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The MTCT-Plus Initiative

The MTCT-Plus Initiative. Wafaa El-Sadr, MD, MPH Mailman School of Public Health Columbia University. What is the MTCT-Plus Initiative?. MTCT-Plus Initiative is an HIV care and treatment program that establishes HIV primary care services for

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The MTCT-Plus Initiative

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  1. The MTCT-Plus Initiative Wafaa El-Sadr, MD, MPH Mailman School of Public Health Columbia University

  2. What is the MTCT-Plus Initiative? MTCT-Plus Initiative is an HIV care and treatment program that establishes HIV primary care services for • women identified as HIV infected through perinatal prevention programs • their infants and children • family/household members

  3. Why Was this Model Selected? • Rapid global expansion of pMTCT programs • Recognition of consequences of loss of mothers on health of the child, the family and the community and opportunity to have a positive impact on the families • Appeal of linking a treatment intervention (MTCT-Plus) to a prevention intervention (pMTCT)

  4. Fundamentals of MTCT-Plus • HIV primary care that includes provision of antiretroviral therapy • Family-centered care • Comprehensive care via multidisciplinary team with attention to clinical, psychosocial and environmental issues • Focus on adherence and retention in care

  5. Demonstration and Planning Sites Thailand MTCT-Plus site Planning grant

  6. MTCT-Plus Demonstration Sites Cote D’Ivoire Kenya (2) Mozambique Rwanda South Africa(3) Thailand Uganda(2) Zambia

  7. Planning Grants • Cameroon • Democratic Republic of Congo • Ethiopia • Kenya • Mozambique • Nigeria • South Africa • Tanzania • Zambia • Zimbabwe

  8. Site Characteristics • Local leadership • Diverse settings • Varied experience in HIV care • Varied resources

  9. Service Delivery Sites Partner organizations Site support activities Site Monitoring (JSI) Data management (JSI) Women’s Leadership Group Site Directors Group MTCT-Plus Secretariat Mailman School of Public Health Columbia University • Working groups: • Clinical care • Training • Procurement • Evaluation • Research

  10. What Resources Does MTCT- Plus Provide to the Sites? • Funding to support staff • Funding to support key laboratory tests e.g. CD4 cell count, infant diagnostics • Funding to support patient costs e.g. transportation • Funding to enhance site capacity and infrastructure continued…

  11. Other Resources Provided by MTCT-Plus • Clinical Manual and treatment algorithms • Central procurement of MTCT- Plus medications: cotrimoxazole, isoniazid, dapsone, antiretrovirals, multivitamins • Staff training with focus on multidisciplinary team of providers • Site support • Data management • Program evaluation

  12. Women attending ANC clinics pMTCT programs Enrollment into pMTCT programs Enrollment into MTCT-Plus HIV-infected partners and children • Long-term HIV care services, including: • • Family-centered services • • Clinical & immunologic monitoring • • TB prophylaxis & treatment • • Prophylaxis for opportunistic infections • • Antiretroviral therapy when indicated • • Psychological & social support services • Prevention services • • Nutritional counseling & support • Outreach activities MTCT-Plus

  13. Timeline • Sites announced in July 2002 • Facility readiness • Development of Clinical Manual • Recruitment of site staff • Establishment of site procedures and resources • Procurement plans for medications • Staff training

  14. MTCT-Plus Monitoring and EvaluationGoals • Provide means to monitor patient progress and outcomes • Permit ongoing monitoring and evaluation of delivery sites and sharing of experiences across sites • Allow monitoring and evaluation of overall program impact

  15. Patient Data Collection SystemGuiding Principles • Patient care is facilitated by availability of complete medical record • Care is provided by multidisciplinary team e.g. adult provider, pediatric provider, outreach workers, etc • Sites have diverse resources and capabilities • Importance of rapid feedback to the sites • Need for cross-site evaluation and assessment of key parameters for programmatic impact

  16. Patient RecordsSite Resources • Medical record system varies from site to site • Few have established systems for continuity care • Few have mechanisms for documentation of contact with non-clinical providers • Few have computers in the clinical setting • Few have patient databases and data entry/management experience

  17. MTCT-Plus Clinical Manual • How to manual rather than guideline • Includes step by step instructions with regard to adult/pediatric care • Includes roles of clinical and non-clinical providers • Visit by visit instructions

  18. How Were the Data Forms Developed? • Patient forms were developed to reflect the principles and procedures described in the Clinical Manual • Site feedback and pilot testing • Translated into French, Portuguese and Thai

  19. Characteristics of the Patient Data Forms • Simple • Skip patterns as appropriate • Use of checkboxes • Provide space for extra notes by providers • Multi-copy to serve as patient chart at some of the sites • Data Collection Manual

  20. Types of Forms • Separate forms were created for adult and pediatric patients(infants/children < 15 yrs) • Forms were designed to collect patient information at various points of the program including: • Intake and enrollment visits • Follow-up visits • Laboratory test results • Pediatric HIV test results • Non-Clinical contact visits • Program discontinuation

  21. Enrollment Forms(Adult and Pediatric) • Records clinical information: • past medical history • past and current use of ARV or medication for OI prophylaxis • family planning methods/pregnancy status • current signs and symptoms/physical exam • WHO staging indicator conditions • Lab tests and referrals requested • To be completed by clinician conducting the examination

  22. Adult Enrollment Form

  23. Adult Enrollment

  24. Adult Enrollment

  25. Adult Enrollment

  26. Follow-up Forms(Adult and Pediatric) • Information on the enrollment form • Additional information: • ARV adherence questions (if on ARV) • other health care provider use • MTCT-Plus services received • To be completed by clinician conducting the examination

  27. Adult Follow-up Form

  28. Adult Follow-up Form

  29. Laboratory Result Form

  30. Infant HIV Test Results

  31. Non-Clinical Contact Form • Records patient contacts other than clinical visits including: • Adherence Support/Counseling • Support Group • Psychosocial Counseling • Home Visit • Social Services • Nutrition • Other Referral • To be completed by appropriate person of the team e.g. counselor, peer worker, social worker, educator, outreach worker

  32. Non-Clinical Contact Form

  33. Data Collection Options • At sites where data forms will serve as medical records, duplicates are sent to the Data Management Center (DMC) • For sites using their own medical records system, data are abstracted and sent to DMC • For sites able to enter data on-site, MTCT-Plus database is provided and files emailed to DMC

  34. MTCT-Plus Patient Data Manual • Description of patient data forms including detailed directions on how to answer questions • Instructions on completion of MTCT-Plus forms • Training on-site and by conference calls

  35. Experience to Date • Enrollment into MTCT-Plus program began in February 2003 • As of May 30, 2003, 461 patients have been enrolled at seven MTCT-Plus program sites

  36. Total Adults Enrolled (339) Index Woman No. (%) Antepartum 108 (32) Postpartum 149 (44) Household Members Partners 78 (23) Number (% Female) 262 (77%) Mean Age (range) 29 (17-51) Baseline Median CD4 Count 201 cells/mm3 Baseline WHO Stage (%) Stage I 59% Stage II 20% Stage III 16% Stage IV 4% Eligible/On ARVs at baseline 111 Eligible/On OI proph. at baseline 160

  37. Total Children Enrolled (122) Child (recent pregnancy) 99 Other Child (born to index woman) 22 Number (% Female) 58 (47%) Mean Age (range) <1 yo: 3 mo (0-9 m) >I yo: 3 yrs Baseline Median CD4 Count 651 cells/mm3 HIV-exposed, indeterminate 97 HIV-Infected 25 CDC Category N 32% CDC Category A (WHO Stage I) 28% CDC Category B (WHO Stage II) 36% CDC Category C (WHO Stage III) 4% Eligible/On ARVs at baseline 5 Eligible/On OI proph. at baseline 100 Index Woman Enrolling Household Members 173

  38. What can MTCT-Plus Accomplish? odecrease in morbidity and mortality ofurther reduction in MTCT oinvolve persons with HIV in the programs ostrengthen local health care capacity opromotion of VCT, pMTCT cascade and other HIV prevention strategies o decrease stigma and enhance support to persons with HIV in the community o develop reproducible models of care in a range of health care settings

  39. Key IndicatorsPatient-Related • Adherence with care • Adherence with treatment • Hospitalizations • Morbidity • Mortality

  40. Key IndicatorsSite-Related • Women, children and partners enrolled • Patient retention • Multidisciplinary team • Patient satisfaction • Staff retention • Linkage to other clinical (e.g. Tb programs), community programs and resources

  41. MTCT-Plus Program Impact • Number of families enrolled and retained in care • Diversity of sites and models • Expansion of program and sites • Impact on prevention practices e.g. VCT, sexual transmission • Impact on attitudinal factors including stigma

  42. Expansion of MTCT-Plus Sites

  43. Expansion of HIV Care and Treatment Programs MTCT-Plus TB/HIV Other care & treatment programs

  44. The Way Forward Actively seek answers to clinical and operational questions

  45. Acknowledgements Foundations supporting the MTCT-Plus Initiative Bill & Melinda Gates Foundation William and Flora Hewlett Foundation Robert Wood Johnson Foundation Henry J. Kaiser Family Foundation John D. and Catherine T. MacArthur Foundation David and Lucile Packard Foundation Rockefeller Foundation Starr Foundation United Nations Foundation

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