Introduction of the new PMTCT Policy and Guidelines

1. Introduction of the new PMTCT Policy and Guidelines Parliamentary Portfolio Committee on Health 4 March 2008

2. Outline • Purpose • Policy and Guidelines in brief • Recommended approach to implementation • Conclusion • Recommendations

3. Purpose • To provide an update to the Health Portfolio Committee on progress with the introduction of dual therapy for PMTCT, for • Information, • Discussion, and • Advice

4. Guidelines in brief • Approved by the Minister on the 12 February 2008 • Policy approach addresses four stages of intervention • Primary prevention • Especially among women of child bearing age • Antenatal care activities • Activities during labour and delivery • Postnatal care including safe infant feeding

5. Guidelines in brief • Early booking • Routine offer of HIV testing • Approach and algorithm outlined • Repeat test at 34 weeks if HIV negative • Counselling on safe infant feeding • Affordable, Feasible, Acceptable, Safe, Sustainable (AFASS) criteria emphasised

6. Guidelines in brief • Dual therapy – AZT + sdNVP • AZT from 28 weeks (or as soon as possible thereafter but before the onset of labour) and through labour + sdNVP at labour • Baby – sdNVP + AZT (7 OR 28 days) • Cotrimoxazole – mothers and babies • Nutrition interventions • Supplements – HIV positive pregnant women, and or • Food supplements • Other social security interventions

7. Guidelines in brief • CD4 count at HIV positive diagnosis OR earliest afterwards • HAART if < 200 and/or WHO stage 4 • Comprehensive plan guideline • Prioritisation of pregnant women at service points • O&G units to consider providing HAART • Safe obstetric procedures • Intensive infant feeding education and support • Early testing - PCR for babies • Data management and reporting • Document is on the Departmental website • Being prepared for printing and distribution with training

8. Guidelines in brief • Major developments relate to • Addition of AZT to sdNVP • Infant feeding policy • Implications • Longer course of therapy • Require more complex health systems support • Drug adherence support is critical for the realisation of health outcomes • Especially for safe infant feeding • Expected improvement in efficacy • > 90% in clinical trials (sdNVP was 50% in clinical trials) • Reduction in risk of resistance development • Challenges • Access • Monitoring • Budgets • Communication

9. Approach to implementation • Considerations for readiness to provide the service may include: • A facility manager • Trained team on site • Adequate physical space • Other relevant services- BANC, FP, basic HIV & AIDS services • Reasonable access to laboratory services

10. Approach to implementation • Efficient Information management systems • Good record of adherence to drug dispensing SOPs for OI Management & ARVs • Reasonable demand, utilisation & supply numbers on the current PMTCT Programme • Maximise access and efficiency • Patient/treatment tracking system in place • Efficient links with district & province • Efficient links with community-based organisations

11. Approach to implementation • The following health facilities may be considered during the introduction phase: • Comprehensive Plan (CCMT) service points • Non-CCMT hospitals with O & G units & ANC services • CHCs with Maternal and Obstetric Units & established comprehensive HIV & AIDS and MCWH programmes • Other PHC facilities that fulfill the criteria above

12. Approach to implementation • District-based approach • District manager • Mapping of current PMTCT services in each sub district • Identification of facilities for implementation of full package new PMTCT guideline • Establishment of effective referral systems in each sub district • Seamless information management • Identify elements for the different levels with minimal negative impact on access • Work closely with local municipality health services • Supporting coordination of implementation • PMTCT and MCWH coordinators • Sub district “complexes” of facilities to inform provincial implementation plans

13. Approach to implementation • “Medicine Act” of 1965 and the “Nursing Act” of 1978 provide regulatory framework for the handling of medicines • All ARVs are Schedule 4 drugs • Require a prescription by a Doctor (Medicines Act) • Nursing Act, 1978 • Handling of medicines by nurses (Section 38A) • Examine, diagnose illness or defect • Authorisation • DG, HOD, Medical Officer of Health in Local Authority, medical officer of an organisation – DG designated after consultation with pharmacy Council • Consultation with Nursing Council • Only whenever the services of a medical practitioner or pharmacist are not available • Adhere to regulations GN R2418 of 1984

14. Approach to implementation • Small clinics and PHC centres with ANC services • VCT • Infant feeding counselling and support • CD4 testing • TB screening • Nutrition support • Social support • PCR testing • Haemoglobin monitoring • Larger centres with easy access to a doctor should be considered for prescription of dual therapy • Clients may be referred to these centres for the original prescription • AZT could be delivered to the smaller clinics on patient-name • Consider invoking the regulatory provisions in order to increase access • Quality assurance will be critical

15. Laboratory services • Haemoglobin monitoring • Point-of-care, hand held devices used • Laboratory tests may be required in complicated cases • More training to be done • VCT • Rapid test kits used • Quality assurance system in place – provinces to improve adherence to programme • Access to CD4, Viral load, and PCR has improved considerably over the comprehensive plan period • Turn-around-times to be improved • Courier services to be expanded to meet demand • Resistance surveillance • Annual antenatal survey • Virologic failure amongst comprehensive plan clients • Opportunity to improve technology for better efficiency • Especially in remote areas

16. Information management and research • Cover core indicators outlined in guideline document • Starting with 13 (currently 7 reported on) • Facility to District to Province to National • Feedback to all who need information • To be expanded after twelve months • Cover all indicators in the guideline • Operational research and questions • Awareness and knowledge, uptake, health systems issues, quality, access • Outcomes • Part of training programme

17. Communication and Social Mobilisation • Provincial EXCOs • Provincial Councils on AIDS • District AIDS Councils • General public • By the NDOH • By the Provinces • Communities • Mass media, Province and District-based Indaba’s, etc

18. Communication and Social Mobilisation • What to communicate • The PMTCT package • Primary HIV Prevention • Early ANC booking • Benefits of VCT • Male and partner involvement • Community involvement & support • Safe infant feeding • Adherence and support • Where to access all relevant services • Importance of follow up

19. Approach to training • Update current PMTCT manual – MCWH & HIV and AIDS Clusters • Manual to be printed by 25 March 2008 • Training to start on 31 March 2008 • Short term in-service information updates • Course is envisaged to be 7 days • Counselling, haemoglobin monitoring, other drug toxicities, PCR, safe infant feeding, nutrition for the mother, dual therapy, programme monitoring and evaluation, and other relevant aspects

20. Approach to training • Master trainers and course directors - 10 per province – critical mass • Over three weeks in April • Train-the-trainer • Down-cascade • Prioritise identified service points • Facility managers, hospital CEOs, all participating staff, support services staff • District managers and local health municipal services • All relevant units in province • Health service providers to be trained by midMay in all nine provinces • Pre-service through the relevant institutions

21. Provincial support • NDOH • Printing and distribution of all relevant materials • Information dissemination and provincial workshops • Monthly provincial support visits for the first 12 months • MCWH and Nutrition, HIV & AIDS, QA units • Implementation of the training programme • Quarterly progress review meetings • Information management and updating the DHIS • Development and monitoring of conditional grant business plans – DORA • Ensure adequate resources for the MTEF period

22. Estimated cost (NSP targets) • 281.42m (2008); • 323.18m (2009); • 363.03m (2010) • 378.84m (2011).

23. Proposed PMTCT - MTEF Budget

24. RESOURCE IMPLICATIONS • Items to consider for 2007/08 (the next six weeks) • Printing and distribution • Guidelines, IEC, Training manual, facility register, support visit tool • Training of trainers • Stakeholder meetings • Budgets available from NDOH • Provinces to submit business plans to the DG by 14 March 2008 • Service points identified • Patient target numbers • 12 month plans • Indicating starting date

25. Progress • HODs have been briefed • Detail of policy and guideline discussed with provincial HAST managers • Approaches to implementation discussed with provinces • Developing provincial business plans • NHC Council briefed • Commitment to support implementation of the policy and guideline • Local municipalities keen to contribute

26. Conclusion • The new policy and guidelines for PMTCT has been approved • National operational plan to be informed by provincial business plans • Some provinces may be more ready than others • All nine provinces should have started by end of May 2008 • NHLS to ensure support to implementation • NDOH to ensure allocation of budgets during the adjustment bid process • Monitoring and evaluation essential • Pharmacovigilance • Resistance surveillance • Conclusion of current programme evaluation

27. Recommendations • It is recommended that the Parliamentary Portfolio Committee on Health; • Takes note of the progress towards the implementation of the new PMTCT policy and guidelines • Supports successful implementation of these guidelines