1.
IMPLEMENTATION &
SUSTAINABILITY OF
HIV DRUG RESISTANCE
SURVEILLANCE IN AFRICA CAPE TOWN, SOUTH AFRICA
8–10 JULY 2013
IMPLEMENTATION &
SUSTAINABILITY OF
HIV DRUG RESISTANCE
SURVEILLANCE IN AFRICA CAPE TOWN, SOUTH AFRICA
8–10 JULY 2013
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TABLE OF CONTENTS
1. Introduction
. . . . 22. Meeting Objectives
. . . . 23. Participants
. . . . 24. Meeting overview
. . . . 3DAY 1 . . . . 3
Session 1: Overview of HIV Drug Resistance (HIVDR) at the global level and WHO’s response . . . . 3
Session 2: WHO Early Warning Indicators (EWIs) of HIV Drug Resistance . . . . 3
Session 3: Surveillance of transmitted HIV Drug Resistance (TDR) in recently infected individuals . . . . 3
Session 4: Surveillance of HIV Drug Resistance in populations initiating ART; i.e. PDR . . . . 4
DAY 2 . . . . 5
Session 5: Surveillance of acquired resistance in patients on ART . . . . 5
Session 6: Surveillance of initial HIV Drug Resistance in paediatric populations <18 months of age . . . . 6
DAY 3 . . . . 6
Session 8: Country presentations of identified priorities for HIVDR surveillance . . . . 6
Session 9: WHO HIVDR laboratory network update . . . . 8
Closing remarks . . . . 8
Acknowledgement . . . . 8
ANNEX 1: List of Participants
. . . . 9ANNEX 2: Agenda
. . . . 101. 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.
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, iv. Identify technical support needs that WHO will need to provide in the short term to assist with implementation. and
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 full meeting agenda can be found in Annex 2.
DAY 1
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 ARV- naive and ARV-exposed individuals
iii. Acquired drug resistance (ADR) surveys
iv. Surveys of HIVDR in infants < 18 months of age (paediatric)
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 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 M&E:
i. On-time pill pickup
ii. Retention in care at 12 months iii. Pharmacy stock-outs
iv. 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 months after ART initiation. WHO currently provides a target for clinic level viral load suppression for the 12 months 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.
Key discussion points:
• EWI provide the necessary program context for interpreting survey of TDR, PDR and ADR.
• Data abstraction and reporting should be the responsibility of the ART clinic (WHO’s EWI data abstraction tool facilitates this process). Whenever possible, query programs should be developed in countries to facilitate EWI monitoring in countries with electronic medical or pharmacy records; i.e. as in Namibia.
• EWIs are designed to provide site level information;
when all sites report or a representative sample of sites report a national picture of ART programme functioning vis a vis EWI is obtained.
• EWIs are meant to signal a possible problem in ART clinic or programme functioning and prompt additional investigation. EWI results are never punitive and always promote treatment and care optimization.
• In regards to the drug stock out indicator, a stock out occurs whenever a drug routinely available at the site is not available. If a fixed-dose combination (FDC) is out-of-stock but its individual drug components are available, the EWI would still indicate a pharmacy stock-out, as the FDC is out of stock. The indicator is not meant to capture availability of all routinely displaced antiretroviral drugs at a clinic and does not indicate that a treatment interruption has occurred.
• The lost to follow-up (LTFU) indicator was excluded from the revised set of EWI because no data were available to quantify the emergence of HIVDR among this population. Additionally, the retention and LFTU indicators are closely related. The updated EWI retention indicator definition has been modified to be the same as the PEPFAR/UNGASS 12 month retention indicator, which greatly facilitates data abstraction and reporting burden for countries.
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, the draft WHO recommendation is 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, duration and survey sites should be the same as 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) 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.
Discussion points:
• HIVDR surveillance information obtained from TDR survey and PDR surveys are complementary and not necessarily the same. This is the case because some PDR survey participants will have had prior ARV exposures and true TDR may have reverted to wild type by the time treatment is initiated.
• The age criterion is important to minimize the likelihood of including chronically infected individuals.
• For South Africa, the national prevalence of HIV is variable, should the TDR survey be done regionally? If it is possible in light of sample size, performing regional analysis can be considered. However, it is important to consider the usefulness of such an exercise, as it is unlikely that different regional findings will lead to separate PrEP or PEP recommendations per region.
• Will the TDR survey be nationally representative if regional contribution of samples is different due to regional different prevalence or use of different eligibility criteria? No, TDR results will only reflect the population covered by the surveillance method onto which it is being piggybacked.
• Estimated budget: around USD 100.000 in addition to HIV surveillance costs.
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. The draft protocol proposes that 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.
Key discussion points and clarifications:
• Should the focus be on initiators without ARV exposure or with and without ARV exposure? This choice will depend on country-specific circumstances, but a
“decision algorithm” was proposed and discussed to assist country decision making. Critical issues include whether the group of patients with prior ARV exposure is sufficiently large and/or programmatically relevant to merit HIVDR surveillance.
• How should patients be screened for prior ARV exposure? Ideally health information systems should
Nevertheless, a specific questionnaire can be developed and applied in settings where this information is not routinely available. It was suggested that patients with unknown category should be excluded from PDR surveillance.
• What about patients receiving ART in the private sector?
Private sector sites should be included in the sample frame as well so that patients attending these clinics can be sampled thus enhancing the representativeness of the survey results. However, access to these clinics may be challenging and not feasible.
• The survey is not powered to provide statistically meaningful estimates of HIVDR according to the type of prior ARV exposure. Therefore, it is not possible to detect a relationship between HIVDR and particular types of exposure. Nevertheless, this information can be collected, and could be used to prompt additional investigations.
• Data collected are not meant to make clinic-level assessments. The purpose of the survey is to derive national prevalence estimates.
• Determination of pre-treatment viral load is not necessary to perform PDR surveillance. HIVDR testing can be done without viral load quantification as in this setting all are assumed to detectable virus (>1000 copies/mL) as they are initiating treatment.
• Estimated budget: around 125.000 USD to perform national PDR survey.
DAY 2
Session 5: Surveillance of acquired 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 proposed 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
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.
Key discussion points and clarifications:
• What to do with samples that fail to genotype? ➔ Sample size calculations and the guidance on the analytical plan will account for this possibility. These patients might be considered in the possible HIVDR category.
• Should the same clinics be sampled each year? ➔ No, it is preferable to choose different sites as programmes evolve and keeping the same sites may therefore no longer represent programme realities.
• The proposed survey is powered to detected HIVDR among all individuals surveyed, and not only among individuals surveyed failing ART. Thus, the denominator should be the number of patients on ART who are enrolled in the survey, not the number of patients failing ART.
• A study has been performed tracing patients LTFU and performing VL and HIVDR measurements after re-initiation of therapy (Leubbert et al CID 2012). This study has found virological failure with drug resistance in nearly 25% after resumption of first-line.
In order to better understand the ability of countries to perform the survey, participants were asked whether countries had available at the central level information on the number of people on ART at 12–24 and at 48–
60 months by clinic. Country responses are provided below:
Botswana: Clinic-level data on numbers of patients on ART by duration of therapy are available, both centrally and at the clinic.
Lesotho: Data are available at the site-level, not at the central-level, and system is paper-based.
South Africa: Data are available covering over 4000 clinics. However, low-end clinics use paper-based forms though they will eventually adopt the country’s electronic system. The paper-based clinics should report centrally for all time periods, but many do not do so in a timely manner, thus potentially biasing the sample.
Mozambique: Only certain clinics have this information in a few provinces. Only cumulative number of individuals on ART is available, not specified by duration on therapy.
Zimbabwe: Data are available at the site level, not at national level.
Namibia: Information is available.
Swaziland: Information is available, but issues with data completeness and accuracy require further analysis.
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 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 EID testing, and children already receiving ART are excluded.
Key discussion points:
• The survey is not powered to detect statistically relevant associations between HIVDR and individual PMCTC regimens, though it can provide an entry-point to guide further data gathering and analysis.
• High levels of pre-treatment non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance may jeopardize the ability of countries to employ protease inhibitor (PI)-sparing strategies.
DAY 3
Session 8: Country presentations of identified priorities for HIVDR surveillance
This session provided an opportunity for countries to present their draft HIVDR surveillance priorities and plans for 2013–2017 developed during the meeting.
ZIMBABWE
1. EWI: next round will be performed in select sites in 2014 using PPS to choose sites to permit national level aggregation of data in a way to provide nationally representative results. There is a goal of covering all sites by 2017, funds have been budgeted already.
Challenges: most facilities are paper-based therefore EWI data abstraction can be difficult. Action: The country is introducing an electronic pharmacy module (ePMS) and query programs to abstract data for EWIs will be written with this new system. This approach will greatly facilitate EWI reporting from all sites in the country.
2. TDR: a survey was performed in 2013; DBS specimens need to be sent out of the country for testing. The next
ANC survey will be performed in 2014.
3. PDR: tentatively the plan is to perform the survey among ART initiators without exposure in 2014.
Information on prevalence and type of exposure will be collected to decide when to do survey among initiators with exposure.
4. ADR: tentatively the plan is to start protocol
development in 2014. Both PDR and ADR surveys are part of funding line within the framework of Global Fund surveillance activities.
5. Paediatric survey: a pilot was performed in 2012;
protocols will be prepared in 2013. In 2014 samples will be used from PMTCT effectiveness study funded by PEPFAR to obtain comparable information. Challenge:
early infant diagnosis (EID lab) forms are incomplete;
this will be addressed by training.
LESOTHO
1. EWI: plan is to integrate EWI monitoring into M&E system in 2013
2. TDR: survey will be integrated into HIV sentinel surveillance protocol in September 2013. Previous HSS sample size included enough eligible pregnant women.
DHS survey is planned in 2014 and this could also be combined with TDR.
3. PDR: protocol for survey among initiators to be
developed and implemented in 2014, with funding from the Global Fund.
BOTSWANA
1. EWI has been done, but has to be extended and integrated into M&E system. Staff at facility level must be trained to collect data.
2. Monitoring strategies are being developed. Botswana’s 5-year plan is being finalized by the end of August 2013. The priorities for HIVDR monitoring are, in order of importance: 1) EWI, 2) ADR, 3) PDR, and 4) paediatric survey.
SOUTH AFRICA
HIVDR working group was formed in 2012, consisting of a clinical team, a lab group (NHLS/NICD), epidemiology and database development team. HIVDR monitoring surveys will be integrated in national health budget, but funded by CDC and Global Fund in the interim.
1. TDR: surveys could piggyback on ANC, VCT, male circumcision clinics or household surveys. The specimens are preferably plasma or DBS for remote sites. Debate is on-going whether TDR surveys should be nationally or regionally representative, given the
There is no consensus yet on how to perform provincial sampling so that a nationally representative estimate of TDR will be obtained. However, performing separate regional surveys does not seem feasible because of costs and because it is unlikely that regionally specific guidelines will be developed.
2. PDR: PDR surveillance is felt to be less of a priority when compared to TDR.
3. ADR: a high priority with plans to perform this survey under an existing Global Fund grant. Challenge:
performing PPS when information (i.e. number on individuals on ART) from certain clinics, particularly the smaller ones, is not available. Strategy to deal with this is currently being developed.
4. Paediatric survey: feasible to perform in context of EID and budget is allocated.
NAMIBIA
1. EWI: EWI monitoring to be performed annually between 2013 and 2017. Data will be collected using the electronic dispending tool, validated with ePMCS at all main sites for adults and children. Namibia noted that viral loads returned to sites were not always recorded correctly by data entry clerks and corrective action has been taken. Additionally ePMS will be updated to capture viral loads performed at 6 months after ART initiation.
2. TDR: planned for 2014 and 2016 piggybacking on ANC sentinel surveillance. There are 150 plasma specimens stored from a survey in 2012.
3. PDR: surveys among initiators with/without exposure planned in 2014 and 2017. Nationally representative using PPS to select 15–20 sites, plasma specimens to be used.
4. ADR: planned in 2015 for both time points (12–24 and 48–60 months) in adults and children. Nationally representative using PPS to select 15–20 sites, plasma specimens to be used.
5. Paediatric survey: planned for 2014 together with the PMTCT impact evaluation. After 2016 the survey will be integrated with EID every 2 years.
6. Budget: global fund/PEPFAR MOZAMBIQUE
1. EWI: new sites planned to be added every year, starting with 20% in 2014, up to 50% in 2017. Protocol will be developed in 2013.
2. TDR: piggyback on ANC surveillance every 2 years. In 2011 230 samples were found to be eligible. The round for 2013 is on-going. DBS collected, could potentially be sent to KEMRI lab in Kenya. Sufficient sample size is
3. PDR: the protocol for initiators without exposure is of interest to the country will be developed in 2015 based on final WHO guidance. The protocol for initiators with exposure is less of a priority and will be developed in 2017.
4. ADR: consider the passive surveillance among switchers or cross-sectional survey at different time points, to be implemented in 2014.
5. Paediatric survey: 490 specimens have been collected and sent to Montpellier for genotyping, results are pending. Survey should be done every 2 years before guideline revision.
6. General challenges include shortages of staff and funding.
SWAZILAND
1. EWI: introduce system for routine monitoring and train facility staff. To be performed in 2014 and 2016 in all sites using electronic data.
2. TDR: integrate with ANC surveillance in 2014 and with DHS in 2015. Samples, preferable DBS, will be sent to South Africa for genotyping. Funding: PEPFAR.
3. PDR: first round among initiators with/without exposure to be performed in 2015 using DBS.
4. ADR: survey at time points 12–24 months and 48–60 months to be performed in adults in 2015 and in children in 2016. Funding: GF and PEPFAR.
5. Paediatric survey: follow-up on genotyping results of 490 samples sent to France. Data analysis and report writing is pending. Second round of 490 DBS planned for 2014. Samples can also be sent to KEMRI in Kenya.
Proposed funding: UNICEF.
MALAWI
1. EWI: yearly in all ART facilities with monitoring of indicators 1–4. The conditional indicator number 5 (viral load) will only be collected in facilities with VL testing infrastructure. Use 2014 to train facility staff and start in 2015. Funding: PEPFAR.
2. TDR: piggy back on ANC sentinel surveillance in 2014 and 2016. Using epidemiological criteria, 337 women from 54 facilities were eligible in the previous year.
Central lab will collect DBS for shipment to designated laboratory. Funding: to be included in ANC surveillance budget.
3. PDR: perform survey among initiators without previous exposure in 30 clinics using PPS and repeat every two years. Currently the number of initiators with previous exposure is not available. Therefore decision tree presented at meeting will be used to determine
necessity of performing this survey, potentially in 2017.
Funding: unsure.
4. ADR: used PPS to select 20 ART clinics for survey in 2015. Currently funding is available for 4 sites using the former prospective approach. This funding could potentially be re-allocated for the cross-sectional survey. Future funding: CDC, Global Fund.
5. Paediatric survey: 5 EID labs are present so the total sample size will be 490. Survey to be performed in 2014 and 2016.
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.
Closing remarks
A new HIVDR global report is planned for 2015. This should provide critical data for the next revision of WHO’s 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.
Acknowledgement
The WHO wishes to acknowledge the support of the African Society of Laboratory Medicine for its support with the logistics of the meeting.
ANNEX 1: LIST OF PARTICIPANTS
8–10 July 2013, Cape Town, South Africa
South Africa Mukesh Dehda DOH dhedam@health.gov.za
South Africa Augustin Ntilivamunda WHO focal person ntilivimundaa@za.afro.who.int
South Africa Sergio Carmona NHLS Sergio.carmona@nhls.ac.za
South Africa Justen Manasa Africa Centre jmanasa@africacentre.ac.za
South Africa Gillian Hunt NICD gillianh@nicd.ac.za
South Africa Tonji Durant CDC officer durantt@sa.cdc.gov
South Africa Trevor Peter ASLM tpeter@clintonhealthaccess.org
South Africa Samuel Oladoyinbo CDC officer oladoyinbos@sa.cdc.gov
South Africa Wendy Stevens NHLS Wendy.stevens@nhls.ac.za
South Africa Francesca Conradie SA clinician’s society fconradie@witshealth.co.za
South Africa K Jamaloodien kjamaloodien@gmail.com
South Africa Gary Maartens Gary.maartens@uct.ac.za
South Africa Jeena jeena@ukzn.ac.za
Namibia Francian Tjituka tjituka@nacop.net
Namibia Anna Jonas jonasa@nacop.net
Namibia Claudia Mbapaha mbapahac@nacop.net
Namibia Negussie Taffa CDC Officer Vik1@cdc.gov
Namibia Steven Hong Tufts Namibia Centre shong@tuftmedicalcenter.org
Botswana Dinah Ramaabya dramaabya@gov.bw
Botswana Marina Anderson manderson@gov.bw
Botswana Masada Mine mmine@bhp.org.bw
Botswana Tebogo Madidimalo WHO focal person madidimalot@bw.afro.who.int
Zimbabwe Janet Dzangare jdzangare@atpzw.org.zw
Zimbabwe Mutsa Mhangara Mutsa.mhangara@gmail.com
Zimbabwe Owen Mugurungi Atp.director@ymail.com
Zimbabwe Christine Chakanyuka Musanhu WHO focal person chakanyukac@zw.afro.who.int Zimbabwe Brian Pazvakavambwa WHO regional officer pazvakavambwab@zw.afro.who.
int
Swaziland Velephi Okello vjokello@gmail.com
Swaziland Sandile Dlamine sbdlamini@nercha.org.sz
Swaziland Gugu Maphalala gpmaph@hotmail.com
Lesotho Keletso Ntene keletsontene@yahoo.ca
Lesotho Mamoeketsi Nkemele mcnkemele@gmail.com
Lesotho Haroon Seruli hseruli@yahoo.com
Lesotho Tlali Mpholo tlalimpholo@yahoo.co.uk
Mozambique Adolfo Vubil avubil@gmail.com
Mozambique Abdou Moha WHO focal person mohaa@mz.afro.who.int
Malawi Hannock Tweya H_tweya@lighthouse.org.mw
Malawi Sikhona Chipeta smchipeta@gmail.com
ANNEX 2: Meeting agenda
Day 1
8:30–9:00 Registration
9:00–9:30 Welcome remarks WR-South Africa
ASLM WHO-HQ
9:30–9:40 Individual participant introductions Meeting participants
9:40–10:20 Session 1: Overview of HIV Drug Resistance (HIVDR) at the global level and WHO’s response Objective: Review current evidence of HIVDR from global to regional perspective
Chair: Michael Jordan
9:40–9:55 2012 WHO global HIVDR report WHO-Bertagnolio
9:55–10:00 Q/A: Questions for clarification relating to the WHO 2012 HIVDR global report
10:00–10:15 WHO global strategy for the surveillance and monitoring of HIVDR WHO-Bertagnolio 10:15–10:35 Coffee Break
10:35–11:40 Session 2: WHO Early Warning Indicators (EWIs) of HIV Drug Resistance Objective: Review of WHO-recommended HIVDR EWIs and 2012 simplifications Co-chairs: Jhoney Barcarolo and Silvia Bertagnolio
10:35–10:55 Overview of WHO HIVDR EWIs WHO-Jordan
10:55–11:10 Country experiences with HIVDR EWIs, findings, challenges and public health action (5 minutes each)
• Namibia
• Malawi Namibia
Malawi
11:10–11:40 Q/A – Discussion: ART programme use of EWI data, feasibility, integration and scale-up
11:40–13:00 Session 3: Surveillance of transmitted HIV Drug Resistance (TDR) in recently infected individuals Objective: Review WHO concept note for surveillance of transmitted HIV Drug Resistance in recently infected
Populations: Relevance, feasibility, prioritization and adaptation at country-level Co-chairs: Michael Jordan and Jhoney Barcarolo
11:40–12:00 Country experiences (5 minutes each): Results, public health actions, what went well, and what we would like to do differently
• South Africa
• Botswana
• Mozambique
South Africa Botswana Mozambique 12:00–12:20 Surveillance of transmitted drug resistance (TDR) in recently
infected populations: Overview of 2013 concept note for nationally representative surveillance of transmitted HIVDR
WHO-Bertagnolio
12:20–13:00 Q/A – Discussion: TDR surveillance in recently infected individuals: Programmatic relevance of data, feasibility, comments on proposed concept note
13:00–14:00 Lunch
14:00–15:00 Individual country working groups: Surveillance of TDR
15:00–17:45 Session 4: Surveillance of HIV Drug Resistance in populations initiating ART; i.e. pre-treatment HIVDR (PDR)
Objective: Review WHO concept note for surveillance of resistance in populations initiating ART; its relevance, feasibility, adaptation and implementation at country level
Co-chairs: Michael Jordan and Jhoney Barcarolo
Results, public health actions, what went well, and what we would like to do differently (5 minutes each):
• Swaziland
• Zimbabwe Swaziland
Zimbabwe 15:15–15:40 Surveillance of pre-treatment HIVDR (PDR): Overview of 2013
concept note for nationally representative surveillance of resistance in populations initiating ART
WHO-Bertagnolio
15:40–16:30 Q/A – Discussion: Surveillance of PDR in populations initiating ART: programmatic relevance data, feasibility, prioritization and preferred approach for implementation
16:30–16:45 Coffee Break
16:45–17:45 Individual country working groups: Surveillance of PDR
Day 2
9:00–11:40 Session 5: Surveillance of acquired resistance in patients on ART
Objective: Review WHO concept note for surveillance of acquired HIV Drug Resistance (ADR) in patients on ART; its relevance, feasibility, adaptation and implementation at country-level Co-chairs: Silvia Bertagnolio and Jhoney Barcarolo
9:00–9:15 Country experiences (5 minutes each): Results, public health action, what went well, and what we would like to do differently
• Malawi
• Namibia Malawi
Namibia 9:15–9:40 Surveillance of acquired HIVDR: Overview of 2013 concept note
for nationally representative surveillance of ADR in populations on ART
WHO-Jordan
9:40–10:25 Q/A – Discussion: Programmatic relevance of data, feasibility and comments on proposed concept note 10:25–10:40 Coffee Break
10:40–11:40 Individual country working groups: Surveillance of ADR in populations on ART
11:40–13:25 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; its relevance, feasibility, adaptation and implementation at country level Co-chairs: Michael Jordan and Jhoney Barcarolo
11:40–11:55 WHO-recommended protocol for surveillance of HIVDR in
paediatric patients <18 months of age WHO-Bertagnolio 11:55–12:10 Country experiences in implementation, results, public health
action, what went well, and what we would like to do differently:
Examples from 2 Southern African countries (5 minutes each)
• Zimbabwe
• Swaziland Zimbabwe
Swaziland
12:10–12:40 Q/A – Discussion: Programmatic relevance of data and preferred approach for implementation 12:40–13:25 Individual country working groups: Surveillance of HIVDR in infants < 18 months of age 13:25–14:25 Lunch
14:25–16:00 Session 7: Working group discussion on HIVDR surveillance
Rapporteurs: Each country will select one representative to present on Day 3 14:25–14:35 Orientation to working groups, review of session goals,
presentation template and feedback questionnaire WHO-Bertagnolio
14:35–16:00 Working group formation (1 country 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 public health priorities and feasibility of implementation. Each country should respond to the following 3 questions, complete the feedback questionnaire 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. Plans should include a feasibility assessments for early warning indicators of HIVDR, surveillance of transmitted, pre-treatment/acquired HIVDR, and HIVDR in infants < 18 months of age
2. Identify necessary collaborations and external support for realization of immediate, medium, and long- term term national HIVDR surveillance priorities
3. Identify resources/changes necessary to ensure sustainability of medium and long-term HIVDR surveillance priorities
4. Complete feedback questionnaire
Day 3
9:00–11:45 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 programme and public health decision making, anticipated challenges and solutions to implementation of identified short, medium and long term goals
Co-chairs: Silvia Bertagnolio, Michael Jordan and Jhoney Barcarolo 9:00–09:30 Country working group session to finalize oral presentations
09:30–10:30 4 country presentations (10 minutes each); feedback and questions (5 minutes each) 10:30–10:45 Coffee Break
10:45–11:45 4 country presentations (10 minutes each); feedback and questions (5 minutes each) 11:45–12:15 Session 9: WHO HIVDR laboratory network update
Objective: Update on WHO laboratory network and future directions Co-chairs: Silvia Bertagnolio
11:45–12:00 WHO HIVDR Laboratory Network Update: “Who is Who” in the network; available services and cost; short-term and medium term goals
WHO-Jordan
12:00–12:10 Technical cooperation to support HIVDR surveillance in Africa:
(10 minute presentation)
• Building laboratory capacity for HIVDR testing in Africa ASLM 12:30–12:45 Closing remarks – way forward – confirm schedule of the 1 on 1
discussion in the afternoon ASLM
WHO-HQ 12:45–13:45 Lunch
13:45–17:15 Session 10: One-to-one discussions between country teams and WHO to finalize agreements on cooperation in the short term (30 minutes per country team)
Notes
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Notes
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Switzerland
E-mail: hiv-aids@who.int www.who.int/hiv
