Relates to activity #7108.

Table 3.3.04: Program Planning Overview Program Area: Medical Transmission/Injection Safety Budget Code: HMIN Program Area Code: 04 Total Planned Funding for Program Area: $ 2,000,000.00

Program Area Context:

Key Result 1: Scale up injection safety initiatives from current four provincial hospitals and three provinces to eight provincial hospitals and five provinces Key Result 2: Support use of sharps disposal containers in all intervention provinces to improve health waste management and reduce needle stick injuries Key Result 3: Develop and disseminate injection safety messages to health workers and communities that improve injection practices and reduce inappropriate demand for injections

CURRENT PROGRAM CONTEXT A study conducted in Kenya by the World Health Organization in 2003 revealed that medical transmission of HIV and other blood borne infections occurs through unsafe medical injections resulting from unnecessary therapeutic injections, use of non-sterile injection equipment, needle stick injuries and poor disposal of used needles and other medical waste. Inappropriate injection use arises from both client demand and prescriber preference. Additionally, essential drug kits supplied by the Ministry of Health (MOH) include significant parenteral drugs without adequate supplies of injection equipment. This failure to systematically provide sufficient injection equipment supplies was identified as a key contributor to widespread reuse of syringes and needles. A majority of health care facilities also report stock-outs of disposable injection supplies in the year, a situation that favors re-use of injection devices.

A 2003 survey of health workers by the Expanded Program for Immunization (EPI) in Kenya revealed that over 70% of respondents received an average of 1.5 injections per year. Needle stick injuries within the previous six months were reported by 58% of health care workers. These findings support those of an earlier study by the University of Nairobi among 214 nurses in Nairobi, which reported 61 % needle stick injuries in health care workers over a three-month period. Needle recapping accounted for 46% of the injuries while 12% occurred in the process of sharps disposal.

Basic approaches being employed to achieve national safe injection practices include: development, dissemination and implementation of national policies on injection safety and post exposure prophylaxis; training of health workers on safe injection practices; proper use of auto-disable or protective injection devices; infection control and medical waste disposal procedures; advocacy to decrease demand for injections; improved logistics management to eliminate stock out of injection devices, strengthening of facility-level infection prevention committees for monitoring and supervision; and provision of sharps waste containers for appropriate waste management. Advocacy with the government aims to secure the required budget for adequate injection/infusion supplies and review of both the essential drug list and various treatment guidelines. To achieve sustainability, local training institutions including the Kenya Medical Training College and medical universities will be assisted by JSI-MMIS and JHPIEGO to review teaching curricula to include safe injection practices.

The original Track 1 award to John Snow Inc. led to the creation of a National Injection Safety Committee with membership from senior Ministry of Health personnel and non-governmental organizations. This committee has drafted a policy on injection safety for MOH ratification. To date 1.000 health care workers, 46 trainers, 80 logistics officers and 200 waste handlers have been trained in safe injection practices.

BARRIERS ENCOUNTERED / STRATEGIES FOR RESOLUTION The MOH strongly supports the injection safety initiative but lacks a system to monitor adherence to policies at facility level. This hindrance will be overcome through the reactivation of Infection Control Committees at each facility. Track 1 funding is insufficient to achieve national coverage by 2009 and country-programmed funds have been increased by over 100% to overcome this. In addition the intervention strategy will change from one of supplying 100% of injection devices to one of meeting stock gaps as advocacy for government to procure more supplies and rationalize injection use are also stepped up. Frequent staff transfers create a sustained training gap. This will be addressed by institutionalizing safe

injection practices in the curricula of medical training colleges.

NEW INITIATIVES Rolling out the national policies and training health workers throughout the country will benefit from COP funding and result in improved practices at over 1,000 health facilities in five provinces. Simple segregation of medical waste at these facilities will be a small investment to reduce injuries. While the procurement and use of auto-disable injection devices has improved, the cost of protective injection devices remains high and needle stick injuries due to recapping are common. Linkages to the counseling and testing program to encourage health workers to know their status and to the ART program for delivery of post exposure prophylaxis will be strengthened to reduce HIV transmission in medical settings.

WORK OF HOST GOVERNMENT AND OTHER DONORS MOH syringe procurement in their 2005-06 budget included 50% auto-disable devices. The Kenya EPI program, with support from GAVI, has been the leader in injection safety, with 100% procurement of auto-disable, single use injection equipment, but this funding is declining in the next year; increased investment by Government of Kenya and other donors will be required.

Program Area Target: Number of individuals trained in medical injection safety 12,000

Table 3.3.04:

One of the core pillars of injection safety is the appropriate management and disposal of used needles. Medical sharps must be disposed of in a manner that poses no risk of HIV transmission to health care workers and the community. Waste disposal has been identified as a major drawback to achieving injection safety. Many health care facilities throw used injection devices into open pits at unsecured sites accessible to humans, animals and birds. This activity will fence off waste disposal sites at hospitals and support covering of pits for sharps disposal. Personal protective equipment will be issued to waste handlers to prevent needle stick injuries. A contractor will be identified to carry out this activity which will contribute to the prevention of HIV transmission through medical injections.

Table 3.3.05: Program Planning Overview Program Area: Condoms and Other Prevention Activities Budget Code: HVOP Program Area Code: 05 Total Planned Funding for Program Area: $ 18,083,000.00

Program Area Context:

Key Result 1: 3.29 million individuals reached through community outreach Key Result 2: 16,300 individuals trained to promote HIV/AIDS prevention Key Result 3: 38,400 targeted condom outlets supported

CURRENT PROGRAM CONTEXT Prevention efforts in Kenya are established, integrated, and involve the continuum of interventions which have been shown in this country and elsewhere to reduce transmission. As described in our Five-Year Strategy, awareness of AIDS is almost universal. However, we will continue to address information gaps and stigma by emphasizing programs that involve specific prevention services rather than general awareness-raising. In addition, Kenya's HIV epidemic is maturing, and shifting patterns of risk may necessitate additional prevention approaches in the Condoms and Other Prevention (OP) program area.

Recent analyses of national HIV data (JAIDS, 2006) suggest that most-at-risk populations in Kenya are defined by risk behaviors and by demographics, particularly region of residence. Both men and women in Nyanza Province are twice as likely to have HIV infection compared with those in Nairobi. Women in the highest wealth quintile are 2.6 times more likely to have HIV infection compared with women in the poorest quintile. Widowed and divorced women have very high HIV prevalence. Among women who drink alcohol, HIV prevalence is 19%, compared with 9% among those who have never drunk alcohol, and men who drink frequently are also at higher risk for HIV infection. In Kenya, HIV discordance within married couples is high: 50% of married HIV-infected persons have an HIV-negative spouse (DHS 2003). HIV-negative partners in discordant couples are Kenya's largest high risk population, although the vast majority of these individuals are unaware of their own and their partner's HIV status. Indeed, HIV risk perceptions appear distorted in Kenya: according to the 2003 DHS, men and women who consider themselves to be at low risk for HIV are, in fact, the most likely to be HIV-infected.

Condom use with non-marital, non-cohabitating partners is still low in Kenya: less than 25% of women and 50% of men who had engaged in high-risk sex used a condom, and the same usage rates occurred among young women and men, aged 15-24. Implementing partners distribute either socially marketed condoms from the private sector provided by DFID, or public sector condoms provided by the Government of Kenya (purchased through Global Fund or World Bank grants). However, in future DFID cannot be relied on to fulfill this need. USG does not at present procure condoms in Kenya.

NEW INITIATIVES The most significant new initiatives are prevention with positives (PwP) and expanded substance abuse interventions. PwP will be incorporated into care, treatment, counseling and testing, AB, and OP activities. Given that most HIV-infected people with an HIV-negative spouse do not realize that they are in an HIV discordant marriage, partner testing for all HIV-infected persons will be promoted and integrated into care and treatment programs wherever possible. Counselor and provider training in how to support discordant couples will be strengthened and expanded. Other PwP interventions will support HIV-infected persons who chose to be sexually active to have healthy sexual lives with minimal HIV transmission risk and will include improved STI management for HIV-infected persons and their partners, condom promotion, linkages to family planning and PMTCT programs, and substance abuse counseling. PwP activities will be conducted in partnership with organizations of PLWHAs and PLWHA leadership will be a cornerstone of USG PwP efforts.

Our substance abuse initiatives with adults will continue, and several local CBOs will be assisted to develop prevention activities among substance-abusers in urban Nairobi and Mombasa. A new initiative will be developed with substance-abusing youth in the slums of Nairobi, and one partner will develop the capacity of community-based organizations to work with adults and youth addicted to alcohol and/or drugs. Another will not only promote AIDS prevention activities with substance-abusers but also make referrals for counseling and testing and ARV treatment for those who require it. They will also develop a twinning

activity to set up substance abuse treatment centers in Nairobi. A targeted evaluation will assess the alcohol and substance-use risk behavior of urban slum-dwelling adolescents in Nairobi and Mombasa. The information will serve as a basis on which interventions aimed at alcohol and substance-use risk reduction among slum-dwelling youth can be implemented and youth brought into mainstream society. We will also continue to work with the Ministry of Education to introduce substance abuse prevention information to the life skills education materials used in schools and teacher training colleges.

Support of a behavioral intervention component of a male circumcision project that targets high-risk vulnerable young men and emphasizes faithfulness, correct and consistent condom use, and early treatment of STIs will continue in 2007. OP programming from 2006 focusing on most-at-risk populations including transport workers, commercial sex workers, and out-of-school youth will continue in 2007. Another 2006 intervention that targeted female sex workers in Kisumu will continue and expand in 2007. Interventions will include finding alternatives to CSW for the young women engaged in sex work, promoting testing and treatment for STIs, and empowering them to maintain correct and consistent condom use. We will also build on last year's pilot projects targeting domestic workers, male sex workers, and men who have sex with men.

BARRIERS ENCOUNTERED / STRATEGIES FOR RESOLUTION High-risk associated with occupational status is identified as an ongoing problem in our Five Year Strategy, and we will increase the number of prevention activities at worksites in seven provinces. The twinning relationship between Kenya National Union of Teachers and American Federation of Teachers will continue. We will increase our support through interventions along the transportation corridor connecting Mombasa with Kampala, providing comprehensive prevention programs to the referenced target populations. Other ongoing programs include activities targeting uniformed services, refugees, nomadic populations, worksites, intravenous drug users, substance abusers and the physically and mentally disabled among others. Within the uniformed services and the military, control of STIs and peer education will continue to be a focus.

WORK OF HOST GOVERNMENT AND OTHER DONORS Through the World Bank MAP assistance to the National AIDS Control Council (NACC), small awards were given to local NGOs and CBOs in prevention activities in 2006. To date, over 5,400 grants totaling over $30 million to CBOs have been awarded. The WB is working closely with NACC to develop a nationwide civil society program that addresses the spectrum of AIDS concerns in the community. This new project, "TOWA," (Total War on AIDS) is to be funded in FY 2007 as soon as the results of an audit are addressed. DFID is in the process of designing a new health strategy and will no longer be funding civil society but instead directing their assistance to the Government of Kenya. A gap may therefore be experienced not only in condom procurement, but also in support to NGOs and CBOs. The Global Fund will continue its support to 26 NGOs with over $2.8 million for Phase 2 through NACC. At the implementation level, NASCOP is conducting an intervention to target CSW, IDUs, MC, and condom promotion at the grassroots level throughout the country and USG support for NASCOP will be expanded in '07 under a new cooperative agreement awarded in late 2006.

Program Area Target: Number of targeted condom service outlets 38,363 Number of individuals reached through community outreach that promotes 3,285,500 HIV/AIDS prevention through other behavior change beyond abstinence and/or being faithful Number of individuals trained to promote HIV/AIDS prevention through other 16,305 behavior change beyond abstinence and/or being faithful

Table 3.3.05:

The management and staffing budget for CDC is used to ensure that there is adequate staffing and administrative support for CDC's PEPFAR-related activities detailed in the COP and not already accounted for in the individual program areas. In this activity area, the Ministry of Health receives technical support with development and distribution of policies, guidelines and plans for implementation of HIV prevention and treatment programs. More than one hundred local and international Non Governmental Organizations, Faith Based Organizations and Community Based Organizations implementing HIV prevention and treatment programs have received technical and administrative support. Collectively, the team provides high level technical, managerial and administrative support for our partner activities and helps to ensure high quality PEPFAR programs. The reprogrammed funds will be used to assess data management needs for our partners.

Table 3.3.12: Program Planning Overview Program Area: Laboratory Infrastructure Budget Code: HLAB Program Area Code: 12 Total Planned Funding for Program Area: $ 14,719,300.00

Program Area Context:

Key Result 1: Increased capacity of health systems including improved logistics management and distribution resulting in fewer test kits or reagent stock-outs for HIV testing and care, and increased numbers and quality of human resources at laboratories at all levels. Key Result 2: Improved quality assurance for 500 sites testing for HIV and 60 laboratories measuring CD4 counts to screen and monitor patients on anti-retroviral therapy (ART). Key Result 3: Implementation of the Medical Laboratory Services of Kenya National Policy guidelines and the 2005-2010 Strategic Plan, with national and regional laboratories effectively serving as reference laboratories for the country

CURRENT PROGRAM CONTEXT The Ministry of Health/National Public Health laboratory Services (NPHLS) through the national HIV reference laboratory (NHRL) had established four provincial/regional laboratories to conduct national QA for HIV rapid testing under the National AIDS and STI Control Program (NASCOP) cooperative agreement by September, 2006. The four remaining provincial/regional laboratories will be established during FY 2007. Seven provincial/regional laboratories and 13 other high volume CD4 testing labs are enrolled in the external quality assessment program for CD4 testing. In 2007, all sites conducting HIV rapid testing and/or CD4 cell count testing will be enrolled in relevant proficiency testing programs. With the support of the Association of Public Health Laboratories (APHL), the NPHLS has developed the National Laboratory Policy Guidelines from which the five-year National Laboratory Strategic Plan (2005-2010) to be launched in September 2006 has been developed. These documents will guide the implementation of the NPHLS activities.

The APHL, HHS/CDC and Management Sciences for Health/Rational Pharmaceutical Management+ (MSH/RPM+) will continue to help the NPHLS in the implementation of the plan. Part of the implementation of the strategic plan will involve decentralized supervision of lab activities from national and provincial to district levels. MSH/RPM+ will take on activities formerly implemented by JSI/DELIVER, the logistics management information system (LMIS) for warehousing and distribution of laboratory reagents and equipment, and will help transition the LMIS function to the Kenya Medical Supplies Agency (KEMSA). MSH/RPM+ will also continue to develop and support NPHLS/NASCOP in implementing standard operating procedures (SOPs) for laboratory services. The Kenya Medical Research Institute (KEMRI) will continue to support training and reference laboratory activities.

In Kenya, 60 facilities now provide CD4 measurement for ART patients, and 550,000 HIV monitoring tests will be performed at these laboratories. Nationwide scale up of ART services will ensure that five million HIV tests are performed, 3 million of which are supported under laboratory services. 90 facilities will receive additional laboratory staff, and other partners will do quality assurance and training of personnel, including SOPs and improved laboratory practices (i.e., correct calibration and blood spot validation). There continue to be unmet needs in laboratory services, in particular support to laboratories in rural areas, and the need for increased logistics/transport in the referral network.

NEW INITIATIVES In its fourth year of PEPFAR, the laboratory services program area has prioritized procurement and human resources to expand and maintain laboratory services in Kenya. The bulk of funding will go to the Partnership for Supply Chain Management (PFSCM or SCMS) for procurement of an additional 16 low throughput CD4 machines and seven high throughput CD4 machines for district and provincial hospital laboratories, respectively. In addition, the PFSCM mechanism will be used to procure TB sputum tests, both rapid and long ELISA test kits, and other lab reagents and supplies to support HIV prevention and treatment (HIV serology, CD4 cell count monitoring, routine hematology and chemistries).

With the expanding roll out of ART in Kenya, a system to ensure validation of monitoring, competency of

laboratory personnel, good laboratory practice (GLP), continuing training in clinical chemistry, hematology and CD4 testing will be important. Most of technical evaluation of lab technologies is expected to shift to the NPHLS in FY 2007 but highly complex assays like drug resistance testing, alternative and more cost effective tests for early infant diagnosis (ultra-sensitive p24 antigen assays), and incidence testing assays (BED) for routine surveillance will still be conducted at KEMRI. Expansion of the proficiency testing program for HIV rapid and confirmatory tests and CD4 cell count determination will be another priority, with KEMRI assisting in the development of national CD4 cell count standards, development of proficiency panels, and assistance with supportive supervision and oversight of QA procedures. In response to the dramatic expansion of early infant diagnosis to support pediatric ART, procurement of requisite reagents and supplies through SCMS will be used to increase capacity to conduct infant PCR testing in more sites. Increased access to ART also calls for microbiological lab tests to monitor opportunistic infections (OIs) but capacity for such tests is largely unavailable in Kenya. Approaches to assist with development of a microbiology lab to help with supportive supervision, specimen transport, quality assurance and monitoring and evaluation of OIs will be put in place.

BARRIERS ENCOUNTERED/STRATEGIES FOR RESOLUTION Test kit shortages have been the major barrier in rapid scale-up of testing, with fall out for care and treatment scale-up as well. This program area will strengthen the logistics system for test kits and lab reagents and include procurement to help meet the demands of rapid scale-up. The 2007 COP commits us to support over 50% of the total national need for test kits but GOK support for procurement of test kits and other HIV/AIDS commodities is uncertain, so without plans for meeting 100% of the need we will retain a buffer stock of test kits outside the national system to support critical programs.

Other barriers encountered include weak supportive supervision by NPHLS, LMIS management and laboratory network systems. With support from APHL, ASCP and KEMRI, the NPHLS will train more trainers of trainers to provide field supervision support and also strengthen data management at the national reference laboratory, eight provincial and six pilot district laboratories. Laboratory network systems will improve the quality of services by enabling labs to solve common problems through shared best practices. The present paper-based data management will gradually transition to a software-based system.

WORK OF HOST GOVERNMENT AND OTHER DONORS The Laboratory Interagency Coordinating Committee (ICC) continues to link MOH with technical partners and donors. It has finalized the national laboratory policy guidelines and strategic plan, which donors will assist in implementing in the next year. The National Technical Committee on Laboratory and Blood Safety continues to monitor the performance of HIV test kits, and recommend appropriate test algorithms and technologies for monitoring ART. Global Fund procurement has been slow and inconsistent, and at this time there is no plan for additional procurement in 2007 through Global Fund. As a result, USG will support most of the country's procurement of test kits, with limited support of other donors including the Japan International Cooperation Agency.

Program Area Target: Number of tests performed at USG-supported laboratories during the 3,560,000 reporting period: 1) HIV testing, 2) TB diagnostics, 3) syphilis testing, and 4) HIV disease monitoring Number of laboratories with capacity to perform 1) HIV tests and 2) CD4 tests 60 and/or lymphocyte tests Number of individuals trained in the provision of laboratory-related activities 1,800

Table 3.3.12:

The management and staffing budget for CDC is used to ensure that there is adequate staffing and administrative support for CDC's PEPFAR-related activities detailed in the COP and not already accounted for in the individual program areas. In this activity area, the Ministry of Health receives technical support with development and distribution of policies, guidelines and plans for implementation of HIV prevention and treatment programs. More than one hundred local and international Non Governmental Organizations, Faith Based Organizations and Community Based Organizations implementing HIV prevention and treatment programs have received technical and administrative support. A team of 29 personnel engaged full time at CDC-Kenya carries out this support. The 29 positions include 3 direct-hire United States government staff and 26 locally hired staff. One of the direct hires is in Technical leadership/management position. The other two are in Technical Advisors/Program manager's positions. Of the locally hired staff, five are Financial/Budget staff and 21 are administrative/Support staff. Two of the five finance and budget staff are engaged in day-to-day monitoring and training of the cooperative agreement partners that are funded through PEPFAR. Among the two is the Finance Director who is responsible for budgeting and resource planning including budgeting for CDC's COP entries. Collectively, this team provides high level technical, managerial and administrative support for our partner activities and helps to ensure high quality PEPFAR programs.

Plus up: The United States Centers for Disease Control and Prevention will employ 1 full-time staff who will oversee data collection and submission for reporting as required by the Office of the Global AIDS Coordinator (e.g. semi-annual and annual reports) as well as other key stakeholders (e.g. Kenya Ministry of Health). This data management manager will oversee CDC Emergency Plan programs.

"Cost of Doing Business" Assessment The cost of doing business associated with the CDC management and staffing entry (GHAI funding) cover ICASS and Capital Security Cost Sharing (CSCS) taxes.

Table 5: Planned Data Collection

Is an AIDS indicator Survey(AIS) planned for fiscal year 2007?  Yes
No If yes, Will HIV testing be included?  Yes
No When will preliminary data be available? 12/28/2007

Is an Demographic and Health Survey(DHS) planned for fiscal year 2007?  Yes
No If yes, Will HIV testing be included?
Yes  No When will preliminary data be available? 4/15/2009

Is a Health Facility Survey planned for fiscal year 2007?
Yes  No When will preliminary data be available? Is an Anc Surveillance Study planned for fiscal year 2007?  Yes
No if yes, approximately how many service delivery sites will it cover? 46 When will preliminary data be available? 3/28/2008

Is an analysis or updating of information about the health care workforce or the
Yes  No workforce requirements corresponding to EP goals for your country planned for fiscal year 2007?

Other significant data collection activities

Name: National Health Accounts Survey Brief description of the data collection activity: The primary focus of this household survey will be the assessment of the impact of large inflow of funds (from GFATM, PEPFAR and GOK) on the households seeking HIV care. It will include three distinct sub-analyses focusing on HIV/AIDS, Reproductive Health and Child Health. Preliminary data available: July 18, 2008