World Health Organization Policy review of HIV and TB guidelines for high HIV/TB burden African countries HIV/AIDS Department World Health Organization

WHO 2010 ART guidelines Target Population ART guideline HIV+ asymptomatic patients ARV-naïve individuals CD4 < 350 cells/mm3 HIV+ pregnant women CD4 < 350 cells/mm3 irrespective of clinical symptoms or WHO clinical stage 3 or 4 irrespective of CD4 cell count HIV/TB co-infection ARV- naïve individuals Presence of active TB, irrespective of CD4 count

Collaborative TB/HIV Activities WHO 2004 Interim Policy on Collaborative TB/HIV Activities A. Establish NTP-NACP collaborative mechanisms Coordinating bodies for effective TB/HIV activities at all levels Conduct surveillance of HIV prevalence among TB cases Carry out joint TB/HIV planning Monitor and evaluate collaborative TB/HIV activities B. Decrease burden of TB among PLHIV (the "Three I's for HIV/TB") Establish intensified TB case finding Introduce INH preventive therapy Ensure TB infection control in health care and congregate settings C. Decrease burden of HIV among TB patients Provide HIV testing and counselling Introduce HIV prevention methods Introduce co-trimoxazole preventive therapy Ensure HIV/AIDS care and support Introduce ARVs

WHO 2010 IPT/ICF Recommendations Use of four-symptoms screening algorithm to rule out active TB and offer IPT Four symptoms include cough, fever, weight loss and night sweats Past history of TB and current pregnancy should not be contraindications for IPT TST or chest radiography are not required

Estimated 2009 HIV/TB and HIV burden Country People with HIV-Figure in '000 (% of global HIV-positive people) People with HIV and TB- Figure in '000 (% of global HIV/TB burden) People eligible for ART at CD4 < 350 cells ('000) People on ART ('000) ART coverage (%) People living with HIV screened for TB ('000) Botswana 320 (1.0) 6.8 (0.6) 170 145.2 83 159.1 11700 Ethiopia N/A 34 (2.8) 176.6 24.1 2403 Kenya 1500 (4.5) 53 (4.4) 710 337 48 14.1 Lesotho 290 (0.9) 8.7 (0.7) 130 61.7 Malawi 920 (2.8)  27 (2.3) 440 198.8 46 Mozambique 1400 (4.2)  54 (4.5) 570 170.2 30 24.3 2429 Namibia 180 (0.5)  9.2 (0.8) 93 70.5 76 87.5 17700 Nigeria 3300 (9.9) 87 (7.3) 1400 303 21 195.1 1853 South Africa 5600 (16.8)  290 (24.2) 2600 971.6 37 433.7 23600 Swaziland 10 (0.8) 80 47.2 59 8.4 2107 Tanzania 1400 (4.2) 38 (3.2) 660 199.4 5.5 153 Uganda 1200 (3.6) 520 200.4 39 57.7 Zambia 980 (2.9)  23 (1.9) 283.9 64 Zimbabwe 1200 (3.6)  48 (4.0) 640 218.6 34 Total  18470 (55.5) 742.7 (61.9) 8453 3384.1 38 1009.5 61945 These 14 countries were chosen because they account for 62% of the global HIV/TB burden. Source : 2010 Stop TB global surveillance report, UNAIDS Report on global AIDS Epidemic 2010

Objectives and Methodology Compare national HIV, TB and HIV/TB guidelines for 14 African countries with recently released WHO ART and HIV/TB guidelines Methodology: Main guidelines were collected from the following sources: National HIV Guidelines National TB Guidelines HIV/TB and TB infection control Guidelines Standard abstraction form was used to review recommendations on: ART initiation criteria The Three I’s for HIV/TB The Three I's for HIV/TB monitoring and evaluation indicators

Source : National HIV, TB and HIV/TB Guidelines Country National ART guidelines National TB control guidelines HIV/TB, ICF, IPT, OI guidelines TB infection control guidelines Botswana 2008 2007 Ethiopia Kenya 2011 2009 Lesotho Malawi Mozambique 2010 Namibia Nigeria South Africa Swaziland Tanzania 2006 Uganda Zambia Zimbabwe 43 guidelines dating from 2006 to the present – HIV/TB guidelines for 8 countries and TB infection control guidelines for 7 countries * Published guidelines, Drafts, Preliminary drafts

ART initiation criteria in people with HIV Country (Year of publication of ART guidelines) Asymptomatic people People with HIV and TB Pregnant women Botswana (2008) <250 Irrespective of CD4 count Ethiopia (2008) <200 <350 Kenya (2011) Lesotho (2007) Malawi (2011) Mozambique (2010) Namibia (2010) Nigeria (2010) Irrespective of CD4 count* South Africa (2010) Swaziland (2010) Tanzania (2009) Uganda (2008) Zambia (2010) Zimbabwe (2010) All figures in cells/mm3, Guidelines in white are similar to WHO recommendations. * Nigeria's TB and HIV/TB guidelines and Zimbabwe's HIV/TB guidelines recommend ART for people with HIV and TB at CD4 count < 350 cells/mm3

ART initiation for asymptomatic people 2010 WHO Recommendation : CD4 count < 350 cells/mm3 ≤ 350 Kenya, Lesotho, Malawi, Namibia, Nigeria, Swaziland, Zambia, Zimbabwe ≤ 250 Botswana, Mozambique, Uganda ≤ 200 Ethiopia, South Africa, Tanzania CD4 Count

ART initiation for people with HIV and TB 2010 WHO Recommendation : ART irrespective of CD4 count Irrespective of CD4 count CD4<350 cells Botswana Ethiopia Kenya Lesotho Malawi Mozambique Namibia South Africa Nigeria Tanzania Swaziland Uganda Zimbabwe Zambia Zambia recommends ART at CD4 count > 350 cells/mm3 if any other stage III or IV illnesses Ethiopia recommends ART for all extrapulmonary and disseminated TB patients

ART initiation for pregnant women with HIV 2010 WHO Recommendation : CD4 count < 350 cells/mm3 Irrespective of CD4 count CD4<350 cells CD4<250 cells CD4<200 cells Malawi Kenya Botswana Ethiopia Lesotho Tanzania Mozambique Namibia Nigeria South Africa Swaziland Uganda Zambia Zimbabwe Although Mozambique, South Africa and Uganda are similar to the WHO ART recommendation for pregnant women, they recommend a lower CD4 count for asymptomatic people. Malawi, under Option B+, recommends lifelong ART for all pregnant women irrespective of CD4 count

Different guidelines followed by different countries Co-trimoxazole prophylaxis 2006 WHO Recommendation : CD4 count < 350* cells/mm3 or WHO stage 3 or 4 CD4< 200 Cells or WHO Stage 3 or 4 Botswana All HIV positives Kenya, Malawi, Swaziland CD4< 200 Cells or WHO Stage 2, 3 or 4 South Africa Different guidelines followed by different countries CD4< 250 Cells or WHO Stage 2, 3 or 4 Uganda CD4< 350 Cells or WHO Stage 2, 3 or 4 Mozambique, Tanzania, Zambia, Ethiopia**, Zimbabwe CD4< 350 Cells or WHO Stage 3 or 4 Lesotho, Namibia, Nigeria *Countries may choose to adopt a CD4 threshold of < 200 cells/mm3 **Source: Ethiopia's Co-trimoxazole prophylaxis guidelines, 2006

Indicators on the Three I's for HIV/TB National policies for HIV, TB and HIV/TB, and the Three I's for HIV/TB Country ICF IPT TB infection control Indicators on the Three I's for HIV/TB Botswana NAP NAP, NTP NTP Ethiopia NAP, NTP, HIV/TB NTP, HIV/TB HIV/TB Kenya NAP, OI, NTP x Lesotho Malawi NAP, NTP** IC Mozambique NAP, NTP, IC Namibia NTP, IC Nigeria NTP, HIV/TB, IC South Africa NAP, NTP, IPT Swaziland* NAP, IPT NAP, IC NAP, IPT, IC Tanzania Uganda HIV/TB, IC Zambia NAP, NTP, ICF NTP**, ICF Zimbabwe NTP**, HIV/TB** Eight countries have guidelines on ICF and IPT specified in both their national ART guidelines and national TB manuals. Six countries also include TB infection control policies in their national ART guidelines. NAP – National ART Policy, NTP – National TB Policy, ICF – National intensified TB case finding guidelines, IPT – National IPT guidelines, IC – TB infection control guidelines, OI – National guidelines on management of HIV-related opportunistic infections Note: * 2011 NTP for Swaziland recommends Three I's for HIV/TB but do not mention any guidelines ** These guidelines do not recommend IPT

Countries recommending the Three I’s for HIV/TB Country ICF IPT TB infection control Botswana ✓ Ethiopia Kenya Lesotho Malawi Mozambique Namibia Nigeria South Africa Swaziland Tanzania Uganda Zambia ✓* Zimbabwe ✗ * Zambia: Preliminary draft on ICF guidelines recommends IPT

TB screening criteria for IPT 2010 WHO Recommendation : Symptom-based screening Botswana Ethiopia Kenya Lesotho Malawi Mozambique Namibia Nigeria South Africa Swaziland Tanzania Uganda Zambia Zimbabwe IPT not recommended Symptom-based Symptom-based + sputum smear microscopy + chest X-ray Symptom-based + sputum smear microscopy + chest X-ray + TST LEGEND Initiation criteria Note: The map shows IPT initiation criteria recommended by the most recent guidelines for a country

Abnormal chest findings TB exclusion criteria for IPT initiation 2010 WHO Recommendation : Four-symptom screening for cough, fever, weight loss and night sweats BOTSWANA NTP 2007 NAMIBIA* NAP 2010 KENYA OI 2008 NTP 2009 Enlarged glands Diarrhoea WHO recommendation SOUTH AFRICA IPT 2010 ETHIOPIA HIV/TB 2008 ZAMBIA IPT 2010 MALAWI NAP 2011 NIGERIA*** NAP 2010 SOUTH AFRICA NAP 2010 Coughing blood Coughing blood Chest X-ray MOZAMBIQUE NAP 2010 TANZANIA** NAP 2009 Sputum smear Sputum production Chest pain Chest pain Enlarged glands KENYA NAP 2011 Chest X-ray Loss of appetite Loss of appetite Loss of appetite SWAZILAND NAP 2010 Abnormal chest findings Swelling Chest pain UGANDA NTP 2010 LESOTHO NAP 2007 Chest pain Coughing blood Chest pain Shortness of breath Shortness of breath Shortness of breath Enlarged lymph nodes Enlarged lymph nodes Sputum smear TST Night sweats The criteria to rule out active TB before starting IPT differ across the 12 countries and also across national ART guidelines, national TB guidelines and HIV/TB guidelines. Night sweats Night sweats Night sweats Night sweats Night sweats Night sweats Sputum smear Chest X-ray Weight loss Night sweats Weight loss Weight loss Weight loss Weight loss Weight loss Weight loss Weight loss Chest X-ray Night sweats Fever Fever Fever Fever Fever Fever Fever Fever Fever Cough Cough Cough Cough Cough Cough Cough Cough Cough Cough Cough * 2011 TB guidelines for Namibia recommend enlarged lymph nodes as an additional symptom ** 2006 TB guidelines for Tanzania recommend chest pain as an additional symptom *** 2008 IPT guidelines for Nigeria recommend weight loss as an additional symptom, 2010 NTP guidelines do not recommend chest X-ray and sputum smear microscopy

Exceptions to WHO recommendations on IPT 2010 WHO Recommendation : IPT to all irrespective of previous history of TB or current pregnancy and IPT with ART also recommended Botswana and Mozambique – No IPT initiation in pregnancy Botswana and Tanzania – IPT not for children South Africa – IPT with ART is a conditional recommendation Lesotho – IPT offered to TB-exposed HIV infected children and at pilot sites where active TB can be ruled out Malawi – Stop IPT when patient is started on ART Kenya and Swaziland– IPT provided in clinics with TB screening, adherence counselling and patient follow-up services Uganda – IPT provided in institutions with adequate human resources, infrastructure, and equipment and logistics Botswana – Only for 16 years and above

Indicators for monitoring and evaluating performance on the Three I’s for HIV/TB ICF IPT Yes No Yes No Lesotho Ethiopia Malawi Mozambique Namibia Nigeria Swaziland Uganda Zambia Botswana Kenya South Africa Tanzania Zimbabwe Botswana Ethiopia Lesotho Mozambique Namibia South Africa Swaziland Uganda Kenya Malawi Nigeria Tanzania Zambia Malawi, Namibia, Nigeria, Swaziland and Uganda have indicators for TB infection control

Limitations Guidelines may be outdated and/or in the process of being updated Written policies may not reflect programme implementation Other guidelines covering ART and the Three I’s for HIV/TB may exist - Infection control guidelines - Monitoring and evaluation guidelines

Conclusion Many countries follow the recently released WHO guidelines - Asymptomatic patients – 8 countries - HIV/TB co-infected people – 7 countries - Pregnant women – 10 countries Malawi recommends lifelong ART for pregnant women irrespective of CD4 count (Option B+) Almost all countries have recommendations on the Three I’s for HIV/TB CPT initiation criteria differs widely across countries ICF and IPT guidelines specified in both NAP and NTP for many countries Many countries have ICF and IPT indicators Room for improving monitoring and evaluating progress on TB infection control

Recommendations ART policy IPT policy Revise ART eligibility criteria where necessary IPT policy Adapt policies to recommend IPT for all, including pregnant women, previous TB patients and PLHIV on ART Simplify criteria for IPT initiation Monitoring and evaluating of the Three I's for HIV/TB Include indicators on ICF and IPT in National ART Guidelines Adapt and implement indicators for TB infection control

Thank you…