achievements in FY06 and the planned scale up in 2007, JHU have proposed 100% increase in funding for the FY07.

The following indicators will be used to monitor the program: (1) Number of HIV+ clients from VCT/PMTCT/ART clinics screened for TB (2) Number and percentage of TB patients recorded to be HIV+ (3) Number and percentage of registered TB/HIV patients accessing ART for the reporting period (4) Number and percentage HIV/TB accessing CTX for the reporting period.

This is a continuing activity from FY06. In FY06, I-TECH supported HIV counseling and testing services in 31 ART hospitals; this included an initial site assessment, site level training in collaboration with JHPIEGO, minor renovation, improving data collection and reporting, and supervision of counseling and testing services. This activity was introduced to the hospitals in the four regions of Addis Ababa, SNNPR, Benesahngul & Gumuz, and Gambella. The site level support aimed at improving performance to deliver quality HIV Counseling and testing services for the community and patients. The partner is on track according to the original targets and workplan. We have increased funding based on the achievements from partially FY06. This activity is linked to COP ID # 5618 and 5754 (palliative care basic and TB/HIV) and COP ID 5664 (treatment: ARV Service).

JHU will support training of health professionals and lay counselors and implementation of integrated counseling and testing activities as part of ART/VCT/PMTCT/TB/STI and the comprehensive care package at all hospitals (public, private, company owned) in the four regions of Addis Ababa, SNNPR, Gambella and Benishangul Gumuz. JHU will provide technical assistance in ensuring all relevant counseling and testing protocols are followed appropriately and consistently.

To increase uptake of CT services beyond site level, outreach program will be supported to target various populations such as the disabled, those within refugee camps and other sectors such as private, schools, universities, factories, faith and cultural based environments. CT outreach services will focus on ensuring that family members will have the opportunity to be tested, in particular, focus will be provided to reach partners and strengthen couples counseling with focused attention to discordant couples. In addition, pediatric focused CT services will be developed in collaboration with pediatric lead partners. JHU will collaborate with USG partners working with refugees. . After working hours, weekend and holiday Counseling & Testing services will be supported. Awareness campaigns in the community will be conducted and promoted in collaboration with PLWHA and related associations and CBO and at site level including distribution of educational materials and commodities support to include procurement and distribution of condoms and modest site renovation. CT cadres will be expanded and same hour result models through HIV testing at point of service instituted. CT services representatives will be integrated into the multi-disciplinary care teams. The use of lay counselors, provider initiated HIV testing and opt out HIV testing models in ANC and TB clinics will be instituted. Referral and linkages between testing sites and follow up care will be strengthened and expanded to ensure a comprehensive continuum of care.

Support will also cover management of informatics and compliance with MOH reporting requirements including counseling data management and utilization of data at site and regional level. JHU will support the sites on preparation of reports and timely submission of quarterly report to Woreda/Zonal/RHB/MOH. JHU will also support sites to establish administrative and technical coordination mechanisms to build a strong management system at the hospital.

JHU will implement a quality assurance program and ensure the implementation of quality improvement projects and trainings and closely work with community and other sectoral stakeholders to promote CT services. JHU will organize stress and burnout management sessions for counselors and other staff of HCT program. By improving the performance of HCT service in 42 hospitals will increase access HIV counseling & testing service for the community it serves.

All activities will be closely monitored by JHU regional office staff and central office Clinical Advisors. The university will support to strengthen administrative and technical coordination mechanism to improve the management system of the service. The activity will help to reach PEPFAR Ethiopia target for care and treatment.

Technical Support for ART Scale-up

This is a continuing activity from FY05, FY06 and relates to activities in Counseling and Testing (5728), TB/HIV (5754), Palliative Care (5618), PMTCT (5641), STI Services (5800), Laboratory Support (New) as well as activities implemented through the Twinning Initiative (5678).

JHU has played a critical role as the lead for Advanced Clinical Monitoring and Private Hospital Involvement and has supported implementation of ART in Operation Zone 3. Partner is currently well on track in meeting targets for COP06.

In FY07, JHU will continue to support FY06 ART facilities and will expand from 20 to 45 sites in collaboration with the RHB, according to national guidelines. JHU support will be divided among several programmatic activities: direct site level support, mentoring, human resources, infrastructure, training, quality care, expansion of ART to the private sector, pediatric care, laboratory diagnostics, site level management, community level support, and evaluation of outcomes. To create capacity increase, JHU will invest in personnel to support ART technical assistance activities at site level and will augment its support to the regions by sponsoring regional meetings, collaborative activities and by participating in the RHB ART coordinating and implementation teams. JHU will address region specific challenges to scaling up while simultaneously preparing new hospitals for provision of free ART and maintaining quality mentorship at established ART sites.

JHU will provide expertise at all levels of ART provision, ranging from ART sites multidisciplinary team mentoring and supportive supervision visits to leading the effort in creating a cadre of local university mentors at AAU and Debub. These mentors will provide clinical stewardship and develop additional expertise in data processing and management at the ART sites. JHU clinical advisors will continue to be the primary source of current technology transfer at site level; however, additional technical support will come from partners such as the International Twinning Center who will identify qualified professionals to augment new ART sites capacity and strengthen established sites.

Recognizing that the large majority of patients are lost between CT and the ART clinic, JHU will invest significant resources in assuring improved networking and inter and intra-service linkages with CT, TB, ANC, STI and PMTCT services and community based care services. It will be based on the "Referral Network model for Ethiopia" project completed by JHU in FY06. JHU will support the hospital sites and RHB activities in transferring patients from hospital ART clinics to locally networked health centers. Technical assistance for transfer readiness and assistance with identification of patients, development of mentoring SOPs and case review for difficult cases will be provided.

To minimize the loss of trained personnel at sites, JHU will increase its investment of resources by developing a cadre of nurse specialist mentors who will provide on-site follow-up and mentoring for ART nurses, as well as train adherence counselors, lay counselors, and peer educators. JHU plans to train or identify persons affiliated with PLWHA associations in an effort to promote ownership, communication, policy drafting, and overall sustainability of ART programs.

In FY07 JHU will address the large disparity of needs at site level vis-à-vis supply and demand for services within its operational zones. This is due to high urban prevalence rates, limited resources and increased in-migration. JHU will manage these by increasing site-capacity through renovation activities, training and innovative methods to improve human resource retention. JHU will strengthen the referral linkages between hospitals, health centers and CBO to improve service delivery. JHU will support linkage of treatment, care and support services with PLWHA associations. JHU will concentrate its efforts on increasing entry points, increasing awareness, and supporting community outreach programs, such as mobile VCT. JHU will continue to strengthen PIHCT, TB/HIV and malaria/HIV referrals, and will tackle the difficult issue of stigma and gender inequality via education, communication and policy reform. Again, JHU will re-enforce the involvement of PLWHA associations as an integral component of PEPFAR implementation effort in these regions (please see Narrative on Involvement of PLWHA).

In FY07, collaborating with ICAP, JHU will continue to support all sites in implementation

of pediatric care by training pediatricians and through improved integration of pediatric ART into current ART activities. JHU will focus on improved entry points for children by supporting family focused care and family testing, PIHCT and improved infant follow-up after PMTCT. JHU will implement a pediatric mentorship program and will ensure increased access to DBS DNA PCR testing for early HIV diagnosis.

JHU will initiate and expand to all sites, pharmacy related adherence programs which will include the use of pill counts, pill boxes, calendar reminders and patient education materials. JHU will work closely with the MOH, GLOBAL FUND and the RHB to ensure that once OI drugs have been purchased, that they will be distributed to sites as needed and according to stock. JHU will work with sites to develop a fair program for OI drug access for all HIV+ patients especially, CTX for TB patients, pregnant women and HIV exposed children.

The availability of consistent and quality laboratory services at all these sites is critical to ensure the provision of quality comprehensive HIV/AIDS services. In FY07, a comprehensive site level laboratory support to all hospital networks in the operation zone will be implemented. The support will focus on site-level support and specific activities will include (1) initiation and improvement of the site level laboratory quality system with main emphasis on initiation of quality assurance programs in partnership with EHNRI and the respective regional reference laboratories; (2) following up and ensuring uninterrupted quality laboratory services, (3) capacity building of site laboratories, and (4) provision of standard trainings using nationally approved curriculum, in collaboration with partners .

JHU will expand MOH Basic ART Training activities within the hospital setting. Emphasis will be given to training inpatient personnel, new graduates, pediatricians, ANC providers and OB/GYN so that ART services may be expanded accordingly. Language barriers in the emerging regions such as Gambella will be addressed through local language training opportunities. JHU will continue to supplement Basic Training through HIV telemedicine and will work with other partners to expand services to distant regions through the use of satellite connections and possible portable videoconference capabilities.

In association with JPHIEGO, SBMR for ART will be introduced in FY07. These measures will assist with measurement and improvement of quality services at site level. Performance on agreed indicators will be measured at each facility and district and comparative reports produced. To the extent that performance measurement identifies gaps, assistance will be provided to address needs. M&E training for ART and laboratory technicians will be added to the basic training package. JHU will continue to support training on M&E of ART and will work with the MOH to develop and distribute IEC materials.

JHU will support the MOH in expansion of free ART technical support to the private sector facilities located in Addis Ababa. This expansion will increase JHU's site support activities by more than 40%. Human resource and funds to address this scale up will need to be reflected and appropriated.

Clinically Focused Record Systems

ACM achievements thus far include protocol development, finalized steering committee governance structure, and site level readiness activities at the seven participating university hospitals, in issues ranging from staffing, standardized data collection and medical records management, equipping data units with necessary minor equipments and supplies, training of staff on use of national M&E tools, development of an electronic medical record system, currently implemented at two of the seven sites, development of a draft laboratory SOP to meet the specimen repository standards and operational plan for supportive supervision of all consortium member sites. The above has been accomplished through extensive planning and partnership with USG partners to meet inter-region project objectives. In addition, an extensive brainstorming meeting was held with lead Principal Investigators of all ART implementing USG university partners, local university partners, PEPFAR Ethiopia and collaborative institutions to identify future collaborations for targeted evaluation that would support the primary objectives of the project and also increase the university hospital capacity to twin with local and international institutions.

Support will continue to develop and implement standardized protocols and tools to collect data in a sample of HIV+ patients put on ART in the seven universities. Intensive monitoring and evaluation of approximately 3,000 patients on ART will provide critical information on a large scale ART distribution without piloting on a small scale.

This activity will improve case management of treatment services at the university hospitals and will enhance the capacity of these universities to provide technical assistance and training to clinicians, residents, and medical students in support of the overall service provision under the PEPFAR Ethiopia program. Data generated through this multi-site project will inform and improve ART delivery in Ethiopia by providing information on issues as important as ART associated toxicities and early mortality.

The multi-site patient database and specimen repository will facilitate operational research and scientific inquiry pertinent to HIV/AIDS through in-depth monitoring of treatment acceptance and adherence; assessment of indicators of adherence; clinical and virologic efficacy of treatment protocols; assessment of monitoring protocols (CD4); evaluation of drug toxicity, drug-interactions and viral resistance; and investigation of potential barriers to expanding ART access in Ethiopia. The project will provide training to staff required for collection of additional data to answer programmatic issues and perform follow-up of patients.

Also under this activity, JHU will support capacity building of health care and service providers and regional health authorities to record, store and share information to support provision of appropriate services to individual HIV patients and their families, across the continuum of care. These information systems will be flexible, adaptable, and compatible with a variety of health care information systems in use in the country and will support program monitoring and evaluation.

JHU's team of healthcare informatics experts will provide expert technical input in developing a data model for HIV care and will work with the CDC informatics group and the national committee to develop an infrastructure for installation of electronic health records for the purpose of supporting the longitudinal care needed to combat HIV over the long-term. When an electronic patient record system for HIV care (or for overall hospital care) is developed, the JHU team will provide guidance on its implementation nationwide as well as on site technical support and training for the hospitals in its four regions. This activity will include provision of the CDC medical record folders if supported.

PLUS UP FUNDING: Many Ethiopians are infected with HIV and many of these do not know their status. Health facility personnel are at increased risk of exposure and infection while caring for patients with known or unknown HIV status. Victims of sexual assault are also at high risk of being infected. It is scientifically established that a short course of prophylactic treatment with combination ARV drugs markedly reduces risk of transmission to these people if administered soon after exposure. So far, there is no established protocol and arrangement for providing PEP in health facilities. This is one reason for health workers to be reluctant to provide necessary medical care for PLWHA, and subtly contributes to stigma and discrimination by health care workers. Sexual assault is common in Ethiopia; and victims have no access to information and HIV/AIDS preventive services. There is a critical need for appropriate current information on available services as well as access to services. Through the plus up fund, PEPFAR Ethiopia will support development of required PEP guidelines concerning procedures and commodities for testing and prophylactic treatment. Such arrangements must eventually be routinely available in all health facilities so that exposed health workers and victims of sexual assault will have access to immediate prophylactic treatment. This will be provided at ten selected health facilities using the plus up funds and scaled-up in COP08.

PLUS UP FUNDING: PEPFAR Ethiopia supports in and pre-service training to develop human capacity essential for the HIV/AIDS program. Training of trainers, clinical mentors and care providers is done at various venues through ad hoc arrangements. The lack of a national training center with capacity to support standardized, comprehensive and practical HIV/AIDS training is a major gap in Ethiopia. Consequently HIV/AIDS training has largely been didactic and specific-area focused, not linking care, treatment and prevention, nor facility with community-based services. Creation of a national center with the primary goal of providing quality and comprehensive training is a priority of the Ministry of Health. The ALERT hospital-health center-community network has been designated for this purpose. ALERT's established ART and care services are well linked with community services. ALERT has training facilities and is affiliated with Addis Ababa University. It is co-located and linked with an international center well prepared for operations research. Overall it is well suited for HIV/AIDS training and technical support activities. Providing this critically needed support for the national HIV/AIDS care and treatment program scale-up requires expansion of the ALERT training facility. PEPFAR Ethiopia, with other partners like the World Bank and GFATM, will support plans to strengthen ALERT's training capacity and will use the ALERT Hospital HIV/AIDS services network extensively to provide in-service and pre-service training to physicians, counseling nurses, pharmacy personnel, lab technologists, home-based care volunteers and community counselors. Given its network of clinical services, laboratory infrastructure and community between the hospital and its catchment health centers, ALERT can easily be transformed into a national center of excellence to provide TOTS and all central training activities. All in-service training in care and treatment, and possibly others, which have been provided in various (usually costly) venues will be provided at this center much more cost-efficiently; and it will help in standardizing training.

In COP06, PEPFAR Ethiopia supported national laboratory infrastructure support and implementation of quality assurance programs. These responsibilities included supporting major laboratory renovations and training of laboratory personnel. In FY07, JHU- TSEHAI will assume responsibility of regionalized laboratory support; at the levels of the regional laboratory, hospital and health center for operational zone 3 (Addis Ababa, SNNPR, Benshangul Gumuz and Gambella).

In FY07, JHU will initiate regionalization of the national laboratory support. With regard to laboratory diagnostics, JHU will continue to work closely with national, regional and site level laboratory services to ensure the highest quality of care. JHU supported development and dissemination of SOP for all nationally purchased machines (CD4, hematology and chemistry). JHU will work with EHNRI, CDC and other laboratory partners to update and train personnel on the SOP at the national level as well as provide regular refresher regional trainings (HIV serology-rapid testing, CD4, chemistry/ hematology, TB smear microscopy and OI diagnosis). A total of 100 laboratory personnel will be trained.

JHU will support the RHB and national programs in forecasting and implementation of its HIV related tests (including rapid tests, CD4, hematology and chemistry tests as part of the national program to monitor ART). The 4 regional laboratories and 45 ART hospitals will be linked with health centers within the regions. Working with local, regional and PEPFAR Ethiopia partners, JHU will support HIV related laboratory testing to support the health centers in( JHU) operational zone 3. New and innovative networking, communication, reporting and supply transport systems will be devised to achieve this goal.

PEPFAR Ethiopia and EHNRI have instituted national level external quality control systems. JHU will work directly with the regional lab, hospital labs and health center personnel to implement and monitor these QA and QC measures at the sites. Implementation of QA and QC guidelines will be expanded to all additional sites including Cohort 3 sites. JHU will support the national programs of QA for blood safety, VCT, PMTCT, TB prevention, HIV and OI surveillance by disseminating the guidelines to the regional level and assuring uninterrupted links between health center, hospital, regional and national laboratories.

JHU laboratory staff will work closely with EHNRI, CDC, ASCP, APHL and other laboratory partners to ensure the regional implementation of national laboratory training. JHU will work with partners to develop on-site training and CME program for lab technicians. All training will require practical components and on-going follow-up to ensure adequate technology transfer.

In JHU supported ART hospitals, there is a lack of simple diagnostic tests and tools that could improve the lives of many HIV patients. Therefore, JHU will seek to improved OI diagnostics by piloting a program to introduce simple laboratory techniques to diagnose common OI such as cryptococcosis, isospora, microsporidia, and cryptosporidiosis. An effort to introduce modified acid fast staining to hospital laboratories will be made with an overall emphasis of increased performance and supervision of regional capacity building.

JHU will technically assist referral laboratory services; specimen collection at health centers or peripheral hospitals and transport to next hospital laboratory and/or regional laboratory for diagnosis and monitoring ART. Technical support will be provided in specimen collection, transportation, patient sample tracking, reporting of results and implementing standard guidelines/procedures are followed.

On-site visit and technical assistance to site laboratories will also include laboratory management, internal re-organizational lab set up, specimen management, test procedures, documentation, reporting, inventory management, and inventory and stock management of laboratory supplies at each health facility.

JHU will support the national laboratory reporting systems and will conduct regular mentoring on standard record keeping and timely and accurate reporting.

Site Level Data Support

This is a new activity for FY07. This activity relates and linked to other program areas including Counseling and Testing, TB/HIV, Palliative Care, PMTCT in addition to ART services provided in Addis Ababa, SNNPR, Gambella and Benishangul Gumuz regions. This activity will also be strengthening the implementation of the national HMIS.

The MOH has established a chronic disease record-keeping system for the national ART program. Standardized tools include intake and follow up forms, pre-ART and ART registers, monthly cohort analysis and reporting forms among others. The national ART monitoring and evaluation system provides the means to collect data in a standardized manner. However, data at site level is currently under-utilized.

The ART program would be strengthened further by increasing the capacity of treatment-providing hospitals, RHB and regional universities to collect, manage, analyze and utilize ART-related data generated at site level for decision making to improve clinical and program management.

PEPFAR Ethiopia is planning to expand provision of comprehensive HIV/AIDS services to 131 hospital networks in COP FY07. Despite the rapid expansion of HIV/AIDS services all over the country very little attention was given to systematically analyze, document and share the information by stakeholders at all levels (i.e. health care personnel at facility level, health managers at zonal and regional level). Consequently, limited information is available on the quality of services, barriers to utilization of services, and best practices in PMTCT, HCT, TB/HIV, palliative care and ART services.

JHU will provide technical support to 40 hospitals (32 public and 8 private), four RHBand two regional universities, to assess and monitor HIV/AIDS services coverage, quality and supporting processes. In addition, JHU will support development of data collection systems streamlined to capture required data for calculation of standard indicators.

Institutions will be supported to fully and effectively manage and use the data. Sites will be assisted in appropriate ways to tabulate and visualize their data such as through the use of GIS, tables, charts, line and bar graphs and other standard methods. Appropriate options for tabulation include aggregation of data by patient, clinic and regional levels.

Specific activities include training of health care providers at facility level in basic computer skills and data management which includes data entry, data analysis, technical paper writing and presentations, and provision of technical support. The support will include bi-annual regional review meetings which will serve as a forum where facilities will present their data and share experience. The support to the sites will strengthen the national M&E system the MOH/HAPCO and regions are developing with other PEPFAR Ethiopia funds. JHU will also support documentation of best practices and presentations of findings and experiences at local and international scientific and programmatic forums.

Implementation mechanisms for this activity will include providing the necessary modeling at sites and RHB within JHU regions.

Longitudinal Surveillance of HIV/AIDS Treatment under the Emergency Plan (L-STEP)

This is an existing activity from FY06. This activity is linked with the various surveillance support activities (5717, 5585) and HIV care and treatment programs supported through PEPFAR Ethiopia. We have kept the funding flat lined because the exact implementation modalities are being clarified and refined by various stakeholders in this project. No funds from FY06 have been received by the partner as of September 2006.

A strong standardized national patient monitoring system establishes the critical foundation for routine ART program monitoring as well as more advanced evaluation activities. When the national monitoring system is fully functional, group-level cohort outcome information from all sites will be reported to the national program on a quarterly basis. Group cohort information will be critically valuable data source for the national program on aggregate ART program outcomes such as program retention. But, this aggregation information has limitations such as it does not allow further investigation of variations in quality and outcomes by individual level characteristics, (e.g.age, sex, and health status) at start of ART. In the absence of widespread site-level capacity to record, process, automate and analyze individual longitudinal patient data, additional ART program evaluation activities will benefit national ART program planning and implementation.

L-STEP annually abstracts a limited number of data elements from existing medical records from a sample frame of new patients on ART in the last 6-12 months at a representative sample of ART sites. This retrospective cohort methodology will yield several advantages: (1) rapidly establishes a way to evaluate and improve treatment efforts; (2) can be repeated annually to reflect the changing and expanding patient population; (3) draws upon the existing standardized national monitoring system; (4) complements the ACM by drawing information from a representative sample of ART sites (whereas the ACM is 7 selected university-supported ART sites); (5) yields information on additional measures (additional outcomes, quality of care, and behavioral measures) not collected on the national aggregate group cohort form; (6) collects individual-level information, which implies that individual characteristics such as age, sex, health status at start of ART, etc. can be associated with the study outcomes of interest; (7) incorporates site-level review of record quality, by including site-level personnel in the data collection exercise; and (8) builds monitoring and evaluation capacity at participating ART sites by including site-level personnel in the data collection exercise.

The primary objectives of this proposed evaluation project are to describe the quality and outcomes of ART services among a representative sample of individuals on ART for 6 and 12 months, and to analyze the variation among these measures by sub national, facility, and individual-level characteristics. Since most of the quality and outcome measures will be abstracted from the standardized patient monitoring system, there is a finite set of potential variables from which to choose. Sample indicators to prioritize from this list include: (1) point of entry into HIV care and source of referral to ART; (2) time from eligibility to treatment initiation; (3) proportion retained in ART program and reason for loss (stop, transfer, death); (4) adherence to ARV drugs; (5) regimen switch (from first to second line) and timing of switch; (6) change in health status as measured by weight, functional status, CD4 count; (7) incidence and duration of hospitalizations; and (8) prevalence and incidence of active tuberculosis (TB).

The existing patient monitoring system should be reviewed by all interested stakeholders to decide upon the evaluation priorities (i.e. the extractable, useful indicators to be measured in this type of periodic national evaluation).

In addition, the core evaluation activity could be supplemented by a prospective interview component to measure additional outcome measures not extractable from the medical record, such as: (1) sexual and alcohol/drug risk behaviors; (2) receipt of prevention services as part of HIV care and treatment; and (3) development of HIV drug resistance (as special topic in a limited number of sites, in collaboration with the WHO HIV drug resistance working group.

This additional component could either involve selecting a random subsample of the retrospective cohort and interviewing them at several points in time, or selecting a cohort

of newly enrolled patients and interviewing them at several points in time. This interview component would complement the ACM behavioral extension (that is proposed and under consideration) by providing similar behavioral information from a representative sample of treatment sites rather than the selected university treatment sites.

The evaluation seeks to compare outcomes by facility; a short facility survey on all participating sites will facilitate this analysis. The domains of the facility survey might include the availability of HIV-related services, capacity of the laboratory and pharmacy, and specific aspects of ART services (staffing, infrastructure, characteristics of service provision, etc.) at the facility.

Clinical Simulation Technology (TheraSim) to support training on ART

This is a new activity for FY07. This activity is linked to the various HIV treatment services activities supported by PEPFAR. The capacity for rapid scale-up of ART is severely limited by the rapid turnover of trained and experienced HIV clinicians. To reduce the turnover of ART clinicians and to improve the knowledge base of both urban and rural clinicians, JHU will introduce continuing medical education and clinical decision support.

The success of the PEPFAR Ethiopia ART program depends on the skills and stability of the ART team -- doctor, nurse, pharmacist and lab personnel. Clinicians who are trained often quickly find better-payig positions outside of the public sector. After graduating from medical school, general practitioners are expected to spend 2-4 years in public hospitals with many placed in isolated regions. These clinicians report feeling cut-off from learning and desireing increased support in clinical decision-making. Consultations with more experienced clinicians are often impossible due to lack of communication technology.

To improve the clinical skills of rural clinicians, increase their capacity for appropriate decision making, and address there desire for professional growth, JHU will continue to implement a distance learning program making use of the initial ART training implementation platform and infrastructure developed with JHU - TSEHAI in FY06 and commercial products such as "TheraSim", a computer and handheld based program for clinical decision support. For physicians in urban settings, JHU will continue to provide the training centers and ART clinics with access to the training programs via CDs or the worldwide web. PEPFAR Ethiopia believes that improving information transfer regarding HIV will reduce turnover of geographically isolated clinicians as well as overwhelmed urban clinicians and hence will improve the total quality of HIV/AIDS care.

TheraSim, Inc. is a US-based company that provides software and services internationally to measure and improve the quality of clinical practice for HIV/AIDS and a variety of chronic and infectious diseases, including malaria, TB, hepatitis and diabetes. The prevalent system of capacity-building in Ethiopia has several challenges, including the need for rapid scale-up of clinical capacity and expertise in treating patients with HIV/AIDS, high cost and slow response of classroom-based learning; an ongoing need for clinically-based mentoring following didactic training; and the general absence of empirical data after drug distribution. TheraSim monitors and addresses gaps in clinical competency following existing classroom-based training and helps to improve patient outcomes in the ever-changing therapeutic environment.

The TheraSim Clinical Quality Assurance System has four key components: simulation-based assessment and intervention, EMR, Decision Support and Dashboard reports. The System is both internet- and CDROM-based, providing simulation of hypothetical patients in various stages of HIV/AIDS. The simulated cases can be adapted for use by nurses, basic-level physicians (those who see few HIV/AIDS patients) and expert level clinicians. TheraSim uses WHO-approved guidelines, or country-specific guidelines where they exist, and regionally-appropriate pharmacology and treatment modalities with authentic "virtual" case studies for diagnosis and treatment of HIV/AIDS and co-morbidities. It complements other training methods such as formal training, bedside teaching and case discussions. The System uses simulated cases for which healthcare choices on diagnosis and treatment need to be made, then gives feedback on these choices and refers to the country guidelines as well as relevant international guidelines. TheraSim can be adapted for training nurses and allied health professionals as needed.

To achieve the next phase of support, TheraSim will expand its deployment of they System in Ethiopia through its innovative mentoring and clinical decision support system for an additional 700 health care professionals beyond the 500 already being supported under a separate grant to efficiently advance existing capacity building efforts by improving and measuring the quality and outcome of clinical practice, including ART delivery for HIV/AIDS and the treatment of TB, in compliance with published national treatment guidelines.

TheraSim will seamlessly augment efforts that it has implemented with the CDC and with other programs that have already been developed and deployed. For example, I-TECH has

developed training curricula for ART, management of OI, and PMTCT with the support of international partners and has organized numerous trainings. These training programs primarily reached health professionals in the public sector. Various institutions have organized two to five-day basic training workshops on HIV/AIDS management, one-day advanced courses for clinicians, and evening seminars on specific topics, usually attended by clinicians of both the public and private sectors. So far, however, no reliable and accessible system exists to assess the skills of individual health workers or the overall effect of existing training activities, provide ongoing mentoring and support, provide clinical support to reduce medical error, nor to report clinical skills and patient outcomes.

TheraSim and JHU-TSEHAI will deploy TheraSim's field-tested Clinical Performance Management computer-based decision support ("TheraSim CPM") system for rapid and effective ongoing mentoring of healthcare workers throughout Ethiopia and PEPFAR Ethiopia goals. The system will continue to use regionally appropriate pharmacology and treatment modalities with authentic case studies for diagnosis and treatment of HIV/AIDS and TB.