Session 6: Isoniazid Preventive Therapy (IPT), Part I: Patient Eligibility and Preparation

1. Session 6: Isoniazid Preventive Therapy (IPT), Part I: Patient Eligibility and Preparation

2. Introduction • TB is the leading cause of death among PLHIV • Isoniazid Preventive Therapy (IPT) is used to prevent TB among PLHIV who do not have TB disease and meet eligibility criteria for IPT • IPT is one of the 3 I’s strategies to reduce the burden of TB among PLHIV

3. Learning Objectives • By the end of the session, participants should be able to: • Explain the rationale for IPT • Determine which patients are eligible for IPT • Explain and prepare patients for IPT • Describe how to start and monitor IPT • Manage common side effects associated with IPT

4. Rationale for IPT (1) • Aim of introducing IPT to PLHIV is to prevent active TB in patients who do not have it • WHO/UNAIDS recommends use of IPT for PLHIV in areas where co-infection is > 5% • An estimated 10-15% of PLHIV have active TB disease • Over 30% of AIDS-related deaths among adults are due to Tuberculosis

5. Rationale for IPT (2) • MOHSW Policy statement for IPT • Health facilities (H/F) with sufficient capacity will be accredited to offer IPT in strict compliance with national and international guidelines • INH will be provided to eligible patients free of charge in accredited H/F • MOHSW will: • develop a procurement and logistical management plan for sustainable provision and supply of INH at service delivery points • be the accrediting body and regularly monitor and evaluate IPT use in the country

6. Purpose of Using IPT • IPT is aimed at decreasing the risk of a first or recurrent episode of TB • Among PLHIV, IPT is likely to provide protection against the risk of developing TB by decreasing the risks of: • Progression of recent infection • Reactivation of latent M. Tuberculosis • IPT programs decrease rate of TB in the community and improve TB control

7. Role of IPT in Preventing TB Disease Early progression (5%) Adapted from Phil Hopewell IPT Late progression(5%) Inadequate Immunological Defenses Inadequate Infection (30%) IPT Immunologic Defenses Adequate I.C. Containment (95%) Adequate Exposure Continued containment (90%)

8. How Long Does IPT Work? • The IPT prevention effect against TB lasts for 1–2 years after the 6-9 month course and then the risk of TB gradually returns because of new exposures • After 1-2 years, re-infection may occur and secondary IPT is recommended

9. PLHIV Eligible for IPT

10. Who Should Receive IPT in Tanzania? • People at high risk for TB such as: • HIV exposed and unexposed infants of mothers with pulmonary TB • All children <5 yrs in contact with smear positive TB patient • All persons who are HIV positive and in particular those who are: • Family members of a sputum smear positive TB patient • Prisoners • Hospitalized patients and outpatients • Health care workers • Individuals in congregate settings

11. IPT Exclusion Criteria (1) • Exclusion: • TB suspect / patient with confirmed active TB disease • Patient currently on TB treatment and those with history of completed TB treatment and/or IPT in the past 2 years*

12. IPT Exclusion Criteria (2) • Medical contraindications to INH* (current or prior) • Intolerance/allergy to INH • Chronic/acute liver disease • Alcohol abuse • Poor compliance / adherence • Terminal AIDS stage 4 (as per WHO palliative care definition) • Pregnant mothers

13. Inclusion Criteria for IPT • Those who are eligible for IPT: • Have been documented as HIV positive • Are fifteen years of age and above • Do not meet any of the exclusion criteria

14. Case Study 1: Assessing Eligibility for IPT • Malika is a 41 year old teacher who is referred to CTC after having been diagnosed HIV-positive at VCT. She is very woried about her health since she has two young children under 5 whose HIV status is unknown. She does not report signs and symptoms of tuberculosis • How would you assess this patient for TB?

15. Case Study 1 (continued) • Tick appropriate response • Do you have the following: yes no • Cough for ≥ 2 weeks? □ √ • Coughing up bloodstained • sputum (haemoptysis)? □ √ • Fevers for ≥ 2 weeks? □ √ • Noticeable weight loss for new • patients or a 3 kgs weight loss in • a month (subsequent visit)? □ √ • Excessive sweating at night • for ≥ 2 weeks? □ √ ....... this patient is HIV-positive but she is apparently “healthy”!

16. Case Study 1 (continued) HIV-infected patient with ALL answers NO on the TB questionnaire No need to undertake AFB microscopy This patient is considered an asymptomatic PLHIV. Therefore: Assess for IPT eligibility

17. Case Study 2: Assessing Eligibility for IPT • Maisha is a 39 year old taxi driver from Kabwete and has been living with HIV for 3 years. On this visit to the Kabwete CTC he complains of fever and cough which have lasted for the past 3 weeks. Upon further questioning, he admits to having lost 3 kg in the last month.

18. Case Study 2 (continued) • Tick appropriate response • Do you have the following: yes no • Cough for ≥ 2 weeks? √□ • Coughing up bloodstained • sputum (haemoptysis)? □ √ • Fevers for ≥ 2 weeks? √□ • Noticeable weight loss for new patients • or a 3 kgs weight loss in a month • (subsequent visit)? √□ • Excessive sweating at night • for ≥ 2 weeks? □ √ .....This patient has several signs/ symptoms that qualify him to be a “TB suspect”

19. Sputum Request Form MOHSW Tanzania • If you suspect TB in a patient, use the sputum request form to refer the patient to the lab for a sputum test

20. Case Study 3 • Fatim is a 34 year old police officer who has been attending another CTC but was recently transfered to the city. As a new patient to your clinic, you decide to assess her TB status. • How will you introduce the subject of TB screening?

21. Case Study 3 (continued) • Upon further discussion with Fatim, you discover that she has had a fever for about 10 days. Her weight is 48 kg and she looks a little wasted. She knows that her weight was 55 kg 3 months ago. She denies having a cough but says she has chest pain. She has no memory of ever having had an opportunistic infection.

22. Case Study 3: What Are the Next Steps? • You discover the following additional information while you are discussing her case: • Physical examination is negative • Hb: 10.3 • CD4: 180 (1 week ago) • She is not on ART

23. TB Screening Questionnaire Tick appropriate response Do you have the following: yes no Cough for ≥ 2 weeks? □ √ Coughing up bloodstained sputum (haemoptysis)? □ √ Fevers for ≥ 2 weeks? □ √ Noticeable weight loss for new patients or a 3 kgs weight loss in a month (subsequent visit)? □ √ Excessive sweating at night for ≥ 2 weeks? □ √ Hmm!!! This patient has borderline symptoms

24. Case Study 3: Next Steps? • Does the patient have active TB? • Do you think it is relevant to investigate the patient’s and relatives’ history? • Findings: • AFB microscopy test: negative (saliva seen) • CXR: negative for active TB • Patient does not report history of past TB • The patient’s father who stays at her home is on TB treatment

25. Case Study 3: Conclusions • What is your conclusion? • Does the patient have TB? • If yes, would you start TB treatment? • Otherwise, is the patient eligible for IPT? • Do you suggest to conduct additional investigations? • How do you plan the follow-up?

26. Before initiating preventive therapy, active TB must be excluded! • Due to the increased rate of smear negativity in HIV-infected individuals, a chest radiograph is necessary in addition to a negative sputum smear to exclude active TB with any certainty

27. Assessment of IPT Eligibility

28. IPT Algorithm -1

29. Counselling IPT Algorithm - 2

30. Preparation of the Patient for IPT

31. Adherence Education and Counseling Flow Chart PLHIV is eligible to start IPT PLHIV is referred to Adherence Nurse Pre-IPT Adherence Counselling • Assess patient’s knowledge of HIV and TB • Recommend Treatment Assistant • Educate patient about the relationship between HIV and TB • Educate about importance of IPT • Explain drug regimen, side effects and importance of adherence • Identify barriers to adherence and strategies to overcome barriers • Assess patient’s readiness to start IPT • Document in Adherence checklist Source: SOP for HIV care and treatment – NACP MOHSW Tanzania

32. Prescribing IPT • Write down the dose and duration of INH • Dose: 300 mg daily • If patient weighs <30 kg: dose 5 mg/kg • Duration: 6 months • Pyridoxine • Dose: 25 mg daily • Duration: 6 months

33. What is Considered Good IPT Adherence? • An uptake of 80% or more of the total doses of IPT is enough to achieve the protective effect • At the end of 6 months, patient should have taken 180 pills (which =100%) • If patient has not taken at least 80% (144 doses), then needs to continue on IPT to complete the total within a maximum time of 9 months

34. Group Discussion: How Do You Assess Whether Your Patients Are Adherent?

35. Follow Up Visits • Give dates for follow up appointments at monthly follow up (whether PLHIV on ART or in care) • At the follow up visit: • Assess adherence • Continue counselling/continuous education • Assess for side effects • Screen for development of active TB (even if patient is on IPT) • Check for signs and symptoms of TB • Use screening tool • Check drug supplies

36. Remember: It is Still Possible to Miss TB During IPT • In a study done in Tanzania, it was found that of the 93 patients studied, 14 (15%) had active TB of which: • 10 (71%) had clinical TB (symptoms or chest radiograph findings) • 4 (29%) had subclinical TB (positive sputum AFB stain or culture results but no symptoms or chest radiograph findings)

37. Assessing Adherence • Patient self-report • Detailed interview • Pill counts • Pharmacy refill data

38. Role Play Activity

39. Case Study: Adherence During IPT • 38 year old HIV-positive male at the end of the 2nd month of IPT travels to a relative’s funeral without informing the CTC staff. Before leaving, he takes the last 4 tablets of INH. One month later he comes back to the CTC reporting having missed doses for the past 4 weeks. • What action will you take?

40. Other Challenges to IPT Implementation • For patients, the following may affect success of IPT programs: • Financial barriers affecting travel to collect drug supply leading to missed appointments • Secrecy and stigma with PLHIV who fear being seen collecting medications • Fears of being on the drug for a long time • Fear of side effects, based on experiences of peers • Inadequate access to food

41. Adherence Support Strategies for IPT Programmes

42. Adherence Support • Patient education and counselling • Access to uninterrupted medication supply • Medication reminders • Medication partners • Ongoing support and reinforcement

43. Patient Education and Counselling • Patient education should take place prior to IPT initiation, but should also continue throughout the course of IPT use Remember, adherence may decrease over time

44. Ensuring Uninterrupted Supply of IPT • Ensure that patients understand where, when, and how to obtain medications • Avoid “stock outs” by accurately balancing needs and consumption • Assist patients to safeguard medicines • Provide access to care to patient’s household, limiting pressures to share medicines

45. IEC and Peer Educators • Educate patients and the public on TB • Use TB patients or those who have been on IPT to educate other patients • Use the support of peer educators to conduct counselling/education for PLHIV on IPT

46. Side Effects of INH

47. Side Effects and Management

48. Concurrent Use of Herbs • There is potential for interaction between herbs and INH • Unless the components of the herbs are known, concomitant use should be discouraged

49. Case Studies on Side Effects

50. Case Study 1 • 56 year old HIV-positive man started IPT 3 weeks ago - dose of 300 mg/day. He comes back to CTC complaining of itching skin lesions on upper body for 5 days • He has no other signs/symptoms • Clinical examination shows rash, no ulcers • Is this due to drug toxicity or another acute illness?