HomePEPFAR SAB Meeting Notes – October 2, 2023

# 									PEPFAR SAB Meeting Notes – October 2, 2023							

Bureau of Global Health Security and Diplomacy

November 3, 2023

**Welcome**

**Time: 09:00-09:10**
        - *Call to order, FACA compliance: Nicole Espy*
        - *Welcome and other formalities: Mike Reid & Chair del Rio*

Notes:
        - Nicole Espy, the designated federal officer for the PEPFAR Scientific Advisory Board commences the meeting and introduces Dr. Mike Reid, Chief Scientific Officer, Dr. Carlos del Rio, Board Chair, and Ambassador Dr. John Nkengasong.
        - Dr. Mike Reed reads agenda aloud.
        - Dr. Carlos del Rio and Ambassador Dr. John Nkengasong offer opening remarks

**Session 1: Global Health Security and Diplomacy and PEPFAR: Introduction to New Bureau**

**Time: 09:10-10:15**
        - *Opening remarks, Ambassador Nkengasong*
        - *Presentation on the new bureau and PEPFAR’s strategic priorities (Dr. Becky Bunnell, acting PDAS, PEPFAR-GHSD)*
        - *Q&A – Open discussion with the Scientific Advisory Board members (SAB) and Ambassador Nkengasong*

Notes:
        - Ambassador Dr. John Nkengasong emphasizes the Importance of elevating science
        - Introduces new GHSD and PEPFAR staff
        - PEPFAR as process, platform, and program           - SAB as sounding board 
        - How to protect and sustain the programming
        - Being a part of a bureau will elevate PEPFAR’s visibility
        - Dr. Becky Bunnell’s presentation happened after Q&A           - Bureau is not trying to duplicate interagency expertise, but to elevate it
          - 4Cs
          - PEPFAR has previously experienced authorization lapses             - Will continue to operate in same manner despite the lapse 
          - 5-year strategy             - Emphasis on pillars 2, 3, 5               - Activating science pillar: use existing data
              - Without PEPFAR, millions of children would suffer by 2030 – more deaths, more orphaned
              - Implementation science to rapidly build and disseminate science 
        - AMB’s Nigeria visit – secured pledge for more domestic health spending
        - What do we need to sustain the response?
        - Political, programmatic, financial

SAB Q&A w/ AMB
        - Carlos del Rio: How to communicate success and hope AND urgency?           - Amb: must be careful not to become vulnerable to our own success. HIV has been dropping off the political radar in some countries. We need to do more to communicate and elevate it as serious health and security threat. It won’t be eliminated or eradicated, but it can be controlled to the point of ending it as a “public health threat.” 
        - Mitchell Warren: Can you offer insight into reauthorization?           - AMB: Actively pursuing a clean 5 year reauthorization, not a 1 year. Anything short of a 5 year “clean” reauthorization will undermine success and authority in global AIDS response. Lead with facts. Will not be drawn into controversy. PEPFAR does not contribute in any way to abortions. Maintain positive spirit – PEPFAR saves lives. 
        - Jesse Milan: Several SAB members have also served on President’s Advisory Council on HIV/AIDS. PEPFAR is discussed among them too.
        - Francis Ssali: 1. Treatment for the positive is now a Key integral part of the Prevention and we need it to sustain epidemic control.      2. The population in SSAfrica is young , averaging 16 years in some of the countries. It is vulnerable to new infection and stopping HIV/AIDS will hinge on preventing new infection in that population.

Q&A w/ Becky Bunnell
        - Judith Auerbach: What’s happening with social and behavioral science to integrate into PEPFAR?           - AMB: introduced Ingrid as Director of B Sci. Integration (into multiple work areas) is a work in progress.
          - JA: With respect to the robust integration of social and behavioral science, I hope we will look beyond the implementation of behavioral interventions to include social-structural analysis and interventions/programs.  I’m sure a number of us on the SAB would be happy to help strategize about this. 
        - Peter Berman: how can the board contribute to convos about sustainability, including science and evidence?
        - Carole Treston: Thank you for the tools to communicate with constituents. Appreciation for use of “end HIV as a public health threat” as clearer language
        - Greg Millett: how much funding is going to the bureau itself?           - AMB: resources are often reshuffled. Specific numbers are still being discussed
          - Becky: private sector has seen the cost and effect of pandemics like covid 
        - Christine Nabiryo: SAB traveling to the field? Appreciative of updates today...wondering how how we can have more regular updates outside of the Board meetings. Seems like this has been minimal between meetings           - There are some countries where only the state dept can react in – in the event of outbreaks 
        - Sofia Gruskin: what’s been the response from countries about the bureau integration?

**Session 2: Updates in Prevention: Review of prevention science and update on CAB-LA rollout**

**Time: 10:15-11:00**
        - Summary of ongoing relevant prevention research (Mr. Mitchell Warren, AVAC)
        - Status update on CAB-LA rollout (Dr. Robyn Eakle, PEPFAR-GHSD)
        - Q&A – How should PEPFAR be prioritizing prevention strategies?

Notes:
        - What’s New & Next in HIV Prevention – Mitchell Warren
        - Status update on CAB-LA rollout – Ashneil Jain in place of Robyn Eakle           - PEPFAR has aggressively expanded PrEP and continue to scale ambition as part of next budget cycle and beyond             - 5 countries for initial allocation of CAB-LA for Q1 in FY24               - Additional countries will be included over time                 - Limitation: manufacturer supply (they will scale up)                   - Nano mills 
              - Malawi, Ukraine, Vietnam, Zambia, Zimbabwe 
          - Discussion             - Susan Swindells: what, if anything, can PEPFAR do to assist scale up of production?               - Ashneil: enabling generic manufacturers to assist with scale up of production 
            - Ken Mayer:
            - Quarraisha: concerns about accelerating access – thinking ahead
            - Connie Celum: how can we do better with future products?
            - Lejeune Lockett: plan for access, for prioritizing who gets it? Plan for sustaining access? Which groups are being targeted?               - Guidance to country teams – prioritize and focus on pops most at risk 
            - MW: the market for PrEP wasn’t there until PEPFAR pushed in 2020               - Ken Mayer: Can’t the huge purchasing power of PEPFAR can be used to support scaling up nano-mills sooner than later?                 - Pepfar can signal using purchasing power 
              - Focus on building sustainable market
              - Role of PrEP in countries who have reached 95s vs countries who have not reached targets 

**Session 3(a): Optimizing Cardiovascular Outcomes for PLHIV: Role of Statin Therapy for PLHIV in PEPFAR Programs**

**Time: 11:10-11:30**
        - Presentation of data from the REPRIEVE trial on statin therapy for people living with HIV (PLHIV) in PEPFAR programs (Prof. Steve Grinspoon, Harvard University)

Notes:
        - REPRIEVE trial – Steve Grinspoon           - While deaths due to HIV/AIDS is decreasing, CVD DALYs are increasing
          - First globally representative trial of CV primary prevention in PLHIV
          - Hypothesis generating, not powered for subgroup analysis
          - Susan Swindells: are you confident that other statins will work just as well as the one used in the study?             - Can only be truly confident in results with statin used, but other statins could be used (availability varies by country) 
          - Quarraisha: highlighted diversity of risk factors. Risks and body composition 

**Session 3(b): Optimizing Cardiovascular Outcomes for PLHIV: Feasibility of Integrating CVD Disease Management into HIV Care**

**Time: 11:30-12:00**
        - Presentation of implementation science research findings from Uganda (Prof. Semitala, Makerere University). 
        - Q&A – SAB discussion on both presentations (3a and 3b) and implications for PEPFAR programs 

 

Notes:
        - MJAP – Makerere U Joint AIDS Program           - PEPFAR implementing partner
          - Largest HIV clinic in Uganda 
        - Story           - High prevalence of hypertension in Uganda, but poor cascade of care
          - Integration of HIV and HTN care dramatically improved cascade – maintained one year after follow-up 
        - PULESA-Uganda           - HTN care is a priority and is feasible in HIV care
          - Implementation science provides toolbox 
        - Christine N: which other NCDs were assessed?           - HTN was focus, but secondary objectives looked at diabetes, mental health 
        - Chris Beyrer: there are gains for integrating NCDs that are less stigmatized, especially for reaching men – did you look at stigma?           - Not a study focus – no fear or concern identified with HTN care
          - MW: Great point, @Chris Beyrer! I’d also mention that SEARCH continues and is one of the first studies to be adding new PrEP options as well. So this is a great opportunity to think about the PEPFAR platform so broadly (as Becky said at the outset) — treatment, prevention, NCDs, etc. 
        - Greg Millett: behavioral interventions for providers           - While providers thought it would add to workload, but they were surprised to see how efficient integrated care is 
        - Kainne: can we provide services to non-PLHIVs? Did you see non-PLHIVs in the clinics in the study?           - Another group has been studying this – a PH approach not focused on PLHIV
          - HIV care as platform to improve care for other conditions 
        - Fredrick Sawe: have you looked at potential of including other NCDs in your models? Especially low cost interventions?           - Been asked to include guidelines for other conditions 
        - Francis Ssali: We have seen the use of Formulated pills for HIV. How would the results studies presented be used to support co-formulation of Statins and Anti-Hypertensive medicines especially for better adherence and treatment outcomes?

**Session 4: UNAIDS technical consultation on defining and sustaining HIV epidemic control in SSA**

**Time: 12:30-13:30**
        - Reviewing Epidemiology and Modeling from UNAIDS Consultation on HIV beyond 2030
        - Presentation of UNAIDS modeling data (Dr. Jeff Imai-Eaton, Harvard University)
        - Q&A – SAB discussion on presentation and implications for PEPFAR programs.

Notes:
        - 2030 goal – low-level endemicity
        - Sofia Gruskin: How much was the policy environment considered in the modeling?           - Not incorporated yet 
        - Chris Beyrer: real numbers are usually higher than what’s shown in the models – are we capturing accurate numbers? Placebo arms are better proxies           - High confidence based on population surveys 
        - Celia Maxwell: Did mortality factor into the models?           - Will need to look into 
        - Quarraisha: sustainability and what is considered success; validating models against real time data?
        - Connie Celum: could modeling approach look at where biggest payoff could be?
        - Jen Kates: translating graphs into actual numbers of people

**Session 5: Sustainability Agenda: Discussion of PEPFAR’s Sustainability roadmaps**

**Time: 13:30-14:30**
        - Presentation on PEPFAR’s sustainability agenda (Mr. Mike Ruffner and Ms. Sara Dominis, PEPFAR-GHSD)
        - Q&A – SAB discussion on presentation and implications for PEPFAR programs.

Notes:
        - Focus on pillar 2 & 3
        - Two transformations at global level           - Sustaining gains at epi control             - Country led, UNAIDS facilitated
            - Roadmaps to sustainability 
          - PEPFAR transformation             - Response that relies more on local responsibility
            - Guided by UNAIDS and WHO = global normative guidance 
          - Beginning with the end in mind             - Sustained VL suppression
            - Prevent, detect, respond to new infections
            - End/reduce inequities
            - Country-specific future imperatives 
        - Continuous feedback loop that factors in political sustainability, programmatic sustainability, and financial sustainability           - Community and science feedback expected – living documents 
        - What are we considering success?           - Need to align end goal definitions
          - Must consider stigma 
        - Sustainability challenges           - Commodities/supplies (variable cost)
          - Site personnel (fixed-ish)
          - Everything else – TA, training, oversight, systems, overhead (LOE – “functions of govt) 
        - Every country will (and should) have a unique approach and sequencing to sustainability           - Recommend that countries consider sequencing efforts to maximize impact 
        - Success depends on functional systems           - Most systems are under funded
          - Need to be strategic spending asks 
        - There is a pathway using existing           - Commodity costs are stable over time 
        - Francis Ssali: The PEPFAR commodity global procurement model has significantly contributed the a drop in the cost of those commodities e.g. in 2023 the ARVs cost a small fraction of what they cost in 2003, and this has been pivotal in increasing the number of individuals on treat with flat funding. How can PAPFAR extend this model for increased access to other commodities e.g. for NCDs?
        - Bad policy costs money, stigma and discrimination cost money
        - Roadmap as “how”
        - Implied spending as opportunity
        - Need pragmatic understanding of fiscal space           - We don’t want financial burden to flow down to the patient. 
        - Sustainability Science Qs           - J Auerbach: political will as elephant in the room – how is PEPFAR dealing with anti-LGBTQ+ laws in PEPFAR countries and in the US? How to address in sustainability roadmap?             - Becky: DOS is working on whole of govt response on Uganda; safety measures are in place in-country to help patients 
          - Carole T: sustaining healthcare workforce, using the power of pepfar to advocate for universal healthcare coverage.
          - Peter Berman: look at MIC for sustainability successes/efficiencies.
          - Angela Mushavi: Important to get communication experts to help craft messages that are decoded right by the general population and also by politicians and financial experts in Ministries of Health. With reference even to issues of communicating the ”60% reduction in risk of HIV acquisition with VMMC” we know how this statement can be misconstrued to mean that ”no risk of HIV acquisition’ by communities. How can we make sure that ending HIV by 2030 means no need to worry or to fund HIV anymore? How do we create a message that still conveys continued need for funding the HIV response??
          - Jen Kates: how to convey to congress what the money can buy
          - Quarraisha: covid and the erosion of trust in science
          - Christine N: The discourse within the wider Public Health fraternity and at UNGA is UHC/ Health insurance and integration. Given how we have done business as PEPFAR would be useful to explore how we can support countries in the transition within this agenda with evidence base and document the models for effective transition/transformation.
          - Peter Berman: Thanks Christine — appreciate those insights — and of course this work really needs to take place in country — would add also how can universities in countries and in the regions support this effort more — taking over more of this role from US universities.
          - Carole: shining a light on the economic driver that the whole healthcare team, including CHWs & their contributions to GNP of a country, not as a burden, but consumers of goods. Same goes for PLWH as working adults.
          - Ken Mayer: The other challenge is that we spent part of the day discussing mainstreaming HIV and NCDs into health care systems, and now we are discussing sustainability. There are some potential tensions in terms of what will be sustained ultimately. 

**Session 6: Public Comment**

**Time: 14:30 – 15:00**
        - Moderated by Mike Reid & Carlos del Rio
        - Summary of key insights and action items from the meeting.
        - GHSD leadership provides summary comments and closing.

Notes:
        - Benny Kottiri: concerns over how models will be used and perceived.
        - Summary Comments & Closing – Becky Bunnell
        - Nicole Espy adjourns the meeting.

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