INTRODUCTION OF ART IN COMPREHENSIVE HIV/AIDS CARE AND SUPPORT: MONITORING AND EVALUATION John A. Adungosi, MB Chb, MSc, MRIT

ACKNOWLEDGEMENTS Dr. S.K. Sharif, PMO—Coast Province Dr. S.K. Sharif, PMO—Coast Province Dr. H. Shikely, Chief Administrator, Coast General Provincial General Hospital Dr. H. Shikely, Chief Administrator, Coast General Provincial General Hospital Staff of CPGH, Port Reitz District Hospital, Mkomani-Bomu Medical Centre and Magongo Health Centre Staff of CPGH, Port Reitz District Hospital, Mkomani-Bomu Medical Centre and Magongo Health Centre USAID USAID Technical Advisory Partners: Technical Advisory Partners: –Family Health International –MSH/RPM Plus –Population Council/HORIZONS

Purpose of HIV/AIDS care treatment and support programmes: To reduce morbidity and mortality from HIV/AIDS and related complications. To reduce morbidity and mortality from HIV/AIDS and related complications. To improve the quality of life of adults and children living with HIV/AIDS and their families. To improve the quality of life of adults and children living with HIV/AIDS and their families. To assure equitable access to diagnosis, medical care, pharmaceuticals, and supportive care. To assure equitable access to diagnosis, medical care, pharmaceuticals, and supportive care. To promote prevention opportunities within care and support service delivery. To promote prevention opportunities within care and support service delivery.

PEOPLE AND FAMILIES AFFECTED BY HIV/AIDS Human Rights and Legal Support e.g.: PLHA participation Stigma & discrimination reduction Succession planning Socioeconomic Support e.g.: Material support Economic security Food support Medical & Nursing Care e.g.: VCT, Family Planning Preventive therapy OI treatment and HAART Palliative care Psychosocial Support e.g.: Counseling Spiritual support Follow-up counseling Community support Elements of Comprehensive Care and Support

Background Why did the ART program start? 1.Availability of HAART in Kenya: from mid-90s in private hospitals 2.Prohibitive cost of treatment amidst intense public interest 3.Government responses to improve access 4.Increasing availability of ARV drugs due to progressive reduction in prices and initiatives to improve access

Background (2) 5. National consultative meeting on ART –Convened by IMPACT in Sept –Involved local and international stakeholders, donors, researchers, PLHA and community groups –The purpose was to review the ART situation in Kenya and chart the way forward –The result was the setting up of a National ART Task Force

Background (3) National ART task force National ART task force –Composed of local and international stakeholders, community groups, PLHA, professional associations,donors and development agencies –Acts as an advisory board to the NASCOP and Director of Medical Services –Has many sub committees (Drugs, training, Systems development –Provides platform for sharing experiences on ART implementation

 National Adult HIV Prevalence: 10.2%  Project Site: Coastal city of Mombasa  Health Facilities 1.Coast General Provincial Hospital: 700-bed tertiary referral hospital with >70% of beds occupied by HIV/AIDS patients. 2.Port Reitz District Hospital: Government referral hospital. 3.Mkomani Bomu Clinic: Semi-private primary health care clinic. 4.Magongo Health Center: Local government primary health care clinic. Site Information: Kenya

Where is the program implemented? Mombasa: Rationale for Site Selection (1)  High HIV prevalence and disease burden  Sites provide the opportunity to introduce ART at different levels of health care services as well as multiple entry points to ART services within the same catchment area  Sites are linked through a referral network system and to some services that provide elements of comprehensive care and support

Rationale for Site Selection (2): Rationale for Site Selection (2): –USAID supported programs in Mombasa provide elements of comprehensive care and support IMPACT: Prevention activities (BCC, STI management) & care activities (VCT, management of OI, psychological support to PLHA) IMPACT: Prevention activities (BCC, STI management) & care activities (VCT, management of OI, psychological support to PLHA) COPHIA: Home-based care activities COPHIA: Home-based care activities PSI: Condom promotion PSI: Condom promotion Strong political commitment Strong political commitment Where is the program implemented?

How is the program implemented? 1. Establish the Technical Advisory Partners and define the role of each partner: –Partners’ roles FHI/IMPACT: overall implementation and M&E FHI/IMPACT: overall implementation and M&E MSH/RPM Plus: strengthening drug and commodity management MSH/RPM Plus: strengthening drug and commodity management Population Council/Horizons: conducting operational research related to the introduction of ART program Population Council/Horizons: conducting operational research related to the introduction of ART program

How is the program implemented? 2. Develop a concept paper describing the implementation of the program 3. Convene a workshop with local stakeholders to discuss the concept paper The TAP described the ART Program The TAP described the ART Program Local stakeholders provided recommendations on key programmatic issues and the framework for the program Local stakeholders provided recommendations on key programmatic issues and the framework for the program Local stakeholders provided their commitment to support and promote the program Local stakeholders provided their commitment to support and promote the program

How is the program implemented? 4. Establish the ART program management structure Steering Committee:Steering Committee: o Composition: Local stakeholders o Responsibility: Overseeing program implementation Scientific Committee:Scientific Committee: o Composition: Local and international researchers and scientists o Responsibility:Developing realistic minimum package of activities (e.g eligibility criteria, Rx treatment monitoring schedules)

How is the program implemented? 4. Establish the ART program management structure Operational Management team :Operational Management team : o Composition: Program coordinator, ART site team leader, partners’ field officers o Responsibility: Daily management of the program Technical Advisory Partner :Technical Advisory Partner : o Composition: RPM Plus, Horizons, IMPACT, USAID o Responsibility:Providing technical support to the program and the different committees

How is the program implemented ? 5. Conduct assessment of existing capacity for implementing HIV care program including ART 6. Strengthen the capacity based on the findings from the assessment 7. Develop implementation plans 8. Execute, monitor and evaluate the implementation

What have we done so far? 1. All committees have been established –Scientific Committee has defined eligibility criteria and treatment monitoring schedule, Steering Committee approved 2. Assessment of existing capacity was conducted 3. Based on findings from the assessment, an implementation plan was developed with each facility

What have we done so far? (2) The capacity of the CPGH has been strengthened: The capacity of the CPGH has been strengthened: –Training of 37 clinicians, pharmacists and laboratory staff was completed in April, 2003; –Standard Operating Procedures and clinical data collection tools are in place; –Procurement of laboratory equipment is underway (CD4 instrument); –Drug storage and security at pharmacy have been developed; –Nurse adherence counselors were trained in adherence monitoring.

What have we done so far? (3) The CPGH Comprehensive HIV Care Center is operational, providing HIV clinical services, ART, nutritional counseling, TB, STI, and referral to home care, inpatient services, MCH/ANC, PMTCT, and the Pediatric Clinic. The CPGH Comprehensive HIV Care Center is operational, providing HIV clinical services, ART, nutritional counseling, TB, STI, and referral to home care, inpatient services, MCH/ANC, PMTCT, and the Pediatric Clinic. On May 23, 2003, patients started ART in accordance with eligibility criteria. On May 23, 2003, patients started ART in accordance with eligibility criteria.

PATIENT DATA The Comprehensive HIV Care Centre: The Comprehensive HIV Care Centre: –Began clinical care on April 17, 2003 – number of HIV infected patients followed: Female Female Male Male WHO Clinical Staging: –II –III –IV

PATIENT DATA (2) The First Month of ART at CPGH: The First Month of ART at CPGH: –Total: HIV Care- 123; ART 11 –Gender-- =Female/ Male –Range of CD4 counts— –Adherence counseling—all patients participated in a minimum of 3 mandatory adherence counseling sessions prior to starting ARVs –Response to ARVs: Incidence of adverse symptoms— Incidence of adverse symptoms—

MONITORING AND EVALUATION Objectives: Objectives: 1. To improve the capacity of HIV/AIDS clinics, laboratory and pharmacy services in selected public health facilities in Mombasa to support the introduction of comprehensive care including ART 2. To provide ART to 300 patients over a period of five years in accordance with eligibility criteria 3. To sensitize and strengthen communities and PLHA support groups in HIV/AIDS comprehensive care, including ART 4. To explore Operations Research Questions (e.g., What is the effect of DAART upon ARV adherence?)

FORMATIVE ASSESSMENT DATA COLLECTION TOOLS Needs Assessment Tool: Needs Assessment Tool: --National Clinical Guidelines --Physical infrastructure Laboratory services Laboratory services Pharmacy Pharmacy --Human resources and staff capacity --Clinical services and referral mechanism --HIV diagnosis --ARV management --Management Information Systems --Cost Issues

STANDARD OPERATING PROCEDURES Clinical Care and Patient Flow Clinical Care and Patient Flow –Adult and Paediatric Post-exposure prophylaxis Post-exposure prophylaxis Drug and Commodity Management Drug and Commodity Management Laboratory and Other Investigations Laboratory and Other Investigations

DATA COLLECTION TOOLS (2) Patient Clinical Monitoring Forms: Patient Clinical Monitoring Forms: --Comprehensive Care Centre Registration Form --Nursing Assessment for Triage Form --Clinical Management of HIV Patients: First Visit --Follow-Up Review of HIV Patients --Enrollment Form for Adult ARV Treatment --Medical Follow-up of Adult Patients on ART --Referral System Form --Clinic Attendance and Treatment Follow-Up Register

MONITORING AND EVALUATION (3) Indicator Categories: Indicator Categories: Clinical/biological outcomes ARV treatment adherence Occurrence of adverse drug effects Occurrence of OIs, including TB Drug management and inventory control Laboratory monitoring and equipment utilization Referral for community based services, including home care and psychosocial support Training and refresher courses Impact of community outreach on stigma and treatment seeking

MOMBASA PROJECT: M&E PLAN SAMPLE

NEXT STEPS Scale-up project at 3 satellite sites in Mombasa Scale-up project at 3 satellite sites in Mombasa Progressively develop computer-based data entry system at each site Progressively develop computer-based data entry system at each site November 2003: completion of 6 months of ART at CPGH November 2003: completion of 6 months of ART at CPGH –Collect, analyze and report on key findings –Document lessons learned from start-up of ART project –Disseminate data and conclusions to key stakeholders and service providers