National Consultation on the Strategic Use of ARVs in Thailand by Adam's Love Thailand

Report

National Consultation on the Strategic Use of ARVs - Thailand 9 and 10 August 2012

National Consultation on the Strategic Use of ARVs The proceedings of this meeting were recorded by Shravya Kidambi

Table of Contents TABLE OF CONTENTS

ACRONYMS

EXECUTIVE SUMMARY

BACKGROUND & INTRODUCTION

DAY ONE: AUGUST 9TH

OPENING: THE VISION OF THE NATIONAL HIV STRATEGY, 2012-2016 PRESENTATION: THE STRATEGIC USE OF ARVS: GLOBAL EVIDENCE AND EXPERIENCE TO DATE PRESENTATION: THE THAI HIV EPIDEMIC: CAN IT BE CONTROLLED WITH CURRENT APPROACHES? INSIGHTS FROM MODELING AND EPIDEMIOLOGICAL ANALYSIS CLARIFICATIONS & PLENARY DISCUSSION PANEL DISCUSSION: ADDRESSING CURRENT PRACTICES AND CHALLENGES FOR STRATEGIC USE OF ANTIRETROVIRAL TREATMENT SUMMARY, CONCLUSIONS, AND OUTLOOK FOR DAY 2

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DAY TWO: AUGUST 10TH

WELCOME BACK AND INTRODUCTION BY MODERATOR TO OBJECTIVES OF DAY 2 PRESENTATION: ADDRESSING SERVICE DELIVERY CHALLENGES AND OPPORTUNITIES FOR THE STRATEGIC USE OF ARVS SITUATION UPDATE ON TESTING AND COUNSELING AND LINKAGES TO TREATMENT AND CARE IN THAILAND DISCUSSION WORKING GROUP DISCUSSIONS: EXPANDED TESTING AND COUNSELING, LINKAGES TO CARE/TREATMENT, AND ADHERENCE SUPPORT: OPPORTUNITIES AND CONSIDERATIONS IN THAILAND WORKING GROUPS REPORT TO PLENARY SESSION CLOSING

NEXT STEPS

NOTES FROM MEETING OF WORKING GROUP – 22/8/2012

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Acronyms AEM AIDS ANC ART ARV BATS cART FSW HIV IDU KAP KPI MARP MSM MSW MW NHSO OPD PLHIV PMTCT PrEP S&D STI TasP TG TNCA TNP+ TUC TWG UNGASS VCT

Asian Epidemic Model Acquired Immune Deficiency Syndrome Antenatal Care Anti Retroviral Therapy Antiretroviral Bureau of AIDS, Tuberculosis and STI Combination Anti Retroviral Therapy Female Sex Workers Human Immunodeficiency Virus Injecting Drug User Key Affected population Key Performance Indicators Most-at-Risk Populations Men who have Sex with Men Male Sex Workers Migrant Worker National Health Security Office Outpatient Department People Living with HIV Prevention of Mother-To-Child HIV Transmission Pre-Exposure Prophylaxis Stigma and Discrimination Sexually transmitted infections Treatment As Prevention Transgender Thai NGO (Non-Governmental Organization) Coalition on AIDS Thai Network of People Living with HIV/AIDS Thailand Ministry of Public Health - US CDC Collaboration Technical Working Groups United Nations General Assembly Special Session on HIV/AIDS Voluntary Counseling and Testing

Executive Summary The National Consultation on the Strategic Use of ARVs was held on 9-10 August, 2012 in Bangkok, Thailand. The consultation was organized by the UN Joint Team on HIV/AIDS, Thailand MOPH-U.S. CDC Collaboration on HIV and AIDS (TUC), Thai Red Cross Society, and the Ministry of Public Health. The primary goal of the consultation was to provide an opportunity for key stakeholders including decision makers, epidemiologists, modelers, and affected populations to better understand new evidence around strategic use of ARVs and potential applications to Thailand’s national AIDS program. Thailand’s National AIDS Strategy calls for a reduction in new HIV infections by two thirds by 2016. During Day 1, Dr. Wiwat Peerapatanapokin from the East-West Center noted that using AEM estimations on current prevention/treatment efforts, Thailand will fall short of its 2016 target of reducing new infections by approximately 5000 cases. Therefore, new strategies need to be put in place to achieve goals set for 2016. Dr. Charles Gilks, currently UNAIDS Country Coordinator for India and former Director of the Treatment and Care Unit of the HIV/AIDS Department for WHO Geneva, presented the breadth of evidence that exists supporting the early initiation of ARVs at both individual and population levels (treatment and prevention). While this was acknowledged by stakeholders as a beneficial intervention, concerns were raised and discussed related to implementation of treatment as prevention initiatives both for the overall health system as well as affected individuals. Following panel discussions and working group sessions, it was agreed that ARVs should be used strategically in Thailand for treatment and prevention. It was acknowledged that Thailand already has a best practice example of “treatment as prevention” in the form of PMTCT. There was consensus that the biggest benefit to be derived would be in treating all people found to be HIV positive, and strategically conducting VCT among KAPs (target of 90% of KAPs knowing their serostatus). However, using ARVs at a much larger scale than now (i.e. treatment as prevention, PMTCT B+) will require the development of new service delivery models and task shifting. The introduction of completely new services, like PrEP, will need careful consideration, planning and monitoring. Action items to be taken up following the consultation were identified within six major work streams: 1. Service Delivery: Explore options for decentralized care and VCT; sustain / enhance success of PMTCT program; develop strategy to improve coverage of VCT

2. Monitoring: Develop centralized data repository to monitor/evaluate VCT in parallel with building up capacity of data use at service and provincial levels 3. Policy: Develop practical and concrete recommendations on testing and treatment; determine the target population for interventions (e.g. should they be aimed at the general public or at key affected populations?); review ARV policies/legal barriers for migrants, non-Thais, and youth (under 18) 4. Modeling: Develop more cost/benefit and cost effectiveness analyses on using antiretroviral agents as prevention; update Asian Epidemic Model estimates on IDUs, Transgenders, and the effects of behavioral change. 5. Operational Research: Explore possibility of launching a pilot PrEP program; analyze workloads of healthcare personnel to determine current limitations 6. Public Communication: Develop a public communication campaign for increased understanding of potential use of ARVs for HIV prevention

Background & Introduction HIV/AIDS is an issue of continued political and public health significance in Thailand. According to the 2010-2011 Global AIDS Response Country Progress Report for Thailand, there are an estimated 500,000 adults and children living with HIV1 and 10,450 new cases in 20112. According to the Asian Epidemic Model (AEM), it is estimated that 43,040 new infections will occur during 2012-2016. Thailand’s successful anti-retroviral treatment program currently reaches two-thirds of adults and children in need of treatment (CD4 200 cells/mm3 and below), and has contributed to transforming HIV for people in Thailand from a fatal illness to a chronic condition. Free access to ARVs and free universal health care has contributed to people living longer and healthier lives. Thailand has been lauded for several aspects of its HIV prevention policy, ranging from universal HIV counseling and testing in ANC settings (PMTCT) with ARV prophylaxis provision as needed, to the 100% condom use policy among sex workers. PMTCT interventions alone have reduced the number of new infections in children to fewer than 350 cases per year3. Despite Thailand’s success in scaling up critical HIV care/treatment, AIDS remains the number one cause of death among men and women in their prime (ages 15 – 49). It is the official cause of death for 22.6% of males and 30.7% of females in this age group4. The 2010 Thai National HIV/AIDS Diagnostic and Treatment Guidelines recommend CD4 count <350 cells/mm3 as the threshold for ART initiation in patients. The current median CD4 count at ART initiation in Thailand is 63 cells/mm3,5. Late HIV testing and/or delayed CD4 count measurement after HIV diagnosis may explain the delayed initiation of ART in many settings. At the same time, delayed treatment initiation can lead to sub-optimal clinical outcomes for the individual, and contribute to ongoing HIV transmission as people with high viral loads continue to spread HIV throughout their respective communities. During 2010-2011, five new prevention trials showed a positive effect from the use of antiretroviral agents for prevention: four used antiretroviral agents for preexposure prophylaxis for primary prevention and one randomized clinical trial, HPTN 052, studied the prevention benefit through early use of treatment among infected individuals. The evidence from these studies suggests that the use of antiretroviral agents can be effective in significantly improving clinical outcomes, but also serves as an effective HIV prevention measure. 1

Preliminary data from 2011 estimates, UNAIDS/WHO, 2011 Ibid. 3 Global AIDS Report 4 Preliminary data from 2011 estimates 5 Nittaya Phanuphak. (March, 2011). Active Voluntary Counseling and Testing with Integrated CD4 Count Service Can Enhance Early HIV Testing and Early CD4 Count Measurement: Experiences From the Thai Red Cross Anonymous Clinic in Bangkok, Thailand. Clinical Science. Volume 56. 2

A recent meta-analysis of ARV provision among sero-discordant couples reviewed the results from HPTN 052 and seven observational studies. The eight studies identified 464 episodes of HIV transmission, of which 72 were among treated couples and 392 among untreated couples. The conclusion was that even in the worst case scenario, when the HIV infected individual in a sero-discordant couple was taking ARVs; the risk of transmission was more than three times lower than in situations where the infected sexual partner was not taking ARVs6. The biological rationale behind this protective effect is that viral load reduction to undetectable levels significantly decreases the risk of sexual transmission. Thailand, as an upper middle income country, with declining HIV prevalence (under 1.5%)7, is well positioned to consider whether earlier initiation of antiretroviral agents would be a feasible and effective way of reducing new HIV infections. The National Consultation on the Strategic Use of ARVs was held on 9-10 August, 2012 in Bangkok, Thailand. The consultation was organized by UNAIDS, UNICEF, WHO, Thailand MOPH-U.S. CDC Collaboration on HIV and AIDS (TUC), Thai Red Cross Society, and the Ministry of Public Health. The primary goal of the consultation was to provide an opportunity for key stakeholders including decision makers, epidemiologists, modelers, and affected populations to better understand new evidence around treatment as prevention and its potential applications to Thailandâ&#x20AC;&#x2122;s national AIDS program. Specifically, the consultation aimed at addressing the following objectives: 1. Understanding the evidence from completed studies regarding both the impact of ART on improving clinical outcomes at the individual level, as well as its efficacy in reducing the incidence of new infections in the broader population 2. Understanding the perspective of policy makers with respect to changes in treatment initiation considerations, including cost, cost effectiveness, affordability, feasibility, ethics/human rights issues, and burden on healthcare facilities and associated workforce 3. Understanding the perspective of the clinical community and the potential impacts of earlier initiation of treatment on clinical outcomes, adherence and potential for development of resistance

Anglemyer, et al. Antiretroviral therapy for prevention of HIV transmission in HIV-discordant couples. Cochrane HIV/AIDS Group, 10 August, 2011. Accessed at: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD009153.pub2/abstract;jsessionid=49148A2B 82BE2904BDC4 B6B103451B0C.d02t02 7 UNAIDS Country Profile, accessed online at: http://www.unaids.org/en/regionscountries/countries/thailand/

4. Understanding the perspective of civil society and affected populations both with respect to reasons they may support or oppose the promotion of earlier treatment, including the potential for improved quality of life or increased stigmatization 5. Understanding the gender dimensions associated with earlier treatment including any potential negative and positive consequences for men and women having their HIV status identified and beginning lifelong ART Expected Outcomes: 1. Key policy dialogue on evidence from completed studies regarding both the impact of ART on improving clinical outcomes at the individual and population level, as well as its efficacy in reducing the incidence of new infections 2. Policy dialogue on the factors to be considered for prioritization of access to treatment and prevention services using ARVs (consideringâ&#x20AC;&#x201D;among othersâ&#x20AC;&#x201D; cost, cost effectiveness, affordability, feasibility, ethics, equity and human rights issues) and review their integration in the decision making process

Day One: August 9th Opening: The vision of the National HIV Strategy, 2012-2016 Delivered by: Dr Sumet Ongwandee, BATS Dr. Somsak Akkasilp, Deputy Director General, Department of Disease Control Dr. Michael Hahn, UNAIDS

The National Consultation for the Strategic Use of ARVs began with opening remarks by Dr. Sumet Ongwandee from the Bureau of AIDS, TB and STIs (BATS). He commented on the success of Thailand’s current ARV program that reaches over two-thirds of the population in need (CD4 count below 200 cells/mm3) and that has transformed the disease from an infectious disease with a high case-fatality rate into a chronic illness. He also praised several specific initiatives such as the universal coverage program, PMTCT initiatives that have reduced the number of new infections in newborns to 350 cases per year and the 100% condom policy for sex workers. Dr. Sumet also noted the fact that AIDS still remains the number one cause of death for men and women in the 15-49 age range (a total of 28,000 deaths were attributable to AIDS in 20118). In addition, the median CD4 count for ART initiation in Thailand is extremely low (63 cells/mm3)9. This leads to suboptimal morbidity and mortality outcomes and increased viral load in the community. Lastly, Dr. Sumet touched upon the consultation’s goal of reviewing various policy/implementation issues on the strategic use of ARVs to meet the goal of zero incidence and zero AIDS-related deaths. He further noted the critical importance of policy discussions that involve key stakeholders from diverse backgrounds. Dr. Somsak Akksilp echoed Dr. Sumet’s remarks and noted that a consultation implies a true collaboration. He invited all participants to bring their insights and comments to the forefront and highlighted the appropriateness in holding this consultation immediately following the International AIDS Conference 2012 in Washington, DC. He reiterated Thailand’s many accomplishments but cautioned that a high percentage of Thai residents still do not have access to HIV care/treatment. Lastly, Dr. Somsak challenged participants to come up with clear and practical policy recommendations to present to the Ministry of Public Health in terms of strategic use of ARVs and revitalized VCT. Dr. Michael Hahn representing the UN Joint Team on HIV/AIDS noted that there is finally strong evidence to suggest that antiretroviral agents can be strategically used as preventative tools. As a middle income country with a low prevalence of HIV and a 8

Preliminary data from 2011 estimates Nittaya Phanuphak. (March, 2011). Active Voluntary Counseling and Testing with Integrated CD4 Count Service Can Enhance Early HIV Testing and Early CD4 Count Measurement: Experiences From the Thai Red Cross Anonymous Clinic in Bangkok, Thailand. Clinical Science. Volume 56. 9

strong healthcare system and pharmaceutical industry, Thailand is in a very good position to implement treatment as prevention programs compared to other countries; it is not a matter of whether these programs will be implemented but when these programs will be implemented. Since the lives of thousands of Thai residents are at stake, it is important to dedicate our attention to how this paradigm shift will take place and how we can deliver HIV/AIDS services more effectively so that we can reach our goal of an AIDS-free Thailand.

Presentation: The Strategic Use of ARVs: Global Evidence and Experience to Date Presented by Dr. Charles Gilks UNAIDS Country Coordinator for India and Former Director of HIV and AIDS Treatment and Care Unit, WHO headquarters in Geneva

(in millions)

Biologic plausibility exists in strategically using ARVs for prevention. There is a clear gradation of viral load on infectivity and the PACTG 076 trial in 1994 shows that AZT given to pregnant mothers prevents mother to child transmission.

Figure 1:Cumulative Life-Years Gained from Antiretroviral Therapy, 1996–2011

Cumulative life-years gained

ART has been a successful intervention: the cumulative number of lives gained as a result of treatment is now heading towards 25 million life-years (Figure 1).

0 1996

2011

Source: Joint United Nations Programme on HIV/AIDS, 2012.

Current ARV initiatives include the global treatment scale up since 2001 and steadily increasing availability of ARV prophylaxis for prevention of HIV transmission from pregnant women to their infants. However, the strategic use of ARVs for prevention has not yet been widely adopted for the following reasons:    

Persistence of a false dichotomy in either focusing on treatment or prevention Challenges to the continued production of affordable ARVs in light of current trade policy agreements. There is also a fear that funding would be diverted from prevention programs. Persistent views that it is not possible to ‘treat our way out of the epidemic’ since the behavioral component also needs to be addressed Data showing the constant decline in HIV incidence regardless of the global scale up suggests that treatment has no impact on incidence. However, treatment initiation occurs at a median CD4 count that is too low to expect any impact (mean CD4 count at ART initiation is below 200 cells/mm3 in Low and Middleincome Countries.)

Evidence from ecological epidemiology studies in Taiwan, Canada, and South Africa suggests that there is demonstrated effectiveness of ART scale up on prevention. There have also been randomized clinical trials such as the HPTN 052 study and PrEP studies of discordant couples in Sub-Saharan Africa together with epidemiological 13

modeling that explores this question. The test-and-treat model, shown in Figure 2 models the impact of increasing the coverage and intensity of HIV treatment in South Africa. Results show that immediate treatment after testing leads to almost zero incidence. The HIV Modeling Consortium TasP Editorial Writing Group also created a framework to understand the epidemiological impact of cART on HIV transmission (Figure 3). As can be seen, two-thirds of HIV transmission occurs at CD4 levels less than 200 cells/mm3 and approximately a half occurs at CD4 levels less than 350 cells/mm3.

Figure 2:The Test and Treat Model

Figure 3: A framework to understand the epidemiological impact of cART to onward HIV transmission

The randomized HPTN 052 study of healthy, serodiscordant couples showed that treatment reduces by more than 90% the risk of passing along infection to non-infected partners and this finding has been confirmed by several other randomized clinical trials. There have also been several studies to show the effectiveness of PMTCT, including the use of the new â&#x20AC;&#x153;Option B+â&#x20AC;? (life-long treatment initiated in pregnant women regardless of CD4 count). The HIV Modelling Consortium TasP Editorial Writing Group PLoS Medicine 2012 vol 9 e1001259

Moving forward, Thailand should continue to build on its current successes with its PMTCT program. In addition, PrEP can be used as an additional intervention for key affected populations (e.g., MSM, transgender and people who inject drugs). Two randomized studies found that taking ARVs by the HIV-negative partner in a discordant couple (pre-exposure prophylaxis or PrEP) reduced transmission substantially10. Note that the guidances on PrEP are conditional recommendations by the WHO because to-date, only a few studies exist that address this topic. For oral PrEP, the reservoir of uninfected people is far too large and the challenge rests with identifying those at risk for HIV acquisition. While this may be relatively straightforward for some groups, the potential for PrEP remains unclear for others 9. Thailand should revise the threshold for ART initiation (currently CD4 <200 cells/mm3 and below) and improve coverage to 80%, noting that under the test-and-treat model, this will lead to an additional 120,000 patients. While there are concerns related to funding and drug resistance, these concerns should not deter efforts to 10

James Shelton. (December, 2011). ARVs as HIV Prevention: A Tough Road to Wide Impact. Science 23. Vol. 334 no. 6063 pp. 1645-1646

promote expanded ARV treatment. Dr. Gilks noted that treatment as prevention has community, in addition to, individual level advantages.

Presentation: The Thai HIV Epidemic: Can it be Controlled with Current Approaches? Insights from Modeling and Epidemiological Analysis Presented by Dr. Wiwat Peerapatanapokin East-West Centre/Policy Research and Development Institute Foundation

Figure 4:Baseline Scenario for HIV in Thailand 1,400,000 1,200,000 1,000,000 800,000

Living w/HIV and AIDS

Cumulative HIV

20 25

20 20

20 15

20 10

20 05

20 00

19 95

19 90

600,000 400,000 200,000 0

19 85

Number of infection

The National AIDS plan calls for a two-thirds reduction of new HIV infections by 2016. The Asian Epidemic Model (AEM) is a behavioral model that simulates the transmission dynamic in low level and concentrated epidemics.

New HIV

Figure 5:Comparison of Baseline Projections versus Goals AEM provides valuable projections in concentrated HIV settings, particularly in Thailand. Figure 4 shows the baseline scenario for HIV in Thailand. It is estimated that 43,040 new infections will occur during 2012-2016. In Figure 5, the baseline scenario is compared with goals stated in the National AIDS plan. The graph shows that status quo, new infections in 2016 are projected to fall to 7000 per year. This falls short of the expected target of approximately only 3000 new cases, demonstrating that a change is needed in current policies in order to further reduce the incidence of new HIV infections.

A deeper review of the situation shows that the three groups that have the lowest projected drop in new HIV infections based on current behavioral initiatives are females having sex with their husbands/spouses, men who have sex with men (MSMs) and injection drug users (IDUs). To reduce infections by two-thirds, the following behavior changes need to occur by 2016:  Increase in condom use among MSMs to 90% (from current level of 70%)  Increase in condom use by female sex workers (FSWs) to 95% (from current level of 82%)  Increase in condom use among regular partners to 45% (from current level of 2%)  Increase in condom use during casual sex to 75% (from current level of 45%)  Reduction of injection sharing by IDUs to 18% (from current level of 36%)

In summary, it seems extremely difficult to achieve the behavioral change levels needed to reach the 2016 targets and that additional interventions will also be needed to reach desired goals. As a next step, the Asian Epidemic Model was used to study the effects of introducing ARV as prevention. The model assumed that use of ARVs reduced infectivity by 96% but that it did not influence behaviors. Results are shown in Figure 6. Figure 6: New HIV Infections for Various Treatment as Prevention Interventions

The model shows that increasing the CD4 threshold for treatment initiation reduces the number of new infections. In addition, expanding VCT from 30% to 90% in key affected populations further reduces the incidence of HIV. Note that increasing testing and treatment coverage will require additional healthcare capacity since the number of people on treatment is expected to increase to 350,000 (up from 200,000 currently on treatment.)

Clarifications & Plenary Discussion Co-chair: Dr. Somsak Akkasilp Deputy Director General, Department of Disease Control Co-chair: Ms. Supatra Nacapew Thai NGO Coalition on HIV and AIDS (TNCA)

Several participants commented on the usefulness of both presentations in helping to disseminate necessary information needed for effective policy making. The following table summarizes the major concerns raised as well as responses by panelists/other stakeholders: Question/ Concern Treatment as prevention strategies involve giving toxic substances to asymptomatic

Answer All medicines are toxic. There are side effects in terms of long term adherence. Motivation stems from individual desire to stay healthy despite 16

Question/ Concern people. How can incentives be designed to encourage this?

The strategic use of ARVs will replace prevention initiatives Funding is not available for the scale up of ARVs to be used as prevention Additional capacity does not exist in health system to accommodate the influx of patients that would result from a scale up in testing and treatment Stigma/discrimination still remains a major issue in providing services to PLHIVs or KAPs – this issue should be addressed first before new initiatives are put in place

Should improvements be made in condom programming/condom stock outs before adopting new strategies for prevention? Drug resistance

Issues with patent protection and drug pricing

Answer minor side effects. The risk benefit equation is drastically different for people that are healthy versus people that are sick and symptomatic but in order to increase adherence, individuals need to understand that treatment as prevention will bring benefits to the entire community. Treatment should not be perceived as replacing prevention. It instead should be seen as a component of prevention strategies. Funding should not serve as a barrier for the implementation of this strategy. It should also be noted that in the long term, treatment as prevention can be more cost-effective.  Need to conduct further analysis of workloads of healthcare personnel  Task shifting can help in improving capacity in the current health delivery system 

Need to develop effective public communication in partnership with the target community; this includes increased focus on communicating the benefits of earlier treatment and enhanced prevention through earlier diagnosis rather than the stigma of being identified as infected with HIV.  Major behavioral change is needed to improve treatment for infected individuals to reduce transmission.  Activism for rights-based approaches to HIV treatment, care and support is extremely important The strategic use of ARVs should be seen as an intervention that will be used in conjunction with current prevention initiatives. 

Studies show that incidence of drug resistance with ARV scale up is relatively low  Transmission of resistant strains is very limited and has a low incidence  Issues for drug resistance with PrEP should be a separate discussion Strong activism and policy dialogue is needed to address changing trade policies at the international level. 17

Question/ Concern PrEP might be used as a substitute for condoms

Answer PrEP should be seen as an addition, not a replacement of current interventions and this needs to be communicated to the target population

Items requiring follow up/ further discussion:     

Analyze workloads of healthcare personnel to determine current limitations Update Asian Epidemic Model estimates on IDUs, Transgenders, and the effects of behavioral inhibition Review ARV policies/legal barriers for migrants, non-Thais, and youth (under 18) Develop strategy to improve coverage of VCT – without improved HIV case detection, a strategy applying treatment as prevention is unlikely to be successful Determine the target population for strategic use of ARV initiatives

Panel Discussion: Addressing Current Practices and Challenges for Strategic Use of Antiretroviral Treatment Moderator: Dr. Petchsri Sirinirund, the National AIDS Management Center Panelists: Dr. Usah Pruetijirawongse, the Office of Permanent Secretary, MOPH Dr. Peerapol Suthivisetsak, Deputy Secretary-General of the Nation Health Security Office (NHSO) Ms. Supatra Nacapew, Thai NGO Coalition on HIV and AIDS (TNCA) Dr. Panita Pathipvanich, Lampang Hospital Mr. Apiwat Kwangkaew, Thailand Network of People Living with HIV and AIDS (TNP+)

The objective of the panel session was to discuss strategies to maximize the benefit of ARVs and to recognize some of the structural barriers to the implementation of these strategies. Apiwat Kwangkaew started the discussion by stating that the initial global campaign to scale up ARV treatment involved a target of 15 million individuals. Currently, 6-7 million people are still waiting for treatment worldwide. Furthermore, a number of individuals that are eligible for treatment do not have easy access to services leading to wide disparities in the availability of care. He also brought forward the perspective of a person living with HIV in viewing ARVs as toxic substances and noting that the implementation of treatment as prevention requires an attitudinal change and further education on the part of the target population. In addition, the community should also be educated that ARVs should be used in conjunction with condoms as there appears to be a popular misconception that treatment usurps consistent condom use. Lastly, he highlighted the importance of further discussing the individual risk decision making process and its importance in the demand for VCT. Supatra Nacapew echoed that the ARV treatment as prevention initiatives cannot be separated from other HIV prevention initiatives including use of condoms and

behavior change. Successfully implementing strategies such as treatment as prevention will require commitment from stakeholder leadership. She also reiterated the concerns raised in the Clarifications & Plenary Sessions in terms of improving the condom program, issues with patent protection and TRIPS in impacting the affordability of ARVs, the role of stigma and discrimination and the need to develop better mechanisms to increase demand for VCT. Dr. Panita Pathipvanich brought forth a physician perspective and stated that there should be a continuous pipeline of healthcare personnel in the system to accommodate the high turnover and retirement rates. She also confirmed that it will be impossible for the burden to be borne solely by medical professionals and supported the development of task shifting initiatives. In terms of HIV/AIDS initiatives, Dr. Panita emphasized that the three most important things were adherence, earlier testing and increased condom use. Dr. Usah Pruetijirawongse discussed the governance structure in the MOPH in terms of implementation, noting that there is room for improvement in this process. He also clarified the role of the Office of the Permanent Secretary in being responsible for the implementation of programs. He stressed the importance of supporting the National AIDS Strategy for 2012-2016, which promotes harmonization and optimization of HIV services. Healthcare financing is usually viewed as poverty reduction instead of looking at financing from the perspective of outcomes said Dr. Peerapol Suthivisetsak. Health financing also involves improving manpower and contributing to the local economy so it can also be viewed from the perspective of poverty prevention instead of poverty alleviation. Dr. Peerapol also provided insight into the health budgeting process, noting that the budget for HIV has increased since last year and is continuing to respond to ever increasing demand. In terms of treatment as prevention and other initiatives, he stressed the importance of cost-benefit analyses in guiding NHSO funding. Discussion Panelists encouraged the audience to share their thoughts on key policy issues related to treatment as prevention but cautioned that these issues should not be viewed as obstacles to implementation. One of the biggest issues was stigma/discrimination â&#x20AC;&#x201C; stakeholders highlighted the importance of setting a target of zero stigma/discrimination as well as zero new infections in order for any strategy to be effective. It was also noted that the existing healthcare system is already stretched thin and increasing capacity may mean that task shifting initiatives need to be taken into consideration. On the positive side, it was acknowledged that using ARVs as prevention makes sense since it involves prevention for an entire community as opposed to just for an individual. In addition, stakeholders agreed that individuals should know their serostatus as soon as possible but care must be taken to create an environment of confidentiality so people feel comfortable getting tested and post-test counseling must be offered to all in order to improve adherence and knowledge of potential side effects. 19

Summary, Conclusions, and Outlook for Day 2 Presented by Dr. Somsak Akkasilp Deputy Director General, Department of Disease Control, Ministry of Public Health

The first part of this session was dedicated to recognizing that existing funds need to be used as effectively as possible since some funding streams for prevention interventions were ending in the next few years. Dr. Peerapol confirmed that the NHSO is reaching the limit of its fiscal space but noted that funding will always be made available for evidence based interventions. Building on this, Michael Hahn added that a scientific base already exists in terms of the strategic use of ARVs. In addition, he challenged stakeholders to think about the possibility of reimbursing community organizations for the provision of HIV/AIDS services in light of the shortage of medical professionals. Specifically, he broached the idea of community based testing and services or home based testing as a way to improve coverage and reduce stigma/discrimination. Dr. Somsak closed the session by stressing the importance of moving outside our comfort zones and taking into consideration a variety of factors outside of budget considerations in order to develop a strategy. Scientific evidence for treatment as prevention exists but discussion points from the day show that the concern is centered on the implementation of the intervention, which will be discussed during Day 2.

Day Two: August 10th Welcome Back and Introduction by Moderator to Objectives of Day 2 Delivered by Dr. Petchsri Sirinirund National AIDS Management Centre (NAMC)

Dr. Petchsri Sirinirund began the second day of the consultation by summarizing the key issues that were brought up in terms of implementation during the previous day’s discussions and stressed the need to create policy recommendations by the end of the day, as an output of the meeting.

Presentation: Addressing Service Delivery Challenges and Opportunities for the Strategic Use of ARVs Presented by Dr. Charles Gilks UNAIDS Country Coordinator for India and Former Director of HIV and AIDS Treatment and Care Unit, WHO headquarters in Geneva

There are three main domains for the strategic use of ARVs in Thailand: PMTCT, early ART and PrEP for MSMs. Thailand already has an extremely successful PMTCT program but continued investment is required to ensure that the country does not revert back to its earlier state. Thailand should also stretch its goals by safely targeting less than 2% mother-to-child transmission rates 11. One way of achieving this is by providing Option B+ as standard first line therapy for HIV positive women that are pregnant or are thinking of becoming pregnant. The benefits of early ART were noted in Dr. Gilks’ previous presentation on Day 1 but it should be noted that service delivery needs to be massively expanded if prevention benefits are to be realized. There is a need for new service delivery models that focus on retaining atrisk negative HIV individuals. This should be done before considering PrEP as an option for MSMs since the intervention will not prove effective through existing ART centers. The guiding principles of Treatment 2.0 are focused on radical simplification of ART with accelerated scale-up and full integration with prevention. Thailand should focus on the fourth and fifth action areas: adapting delivery systems and mobilizing communities/protecting human rights. In terms of adapting delivery systems, Thailand needs to:  Decentralize services to be as close to the individual as possible since treatment occurs over the long term  Integrate prevention, diagnosis and treatment  Expand options for HIV testing and counseling to increase coverage and make people more willing to seek counseling  Expand task shifting in response to the shortage of qualified health workers 11

International Training Course of Programme Management of Prevention of Mother to Child HIV Transmission, World Health Organization

 

Shift away from the stand-alone delivery of ART services in order to destigmatize HIV services Strengthen procurement and delivery systems

Mobilizing communities involves focusing on the demand side of the equation. Communities need to be engaged in testing and counselling, service delivery, adherence and provision of care and support. Models already exist to prove that community led initiatives work in building adherence. Therefore, there needs to be strong public communication that HIV/AIDS is a community level disease with community level benefits in terms of prevention of transmission. The biggest challenge preventing the success of community initiatives will be getting to zero stigma/discrimination. When implementing treatment as Figure 7:The Test, Treat and Retain Cascade prevention programs, the test, ART eligible treat and retain cascade must be Pre-ART considered (Figure 7). The most care and ART support HIV+ important piece in this cascade is creating the demand for testing and counseling by inducing behavior change. Programs need PrEP for Couple to address individuals’ fear that target groups Counselling the negative consequences outweigh the positive benefits. In addition, programs need to ensure that they create a safe and confidential environment for individuals. Other considerations in terms of implementation include task shifting and treatment simplification. Key stakeholders in Thailand need to consider what roles and responsibilities within HIV care can be reliably provided by the community, as is the case with diabetes care/treatment. Task shifting also needs to be endorsed both by the medical community and by community members in order to be effective. Lastly, there should be a push towards a simplification of the treatment to one pill a day since it improves delivery and adherence both for first line and second line treatments.

Situation Update on Testing and Counseling and Linkages to Treatment and Care in Thailand Presented by: Dr. Sumet Ongwandee Bureau of AIDS, TB, and STIs (BATS) & Mr. Nimit Tienudom AIDS Access Foundation

Dr. Sumet Ongwandee provided an overview in terms of the key statistics and initiatives related to testing and counseling and linkages to care in Thailand. The VCT process, shown in Figure 8, is both client and provider initiated. The lack of a central repository of information makes VCT difficult to track. The NHSO VCT database

showed that in 2011, there were 488,469 counseling cases for adults and 16,943 cases. In addition, it was found that 41.82% of people with STIs opt for VCT in STI clinics versus 16.87% in general OPD.

Figure 8:VCT Process

In terms of the strategic approach, there are several initiatives in place to promote testing such as national call centers, anonymous testing and counseling and free HIV testing twice a year, to name a few. The AIDS management center is also implementing several projects in order to strengthen access to VCT. Despite current efforts, gaps still exist in testing among youth and KAPs and in linkages to treatment. Nimit Tienudom re-emphasized the importance of testing and spoke to the biggest gaps in HIV care from his perspective:  A large percentage of the population are still unaware of their serostatus and practice unsafe sex  Lack of awareness among the HIV positive population of their rights to treatment and care  Lack of individual awareness of their own risks  Lack of streamlined care from initial HIV counseling and testing to treatment  Lack of a unified public awareness campaign  Stigma/discrimination

Discussion Co-Chair: Dr. Suwat Chariyalertsak Chiang Mai University's Research Institute for Health Sciences (RIHES) Co-Chair: Dr. Nittaya Phanuphak Thai Red Cross AIDS Research Centre

Discussion In order to make treatment as prevention more feasible, the upstream process of counseling and testing needs to be strengthened. There are still a number of those who do not come back for post test counseling. Same day results and intensified HIV case finding were also suggested as methods to drive increased testing. There was some debate in terms of the target population for testing and further discussion needs to take place on this issue. On the supply side, it was acknowledged that decentralization is necessary for healthcare delivery and that people in the local communities should drive the change. For task shifting, it is possible for medical technologists to be trained as counselors. However, training other health professionals to do testing should be considered for scaling up the VCT services. As previously mentioned, education campaigns also need to be conducted so that individuals are aware of their entitlements to care.

Items requiring follow up/ further discussion:    

Develop centralized data repository to monitor/evaluate VCT Develop practical and concrete recommendations on testing and treatment Determine the target population for interventions: should they be aimed at the general public or at key affected populations? Develop more cost/benefit and cost effectiveness analyses on using antiretroviral agents as prevention

Working Group Discussions: Expanded testing and counseling, linkages to care/treatment, and adherence support: opportunities and considerations in Thailand Group 1

Practical options for improving HIV testing and counseling

Group 2

Options for improving linkages to care and supporting treatment adherence in the community Examining options for service delivery including task shifting

Group 3

Co-chair: Dr. Nittaya Phanuphak Thai Red Cross AIDS Research Centre Co-Chair: Dr. Ake-Chittra Sukkul Thailand MOPH-U.S. CDC Collaboration on HIV and AIDS (TUC) Co-Chair: Mr. Nimit Tienudom AIDS Access Foundation, Co-Chair: Mr. Apiwat Kwangkaew Thailand Network of People Living with HIV and AIDS (TNP+) Co-Chair: Dr. Panita Patheepawanich, Lampang Hospital, Co-Chair: Ms. Chonlisa Chariyalertsak Head of STD/AIDS Prevention & Control Section, Provincial Health Office, Chiang Mai

Working Groups Report to Plenary Session Co-Chair: Dr. Suwat Chariyalertsak Chiang Mai University's Research Institute for Health Sciences (RIHES) Co-Chair: Dr.Sombat Thanprasertsuk, Senior expert of preventive medicine/ Department of Disease Control (DDC)

Dr. Sombat Thanprasertsuk summarized the results of each working group by highlighting four main streams of work: 1. 2. 3. 4.

Increasing the scale of VCT Creating linkages between VCT and treatment Strengthening human resources Establishing a dedicated working group to address stigma/discrimination

He also suggested establishing a focal point responsible for building evidence around the four main work streams mentioned above and creating an action plan to drive 24

this initiative forward. Leadership should also consider proposing a pilot PrEP project to the NHSO, which can be scaled up if successful. Working Group Discussion Group 1: Practical options for improving HIV testing and counseling      

Develop a media and social network strategy to reduce stigma/discrimination Use trained counselors that have an understanding of the concerns of each risk group Create a market survey to understand the needs of the population Create a safe and confidential environment for testing and counseling Establish linkages between public and private facilities Start conversations with the Ministry of the Interior and the Ministry of Labor to develop a common policy for VCT among migrants

Group 2: Options for improving linkages to care and supporting treatment adherence in the community       

Engage community in designing HIV/AIDS services Create a communication plan and a national labor campaign that is supported by the private sector Train staff in understanding the need for linkages Improve service quality at centers and create a culture of mutual ownership Standardize services across all platforms to ensure equality in terms of service Build awareness among individuals of their own risk and create a sense of ownership so that people do not leave the system midway through the process Create awareness campaigns to ensure that people understand what their entitlements are in terms of the three healthcare schemes

Group 3: Examining options for service delivery including task shifting  

Implement system of same day results. Leverage best practices in order to institute the program in the most efficient and cost effective way possible Build awareness of VCT

Closing Delivered by Dr. Jakkriss Bhumisawasdi Chief of Inspector General, Ministry of Public Health Reported by Dr. Petchsri Sirinirund National AIDS Management Centre (NAMC)

Dr. Petchsri thanked all stakeholders for the intense and fruitful discussions over the past two days. She commented on how Dr.Gilks’ presentations framed the conversations around treatment as prevention and thanked him for his valuable 25

input. While treatment as prevention was acknowledged as a method of both enhancing the quality of life and reducing the number of new HIV infections, stakeholders voiced a number of concerns that needed to be addressed before implementing such initiatives. The prevention effect of treatment can only start when all people including both Thai and non-Thai who need treatment are actually treated. One of the first priorities should be to strengthen the system to treat people that are eligible first (<350 CD4 count). Other implementation concerns raised were ARV prices and patents, stigma and building individual ownership of health. Dr. Jakkriss closed the consultation by reminding stakeholders that the success of the initiative depends on integration at all levels. He thanked stakeholders for their participation and welcomed comments and suggestions to MOPH based on the outputs from the consultation.

Next Steps In order to reach the goal of equity of HIV treatment for everyone with a focus on recruiting KAPs for VCT, the following action items were identified within six major work streams: Service Delivery: 1. Explore options for decentralized (i.e. community based) system of care and VCT 2. Sustain and enhance success of PMTCT program 3. Develop strategy to improve coverage of VCT â&#x20AC;&#x201C; necessary before treatment strategy can be assessed Monitoring: 1. Develop centralized data repository to monitor/evaluate VCT in parallel with building up capacity of data use at service and provincial levels Policy: 1. Develop practical and concrete recommendations on testing and treatment 2. Determine the target population for interventions: should they be aimed at the general public or at key affected populations? 3. Review ARV policies/legal barriers for migrants, non-Thais, and youth (under 18) Modeling: 1. Develop more cost/benefit and cost effectiveness analyses on using antiretroviral agents as prevention 2. Update Asian Epidemic Model estimates on IDUs, Transgenders, and the effects of behavioral inhibition Operational Research: 1. Explore possibility of launching a pilot PrEP program 2. Analyze workloads of healthcare personnel to determine current limitations

Public Communication: 1. Develop an education campaign targeted at altering risk behavior, attitudes towards health, and knowledge of health entitlements

Notes from Meeting of Working Group – 22/8/2012 Following the National Consultation of the Strategic Use of ARVs, Dr. Petchsri convened a meeting to discuss key issues raised during the consultation and next steps. During the meeting, the group mirrored consensus that the goal in terms of treatment as prevention is option 5 shown in figure 9 below but with the modification that VCT will be targeted at KAPs and serodiscordant couples since they account for 94% of new infections. Figure 9: TasP ART Eligibility Policy

CD4 ≤ 200 Recommended

Since 2003

In order to attain this goal, the group identified the following as key next steps:

1. Modeling, cost effectiveness, cost benefit, workload, feasibility, and adherence analyses 2. Policy dialogue, advocacy, and operational plan to reach 90% VCT among KAPs 3. Policy dialogue, advocacy, and operational plan for treat all seropositive partners in serodiscordant couples regardless of CD4 count 4. Consultations on:  Option B+ for pregnant women  Treatment regardless of CD4 count for sex workers, IDU, MSM  Treatment regardless of CD4 count for all 5. Consultations on PrEP for:  Seronegative partners in serodiscordant relationships  Seronegative KAPs 6. Operational plan for public communications