Всемирная организация здравоохранения (ВОЗ / WHO) · Technical Documents

Implementation and sustainability of HIV drug resistance surveillance in Africa Addis Ababa, Ethiopia

31 июля 2014 г. Всемирная организация здравоохранения

Полный текст размещён на сайте публикующей организации. lawenc.com индексирует метаданные и ведёт на официальный источник.

Полный текст

WHO/HIV/2014.5

HIV DRUG RESISTANCE

MEETING REPORT

IMPLEMENTATION & SUSTAINABILITY OF HIV DRUG RESISTANCE SURVEILLANCE IN AFRICA ADDIS ABABA, ETHIOPIA 25–27 JUNE 2013

MEETING REPORT

IMPLEMENTATION & SUSTAINABILITY OF HIV DRUG RESISTANCE SURVEILLANCE IN AFRICA ADDIS ABABA, ETHIOPIA 25–27 JUNE 2013

© World Health Organization 2014 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Layout by L’IV Com Sàrl, Villars-sous-Yens, Switzerland.

TABLE OF CONTENTS 1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2. Meeting Objectives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3. Participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4. Meeting overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Session 1: Overview of HIV Drug Resistance (HIVDR) at the global level and WHO’s response. . Session 2: WHO Early Warning Indicators (EWIs) of HIV Drug Resistance . . . . . . . . . . . . . . . .

3 3 4 4 5 6 6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Session 3: Surveillance of transmitted HIV Drug Resistance (TDR) in recently infected individuals. . Session 4: Surveillance of HIV Drug Resistance in populations initiating ART; i.e. PDR. . Session 5: Surveillance of acquired HIV resistance in patients on ART.

. . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Session 6: Surveillance of initial HIV Drug Resistance in paediatric populations <18 months of age. . Session 7: Country presentations of identified priorities for HIVDR surveillance. . Session 8: Summary of proposed draft country HIVDR work plans 2013-2017. Session 9: WHO HIVDR laboratory network update. . Session 10: Closing remarks. Acknowledgements .

. . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . .

12 19 19 19

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ANNEX 1: List of Participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 ANNEX 2: Agenda. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

1. INTRODUCTION In 2004, WHO and the United States Centers for Disease Control and Prevention (US-CDC), in collaboration with HIVResNet, developed a global strategy for the assessment and prevention of HIVDR. To date, one or more element of the strategy has been implemented in over 50 countries. However, lessons learned from implementation and the evolution of ART programmes suggested that parts of the strategy required updating. In order to maximize country input throughout the revision process and ensure a transparent and collaborative effort, a series of regional consultations were organized between February and July 2013 in Beijing (China), Brasilia (Brazil), Montpellier (France, for francophone African countries), Addis Ababa (Ethiopia) and Cape Town (South Africa) involving country programme managers, technical experts and local and international partners. It is expected that revised methods should facilitate survey implementation and the timely and accurate collection of HIVDR data. New population-based HIVDR surveys should generate nationally representative data to better detect trends over time and improve programme planning and decision making. This report concerns the regional consultation held in Addis Ababa. This consultation was organised with logistics support from the Ethiopian Public Health Association and from the African Society for Laboratory Medicine, whose support WHO would like to gratefully acknowledge.

2. MEETING OBJECTIVES The meeting had four main objectives: i. Provide a platform for countries to share their experiences in implementing HIVDR surveillance activities, ii. Introduce draft revised methods for the surveillance of transmitted, pre-treatment and acquired HIV Drug Resistance and obtain country and partner feedback, iii. Assist countries in the development of draft national HIVDR surveillance plans using available country-specific data, and iv. Identify technical support needs that WHO will need to provide in the short term to assist with implementation.

3. PARTICIPANTS ART programme managers, WHO-AFRO office, WHO-HQ, African Society for Laboratory Medicine (ASLM), PharmAccess African Studies to Evaluate Resistance (PASER), United States Centers for Disease Control and Prevention (US-CDC) and regional experts in HIVDR surveillance (list of participants can be found in Annex 1).

4. MEETING OVERVIEW The meeting was held between June 25 and June 27 2013 and discussions were arranged so as to provide an opportunity for countries to present their experiences in implementing HIVDR surveys using old survey methods, followed by presentations of proposed new draft survey approaches and the development of country plans for the period of 2013-2017. Day 1: (i) presentation of key results from WHO’s Global HIVDR Report 2012, (ii) early warning indicators (EWI), (iii) transmitted drug resistance (TDR), and (iv) Pre-treatment HIVDR (PDR). Day 2: (i) acquired drug resistance (ADR) and (ii) HIVDR in children. Day 3: provided an opportunity for countries to develop, with the support of WHO, country plans for the implementation of HIVDR surveys using proposed new survey methods during the period 2013-2017. The full meeting agenda can be found in Annex 2. overview of the simplifications introduced in 2012 to the recommended set of EWI and their respective targets. Revised guidance recommends that four indicators should be collected and abstracted by all clinics as part of routine monitoring and evaluation: i. ii. iii. iv. On-time pill pickup Retention in care at 12 months Pharmacy stock-outs Dispensing practices

A fifth indicator, viral load (VL) suppression at 12 months, is conditional and should only be monitored in clinics where routine viral load measurement is performed on all patients 12 month after ART initiation. WHO currently provides a target for clinic level viral load suppression for the 12 month time point. Because WHO 2013 treatment guidelines recommend viral load testing 6 months after ART initiation and annually thereafter, new viral load suppression targets for 6 and 18 months will be developed. Early warning indicators should be monitored at all sites dispensing ART. It was emphasized that this can be accomplished progressively through inclusion of larger and larger numbers of sites (ideally sampled in a representative way until all sites in a country are reporting EWI annually). When a representative sample of ART clinics is used, data may be aggregated to estimate each indicator at the national level. EWI alert programme managers and signal the need for additional investigation. In 2012, EWI underwent a simplification process and attempts were made to harmonize definitions with other internationally reported indicators. Specifically, the EWI LTFU was dropped from the set of indicators and the retention indicator which was kept and the definition changed to be identical to the UNGASS 12-month retention indicator. EWI: Topics discussed during question and answer period • How can EWI data abstraction move from a centralized to a decentralized procedure whilst preserving the quality of the data? • How can EWI be best integrated in the ART programs? • What kind of data quality monitoring exists in countries and what kind of guidelines should WHO provide in this matter? • How can EWI data abstraction move from a centralized to a decentralized procedure whilst preserving the quality of the data? • How can EWI be best integrated in the ART programs?

Session 1: Overview of HIV Drug Resistance (HIVDR) at the global level and WHO’s response A brief summary of the WHO HIV Drug Resistance Report 2012 was presented. An overview the WHO Early Warning indicators (EWI) of HIVDR, which underwent revision and simplification in 2012 was presented. Additionally, overviews of draft revisions to the four assessment elements of the global strategy requiring HIVDR genotyping were presented: i. Transmitted drug resistance (TDR) surveys ii. Pre-treatment drug resistance (PDR) surveys in ARVnaive and ARV-exposed individuals iii. Acquired drug resistance (ADR) surveys iv. Surveys of HIVDR in infants < 18 months of age (paediatric) v. Finally, it was stated that the Global Fund for AIDS Tuberculosis and Malaria has encouraged countries for funding of HIVDR surveillance activities.

Session 2: WHO Early Warning Indicators (EWIs) of HIV Drug Resistance This session discussed key lessons from the field in implementing the first generation of EWIs, and provided an

• What kind of data quality monitoring exists in countries and what kind of guidelines should WHO provide in this matter?

Session 3: Surveillance of transmitted HIV Drug Resistance (TDR) in recently infected individuals A draft WHO concept note on the surveillance of transmitted HIV Drug Resistance in recently infected populations was presented for feedback and discussion. The main goal of TDR surveillance is to inform optimal regimen selection for pre- or post-exposure prophylaxis. For economic and feasibility reasons, WHO recommends that countries integrate TDR surveillance into pre-existing HIV surveillance systems or routine diagnostic testing activities, if the reporting system is centralized and reporting rate is >90%. Thus, survey duration and survey sites should be the same used for HIV surveillance. Patient inclusion criteria remain unchanged from previous WHO TDR survey guidance. To maximize the inclusion of individuals with recent infection (i.e. in last 3 years), epidemiological markers (e.g., age <25 year) or laboratory criterion (i.e., CD4>500 cells/mm3 ) should be used. In addition, to minimize inclusion of individuals with prior ARV exposure, women with previous pregnancies should be excluded. Unlike the old TDR survey, the draft concept note presents a method that permits a national estimate of TDR. The national prevalence estimate has advantages over the previous method which only permitted classifications in defined geographic areas. In the draft TDR concept note, the sample size will decisively influence the survey confidence interval. If the estimated sample size is N < 50, the result will be a point prevalence estimate with a very wide confidence interval, thus rendering it inappropriate for programme decision making. Countries should then prioritize other elements of the HIVDR monitoring strategy. If the sample size is between 50 and 200, TDR surveillance can be considered, but results may not be conclusive. If the sample is > 200, significant results are likely to be generated. In order to increase the number of eligible specimens, countries may choose to extend the period or number of sites included in the survey. The preferred method for specimen collection is dried blood spot (DBS), as it avoids the need for cold-chain logistics. However, personnel may need to be training in this method. TDR: Main outcomes of discussion • The CD4 criterion for specimen selection is not compulsory; it is an optional criterion that may be

applied if available. Age and parity remain the main eligibility criteria for TDR surveys. • Recruitment period be extended to increase the sample size. • The group also discussed whether eligibility criteria based on laboratory assay should be recommended, given the trade-offs between accuracy and the feasibility of recruiting enough eligible patients. Overall, it was felt that laboratory assays were too restrictive for the purposes of TDR surveillance as they greatly reduce the sample size limiting TDR survey implementation without providing any advantage.

Session 4: Surveillance of HIV Drug Resistance in populations initiating ART; i.e. PDR The WHO draft concept note for surveillance of resistance in populations initiating ART was presented for feedback and discussion. In 2006, WHO developed a prospective survey method to assess HIVDR by following a cohort of ART initiators and assessing HIVDR at start of treatment initiation (baseline) and 12 months thereafter. This original prospective method has been revised and split into two stand-alone cross-sectional surveys: the first, surveillance of HIVDR among patients initiating first-line ART and the second, surveillance of acquired HIVDR in populations experiencing virological failure while on first-line ART. The recommended duration of patient enrolment is 6 months to ensure timely availability of results for decision making. Separate assessments should be performed in populations (i) initiating ART without prior ARV exposure and (ii) initiating ART with prior ARV exposure, but countries should decide, based on their own needs, whether to do only surveillance in populations without prior exposure or in populations without and with prior exposure. The main goal of performing PDR surveillance is to inform the selection of optimal first-line regimens. Unlike the previous baseline of the acquired HIVDR survey which provided some information on pre-treatment populations, the draft concept note does not use sentinel sites. Rather, the revised draft concept note proposes representative sampling of ART clinics to achieve a nationally representative sample. Specifically use of probability proportional to size (PPS) sampling is proposed. In the PPS method, clinic size is assessed based on the number of new ART initiators per clinic. If the number of new ART initiators is not available, a second method, probability proportion to proxy size (PPPS), may be used, whereby size is based on the number of individuals on ART per clinic. Using the PPPS method would increase the sample size given the potential error in estimating the size of the sites, but in many settings it would be the only feasible approach.

PDR: Main outcomes of the discussion • Determining PDR in both ARV-exposed and non exposed patients initiating first-line is important in some settings. Efforts are needed to collect Information on the % of previous exposures among treatment initiators. • The notion of ‘prior exposure’ to ARVs is preferred than ‘disclosed prior exposure’ to ARVs. Flexibility should be given to countries on the way to document prior exposure. • Defining a group of ‘unclear exposure’ may only add complexity to the protocol. • The assumption that the majority of patients are not exposed may not be true in populations of pregnant women. • Guidelines could be changed to include alternative firstline regimen for populations exposed to ARVs just like for ART toxicity. • PDR in non-exposed do not replace TDR surveys: • In the case of epidemic confined to key populations • To predict the efficacy of first-line regimen in the future PDR: Questions for discussion • From a programmatic point of view, what is the relevance of understanding PDR in ARV-exposed versus non-exposed patients? • Will changes in treatment guidelines for ARV-exposed population not result in too much complexity? • What are the logistical aspects of recruiting 20 patients in several sites (e.g.: ethical approval?). How can we address them?

is important to design a measure of HIV Drug Resistance that can take into account results of unobservable patients (e.g., those who are lost to follow-up, die or who may stop treatment). A number of approaches were discussed, and this issue will be clarified once the concept note is made available later in 2013. Challenges of the implementation of the previous prospective protocol to monitor ADR were highlighted in country experiences. Issues included the cost and complexity of the prospective follow up, lack of representativeness of the data at the country level (limited utility of data at national level for planning), and the importance of using standardized mutation lists for the interpretation of HIVDR data. Draft ADR concept note: main outcomes of discussion • The eligibility and sampling criteria were clarified. • The proposed duration on ART (at least 4 months) as inclusion criteria would be irrespective of whether patient was transferred in a participating clinic while on ART. Obtaining a statement on clinic-level performance is not a goal of this survey and it is not anticipated to have clinic-level survey results. • Sampling is done among patients alive and on first-line ART (survivors). • Information on death and retention may be assessed using EWI and other nationally reported indicators and is at present not captured as part of this survey. • Countries stressed the importance of synchronizing time points considered in ADR protocol with time points for VL monitoring recommended by the WHO treatment guidelines to enhance utility of results for programme decision making. • It was suggested that the ADR survey should be able to use a single VL measurement since it aims at identifying virological failure AND NOT treatment failure (defined by two consecutive VL>1000copies/mL in the WHO treatment guidelines). • It was suggested that it should be possible to conduct the ADR survey on retrospective specimens collected from another investigation can be considered if: »» The population is nationally representative of patients on ART »» There are no major bias are associated with sample collection and testing. ADR: Questions for future discussion • Clarifications on the time points to include in the survey are needed. • The feasibility of including LTFU in the endpoints needs to be considered, as it is not clear whether countries do have nationally representative data on LTFU and deaths that could be used to correct the VL suppression rate national estimate.

Session 5: Surveillance of acquired HIV resistance in patients on ART An outline of a revised draft approach for surveillance of acquired HIV Drug Resistance (ADR) in patients on ART was presented. It was emphasized that the development of the ADR surveillance approach was still at a very early stage. The main goals of ADR surveillance are to assess levels of virological suppression and HIV Drug Resistance among individuals receiving ART to inform selection of optimal second-line ART regimens. As discussed in the context of the PDR concept note, instead of performing prospective monitoring, the new approach relies on cross-sectional surveys at two time points (12–24 months, and 48–60 months), with site selection to be performed proportional to size (PPS) or proportional to proxy size (PPPS) to ensure the national representativeness of survey results. Countries would be able to choose to perform both PDR and ADR sampling at the same sites. In order to account for the fact that a cross-sectional survey only includes patients who are still on therapy, it

• Inclusion on women on option B or option B+ needs further thoughts. • Can the ADR survey protocol include sampling options to accommodate the need to assess resistance prevalence at different time points?

Survey of HIVDR in paediatric populations: main outcome of discussion • Attention should be paid to quality assurance/quality control of both specimens and minimum variables collected on EID testing forms. Notably, incomplete EID requisition forms should not be interpreted to mean ‘unknown exposure’. • The elimination a priori of laboratories performing EID from the sampling frame will affect representativeness of the survey. • Paediatric surveys provide a snapshot of HIVDR among children regardless whether it is transmitted or acquired. However, information on breast feeding and type of ARV exposure (duration and regimen) should be collected and can be analyzed at regional and global level.

Session 6: Surveillance of initial HIV Drug Resistance in paediatric populations <18 months of age The WHO protocol for surveillance of initial resistance in paediatric patients with or without exposure to prevention of mother to child transmission(PMTCT) was reviewed. The main goal of this survey is to support the selection of optimal first-line ART for children. The survey piggybacks on early infant diagnosis (EID) testing, and children already receiving ART are excluded.

Session 7: Country presentations of identified priorities for HIVDR surveillance Ethiopia TDR Design • In August 2011 »» Started in Gondar University Hospital VCT site »» A sufficient number of specimens were collected (DBS and plasma) »» Genotyping has been done and data analysis is ongoing • In 2012 »» Started in Addis Ababa VCT centre »» Sample collection is ongoing. »» Results are pending Public Health actions from HIVDR EWI Results from EWI evaluation communicated to the sites; no other public health or programme action was reported based on having implemented EWI. Way forward regarding the strategy Not specified Limitations and challenges to implementation of HIVDR surveillance For EWI • Weak ART patient record system make data abstraction challenging; significant amount of missing data • Difficulties to convert dates (month and year) from the Ethiopian to the European calendar • Lengthy data abstraction process due to weak record keeping systems • EWI monitoring has not been performed in paediatric populations in Ethiopia For TDR Difficulty in collecting a sufficient number of eligible specimen (N>= 47) in a defined geographic setting over a defined duration of time (3-6 months) using the old truncated sequential sampling method

Kenya EWI : Design • Time period: not reported in country presentation • 50 facilities selected using stratified sampling representing the 8 provinces. • Both adult and paediatric patients included • 4 EWI monitored • Ethical approvals obtained from KEMRI and US-CDC Results Aggregate results suggest that prescribing practices, loss to follow-up, retention and appointment keeping require attention at a large number of clinics sampled. TDR • • • • • Conducted in 2012 TDR survey was piggy backed onto ANC surveillance (7 sites in Nairobi and 4 in Nyanza) DBS were used 39 HIV-positive specimens from eligible women were obtained from Kisumu ANC sites and 84 from Nairobi ANC sites. Testing done at KEMRI-CDC laboratory, a WHO designated HIVDR genotyping laboratory

Results • Overall TDR <5% for PI and NNRTI • Overall TDR >5% and <15% for NRTI PDR (baseline of old WHO prospective method) Design: • Prospective cohort study of consecutively-selected cohort of patients starting ART at 4 ART sites in Kenya (Kisumu and Nairobi sites) • Sites with mature ART programs and high enrolment rates to facilitate enrolment in 3-6 months • 120 participants recruited from each site Results: Nairobi sites could not start due to delays in ethical procedures and logistical issues Kisumu sites: • KDH: 106 patients recruited, 63 tested, 4 with HIVDR mutations NNRTI 6% , NRTI < 5% • FACES: 120 patients recruited, 45 tested, 4 with HIVDR mutations NNRTI TDR 8.8 % Public Health Action envisaged • Improve surveillance for HIVDR in country. Consider the population (national level) TDR and paediatric surveys depending on sample seizes of eligible populations • Build capacity on HIV DR and Viral load interpretation • Prevention of transmission • Use of combination of prevention activities including: voluntary medical male circumcision (VMMC), PMTCT, Prevention with Positives (PWP), Behavioural and other targeted interventions for MARPS. • Treatment for all eligible (current coverage for adults 79%, Paediatric 42%). Acknowledged knowledge gap among individuals who are HIV-infected and not yet diagnosed. • Bolster treatment monitoring to detect detect early virological failure, enhance adherence and change treatment in a timely manner to minimize emergence of preventable HIVDR and enhance levels of clinic retention. Way forward regarding the strategy • Not specified

Imitations and challenges EWI: None reported TDR : • Failure to meet the minimum sample size requirement (e.g.: Kisumu). • Sub-optimal genotyping success rate due to poor quality of specimens PDR (prospective baseline) • Challenges with database on site (difficulty to abstract relevant data required for survey analysis) • Client enrolment and follow up • Missed opportunities • Human resource shortages at MOH site • Due to small sample size and geographic specific sampling, results from Kisumu do not permit generalization to country level

Ghana EWI : Design • Period assessed: first quarter 2010 to first quarter 2011: EWI monitoring 123 facilities • 6 indicators monitored Results • Three of 6 indicators were monitored at 123 facilities • For 66 facilities, prescribing practice (EWI1) was as per national guidelines • For both appointment keeping (EWI5) and client retention on first line (EWI3a) hardly any of facilities met the ≥ 90% target. • Overall appointment keeping and retention on first-line ART at 12 months merit attention at the clinics monitored. TDR Design • 2007 to 2009 the Eastern Region of Ghana • 60 plasma specimens collected from pregnant women attending ANC (first pregnancy) • Reference laboratory not specified Results Only two individuals with major HIVDR mutations. TDR level the study population in 2009 was classified as low (< 5%). PDR(baseline of prospective survey) and ADR • Initiated in 2008 • 10 ART sites participating selected based on their experience in providing ART • The sites were divided in two batches of five sites each • Two lots (T1 , T2) of 130 samples from each site over a period of two years • Batch 1: sample collection starts in April 2008. • Batch 2: sample collection starts in October 2009 and completed in October 2011 • All samples were collected and transported to NMIMR and stored according to WHO guidelines Results None reported. Specimens have not tested yet. Way forward and Public Health action taken To be defined after testing of specimens has been completed

Public health Action envisaged Not defined Ghanaian proposed way forward regarding the WHO strategy • To revise the national HIVDR Plan and three HIVDR protocols after updated by WHO • Prioritize survey of transmitted and acquired HIVDR • Update of HIVDR database with new samples to be collected. • Monitor sites conducting transmitted and acquired HIVDR to improve participant recruitment and adherence to survey procedures and documentation processes • Specimens to be sent to NICD South Africa for sequencing pending availability of funds • Seek support to: »» Continue HIVDR resistance surveys in line with revised WHO guidelines »» Review EWI data collection process to facilitate accurate collection of all 5 indicators and evaluate the in-country use of EWI to minimize emergence of HIVDR in Ghana. »» Establish appropriate data entry mechanism for HIVDR Database to meet global standards. »» Prepare the national lab (NMIMR) for WHO designation for HIVDR testing through a pre-accreditation visit. Limitation and challenges EWI • • • • • Incomplete electronic data capture due to gaps in client booklets and limited direct utilization of software by staff Limited generation and utilization of results by facilities Analysis mainly prompted at national level Break in service due to equipment faults and staff attrition Difficulty with validating drug pick-up at where dispensing site is not close to prescribing point

TDR Failure to attain sample size in two different locations due to low HIV prevalence in defined age group despite high pregnancy rate. ADR • • • • • • (prospective method) Specimen collection in the second year (T1) experienced some challenges Unexpectedly high rate of lost to follow up a significant finding Few deaths Important number of transfers out Poor tracking by HCW to ensure eligible patients received specimen collection Lack of funding to finalize the HIVDR testing

Nigeria EWI Not reported TDR Not reported PDR (baseline of old prospective method) • Pilot conducted at 2 sites following WHO prospective methods • Data and specimens collected at baseline. • Genotyping at baseline for all samples has been performed at WHO designated lab in Atlanta. Results • 283 participants enrolled from the two sites (Site 1 =140, Site 2 = 143) • Median CD4 was 149cells/ml (1-515) • Viral load only performed for 266 patients (insufficient volume of samples). • Genotyping analysis on 271 patients • Interpretation of HIVDR mutation using Stanford database and including minor mutations and polymorphism. »» RT DR - 21.4% (58/271) »» PI DR - 4% (10/271)

ADR Not reported Public Health Action envisaged • Increase advocacy for prevention to reduce transmission of HIV infection in general and of resistant strains in particular Way forward regarding the WHO strategy • Continue the study to 12 months and determine ADR at Month 12 • Conduct Critical evaluation of results to guide the development of the National Guidelines on use of ARVs Limitation and Challenges • IRB issue for the sites • Lack of commitment by some staff • Storage and transport of specimen difficult • Frequent staff rotation within the hospital made enrolment of patients challenging • Missed patients for recruitments • Longer time than expected for enrolment • Poor infrastructure and weak record keeping systems • Workload and staff capacity made time limited for enrolling patients for survey • Ensure strong government leadership and participation • No two facilities have same ART clinic flow; this individual site SOPs need to be developed regardless of survey method Tanzania EWI Design and time lines • 2009: 8 facilities in 3 regions participating, trained HCW - Iringa and Mwanza regions • 2010: 55 of 101 electronic sites participating • 2012: 35 facilities in 17 regions participating • EWI monitored not indicated Results Not communicated TDR • • • • 2008 and 2011 Two HIVDR threshold surveys done and piggybacked on ANC Sentinel surveillance Number and type of samples not communicated Reference laboratory not specified

Results Not communicated Way forward regarding the WHO strategy • Strengthen coordination role of the national HIVDR technical working group (TWG) • Mobilize more resources HIVDR activities especially for PDR and ADR surveys • Review the National HIVDR to accommodate new updates when available • Forge partnerships to build local capacity of individual and institutions doing HIVDR activities especially genotyping capacity • Maximally use the existing electronic system to address HIVDR programmatic and patient issues (maximize retention, minimize LTFU) Public Health Action envisaged • Report on EWI disseminated in 2013 • Results shared in a dissemination workshop and facilities wrote their improvement plan in addressing gaps observed.

Limitations and challenges • Lack of local capacity for HIVDR testing is the single most important challenge: 2008 & 2011 specimens not yet tested • Time consuming procurement and ethical clearance processes including data and Material Transfer Agreements • Insufficient funding for HIVDR activities • Coordination of HIVDR activities done by multitude of stakeholders (ART sites, Lab, etc.) • Capacity Building – missed opportunities for lab capacity building and record keeping strengthening • Methodological complexities of current TDR survey method makes it unappealing Uganda EWI Design and time lines Three surveys completed • 2007 in 41 sites • 2008/9 in 76 sites • 2012 in 100 sites • 4 EWI monitored all years Results (% of clinics sampled achieving WHO target) • Patient retention: 2007: 71%/2008:75%/2012:91% • On time drug pick up: 2007: N/A/2008:73.7/2012:89.5 • On time clinical appointment keeping: 2007: 9.8%/2008:14.1%/2012:8.4% • Continuity of ARV supply: 2007: 46%/2008:28.9%/2012:47.4% Limitations and challenges TDR Design • In area where ART has been widely available for 3-5 yrs • Among recently infected, ARV-naïve individuals • Results • Summarized in 5 publications, indicating low to moderate prevalence to NRTI and NNRTI Public Health action envisaged Not reported Way forward regarding the WHO strategy Not reported Limitations and challenges • Minimum resource strategy e.g. use of remnant specimens from sero-surveys has not been possible (logistical, laboratory considerations) • Achieving the required sample size within the planned recruitment period has been challenging using the old TDR method based on truncated sequential sampling • Surveillance activities are expensive • Inability to adapt the WHO Database to suit country needs • Repeat surveys as recommended by the WHO protocol in areas of moderate prevalence not done because of limited funding

Session 8: Summary of proposed draft country HIVDR work plans 2013-2017 Ethiopia Components of the HIVDR strategy included (4 of 5) • EWI, TDR, ADR, HIVDR in Children<18months • Pre-treatment survey to be considered upon results of ADR. Design and time lines • EWI »» 2014 (60 sites). Repeated in 2015 (75 sites). »» Progressively integrate into routine activities of Monitoring and Evaluation activities of the ART program • TDR »» 2014: finalize ongoing survey and initiate a nationally representative survey with ANC SS using 200-250 specimens likely to be available »» 2015 repeat depending on the findings (200-250 specimens) • ADR »» 2014: Finalize existing ongoing survey »» 2015: initiate a nationally representative ADR survey at 20 sites »» 2017: repeat the ADR survey (including paediatric patients) • Paediatric HIVDR »» 2018 including 8 laboratories performing EID Required collaboration/ assistance • No change (structural/managerial) is anticipated • EHNRI/MOH will lead the process • Collaboration with US-CDC and WHO is essential for technical assistance • Funding of HIVDR activities to date has been based on US-CDC and WHO support • Collaboration with local (regional health bureaus) and international (GF, USAID, CHAI, etc.) partners will be strengthened Budget 2014: USD120 000 2015: USD300 000 2016: USD220 000 2017: 200 000 2018 USD120 000 Total: USD 960 000 Source of funding • Financial support from US-CDC and WHO is anticipated to continue • Proposal for Global Fund funding will be prepared and submitted in 2014 Anticipated problems None reported Remarks from discussion • HIVDR proposed activities are already part of the HIVDR plan. They will be a continuity of what is already ongoing. • The GF application (2014)is intended to contain HIVDR activities to increase sustainability • There are 8000 ART sites but the EWI monitoring starts with 60. Development of a plan to scale up EWI to all sites, or a large number of representative sites need to be developed • EWI data abstraction and reporting activities may be devolved to ART clinics.

Kenya Components of the HIVDR strategy included (5 of 5) • EWI, TDR, PDR, ADR, HIVD in Children <18months Design and time lines • EWI »» To be include in routine activities and monitored monthly »» Scale up planned between2014 to 2018 »» Scale up and include 100 additional sites annually • TDR »» 2013/2014 finalize ongoing TDR surveys piggy backed to KAIS (Kenya AIDS indicator survey) and KDHS (Kenya Demographic household survey). »» 2017/18: repeat TDR survey piggy backed to KAIS/KDHS »» Numbers of potentially eligible specimens must be estimated • PDR and ADR »» Ongoing in 2 sites in Kisumu. Enrolment completed and Baseline (prospective survey method) results partially available »» Plan to start survey at 2 sites in Nairobi in July 2013 »» National Cross Sectional MS for adults and children ongoing in 15 sites »» 2 cohorts 12-24 months and 24-36 months »» Support available from the Global Fund to implement in 4 sites annually. However given the change in strategy, these funds may require reprogramming so that updated methods are harmonized with final updated guidance »» 2013/2014: finalize PDR on patients without exposure and collect data on exposure »» 2015/2016: Combine Pre-treatment with 2 components-exposure and without exposure and ADR • Paediatric DR surveillance; infants < 18 months »» Currently EID testing in 6 labs distributed over the country-average of 60,000 tests per year »» Laboratory network for sample transportation and relay of results »» EID database at NASCOP with online portal with a SMS alert and results transmission facility. »» 2013/2014: ¤¤ Conduct assessments for testing labs for storage capacity and backup ¤¤ Work with labs on proper storage for remnant samples ¤¤ Work with sites on improving completeness of the form ¤¤ Prospective storage for at least 3 months in all 6 labs Required collaboration/assistance • TDR »» Finalization of protocol and funding from WHO »» Protocol review-TA from WHO Geneva »» Country analysis and report writing • PDR/ADR »» Finalization of protocol and funding from WHO »» Consultation and lobbying with GF »» Approval for reprogramming • Paediatric DR surveillance »» Development of protocol »» funding Budget • 2013/2014: • 2015/2016: • 2017/2018: • Total: USD 621,000 USD 294,000 USD 250,000 USD 1,165,000

Source of funding • EWI: US-CDC • Ongoing TDR: WHO and GF (plan to request support from WHO) • Future TDR (2017/2018): no funding source identified • PDR/ADR :WHO and GF (approval for reprogramming the survey according to the new protocols to be requested) • Paediatric HIVDR surveillance: WHO. Additional source of funding to be found. Anticipated problems • Sample size calculation for the TDR KDHS (700?) • What will be the inclusion criteria for TDR surveillance and how will patients be screened? • Given anticipated challenges with TDR, priority may be given to PDR • Logistic for specimen collection and storage exist for all surveys Other plans • Compilation and situational analysis of HIV DR work in the country (published and unpublished data) • Development of 2012/13 HIVDR report • Development of the HIV Monitoring Plan Remarks from general discussion • Challenges exist due to record keeping and data abstraction (human resource limitations) to scale up EWI to all sites or large number of representative sites in the country. • Data on how many sites are currently reporting EWI are not available

Nigeria Components of the HIVDR strategy included (5 of 5) • EWI, TDR, ADR, HIVDR in Children <18months • Pre-treatment survey (with and without exposure) are likely to be less of a priority compared to ADR Design and time lines • EWI »» Prioritized by the TWG »» Data abstractors to be trained and lessons learnt from the pilot phase to be applied »» CDC and other IPs involved in the process »» Planned every year from 2013 till 2016 »» Number of participating sites not reported • TDR »» Riding on ANC surveillance is problematic »» TWG are considering using the NARHS survey »» Planned in 2014 and 2015 • PDR »» Design not described. To start in 2016. • ADR »» Protocol almost finalised »» TWG approval obtained »» IRB in process at CDC Atlanta »» Number of participating sites not reported • Paediatric surveillance infants < 18 months »» Planned by TWG »» Support from IHVN »» Proposal submitted NHREC »» Protocol is ready Required collaboration/assistance • Human resources • Funds: source to be identified Budget Not reported

Source of funding • ADR »» CDC funding through the CoAG • Paediatric »» Funding from WHO approved »» Support from IHVN Support from WHO, CDC, GF, IHVN is otherwise mentioned for all activities Remarks from general discussion • A detailed budget will be available once sample size calculations are finalized at the global level • 2016 has a budget which is based on existing methods • There are difficulties to monitor EWI in all the sites. USAID funding currently available • Ideally, methods to embed EWI data abstraction into routine programme monitoring will be achieved. Nigeria is working toward this goal.

Tanzania Components of the HIVDR strategy included (5 of 5) Design and time lines • EWI »» Activities will include ¤¤ update of the training manuals ¤¤ Training of the trainers at the regional level ¤¤ Dissemination workshop »» Start from 200 sites from a total of 25 regions and upscale 200 sites/year for 6 years »» Starts in 2013-2017 • TDR »» Activities will include ¤¤ Protocol Development ¤¤ Genotyping and transporting ¤¤ Procurement of reagents and consumables ¤¤ Data Analysis and Report Writing ¤¤ Dissemination »» Planned in 2013 and 2016 • PDR »» Activities will include: ¤¤ Planning and Implementation ¤¤ Protocol Development ¤¤ Facility assessments (lab, Sites etc) • Genotyping • Procurement of reagents and consumables »» Data Analysis and Report Writing »» Dissemination »» Planned in 2014 and 2017

• ADR »» Time points: 6 & 18m (to be done simultaneously at the same sites as the Pre-Treatment surveys) »» Activities will include: ¤¤ Protocol Development ¤¤ Hire survey coordinators/Subcontract ¤¤ Genotyping ¤¤ Viral load testing ¤¤ Procurement of reagents and consumables ¤¤ Data Analysis and Report Writing ¤¤ Dissemination »» Planned in 2014 and 2017 • Paediatric infants < 18 months »» Activities will include ¤¤ Protocol Development ¤¤ Genotyping ¤¤ Procurement of reagents and consumables ¤¤ Data Analysis and Report Writing ¤¤ Dissemination »» Planned in 2014 and 2016. Other activities and plans • Host HIVDR TWG quarterly meetings • Build Capacity for HIVDR genotyping (institutions and personnel) • Update the HIVDR Strategy with WHO HIVDR update: Integrate into the National HIV Strategic Plan 2013-17 Required collaboration/assistance Technical assistance is required for protocol development of TDR. PDR and ADR as well as for building capacity in HIVDR genotyping. Budget • Updating HIVDR strategy: USD: 20,000 • EWI: USD: 515,000 • TDR: USD:120,000 • PDR/ADR: USD:800,000 • Paediatric: USD: 200,000 • Other activities: USD: 170,000 • Total: USD: 1,825,000 Funding source (NB not clearly reported) • TA: GOVT/ATF /CCHPs • Year 1: GF • Year 2: CDC • Year 3: IP Remarks from the general discussion • Some GF money is available though not earmarked for HIVDR activities • Funding for ADR will be specifically requested. GF indicated interest • Samples will be transported to Mwanza or Kisumu.

Uganda Components of the HIVDR strategy included (5 of 5) Design and time lines • 2013: »» Integrate the 5 EWI into HMIS/DHSI2; »» Integrate electronic tool into existing; »» MOH to engage ASSIST (CQI PEPFAR partner to Train other IPs on EWI) »» Engage IPs to train facility staff on abstraction for EWI • 2014 »» ToTs for all regions »» Facilitated by MOH and ASSIST and supported by PEPFAR partners • 2015 • EWI should be fully integrated into the routine reporting system • National Reports available TDR • • • • 2013: Solicit for funding 2014: ANC Surveillance integration, 30 sites; 150 clients expected to be found. 2015: TDR training using a cascade approach 2016: TDR assessment integrated into AIS /DHS

PDR/ADR • 2013: Review results of ongoing surveys. The two surveys (PDR + ADR) will occur concurrently • 2014: »» Group the existing sites into Large, medium & low volume »» Develop Protocol for Pre-Treatment DR »» Integrating Pre-Treatment HIVDR indicators into the Open-eMRS, • 2015 »» Train IPs as TOTs »» IPs will hold regional trainings for facility staff »» Pre Treatment HIVDR sample collection begins • 2016: Generate national reports Paediatric Infants < 18 months • 2013: Support ongoing studies/surveys • 2014: Review results of these studies/surveys to inform policy • 2015: Conduct new rounds of surveys in preparation for review of guidelines Required collaboration/assistance Budget Source of funding Not reported Remarks from general discussion • Surrogate measures of site size (small, medium, large) implies use PPPS instead of PPS for sampling. All sites should be part of the sampling frame • PEPFAR plans to support EWI until 2016 at which time funding gaps are anticipated; The country will explore addition of surveillance and EWI activities in its GF application.

Zambia Components of the HIVDR strategy included (4 of 5) Paediatric surveillance would likely not be a priority Design and time lines • EWI »» Number of sites to be included not reported »» 2013: ¤¤ redefine the reports in the EMR in purposefully selected pilot sites in order to finalize the revised reports ¤¤ revised EWI in PPS sampled sites, ¤¤ strengthening EMR in the sampled sites ¤¤ generate reports for the baseline (2013-2014) ¤¤ 2014 ¤¤ For the proportion of ART patients not on EMRs “manual” analysis will be conducted ¤¤ Based comparison of manual with EMR country may or may not do future manual EWIs ¤¤ Quarterly runs at national level ¤¤ Enable districts/provinces to run their own reports either at monthly or at least the quarterly basis ¤¤ A staff officer will be identified to monitor and provide feedback to each district regularly »» 2015-2017 ¤¤ Quarterly runs at national level ¤¤ Districts/provinces to run their own reports either at monthly or at least the quarterly basis ¤¤ A staff officer will be identified to monitor and provide feedback to each district regularly • PDR »» ZDHS set for 2013 & includes incidence HIV testing »» Piggyback TDR survey in ZDHS. Need to confirm DHS questionnaire will get information on ARV exposure. Expect to 32,830 DHS respondents »» If prevalence ~ 14.3% = 4,700 HIV positives will be tested with LAG & VL; with expected 5-10% recent infections, we expect 235 – 470 samples »» 2013: ¤¤ Plan a comparison of HIVDR protocol and ZDHS samples ¤¤ Consider use of PMTCT sites (parity & age) and also consider Pre-ART (CD4 criteria, parity and age) ¤¤ Paediatric protocol will be developed concurrently ¤¤ Conduct rapid assessment/desk review to inform protocol development ¤¤ Protocols to designed to be have components that will be routinely collected ¤¤ Obtain ethics approved protocols »» 2014: ¤¤ Running sample testing, or collecting samples from PMTCT and/or pre-ART services ¤¤ Report writing & dissemination ¤¤ Manuscripts development »» 2015: Review and re-submission of the protocol in readiness for 2016 »» 2016: second survey will be implemented in 2016 • PDR »» Data on pre-exposed Initiators is not readily available »» 2013: ¤¤ Pre-Treatment HIVDR survey will not be done in 2013 ¤¤ Focus will be on implementing TDR survey ¤¤ Limited survey will be conducted to provide information on proportions prior exposed/non-exposed initiator. This will inform the full survey in 2014 »» 2014: ¤¤ Protocol development and ethics approvals to be completed by June 2014 ¤¤ Pre-Treatment HIVDR survey will be implemented during second half of 2014 covering prior and non-exposed ¤¤ Manuscript development »» 2016: ¤¤ Protocol revision/Ethic renewal will be completed by June 2016 ¤¤ Second round survey will be implemented during second half of 2016

• ADR »» Specimens for HIVDR were collected from an Adherence Study (FHI360), as well as from the UTH and Chreso – 2009 – 2010 »» Data from the PASER study based on samples collected from private sector »» Data based on over 100 samples from the Advanced Treatment Centre that performed HIVDR is available »» 2013: Data from existing data sources will be used to develop a country background report on HIVDR »» 2014: ¤¤ Protocol development and ethics approvals to be completed by June 2014 ¤¤ Pre-Treatment HIVDR survey will be implemented during second half of 2014 covering prior and non-exposed ¤¤ Will be synchronized with pre-Treatment HIVDR survey using the same sample of sites for data collection ¤¤ Manuscript development »» 2016: ¤¤ Protocol revision/ethic renewal will be completed by June 2016 ¤¤ Second round survey will be implemented during second half of 2016 Resources/assistance needed Not reported apart from funding needs Budget Not clearly reported Source of funding • GRZ – funding annual submitted • GF – proposal to cover 3 years (204-2016) approx. US$760,000 • USG – EMR support, exiting funding to strengthen systems, future new submissions to be made, approx. US$300,000 per year additionally • WHO – will not be in the position to fund future surveys as it has in the past as Gates Foundation funds are expiring in 2013 Remarks during the general discussion • To date, only 50 ART sites have ever reported EWIs. The country will develop a plan to expand EWI reporting to all ART clinics.

Session 9: WHO HIVDR laboratory network update An update on the WHO laboratory network was presented and future directions were discussed. Topics covered included current WHO designated labs, how countries can nominate a laboratory for WHO designation (questionnaire and check list available on WHO HIVDR website), and quality assurance guidance being developed by WHO for use in laboratories performing HIVDR surveillance. ASLM presented an overview of its laboratory capacity building mandate and system for stepwise accreditation for laboratory analyses (CBC, CD4). Nicase Ndembi, WHO ResNet member, presented an overview of commonly observed quality assurance problems observed in HIVDR genotyping laboratories and solutions.

treatment guidelines, scheduled to take place in 2015. Therefore solid, reliable data are needed and countries are invited to share results of HIVDR monitoring surveys as soon as possible. A regional HIVDR meeting is planned for January 2015 to update each other on country progress. First drafts of the new TDR and PDR monitoring protocols are expected in September 2013, with the ADR draft protocol to follow later in the year. The TDR and PDR concept notes which were distributed can be used in national planning. The concept note for ADR is under development. EWI monitoring will be integrated into consolidated M&E guidance.

Acknowledgements The WHO wishes to thank the Ethiopian Public Health Association and the African Society for Laboratory Medicine for the logistical support provided for this meeting.

Session 10: Closing remarks A new HIVDR global report is planned for 2015. This should provide critical data for the next revision of WHO’s

ANNEX 1: LIST OF PARTICIPANTS 25-27 June 2013, Addis Ababa, Ethiopia Kenya Kenya Tanzania Tanzania Tanzania Tanzania Ethiopia Ethiopia Ethiopia Ethiopia Ethiopia Ethiopia Ethiopia Ethiopia Ethiopia Ethiopia Ethiopia Ethiopia Uganda Uganda Uganda Uganda Uganda Zambia Zambia Zambia Zambia Zambia Nigeria Nigeria Nigeria Nigeria Nigeria Nigeria Ghana Ghana Ghana Ghana Rex Mpazanje Clement Zeh B Jullu Bonita Kilama Richard Banda Mary Kibona Mahlet Kifle Frehiwot Negatu Fekadu Adgna Almaz Abebe Wegene Tamene Dawit Assefa Tesfaye Telahun Fikir Melese Kassa Hailu Aschalew Endale Kussito Kursha T Messele Alex Ario Elizabeth Namagale Kaggwa Mugagga Christine Watera Grace Namayanja Albert Mwango Patrick Amanzi Loyd Mulenga Susan Tembo Jonas Mwale Gbenga Akinbiyi Emmanuel Abatta Gashau Wadzani Adeniyi Ogundiran Victor Sebastian Nicase Ndembi Stephen Addo Kwadwo Asante Felicia Owusu Antwi Silas Quay WHO focal person CDC officer Focal person HIVDR program National M+E director HIVDR WG lead WHO focal person CDC officer HIV Nigeria ART program director National M+E director WHO focal person CDC officer WHO focal person CDC ART program director HIVDR working group head WHO focal person CDC officer HIV program focal person HIVDR WG member WHO focal person EHNRI EHNRI EHNRI EHNRI WHO WHO WHO CDC officer CEO ASLM ART program director Program officer ART NPO WHO MRC/UVRI CDC officer ART program director National M+E director mpazanjer@who.int czeh@ke.cdc.gov bjullu@ihi.or.tz bonitakilama@yahoo.com Bandar@tz.afro.who.int kibonam@tz.cdc.gov mahhlun@gmail.com Ermias20002000@gmail.com fekadua@et.afro.who.int Almaz_abe1@yahoo.com wegenet@ehnri.gov.et dawitarm@gmail.com tesfayet@ehnri.gov.et fikirm@et.afro.who.int kassah@et.afro.who.int aschalewe@et.afro.who.int kurshak@et.cdc.gov tmessele@aslm.org riolexus@gmail.com namagalae@yahoo.com kaggwam@ug.afro.who.int cwatera@uvri.go.ug Uwo9@ug.cdc.gov Albert.mwango@moh.gov.zm amnzipatrick@gmail.com lbmulenga@yahoo.com tembos@zm.afro.who.int mwalej@zm.cdc.gov gakinbiyi@yahoo.com Emma_abatta@yahoo.com wadgash@yahoo.co.uk ogundirana@who.int sebastianv@ng.cdc.gov nndembi@ihvnigeria.org saddo@nacp.org.gh kasante@nacp.org.gh Owusa-antiwif@gh.afro.who.int Wej7@cdc.gov

ANNEX 2: AGENDA Implementation and Sustainability of HIV Drug Resistance Surveillance in Africa Addis Ababa, Ethiopia 25–27 June, 2013 Day 1 8:00–8:30 8:30–9:00 Registration Welcome remarks WHO-HQ WR-Ethiopia EPHA WHO-Jordan

9:00–9:15 9:15–10:00

Introduction and Objectives

Session 1: Overview of HIV Drug Resistance (HIVDR) at the global and regional level Objective: Review current evidence of HIVDR from global to regional perspective Co-chair: EPHA and WHO-AFRO What does the 2012 WHO global HIVDR report and other recent WHO-Bertagnolio data suggest about emergence of HIVDR in Africa and WHO HIVDR strategy Q/A Coffee Break Session 2: WHO Early Warning Indicators (EWIs) of HIV Drug Resistance Objective: Review of HIVDR EWIs and 2012 simplifications Co-chair: TBD Overview of WHO HIVDR EWIs: Original guidance,2012 revisions and future directions Country experiences with HIVDR EWIs, findings, challenges and public health action (15 minutes each) • Ethiopia • Ghana WHO-Jordan Ethiopia Ghana

40 min

5 min 10:00–10:30 10:30–11:40

20 minutes 30 minutes

20 minutes 11:40–13:00

Q/A – Discussion: ART program use of data, feasibility, integration and scale-up Session 3: Surveillance of transmitted drug resistance (TDR) in recently infected individuals Objective: Review WHO concept note for surveillance of transmitted resistance in recently infected individuals; discuss its relevance, feasibility, priority and adaptation at country level Co-chair: Country ART programme director and WHO-AFRO Country experiences (10 minutes each): Results, public health actions, what went well, and what we would like to do differently • Tanzania • Uganda • Kenya

30 min

Tanzania Uganda Kenya WHO-Bertagnolio

20 min

Surveillance of transmitted drug resistance (TDR) in recently infected individuals: Original truncated sequential sampling method and overview of 2013 concept note for nationally representative surveillance of transmitted HIVDR

30 min

Q/A – Discussion: TDR surveillance in recently infected individuals: Programmatic relevance of the data and comments on proposed concept note

13:00–14:30

Lunch

14:30–16:00 Session 4: Surveillance of HIV Drug Resistance in populations initiating HAART Objective: Review WHO concept note for surveillance of resistance in populations initiating ART; its Relevance, feasibility, adaptation and implementation at country level Co-chairs: 30 min Country experiences in assessment of pre-treatment HIVDR: Results, public health actions, what went well, and what we would like to do differently (10 minutes each): • PASER PASER • Nigeria Nigeria • Kenya Kenya

25 min

Surveillance of pre-treatment HIVDR: Pre-treatment HIVDR surveillance as part of WHO’s original prospective method of acquired HIVDR and overview of 2013 concept note for nationally representative surveillance of resistance in populations initiating ART

WHO-Bertagnolio

35 min 16:00–16:15

Q/A – Discussion: Surveillance of resistance in populations initiating HAART: programmatic relevance data, feasibility and preferred approach for implementation Closing of first day WHO/ASLM

Day 2 8:30–9:00 9:00–10:30 Review of first day Rapporteur 1st day Session 5: Surveillance of acquired resistance in patients on ART Objective: Review WHO concept note for surveillance of acquired resistance in patients on ART and discuss its relevance, feasibility, adaptation and implementation at country level Co-chairs: Country experiences (10 minutes each): Results, public health action, what went well, and what we would like to do differently • PASER • Nigeria

20 min

PASER Nigeria

25 min

Surveillance of acquired HIVDR: Original WHO prospective method WHO-Jordan for assessment of acquired HIVDR and overview of 2013 concept note for nationally representative surveillance of acquired HIVDR in populations on ART for > 4 months Q/A – Discussion: Programmatic relevance of the data, feasibility, and preferred approach for implementation Coffee Break

45 min 10:30–10:45

10:45–12:00 Session 6: Surveillance of initial HIV Drug Resistance in paediatric populations <18 months of age Objective: Review WHO protocol for surveillance of initial resistance in paediatric patients <18 months of age, discuss its relevance, feasibility, adaptation and implementation at country level Co-chairs: 20 min 20 min WHO-recommended protocol for surveillance of HIVDR in paediatric patients <18 months of age Country experiences in implementation, results, public health action, what went well, and what we would like to do differently: Example from 2 Southern African countries • WHO examples from Southern Africa WHO-Bertagnolio WHO-Bertagnolio

30 min 12:00–13:30

Q/A – Discussion: Programmatic relevance of the data and preferred approach to the options for its implementation. Lunch

13:30–16:30 13:30–16:00

Session 7:Work group discussion on HIVDR surveillance Rapporteur: Each country will select one representative to report on Day 3

Working group formation (2 countries per group with facilitators moving between groups) [coffee available at 15:30 for consumption during working session] Each group should discuss the relevance of WHO HIVDR surveillance methods to their respective ART programmes, considering national and regional public health priorities and feasibility of implementation. Each country should respond to the following 4 questions and develop a 10 minute oral presentation to be presented on day 3: 1. Using country-specific data, develop draft national HIVDR surveillance plans which identify immediate, medium, and long-term national HIVDR surveillance priorities which include feasibility assessments for early warning indicators of HIVDR, surveillance of transmitted, pre-treatment/acquired HIVDR, and HIVDR in infants < 18 months of age 2. Using concept notes and country-specific data develop worked-examples of ART clinic sampling for surveillance of pre-treatment/acquired HIVDR 3. Identify necessary collaborations and external support for realization of immediate, medium, and longterm term national HIVDR surveillance priorities 4. Identify resources/changes necessary to ensure sustainability of medium and long-term HIVDR surveillance priorities

16:00–16:15

Closing of second day

WHO/EPHA

Day 3 8:30–9:00 9:00–10:30 Review of second day Rapporteur 2nd day Session 8: Presentation of identified priorities for HIVDR surveillance Objective: Building consensus on recommendations for HIVDR surveillance based on nationally identified public health priorities, use of data for ART program and public health decision making, anticipated challenges and solutions to implementation of identified short, medium and long term goals Co-chairs: Silvia Bertagnolio and Michael Jordan Country working group session to finalize oral presentations 4 country presentations (10 minutes each); feedback and questions (5 minutes each) Coffee Break 4 country presentations (10 minutes each); feedback and questions (5 minutes each) Session 9: WHO HIVDR laboratory network update Objective: Update on WHO laboratory network and future directions Co-chairs: NHLS/ASLM WHO HIVDR Laboratory Network Update: “Who is Who” in the network; available services and cost; short-term and medium term goals Technical cooperation to support HIVDR surveillance in Africa: (two 15 minute presentation) • Building laboratory capacity for HIVDR testing in Africa • Technical cooperation for lab capacity building for genotyping, including quality assurance Closing remarks – way forward – confirm schedule of the 1 on 1 discussion in the afternoon. Lunch One-to-one discussions between country teams and WHO to finalize agreements on cooperation in the short term (30 min per country team) WHO-Jordan

9:00–09:30 09:30–10:30 10:30–10:45 10:45–11:45 11:45–12:45

11:45–12:00

12:00–12:30

ASLM Nicaise WHO-HQ WHO -AFRO

12:30–12:45 12:45–14:00 14:00–18:00

Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

For more information, contact: World Health Organization Department of HIV/AIDS 20, avenue Appia 1211 Geneva 27 Switzerland E-mail: hiv-aids@who.int www.who.int/hiv

Основные сведения

Организация Всемирная организация здравоохранения (ВОЗ / WHO)

Тип документа Technical Documents

Дата принятия 31 июля 2014 г.

Источник Всемирная организация здравоохранения