The Center for Clinical Care and Clinical Research (CCCRN), with its partner organizations will build upon existing and new strategic partnerships with the public and private sector to support Nigerian health institutions in developing, implementing, monitoring, evaluating and managing HIV/AIDS prevention, care and treatment programs. CCCRN proposes to manage a program that provides HIV/AIDS prevention, care, treatment and laboratory services to HIV infected patients in Imo, Ebonyi and Enugu States called the Service Expansion and Early Detection for Sustainable HIV Care Project (SEEDS). SEEDs will apply innovative, sustainable and cost effective strategies that include decentralization, saturation and continuous quality improvement to ensure maintenance of services in existing facilities and rapid expansion to new ones in assigned states. Leveraging on its prior PEPFAR experience with the AIDSRelief and CHARIS projects, CCCRN will work in Government, Faith Based and Private institutions at primary, secondary and tertiary levels to expand reach of quality HIV care and treatment services.

The ultimate goal of SEEDS is to reduce mortality and morbidity from HIV in assigned states of Nigeria. By the end of the project period,

SO1: The incidence of HIV infections in the target population is reduced.

SO2: Target population persons living with HIV (PLHIV) and their families receive quality HIV care and treatment services.

SO3: Service Delivery Facilities (SDFs) have strengthened organizational and technical capacity to provide and support the provision of high quality HIV and AIDS care and treatment services.

SO4: Service Delivery Partners collaborate with government authorities to sustain HIV and AIDS care and treatment programs.

Comprehensive package of basic care and support services will be provided to 35,298 PLWHA . The package of services provided to each PLWHA includes a minimum of one clinical service and two supportive services delivered at the facility, community, and household (home based care) levels in accordance with the PEPFAR and Government of Nigeria (GON) national palliative care policies and guidelines. The basic care package for PLWHAs include Basic Care Kit (ORS, ITN, water guard, cotton wool, gloves, soap, Vaseline, GV, Methylated spirit); Home-Based Care (client and caregiver training and education in self-care and other HBC services); Clinical Care (basic nursing care, pain management, OI and STIs prophylaxis and treatment, nutritional assessment, nutritional counseling and education, and supplemental or therapeutic feeding support), Laboratory Services (which will include baseline tests - CD4 counts, hematology, chemistry, malarial parasite, OI and STI diagnostics when indicated); Psychological Care (support groups facilitation, adherence counseling, bereavement counseling), Mental Health (anxiety and depression assessment and counseling with referral to appropriate services); Spiritual Care (access to spiritual care); Social Care (linkages and referrals, and transportation support) and Prevention Care (Prevention with Positives)

CCCRN will provide comprehensive OVC services through community based organizations in its focus states. The project will sustain the use of the Child Status Index to assess vulnerability and provide services to OVC. All 4706 children will receive a minimum package of 3 core services from SEEDS which includes health, nutrition and psychosocial support services.

CCCRN will strengthen existing structures to provide access to health services including HIV Counseling and Testing (HCT) prevention and treatment of common infections. All OVC households will receive a preventive care package containing ITN, water guard, water vessel, soap, ORS sachets, and IEC materials on self care and prevention of common infections according to Government of Nigeria (GoN) guidelines. In addition, CCCRN will continue to collaborate with NPI and local government health authorities to ensure free and appropriate immunization to all OVC less than 5 years. Adequate health care will include strengthening linkages and referrals to other facility services (maternal/child health, inpatient and outpatient departments).

Nutritional assessment and demonstration activities will continually be provided for all OVC while rehabilitation of malnourished children will be implemented as a wrap around service leveraged from GoN and other organizations including Clinton Foundation and Markets for the provision of plumpy nut and food supplements respectively.

Psychosocial support will continually be enhanced for OVC with structured home visits, support group activities and provision of age specific educational/recreational kits. CCCRN will support expansion of kid support groups to all SDFs and expand their activities to include periodic social/recreational and educational activities to address issues of stigma and discrimination.

CCCRN will implement WHO 3Is strategy of decreasing the burden of TB among HIV positive patients and strategies for decreasing the burden of HIV among TB patients. CCCRN will ensure routine clinical and symptom driven laboratory screening of all HIV positive clients in Local Partners Treatment Facilities (LPTFs) for TB while TB patients will continue to have access to HIV counseling and testing (HCT). Co infected clients will be offered appropriate care within and outside the LPTF.

35,298 HIV positive patients in care at all supported sites will be screened for TB with clinical symptoms driven laboratory tests. From these , 705 patients are expected to be diagnosed with active disease and will be treated for TB. The TB/HIV program will be in collaboration with State and National Tuberculosis and Leprosy control programs (STBLCP and NTBLCP). Laboratory infrastructure will be upgraded and human capacity developed to ensure adequate TB diagnosis for HIV positive patients. Improved TB diagnostics, GeneExpert will be provided for Imo State to complement the 2 existing machines in Enugu and Ebonyi.

All TB/HIV patients will receive cotrimoxazole prophylaxis therapy (CPT). AR Community Based Treatment Support Service (CBTS) Specialists will work with Community health care providers to ensure contact and defaulter tracking of co infected cases on treatment and also trace family members of PLWHA accessing TB/HIV services to facilitate their TB screening and appropriate care.

CCCRN will continue to implement TB infection control in accordance with the national guidelines on TB infection control by ensuring proper patient triage, specimen collection & processing, waste disposal, proper ventilation and administrative control activities such as active identification of those with TB symptoms and patient segregation.

CCCRN will provide HIV care and support services to 5805 children in all its comprehensive facilities. To increase pediatric enrollment into care and support, CCCRN will strengthen linkages among all service components in its supported SDFs as well as expand community outreach. This activity will require sustaining staff training/retraining and strengthening referral linkages. CCCRN will consolidate on its multi-pronged approach to increase the number of children enrolled into care and support: organization of services to provide family centered care and treatment, PITC (provider initiated testing and counseling) and community mobilization.

The package of care services provided to each HIV positive or exposed child includes a minimum of clinical service with basic care kit and two supportive services in the domain of psychological, spiritual, and PwP delivered at the facility, community, and household (home based care) levels in accordance with the PEPFAR and Government of Nigeria (GON) national care and support policies and guidelines. The basic care package for HIV positive child/care givers in partner sites include Basic Care Kit (ORS, LLITN, water guard, water vessel, soap, IEC materials, and gloves); Home-Based Care (client and caregiver training and education in self-care and other HBC services); Clinical Care (basic nursing care, pain management, OI and STIs prophylaxis and treatment, nutritional assessment- weight, height, BMI, micronutrient counseling and supplementation and referrals, Laboratory Services (which will include baseline tests - CD4 counts, hematology, chemistry, malarial parasite, OI and STI diagnostics when indicated); Psychological Care (adherence counseling, bereavement counseling, depression assessment and counseling with referral to appropriate services); Spiritual Care (access to spiritual care); Social Care (support groups facilitation, referrals, and transportation) and Prevention Care (Prevention with Positives). All HIV positive or exposed childrens nutritional status will be assessed at contact and on follow-up visits, micronutrients will be provided as necessary, and those diagnosed as severely malnourished will be placed on a therapeutic feeding program. This will be done through wraparound services as well as direct funding.

CCCRN will continue to build and strengthen the community components by using nurses and counselors to link health institutions to communities. New and refresher training will be provided for LPTF staff in adherence monitoring. Each LPTF will appoint a specific staff member to coordinate the linkages of patients to all services. This will also build the capacity of LPTFs for better patient tracking, referral coordination, and linkages to appropriate services.

CCCRN will provide automated CD4 testing equipment, hematology analyzers and chemistry machines to 20 new comprehensive SDFs. All these labs will be supported to test for syphilis, PCP, TB, HBV, hematology, chemistry, cryptococcosis and CD4. CCCRN will provide on-site capacity for HIV testing, laboratory monitoring of disease progression and response to treatment, opportunistic infections (OIs) diagnosis and monitoring of antiretroviral drug (ARVs) toxicity. CCCRN will continue to support the improved diagnosis of TB, PCP, cryptococcal infection, syphilis, hepatitis B (HBV), protozoal and bacterial infections. CCCRN will provide clinical viral load (VL) testing for difficult therapy switch decisions and program evaluation. CCCRN laboratory services will support expansion of early infant diagnosis (EID) at PMTCT supported facilities in accordance with the national EID scale up plan by providing standardized training and commodity supplies for collection and transport of dried blood spots (DBS) and clinical samples. To support pediatric diagnostic and treatment, GoN will provide DBS collection material, transportation of specimens/results.

CCCRN will expand diagnostic test menu at treatment site laboratories to include improved TB diagnostics using Gene Expert in Imo State while supporting the 2 machines existing in Enugu (Annunciation Hospital) and Ebonyi (Mile 4 Hospital). SEEDS will continue to support xx satellite facilities with laboratory capacity for HIV rapid testing hematology, CD4 directly or through sample logging.

A lab specialist will be dedicated with the overall responsibility for equipment installation and maintenance in conjunction with approved vendors.

CCCRN will undertake a full-scale implementation of clinical laboratory Quality Assurance (QA) protocols based on local and international practice guidelines; these protocols will include supporting all CCCRN supported labs to meet USG specifications, setting up regional laboratories for training and as quality assurance centre, inter-laboratory testing, laboratory infrastructures ,trainings on proper waste management protocols, subscription to external laboratory system audits, electronic networking of the laboratory documentation system i.e. solving documentation error, quarterly vertical audits of site quality preparation of LPTF laboratories for local & international accreditations subscription to a locally organized EQA scheme for testing not covered by the USG funded testing i.e. hematology and chemistry.

CCCRN SI activity incorporates program level reporting and implementation of both paper-based and computerized Health Management Information Systems (HMIS) for SDFs. CCCRN will continue to strengthen SDF Patient Management Monitoring (PMM) systems using GoN tools and registers. CCCRN will support Electronic Medical Record(EMR) systems for all secondary health facilities. This will include providing training, equipment and other logistical support systems.

CCCRN will strengthen its program for Continuous Quality Improvement (CQI) in order to improve and institutionalize data quality and quality interventions. CCCRN SI team will continue to provide TA to SDFs and personnel to adapt and harmonize existing tools to meet the standards of the GON thus continuing to ensure that monitoring and evaluation of the program is consistent with the national plan for patient monitoring. The The SI team will wor relevant State and Local Government agencies to conduct joint site visits during which evaluations of the utilization of National tools and guidelines, proper medical record keeping, efficiency of clinic services and referral coordination shall be conducted. Data flow including data collection, management and reporting would also be assessed and recommendations for improvement given. Supportive supervision and mentoring is being provided to all on-site staff that collect and utilize data (e.g., clinicians, pharmacists, data entry personnel, administrators). Quarterly M&E form will be conducted in all states of operation to improve national data quality for evidence based interventions.

SEEDS will ensure linkage with the National Blood Transfusion Service (NBTS) and Safe Blood for Africa Foundation (SBFA) in all aspects of its blood safety program. The project will support the NBTS in implementing its primary objective of migrating fragmented hospital-based blood services to centralized NBTS-based blood services nationwide. In addition, SEEDS will train nurses, medical laboratory scientists and community volunteers in its facilities to conduct community education for blood donation, recruit repeat voluntary blood donors from the ranks of current family replacement donors. In this plan SEEDS will be instrumental in working with hospital management and staff at all LPTFs to develop buy-in for the NBTS blood services program, to create support of blood donor organizers, and to strengthen health facility and community focused blood drive activities. SEEDS will support the distribution of IEC/BCC materials obtained from NBTS and SBFA to promote the need for voluntary non-remunerated blood donation. In addition, CCCRN will work closely with SDF management to establish blood transfusion committees to oversee blood use based on national algorithms and standards in the health facilities.

CCCRN will support capacity building at SDFs for universal precautions and appropriate disposal of infectious materials. Linkages will be built with other mechanisms for the distribution of commondities including sharp containers, needle destroyers and incinerators.

Sexual Prevention services will be offered through 13 existing facilities, 20 new comprehensive ART facilities & satellites in Enugu, Ebonyi & Imo states. All programs will promote abstinence until marriage, and mutual fidelity within marriage. It will also include procure education on and distribution of condoms. CCCRN will implement its AB programming activities in line with the overall PEPFAR Nigeria goal of providing prevention services to individuals reached through a balanced portfolio of prevention activities. Through this activity, PEPFAR Nigeria will extend its reach with AB services in more states and communities

The program will support SDF activities targeting HIV + clients, their families and communities who access care at these points of service. Prevention priorities will include behavior change for risk reduction and risk avoidance, counseling and testing. All supported SDFs will provide education and training to patients and community health volunteers on secondary prevention. These will include encouraging status disclosure, counseling for sero-discordant couple, risk reduction, adherence to ART and training for health workers and peer outreach workers. Programs will include reducing societal stigma through appropriate health education at facility and community levels and reducing gender based violence. There will be structured peer education that includes systematic training curricula, refresher training, and training on essential life skills. In addition, age appropriate abstinence only messaging and secondary abstinence messaging will be conveyed to adolescents, especially orphans and vulnerable children receiving both facility and home based support. This service will continue to be extended to schools and NYSC camps. CCCRN through this program will cover communities with AB messages conveyed through multiple media and fora. Utilizing such a methodology, a large number of people will be reached with messages via one method or another, but the counted group will be those individuals that would have received AB messaging: (1) on a regular basis and (2) via the three strategies CCCRN will employ (community awareness campaigns, peer education models and peer education plus activities). CCCRN will reach 62751 people as direct people reached through community awareness campaigns, peer education models and peer education plus activities; indirect beneficiaries as those who receive messages via other multiple media.

Prevention activities will include distribution of patient education materials, community sensitization, increased couple testing, promotion of SDF couple support groups, and advocacy for risk reduction strategies for discordant relationships. High risk reduction measures will include treatment of sexually transmitted infections (STIs) and to a lesser extent on drug abuse. Couples will be treated at SDFs or other referral centers that offer specialized treatment for STIs where necessary.

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CCCRN will increase support for counseling and testing (HCT) services to a total of 80 sites. An emphasis will be placed on satellite decentralization clinics and family members of in care clients. A target of 235,318 persons will benefit from HCT and receive their result. CCCRN will build the capacity at existing and new SDFs to enable them integrate HCT services within care and treatment systems and obtain resources from the GoN and other agencies to increase uptake of HCT services in all points of service in the facilities.

SEEDS will also scale-up couples counseling and testing in all supported sites through organized training, family centered testing and on site mentorship. SEEEDS will promote HCT as a necessary and important arm of HIV prevention in terms of averting new infections and providing treatment for those in need, and post-test counseling will be strengthened to lay emphasis on prevention for positives. Posttest counseling will include full and accurate information on all prevention strategies.

Sites will be actively linked to the Government of Nigeria and other donor agencies to access extra kits and supplies needed, and supported to maintain their regular usage and feedback through the above mentioned strategies. Sites will be trained on forecasting and stock control using bin cards and will maintain a three month buffer stock. SDF will report on inventory and forecasting to the CCCRN and SCMS.

In addition to the general population, SEEDS will target the provision of HCT services to PABAs - especially children, TB patients, STI patients and MARPS. At rural satellite clinics, the project will also target women of reproductive age with combined HCT and STI screening.

SEEDS will train staff on counseling and testing using the GON HCT training curriculum. Non-laboratorians will be used at multiple points of service for facility based HCT where appropriate and when allowed by national policy. To this effect CCCRN will train HCW (counselors, nurses and outreach workers) that will be supervised by onsite laboratorians to assure quality.

The program will support SDF activities targeting HIV + clients,MARPs & their families and communities who access care at these points of service. Prevention priorities will include behavior change for risk reduction and risk avoidance, counseling and testing. All supported SDFs will provide education and training to patients and community health volunteers on secondary prevention. These will include encouraging status disclosure, counseling for sero-discordant couple, risk reduction, adherence to ART and training for health workers and peer outreach workers. Programs will include reducing societal stigma through appropriate health education at facility and community levels and reducing gender based violence. There will be structured peer education that includes systematic training curricula, refresher training, and training on essential life skills. In addition, age appropriate abstinence only messaging and secondary abstinence messaging will be conveyed to adolescents, especially orphans and vulnerable children receiving both facility and home based support. This service will continue to be extended to schools and NYSC camps. CCCRN through this program will cover communities with AB messages conveyed through multiple media and fora. Utilizing such a methodology, a large number of people will be reached with messages via one method or another, but the counted group will be those individuals that would have received AB messaging: (1) on a regular basis and (2) via the three strategies CCCRN will employ (community awareness campaigns, peer education models and peer education plus activities). CCCRN will reach 62751 people as direct people reached through community awareness campaigns, peer education models and peer education plus activities; indirect beneficiaries as those who receive messages via other multiple media.

Prevention activities will include distribution of patient education materials, community sensitization, increased couple testing, promotion of SDF couple support groups, and advocacy for risk reduction strategies for discordant relationships. High risk reduction measures will include treatment of sexually transmitted infections (STIs) and to a lesser extent on drug abuse. Couples will be treated at SDFs or other referral centers that offer specialized treatment for STIs where necessary.

CCCRN will provide PMTCT services in 33 comprehensive ART facilities and 60 satellite sites in Enugu, Ebonyi and Imo states. CCCRN will provide counseling, testing and results to 156,878 pregnant women. Antiretroviral (ARV) prophylaxis will be provided to 5805 women. This activity will include routine provider initiated opt-out HIV counseling and testing (HCT) for all women presenting in antenatal clinics (ANC),labor and delivery wards (L&D) in addition to immediate post-delivery settings for women of unknown HIV status. Counseling will be provided using group and individual pre/post- test counseling strategies and rapid testing based on the National testing algorithms. Same day results will be provided to clients. As part of PMTCT services, partner testing and couple counseling will be strengthened with the provision of Partners Slip and initiation of facility based monthly Couples Forum to enhance disclosure and male involvement. CCCRN through its community and faith-based linkages, will continue to utilize community and home based care services to promote partner testing. Clients will be provided access to free laboratory services including CD4 counts, STI screening (VDRL), Urinalysis, MP and Ultrasound Sound Screening (USS). Free medications including those for OIs and hematinics will also be provided. Strong referral systems that incorporate active follow-up will be strengthened to ensure that women requiring HAART are not lost during referral for ARV services. Referral coordinators will be identified in all our sites and the communities with their capacities built in collaboration with other IPs.

CCCRN will use its community linkages, mother-to-mother support groups and the provision of incentives to encourage HIV+ pregnant women to deliver in a health facility. The incentive package (Mama and Baby Packs) contains basic delivery consumables and immediate baby care items including suctioning bulbs, cord clamps, disinfectant, mackintosh, baby soap and face flannel. All infants of HIV positive woman will be referred to OVC services in order to facilitate care to all affected children.

CCCRN will support the utilization of traditional birth attendants (TBAs) in referral services in addition to the mother-to-mother support groups to reach HIV+ women who deliver outside of the health facility. This activity will help increase referrals, patient tracking and universal precautions to improve PMTCT outcomes.

HIV+ women will be provided infant feeding counseling in pre and postnatal periods with options of exclusive breast feeding with early cessation or exclusive BMS if AFASS criteria can be met using the WHO UNICEF curriculum adapted for Nigeria. Women accessing family planning services will be offered HIV Counseling and Testing. Infants of positive mothers will be linked to immunization and well child care services. Cotrimoxazole prophylaxis will be provided to infants from 6 weeks of age until definitive HIV status can be ascertained.

CHARIS will support the unification process for ARV procurement and distribution to its facilities in Enugu, Ebonyi and Imo States. As part of its expansion plan, CCCRN will support 13 existing facilities, 20 new comprehensive facilities and 60 PMTCT satellites with necessary systems and infrastructure upgrade and ensure skills are in place for efficient forecasting, procurement, storage, distribution of quality anti-retrovirals (ARVs) and improve commodity security. Continuous technical support to SDFs for drug management will continue. This support will include SOPs and training for drug requests, receipts, recording, dispensing, discrepancy reporting, temperature control and disposal of expired drugs.

CCCRN will establish Therapeutic Drug Committees (TDC) comprising of clinicians, pharmacists, palliative care specialists, strategic information advisors and program managers. The TDC reviews drug utilization patterns across all SDFs, assesses scale-up progress and develops required technical support plans. The TDC is replicated at the SDF level to ensure that the ARV supply chain management is clinically informed and logistically supported. Quality assurance covers the entire spectrum from procurement to dispensing. All sites will be provided with ongoing TA by CCCRN Pharmacy & Supply Chain team.

As part of CCCRN decentralization and state saturation strategy, SEEDS will expand treatment to XXX satellites (primary in Enugu, Imo and Ebonyi. SEEDS will provide ARV treatment services to 7844 new patients for a total of 35,298 active adult patients by the end of the year. All PLWHA will be managed in accordance with National standard of care to include CD4 counts and other lab investigations to be performed at baseline, 6monthly and when needed. AR sites will continue integration of prevention with positives (PwP) activities including: adherence counseling; syndromic management of STIs in line with National STI control policy and guidelines; risk assessment and behavioral counseling to achieve risk reduction; counseling and testing of family members and sex partners; counseling for discordant couples; IEC materials and provider delivered messages on disclosure. Cotrimoxazole prophylaxis will be provided for PLWHAs according to the National guidelines.

All SDFs will provide including management of OI management, ART, reliable and secure pharmaceutical supply chain, technologically appropriate lab diagnostics, treatment preparation for patients, their families and supporters and community based support for adherence. SEEDS will adhere to the Nigerian National ART service delivery guidelines including recommended first and second line ART regimens.

SEEDS will strengthen institutional and health worker capacity through the training, retraining and mentoring of health service providers to provide care and treatment services at the facility and community levels. Doctors, pharmacists, nurses, counselors, and community health extension workers will receive training and onsite mentoring that will allow them to provide comprehensive care.

In FY13, 784 children will be provided ART. All SDFs will be strengthened in their capacity to provide comprehensive quality treatment services through a variety of models of care delivery. This includes quality management of OIs and ART, a safe, reliable and secure pharmaceutical supply chain, technologically appropriate lab diagnostics, treatment preparation for patients, their families and supporters and community based support for adherence. This technical and programmatic assistance utilizes on-site mentoring and preceptorship.

Clinical viral loads for children with suspected treatment failure and clinico-immunologic discordance will be supported through leverage. All infected children will be evaluated for ART and followed up using CD4 or CD4% and other laboratory tests as required. AR will provide DBS/DNA PCR technology for early infant diagnosis in addition to the logistic support for transportation of blood samples to designated laboratories in collaboration with GoN.

All ART eligible children will receive treatment following National guidelines. ARV logistics will be supported through the harmonized USG mechanisms for drug supply

CCCRN will continue to build and strengthen the community components by using nurses and counselors to link health institutions to communities. Community Based Treatment Services (CBTS) specialists will continue to support extension of treatment services to the home and community level. The CBTS Specialists will develop a community volunteer structure in collaboration with the Volunteer Services Organization (VSO) in to ensure sustainability of services at LPTFs to include mental health support (psychotherapeutic, psychosocial, depression and substance abuse management) and home based care.