Scoping meeting for the development of guidelines on nutritional/food support to prevent TB and improve health status among TB patients

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Scoping meeting for the development of guidelines on nutritional/food support to prevent TB and improve health status among

TB patients

Meeting Report

Geneva, 2-4 November 2009

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WHO Library Cataloguing-in-Publication Data

Scoping meeting for the development of guidelines on nutritional/food support to prevent TB and improve health status among TB patients: meeting report, Geneva, 2-4

November 2009.

1.Tuberculosis - prevention and control. 2.Tuberculosis - therapy. 3.Diet therapy.

4.Nutritional support. 5.Guidelines. I.World Health Organization.

ISBN 978 92 4 159977 1 (NLM classification: WF 315)

© World Health Organization 2010

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Table of Contents

Executive Summary 1

Introduction 3

Summary of presentations 3

Summary of group work 8

Summary of final plenary to agree on scope of the guidelines and the way forward 9

Annex 1. Programme 11

Annex 2. List of participants 13

Annex 3. Background documents 19

Annex 4. Updated questions NUT/TB 21

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Executive summary

From November 2nd to November 4th 2009 experts in nutrition, tuberculosis (TB) and related scientific areas met in Chateau de Penthes, Geneva to discuss the development of guidelines on nutrition/food support to prevent TB and to improve health status among TB patients.

The current evidence-base on TB and nutrition was reviewed through presentations by different experts and plenary discussions.

Participants were then divided into five groups to discuss five topics encompassing the value of nutritional support for both secondary prevention and tertiary prevention of TB. The aim was to formulate specific research questions and study outcomes that should be addressed through systematic reviews, as a first step for the development of guidelines on TB and nutrition.

The working groups reported to plenary to reach agreements and six research questions were adopted by the plenary:

1. What is the optimal composition of diet for patients receiving treatment for active TB?

2. Should additional micronutrients be recommended as a component of normal care in patients being treated for active TB?

3. Should additional macronutrients be recommended to improve health outcomes for patients being treated for active TB?

4. Should food or monetary transfers be recommended to improve access and adherence to care for patients receiving treatment for active TB?

5. Does food assistance mitigate the financial and social consequences of TB?

6. Are there population level nutritional interventions which could reduce the progression from latent to active TB?

Once the questions were defined, the participants discussed who could perform the required systematic review and various colleagues/organizations indicted their interest in addressing the different questions. It was indicted that interested parties will be contacted for conducting the systematic reviews and meeting participants will be contacted to agree on role division and strategy for resource mobilization.

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Introduction

From November 2^nd to November 4^th2009 experts in nutrition, tuberculosis (TB) and related scientific areas met in Chateau de Penthes, Geneva to discuss the development of guidelines on nutrition/food support to prevent TB and to improve health status among TB patients.

Participants were experts in the areas of nutrition and tuberculosis and all of them submitted the declaration of non-conflict of interest. Following Guideline Review Committee (GRC) recommendations, they were selected considering their expertise as well as a balanced gender, regional and programmatic/research representation. Complete list of participants is included in annex 2.

Background material for the meeting consisted of identified systematic review on the association between TB and nutrition (see annex 3)

The objectives of the meeting were:

• To review the current evidence-base on TB and nutrition

• To review the potential for collaboration between TB and HIV programmes and nutrition

• To identify important knowledge gaps

• To define specific questions that can be addressed through further systematic reviews

• To define specific research gaps that need to be addressed with new original research

• To agree on scope of guidelines on nutrition and TB

• To establish a Guideline Group and agree on terms of references

• To outline plan of work (including commissioned systematic reviews) and budget for the full guidelines development

Summary of presentations

The directors of NHD (F. Branca) and STB (M. Raviglione) welcomed everybody and proposed the names of P. Kelly for Chairman, K. Lönnroth for co-Chairman and T. Bruendl for rapporteur of the meeting. R. Saadeh started with her presentation about the global burden of malnutrition (including over- and underweight) and its devastating impact to infants, children and adults. She also reported about malnutrition as a well known risk factor for TB and that TB affects nutritional status. R. Saadeh encouraged the participants to use the experience of the development of the Nutrition and HIV guideline, where they achieved a good result and to follow the WHO guidelines for writing guidelines.

The session on “The global situation on TB and nutrition” was opened by K. Lönnroth, who reported on the global burden of TB and its relationship with undernutrition and other risk

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factors and social determinants. Undernutrition has very high population attributable fraction for TB globally, and reduction in undernutrition in the general population could dramatically reduce TB incidence. The association between undernutrition and TB is bidirectional.

Different types of macro- and micronutrient deficiencies increase the risk of developing active TB, while TB leads to undernutrition and weight loss. Consequently, many people diagnosed with TB are undernourished at the time of diagnosis. Nutritional support is therefore often needed for people with TB. However, the evidence is lacking or weak for the impact of such support on specific TB treatment outcomes, such as cure rate, treatment interruption and death rate. Lönnroth highlighted the need for more research to inform policy on the role and type of nutritional support as part of the TB treatment and care package.

M. Diepart talked about HIV as an additional risk factor for TB, which also share many nutritional issues with TB. The highest burden area for both HIV and TB, Sub Saharan Africa, is also the area most affected by under- and malnutrition. Mortality rates in pregnant women are three times higher with HIV/ TB co- infection than in HIV alone, regardless of CD4⁺ count.

23.4% HIV positive children develop TB every year. M. Diepart reminded that the combination of HIV, TB and poor nutrition/ malnutrition status lead to high rates of morbidity and mortality and there is need to a better understanding of the mechanisms behind this, and the intervention options.

The second session was opened by S. Walleser, member of the WHO Guideline Review Committee. S. Walleser reported about the need for guidelines to create transparent and evidence-based WHO guidelines. Following steps have to b taken: (1) Scoping the document, (2) Group composition (or consultation), (3) Conflict of interest, (4) Formulations of the PICOT questions and choice of relevant outcomes, (5) Evidence retrieval, evaluations and synthesis, (6) Benefit/risk profile, (7) Formulation of the recommendations, (8) Implementation and evaluation of impact, (9) Research needs or areas of further research and (10) Peer- review process and updating. Aim of the scoping meeting was to fulfil (1) – (4). After formulating the PICOT questions, systematic reviews have to be done on each question and have to be graded with the GRADE working group software to determine the quality of evidence and strength of recommendation.

D. Kapetanovic presented results from a recent WFP/ WHO survey on the current situation on nutritional and food support to TB patients in countries with high TB and/or undernutrition burden. Two questionnaires (one for National TB programs and one for implementing partners) had been sent to 22 high burden TB countries and 36 high malnutrition prevalence countries. In 89% of surveyed countries nutritional advice was provided to TB patients, in

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63% of countries through counselling sessions, and in 37% through leaflets/fliers. Nutritional support had been provided to patients by 84% of countries. While 56% provide nutritional support to all TB patients, 44% provide nutritional support to specific patient subgroups, for example those with specific type of undernutrition, or people with multi-drug resistant TB. D.

Kapetanovic highlighted the great diversity in nutritional and food support across countries, which may be related to clear international guidelines on the topic. This was further underscored by the fact that 69% of countries stated that they require advice and technical support in order to provide nutritional support during TB management. WFP is currently conducting a scientific literature review on topics of nutrition, HIV/ AIDS and TB aimed at preparing the policy papers for WFP Executive Board consideration in 2010. This process should be tightly linked to the process of developing WHO guidelines.

D. Sinclair from the Cochrane Collaboration presented the results of the systematic review

“Nutritional supplements for people being treated for active tuberculosis" by K. Abba et al., 2008. The result showed that there are no well performed RCTs that demonstrate that nutritional supplements improve recovery in children with TB, that there is no evidence that nutritional supplements reduce deaths or improve cure rates during treatment for active TB in HIV negative adults and that there is some evidence that some types of nutritional supplements (Zinc plus multi-micronutrients or Zinc plus vitamin A) improve weight gain in adults with active TB. The review concluded that there are many unanswered questions and research gaps.

P. Papathakis reported about food packages as an enabler to improve TB therapy adherence. The aim of food support is to promote and enable people to approach health services for treatment and stay on treatment by reducing potential barriers such as loss of wages and food insecurity. This could lead to increased TB case detection and improved adherence to TB treatment, while also facilitating nutritional recovery and optimizing response to medical treatment. Finally, it can be seen as a form of livelihood support to alleviate some of the financial burden for patients and their families. Food support can be provided in different types like hot meals, dry ration or vouchers and by different styles of delivery (e.g. weekly, every second week, from health facility, a local store). Besides assistance to affected patients, food packages may also be provided to family members, as well as to health and social workers in order to improve teamwork and performance and to minimize risk of fraudulent behaviour, such as registration of "ghost patients", theft and corruption. P. Papathakis concluded that a well-working food package program should be linked to staff and health education and furthermore to the socioeconomic status (improve economic status of the family, wellbeing), the health care system, treatment and patients.

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Though several positive experiences of the effects of food packages on case detection and treatment adherence have been reported from countries, P. Papathakis emphasized rigorous scientific evaluations were few and provided mixed results.

In a second presentation, P. Papathakis, summarized key messages on the effect on TB on the nutritional status like severe weight loss, altered protein metabolism, micronutrient deficiency (such as Vitamins A, D, E, C; minerals zinc, selenium) and anaemia. She also reported about the improved nutritional status (weight gain, increased appetite and food intake) with TB drug therapy. Finally she said that food assistance may both decrease the cost of staying on treatment and improve the nutritional status, while good nutritional status has definitely an impact on “quality of life” and the ability to return back to work. Most of these reports on benefit are anecdotal and no systematic evaluation has been performed.

A. Van Rie informed about the current state of knowledge in TB, HIV and nutrition in children.

There are large data gaps on the effect of nutritional supplements on TB treatment and children, in TB/ HIV co- infected children and the overall childhood mortality. However, there is data on children, nutrition and HIV suggesting that undernutrition is frequently present in HIV infected children and is a strong predictor of mortality in children on ART. It has been reported that HIV positive children have increased energy needs. A. Van Rie suggested focus on the following unanswered questions: which nutritional supplements improve the outcome of TB treatment in HIV infected children? Which nutritional interventions prevent TB infection and/ or progression to disease in children? And how do we address the three needs: intensive re-feeding, TB treatment and ART?

The Fourth Session was opened by P. Cegielski, who presented over telephone from CDC, Atlanta, US. He reported on the need to determine the relative risk of TB due to undernutrition, independent from other risk factors and to determine the population attributable risk of TB due to undernutrition. He presented data from the USA, based on the NHANES study, with baseline data on BMI and other macro nutritional indicators from 1971 – 1975, and follow up of TB occurrence among 23.808 individuals until 1992. The study showed a dose-response relationship between BMI and TB risk, with risk of TB increasing with lower BMI. Low BMI had a very high population attributable fraction for TB in the USA in the 1970s and 1980s.

The session on country cases was opened by H. Habib with a presentation on the burden of TB in Afghanistan and the experiences of nutritional support to TB patients. The all case TB incidence is 168/ 100.000 per year; the prevalence of all cases is 238/ 100.000 people.

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DOTS was adopted in 1997 and has achieved very good results. H. Habib reported on the food assistance mechanism, where all people diagnosed with TB registered for treatment in the national TB programme should receive a family ration of food, which will feed the family for 8 months. He further reported on a study of 500 TB patients, which showed that 45 % earned less than $ 40 a months and 86.4% had no education. H. Habib concluded that one of the most important enablers for starting and adhering to TB treatment in Afghanistan was free food assistance, although the transportation of the food packages turned out to be a problem. However, he also highlighted that no rigorous scientific evaluation of the initiative has been carried out.

I. Onozaki reported about the experiences of food support to TB patients in Cambodia.

During the period when TB treatment was provided mainly in hospitals, food support was an essential enabler for patients to adhere to treatment, as this partly alleviated the high economic burden of long hospitalization. When decentralization of treatment to primary health care and the community was done, and long time hospitalization seized, the need for food support decreased. Food support continued for some time as part of the decentralized approach, but has recently stopped. It has not been carefully evaluated if this has led to worse treatment outcome or other negative consequences.

P. Kelly presented a study conducted in East Timor (FITTCET study). An RCT was conducted in three urban clinics in Dili to test if nutritional supplementation is an effective adjunctive therapy to enhance TB treatment adherence. In the intervention arm, food support was provided during daily treatment visits to health facilities, while in the control arm only nutritional advice was provided. Conventional TB chemotherapy was provided in both arms.

The study found slightly higher weight gain and reduction in TB symptoms (cough) in the intervention group compared to the control group, but no effect on treatment adherence or other TB treatment outcomes. Actual differences in food intake between the two arms were not known, and the study was analysed on an intention-to-treat basis.

V. Bond from Zambia presented a study conducted in 2006 – 2007 in Zambia and peri- urban South Africa. This anthropological study reported on the experiences of people living with TB in a high HIV prevalence setting with severe food insecurity. Eighteen TB patient households and seventeen comparative non-affected households were visited and data on anthropometric measurements, food, food intake, needs, food aid, welfare support and perceptions and experiences of patients and their families were collected. Findings flag the vulnerability of poor rural households who were tipped into deeper poverty by the presence of TB. Across both countries, most TB patients were unable to work whilst ill. Despite the

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loss of income, all households strived to seek treatment and purchase special food, often incurring debt and selling assets in the process. More extreme and irreversible coping strategies were recorded in Zambia where there was no welfare assistance for TB patients and the nutritional status of children under the age of five in TB patient households significantly worsened by the end of 8 months of TB treatment. In South Africa, the disability grant and sporadic food aid boosted the affected households’ ability to recover from TB.

M. Rossi reported about her experiences with the IAP (Integrated AIDS Program) on food support in Zambia. The program has started in 1992 and targeted chronically ill patients (95% HIV positive). In 1998 they integrated TB care and implemented DOTS by training volunteers as DOT Supervisors. Due the fact of extreme need of food, food rations and supportive treatment were delivered to the people. From the patients’ perspective, food aid was regarded as the most critical element of Home Care package after medical treatment.

Despite the quite good success of IAP, there are challenges to face like sustainability, risk of corruption and the need to twin food support with the empowerment of patients to avoid dependency.

The last presentation was done by F. Erdelmann from WFP. She reported about latest WFP projects and the connection between HIV/ AIDS, drugs, food insecurity and poverty. She also reported about the food by prescription (FBP) objectives (nutritional rehabilitation and/or nutrition support, social safety nets mechanisms, livelihood activities), the role of food and nutrition, the different FBP models (clinic based, clinic- plus, community based) and how to measure success. There are still challenges to face how to handle food in the health sector:

commodities, staff capacity, infrastructure, supply chain management.

Summary of group work

C. Casanovas and K. Lönnroth introduced the group work: the participants were divided in five groups to discuss five topics, encompassing the value of nutritional support for both secondary prevention (preventing TB diseases among people with confirmed / suspected TB infection), and tertiary prevention (preventing negative consequences among people with active TB disease). The aim was to formulate questions using the PICOT framework (see WHO guideline handbook) in order to identify specific research questions and study

outcomes that should be addressed through systematic reviews before guidelines on TB and nutrition can be developed.

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Group 1: Improve TB treatment outcomes through improved immunity (P. Kelly, JP Pena- Rosas, C. Charparro, H. Habib)

Group 2: Improve accessibility, adherence and financial protection through enabling food packages (reducing financial barriers to care, plus financial compensation)

(K. Lönnroth, V. Bond, A. Baddeley, M. Rossi, N. Grede)

Group 3: Improve nutritional rehabilitation and general wellbeing (D. Sinclair, C. Casanovas, D. Kpetanovic, B. Cogill)

Group 4: Reduce incidence of TB through improved immunity (A. van Rie, R. Saadeh, P. Fergusson)

Group 5: Background information about the link between TB and nutrition (P. Papathakis, F. Erdelmann, T. Bruendl, I. Darton Hill)

To assist the group discussions handouts about the considerations in TB/ nutrition and the PICOT framework were provided and S. Walleser from GRC assisted as well. The five groups had 90 minutes to develop questions. Each group presented priority questions and main outcomes, which were further discussed in plenum. The outputs are summarized in Annex 3.

Summary of final plenary to agree on scope of guidelines and way forward

The third day (November 4^th 2009) started with a discussion of conflict of interests.

Afterwards, D Sinclair presented six priority questions which had been distilled from group work discussion the day before. The meeting discussed and refined these questions further.

The following research questions were adopted by the plenary (further specifications are provided in Annex 4):

1. What is the optimal composition of diet for patients receiving treatment for active TB?

2. Should additional micronutrients be recommended as a component of normal care in patients being treated for active TB?

3. Should additional macronutrients be recommended to improve health outcomes for patients being treated for active TB?

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4. Should food or monetary transfers be recommended to improve access and adherence to care for patients receiving treatment for active TB?

5. Does food assistance mitigate the financial and social consequences of TB?

6. Are there population level nutritional interventions which could reduce the progression from latent to active TB?

The meeting then discussed who could perform the required systematic reviews. The WFP team announced that questions (1), (2), (3) are already being addressed in the ongoing Review on TB and Nutrition by WFP, and that they would be further interested in question (4) and (5). D. Sinclair announced that the Cochrane TB group was already planning work on questions 2, 3 and 4, and would be interested to pursue these questions further. Kelly was also interested to work on question (1), (2) and (3), P. Papathakis on question (1) and (3), Bond in (4) and (5).

Afterwards the resources for the project were discussed: WFP stated that they are already supporting the project. P. Papathatkis suggested that USAID should be approached. M. Aziz from the Global Fund wanted to have more and concrete information to explore possible support for the project from the Global Fund.

R. Saadeh announced that WHO will make final decisions about which questions to focus on in the planned systematic reviews and the forthcoming guidelines. All meeting participants will be further contacted to agree on role division and strategy for resource mobilization to conduct the required systematic reviews.

The next meeting for the development of guidelines will be in summer 2010.

F. Branca and D. Weil (senior policy adviser in STB) closed the meeting with encouraging words and thanked everybody for participating and working so hard and motivated during the last two and a half days.

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Annex 1

PROGRAMME

Monday 2 November 2009

08:30 - 09:00 Registration 1. Introduction Session

09:00 - 09:15 1.1. Welcome and Opening Address

Francesco Branca and Mario Raviglione

09:15 - 09:30 1.2. Introduction of the participants 09:30 - 09:40 1.3. Administrative arrangements

09:40 - 09:55 1.4. Objectives and expected outcome of the meeting Randa Saadeh

09:55 - 11:30 1.5. Global Situation

09:55 - 10:15 1.5.a. Burden of TB, importance of undernutrition and other risk factors Knut Lönnroth

10:15 - 10:35 1.5.b. TB and HIV co-infection, importance of undernutrition Micheline Diepart

10:35 - 11:00 Coffee break

11:00 -11:30 1.5.c. Current situation on nutritional/food support in countries - results from a recent survey

Danina Kapetanovic

11:30 - 12:00 1.6. Guidelines Review Committee and the guidelines development process

Silke Walleser

12:00 - 13:30 Lunch 2. Current state of knowledge

13:30 - 14:00 Undernutrition as a risk factor for TB

Peter Cegielski/Ernesto Jaramillo

14:00 - 14:30 The value of nutritional support for TB treatment outcomes: results from a Cochrane Review

David Sinclair

14:30 - 15:00 Food packages as incentive to improve TB treatment adherence Peggy Papathakis

15:00 - 15:30 Paediatric aspects related to TB, HIV and nutrition Annelies Van Rie

15:30 - 16:00 Coffee break

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3. Programmatic aspects

16:00 - 17:30 Country cases

• Afghanistan - Habibullah Habib

• Cambodia - Ikushi Onozaki

• East Timor - Paul Kelly

• Somalia - Ireneaus Sindani

Discussion on programmatic aspects of nutritional support

Tuesday 3 November 2009

09:00 - 10:00 Country cases

• Kenya - Joseph Sitienei

• Zambia/South Africa - Virginia Bond

Sub-regional case: Experiences from the integration of food and nutrition ART support programmes - from East & Southern Africa - Francesca Erdelmann Discussion on programmatic aspects of nutritional support

4. Agreement on scope of the guidelines and questions Facilitator/Methodologist: David Sinclair

10:00 - 10:30 Scoping work to date

Knut Lönnroth/Carmen Casanovas

10:30 - 10:50 Coffee break 10:50 -12:00 Plenary discussion:

Defining questions and outcomes 12:00 - 13:30 Lunch

13:30 - 15:30 Plenary discussion Prioritizing questions 15:30 - 15:50 Coffee break

15:50 - 17:30 Plenary discussion Defining knowledge gaps

Identifying needs for review or original research Wednesday 4 November 2009

09:00 - 09:30 Review of day 2 5. The way forward

09:30 - 12:30 Establish

- Steering Committee and TOR - External Guidelines Group and TOR Develop work plan, define next steps

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Annex 2

L I S T O F P A R T I C I P A N T S

Participants

Virginia Bond

Social Anthropologist Director, ZAMBART Project Lecturer, Health Policy Unit,

Department of Public Health and Policy

London School of Hygiene and Tropical Medicine, London WC1

P.O. Box 50697 Lusaka,

ZAMBIA

Tel.: +260 211 254 710 Fax:

Email: GBond@zambart.org.zm Virginia.Bond@lshtm.ac.uk

Tina Bründl

Fritz Kandlgasse 1/1/18 1210 Vienna

AUSTRIA

Tel.: +43 699 1065 8805 Email: tina.bruendl@spcorp.com

Peter Cegielski

Centers for Disease Control and Prevention Mailstop E-10

1600 Clifton Rd, NE Atlanta, GA 30333

UNITED STATES OF AMERICA

Tel.: +1 404 639 5329 Fax:

Email: gzc2@cdc.gov pcefielski@cdc.gov

Paul Kelly

Associate Professor Director,

Master of Applied Epidemiology Program,

National Centre for Epidemiology & Population Health, College of Medicine, Biology & Environment,

Australian National University.

Building 62, Corner Mills & Eggleston Rds, Acton, Canberra, ACT. 0200.

AUSTRALIA

Tel.: +61 2 6125 56 09 Fax: +61 2 6125 0740 Email: paul.kelly@anu.edu.au

Peggy C. Papathakis Assistant Professor

Food Science and Nutrition Department California Polytechnic State University San Luis Obispo

CA 93407

Tel.: +1 805 756 7205 Fax: +1 805 756 1146

Email: ppapatha@calpoly.edu thakis5@yahoo.com

Maria Mercedes Rossi Infectiologist

Geneva' Representative of the Association Comunita' Papa Giovanni XXIII

1 rue de Varembè Case Postale 96 1211 Geneva 20.

SWITZERLAND

Tel.: +41 22 919 10 42 Fax: +41 22 919 10 48 Mobile: +41 79 882 49 80 Email: mrossi@apg23.org

mararossi.apg23@gmail.com

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David Sinclair

c/o South Asian Cochrane Centre Carman Block

Christian Medical College Vellore 632002

Tamil Nadu INDIA

Tel.: +91 95 17 6373 Fax:

Email: davesinkers@yahoo.com

Annelies Van Rie Associate Professor

Department of Epidemiology

University of North Carolina at Chapel Hill 2104h Mcgavran-Greenberg Hl

135 Dauer Drive Campus Box 7435

Chapel Hill, NC 27599-7435 UNITED STATES OF AMERICA

Tel.: +1 919 966 1420 Fax: +1 919 966 2089 Email: vanrie@email.unc.edu

Global Alliance for Improved Nutrition (GAIN) Bruce Cogill

Global Alliance for Improved Nutrition (GAIN) Nutrition and Infectious Diseases

Rue de Vermont 37-39 1202 Geneva

SWITZERLAND

Tel.: +41 22 749 1766 Fax: +41 22 749 1851

Email: bcogill@gainhealth.org

The United Nations Joint Programme on HIV/AIDS (UNAIDS) Alasdair Reid

UNAIDS HIV/TB Adviser

Prevention, Care and Support Unit

Epidemic Monitoring and Policy Department 1211 Geneva 27

SWITZERLAND

Annabel Baddeley UNAIDS

Prevention, Care and Support Unit

Epidemic Monitoring and Policy Department 20 Avenue Appia

1211 Geneva 27 SWITZERLAND

Tel.: +41 22 791 4409 Fax:

Email: reida@unaids.org

Tel.: +33 643 07 59 63 Fax:

Email: baddeleya@unaids.org

World Food Programme (WFP) Ian Darnton-Hill

Professor (Adjunct)

Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA,

c/o 71 Broadway, Apt.2E New York, NY10006

Tel.: +1 212 809 2238 Fax: +1 917 856 7321 Email: idarntonhi@aol.com Ian.Darnton_Hill@tufts.edu

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Francesca Erdelmann

Programme Advisor HIV/AIDS, Nutritionist HIV/AIDS technical support team

Regional Bureau for Southern, Eastern and Central Africa

World Food Programme Merafe House,

11 Naivasha Road Sunninghill 2157 Johannesburg SOUTH AFRICA

Tel.: +27 11 517 580 Cellular: +27 82 908 1429 Fax: +27 11 517 1642

Email: Francesca.Erdelmann@wfp.org

Danina Kapetanovic

Nutrition and HIV/AIDS Policy Unit World Food Programme

via Giulio Cesare Viola 68-70 Rome, 00148

ITALY

Tel.: +39 06 6513 3065 Fax:

Email: Danina.Kapetanovic@wfp.org

Grede Nils

Nutrition and HIV/AIDS Policy Unit World Food Programme

via Giulio Cesare Viola 68-70 Rome, 00148

ITALY

Tel.: +39 06 6513 3183 Fax:

Email: Nils.Grede@wfp.org

President's Emergency Plan for AIDS Relief (PEPFAR) William Coggin

PEPFAR, Senior Technical Officer, TB/HIV 2100 Pennsylvania Ave, Suite 200

SA-29, 2nd Floor Washington DC 20522

Tel.:

Fax:

Email: CogginWL@state.gov

The Global Fund to Fight AIDS, TB and Malaria (GFATM) Mohamed Abdel Aziz

Senior TB Advisor Health Advisory Unit

The Global Fund to Fight AIDS, Tuberculosis and Malaria

Chemin de Blandonnet 8 1214 Vernier

SWITZERLAND

Tel.: +41 58 791 1422 Fax: +41 58 791 1701

Email: mohamed.abdelaziz@theglobalfund.org

Food and Nutrition Technical Assistance (FANTA 2) Academy for Educational Development

Camila Chaparro, Research Specialist

Food and Nutrition Technical Assistance II Project (FANTA-2)

Academy for Educational Development 1825 Connecticut Ave. NW

Tel.: +1 202 884 8011 Fax: +1 202 884 8432 Email: cchaparro@aed.org

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Washington DC 20009-5721

Pamela Fergusson Nutrition and HIV Advisor

Food and Nutrition Technical Assistance II Project (FANTA 2)

Academy for Educational Development 1825 Connecticut Ave. NW

Washington DC 20009-5721 UNITED STATES OF AMERICA

Tel.: +1 202 464 3964 Fax:

Email: pfergusson@aed.org

International Food Policy Research Institute (IFPRI) Stuart Gillespie

Director, Regional Network on HIV/AIDS, Livelihoods & Food Security (RENEWAL)

Senior Research Fellow, IFPRI c/o WHO, 20 Avenue Appia Geneva 1211

SWITZERLAND

Tel.: +41 22 791 4925 Fax:

Email: gillespies@who.int

Countries

Habibullah Habib

Head of New Initiative Department National TB Control Programme Ministry of Public Health

Darul Aman Sanatorium Road Kabul

AFGHANISTAN

Tel.: +93 700 20 68 13 Fax:

Email: ntp.h.habib@gmail.com

World Health Organization (WHO)

Nutrition for Health and Development (NHD) Francesco Branca

Director

Tel.: +41 22 791 1025 Fax: +41 22 791 4156 Email: brancaf@who.int Maria del Carmen Casanovas

Technical Officer

Country Focused Nutrition Policies & Programmes (NPL)

Tel.: +41 22 791 2968 Fax: +41 22 791 4156 Email: casanovasm@who.int

Randa Saadeh Scientist

Tel.: +41 22 791 3315 Fax: +41 22 791 4156 Email: saadehr@who.int

Ann-Beth Moller Technical Officer

Tel.: +41 22 791 4967 Fax: +41 22 791 4156 Email: mollera@who.int

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Juan Pablo Pena-Rosa

Coordinator

Reduction of Micronutrient Malnutrition (MNM)

Tel.: +41 22 791 2175 Fax: +41 22 791 4156 Email: penarosasj@who.int

Stop TB (STB) Mario Raviglione Director

Tel.: +41 22 791 2663/2514 Fax:

Email: raviglionem@who.int Ernesto Jaramillo

Medical Officer

TB/HIV and Drug Resistance (THD)

Tel.: +41 22 791 3034 Fax:

Email: jaramilloe@who.int Knut Lönnroth

Medical Officer

TB Strategy and Operations (TBS)

Tel.:+41 22 791 1628 Fax:

Email: lonnrothk@who.int Ikushi Onozaki

Medical Officer

TB Strategy and Operations (TBS)

Tel.: +41 22 791 2583 Fax:

Email: onozakii@who.int

HIV/AIDS Micheline Diepart Medical Officer

Anti-retroviral Treatment and HIV Care (ATC)

Tel.: +41 22 791 5486 Fax:

Email: diepartm@who.int

Child and Adolescent Health and Development (CAH)

Constanza Vallenas Medical Officer

Country Implementation Support (CIS)

Tel.: +41 22 791 4143 Fax:

Email: vallenasc@who.int

Nigel Rollins Scientist

Newborn and Child Health and Development (NCH)

Guidelines Review Committee (GRS)

Tel.: +41 22 791 4624 Fax:

Email: rollinsn@who.int

Silke Walleser Technical Officer

Research Policy and Cooperation (RPC) Regina Kulier

Research Policy and Cooperation (RPC)

Tel.: +41 22 971 2162 Fax:

Email: wallesers@who.int Tel.: +41 22 791 2409 Fax: +41 22 791 4169

Email: regina.kulier@gmail.com

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Annex 3

Background documents

1. Abba K et al. Nutritional supplements for people being treated for active Tuberculosis.

Cochrane database of Systematic Reviews. 2008, Issue 4.

2. Academy of Science of South Africa. HIV/AIDS, TB and nutrition - Scientific inquiry into the nutritional influences on human immunity with special reference to HIV infection and active TB in South Africa. Pretoria, South Africa, 2007.

3. Beith A et al. Performance-Based Incentives for Health: A Way to Improve Tuberculosis Detection and Treatment Completion? CGD Working Paper # 122 April 2007. The Center for Global Development, Washington DC, USA, 2007.

4. Cegielski JP, McMurray DN. The relationship between malnutrition and tuberculosis:

evidence from studies in humans and experimental animals. International Journal of Tuberculosis and Lung Disease. 2004, 8(3): 286-298.

5. Lönroth K et al. A consistent log-linear relationship between tuberculosis incidence and body mass index. International Journal of Epidemiology 2009: 1-7

6. Papathakis P, Piwoz E. Nutrition and Tuberculosis: A review of the literature and

considerations for TB control programs. USAID/AED Africa's Health in 2010. Washington DC, USA, 2008.

7. WHO Handbook for Guideline Development - Draft October 2009. Geneva, World Health Organization, 2009.

Other documents used as reference

1. Bond V et al. The converging impact of tuberculosis, HIV/AIDS and food insecurity in Zambia and couth Africa. Final Working Report, February 2009. Renewal Programme.

2. Martins N et al. Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste. British Medical Journal 2009; 339:b4248

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Annex 4

Updated questions NUT/TB

1. What is the optimal composition of diet for patients receiving treatment for active TB?

2. Should additional micronutrients be recommended as a component of normal care in patients being treated for active TB?

3. Should additional macronutrients be recommended to improve health outcomes for patients being treated for active TB?

4. Should food or monetary transfers be recommended to improve access and adherence to care for patients receiving treatment for active TB?

5. Does food assistance mitigate the financial and social consequences of TB?

6. Are there population level nutritional interventions which could reduce the progression from latent to active TB?

Additional notes on NUT/TB questions:

1. What is the optimal composition of the diet for patients during treatment for active TB?

• A background question.

• Generates hypotheses and informs general nutritional advice

What are the nutritional requirements for a patient with TB +/- HIV +/-ART with:

• BMI <18.5

• BMI 18.5 to 25

• BMI >25

• Breastfed infant/Children/adolescent?

• Pregnant/lactating

• Vegetarian diet

• By stage of TB treatment

Supplementation programmes could be operationalised by comparison of these nutritional needs to locally available foods and intake Are there other aspects of advice that require recommendations? E.g. should TB patients eat separately, or use separate utensils?

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2. Should additional micronutrients be recommended as a component of normal care in patients being treated for active TB?

Population subgroups of

interest Interventions Controls Outcomes

• Infant/Child/adolescent/

Adult

• Underweight/not underweight

• HIV-ve/HIV+ve

• HIV+ve on ART/no ART

• MDR-TB/XDR-TB

• Pregnancy/Lactation

• Vulnerable groups:

Homeless/alcoholic/ IV drug use

• High income/Low Income countries?

• Food insecure settings

• IDP/refugee

Single nutrient

• Vit A,

• Vit C

• Vit D

• Vit E

• Arginine

• Zinc

• Iron

• Selenium

Combinations Multi-micronutrients

Normal care +/- Dietary advice +/- Placebo

4 groups of outcome measures were all considered critical to decision making (plus cost) i.e. A clinically significant improvement in any one of: ‘TB

Outcomes’, ’Nutritional Recovery’ or ’Quality of Life’ might lead to a

recommendation; if the benefits outweigh the risks ‘Adverse events’ and if cost effective

TB outcomes

• All-cause Death (End of treatment)

• Treatment success (End of treatment)

• Duration of sputum positivity (?weekly/monthly) Time to sputum conversion

• Relapse rate (2 years)

• Symptom resolution (cough)

• Acquired drug resistance

• Cure (6m-8m) (18-24m for MDRTB)

• Default rate

• Completed treatment

• Reduced complications of nutrient deficiency

• Chest x-ray clearance (children)

Nutritional recovery

• Anaemia

• Normalised vitamin levels

• Weight gain (absolute/%) Age specific measurement

• Measures of immunity

Quality of life

• Many available measures/scales

Adverse events

• Vitamin toxicity e.g. Hypercalcaemia, Nausea, vomiting, Iron overload Cost & cost effectiveness

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3. Should additional macronutrients be recommended to improve health outcomes for patients being treated for active TB?

• Infant/Child/adolescent/Ad ult

• HIV-ve/HIV+ve

• MDR-TB/XDR-TB

• IDP/refugee

• On-site rations (daily)

• Off-site rations (daily)

• Weekly ration

• Monthly ration

• Nutrient dense supplements

Normal care +/- Dietary advice or head-to-head trials

4 groups of outcome measures were all considered critical to decision making (plus cost) i.e. A clinically significant improvement in any one of: ‘TB

Outcomes’, ’Nutritional Recovery’ or ’Quality of Life’ might lead to a

recommendation; if the benefits outweigh the risks ‘Adverse events’ and if cost effective

TB outcomes

• All-cause Death (End of treatment)

• Treatment success (End of treatment)

• Duration of sputum positivity (?weekly/monthly) Time to sputum conversion

• Relapse rate (2 years)

• Symptom resolution (cough)

• Acquired drug resistance

• Cure (6m-8m) (18-24m for MDRTB)

• Default rate

• Completed treatment

• Reduced complications of nutrient deficiency

• Chest x-ray clearance (children)

Nutritional recovery

• Anaemia

• Normalised vitamin levels

• Weight gain (absolute/%) Age specific measurement

• Measures of immunity

Quality of life

• Many available measures/scales

Adverse events

• Vitamin toxicity e.g. Hypercalcaemia, Nausea, vomiting, Iron overload Cost & cost effectiveness

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4. Should food or monetary transfers be recommended to improve access or adherence to care for patients receiving treatment for active TB?

• HIV-ve/HIV+ve

• MDR-TB/XDR-TB

• IDP/refugee

• Weekly ration

• Monthly ration

• Food vouchers

• E-vouchers

• Money

• Other

Improved access

• Case detection rate (%)

• Case notification rate

• Initial default rate Improved adherence

• Default rates

• Completed treatment (6-8M)

• Proportion of planned appointments attended Adverse events

• Ghost patients

• Fake extenders

• Social tension and resentment towards TB patients and HH

• Dependency

• Transportation cost for accessing food package

• Theft

• Corruption

• Distraction from core mission

• Overburdening of programs Cost & cost effectiveness

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5. Does food assistance mitigate the financial and social consequences of TB?

• HIV-ve/HIV+ve

• MDR-TB/XDR-TB

• IDP/refugee

• Weekly ration

• Monthly ration

• Food vouchers

• E-vouchers

• Money

• Other

• Reduced poverty (income, assets)

• Increased number of daily meals

• Dietary diversity

• Reduced negative coping mechanisms (taking out loan, selling assets, taking kids out of school, prostitution, etc)

• Higher percentage with maintained livelihood

• Food expenditure (absolute values / % of total exp) Cost & cost effectiveness

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6. Are there population level nutritional interventions which could reduce the progression from latent to active TB?

Population/Setting Interventions Controls Outcomes Emergencies

High proportion of population undernourished

Contacts of TB

•Single nutrient

•Food fortification

•Food distribution

Reduced incidence of active tuberculosis

Possible additional questions:

In patients with active TB what are the most reliable nutritional measurements?

In undernourished patients with Active TB what drug dose adjustments should be made?

Context specific recommendations?

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For further information please contact

Department of Nutrition for Health and Development (NHD) Email: nutrition@who.int

Web: www.who.int/nutrition

Department of Stop TB Email: tuberculosis@who.int Web: www.who.int/tb World Health Organization 20, Avenue Appia

1211 Geneva 27, Switzerland

ISBN 978 92 4 159977 1