1. Advances Towards Epidemic Control: PEPFAR Contributions
Shannon Allen, PhD USAID, Office of HIV AIDS
Research Division | Microbicide Branch
Good morning everyone, I would like to thank Gustavo and the CONRAD team for allowing us to give a short presentation on...

2. The Evolution of PEPFAR
PEPFAR I ( )
Emergency response
AIDS- a security issue
Rapidly delivering prevention, care, and treatment services
PEPFAR II ( )
Sustainable response
Shared responsibility & country-driven programs
Building & strengthening health systems to deliver HIV services
Scaling up of prevention, care, and treatment service
PEPFAR III (2014-present)
Epidemic control of HIV/AIDS
End of HIV/AIDS as a public health threat
Data, quality, oversight, transparency & accountability for impact
Accelerating core interventions for epidemic control
This is a slide illustrating the evolution of PEPFAR in response to the AIDS epidemic
Phase 1.0: The Emergency response
In Africa where people were dying by the thousands because (ART) was not available in Africa
Recognizing that AIDS was a global security issue, phase 1 focused on building an emergency response and with global governments,
rapidly delivered prevention, care and treatment services to the most devastated geographical areas in Africa
Phase 2.0: Building sustainability
While phase 1 focused on building the emergency response, Phase 2 focused on building sustainability
PEPFAR worked mutually with African governments to build and strengthen health systems and structures to deliver life-saving medicines
And now that this was in place, efforts to scale up prevention, care and treatment could begin
Phase 3.0: Epidemic control
The point at which new HIV infections have decreased and fall below the number of AIDS-related deaths
We are currently in Phase 3 which focuses on sustainably controlling the epidemic and ensuring that AIDS is no longer a public health threat
Here, PEPFAR is pivoting to a data-driven approach that geographically targets the populations that are most burdened by the epidemic
This involves being strategic about targeting interventions that prevent new infections and ensures that people who have acquired HIV are receiving treatment

3. PEPFAR’s 3 Guiding Pillars
Controlling the HIV Pandemic
Accountability
Demonstrate cost- effective programming that maximizes the impact of every dollar invested
Transparency
Demonstrate increased transparency with validation and sharing of all levels of program data
Impact
Demonstrate sustained control of the epidemic; save lives and avert new infections
PEPFAR is focused on 3 guiding pillars for controlling the epidemic
Accountability: creating programs that are cost-effective and maximizing the impact of every donor and host government dollar invested in this effort
Transparency: ensuring that all program data are shared
Impact: sustaining epidemic control by using data to make decisions on where to program investments for saving lives and averting new infections

4. Understanding the HIV/AIDS Epidemic in Sub-Saharan Africa
So where does PEPFAR stand in its current progress towards epidemic control?
10/08/2018

5. This is a map of Africa (from 2016) highlighting the prevalence of adults and children infected with HIV
Can immediately see the burden of the epidemic and how it is concentrated in Africa compared to the rest of the world
Particularly the eastern and southern Africa are most affected (in some cases, countries have between 12 and 27% prevalence)

6. Key Gaps Exist that Need to be Addressed to Achieve Epidemic Control
Eastern and Southern Africa
High prevalence/generalized epidemic
Key Gaps:
Clinical and prevention cascade for priority populations
Prevention interventions to saturation
15-30 age group
Early Treatment - Men – all ages
Western and Central Africa
Low prevalence/generalized epidemic
Key gaps
Clinical and prevention cascade for priority populations
Inconsistent political will to address all priority populations with necessary interventions
Ensuring access to services for young people and men of all ages
Strategies to address stigma and discrimination
No matter if you are looking at Eastern/Southern Africa ( where there is high prevalence) or Western/Central Africa (where there is low prevalence) there are some similar gaps across these contexts
The major one that pops up is prevention
In order to achieve epidemic control, in addition to providing access treatment for hard to reach populations, we need to create tools that prevent new infections in the populations that are most burdened by HIV

7. PEPFAR Approach for Adolescent Girls and Young Women
There are specific populations where the number of new infections are not declining as rapidly as we would like to see
As you all are aware, women and girls are disproportionately affected by HIV/AIDS and PEPFAR is trying to address the high rates of infection in this population in a unique way

8. The Vicious Cycle of HIV Transmission
Young adult men infect adolescent girls & young women (AGYW)
In turn, AGYW go on to infect their male peers continuing the cycle.
There are more than 1000 new infections in AGYW every day in SSA
This must change!
This slide pinpoints the cycle of transmission among young women and their male partners
HIV positive adult men transmit the virus to girls and young women who typically seek out partners that are significantly older than them (for a variety of reasons)
These girls and women, now HIV+, eventually grow up and begin seeking male partners that are more within their age range but end up transmitting the virus to those male partners
Then the cycle is repeated again
10/08/2018

9. Young Women are Disproportionately Affected by HIV
HIV Prevalence Among Women and Men by Age and Country
Eswatini
Tanzania
Lesotho
Zambia
Zimbabwe
Uganda
Women are extremely disproportionately Affected by HIV/AIDS
These are data collected through the Population HIV Impact Assessment (PHIA) project measures the reach and impact of HIV programs in PEPFAR-supported countries through national surveys
results measure national and regional progress toward UNAIDS'
These are graphs from just a few of the high burden countries looking at HIV prevalence among women and men stratified by age
the ages in the graphs begin at 0-4 on the left and go all the way up to 66+; females are the left bars and men are the right bars
Can see by the age of 20-24, young women are significantly more like to be HIV infected compared to their male counterparts
This indicates that there need to be some intervening that needs to happen prior to these young women becoming infected

10. A Comprehensive Program to Break the Infection Cycle
On World AIDS Day 2014, PEPFAR announced an innovative partnership to address this problem: DREAMS.
Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe
A program for young women that focuses on delivering a comprehensive prevention package so they live HIV-free lives.
Core package of interventions:
Empowering girls and young women
Reducing risk of sexual partners
Strengthening families
Mobilizing communities for change
PEPFAR partners had been working tirelessly to address the epidemic in young girls and women
But past efforts had not yielded the impact required to curb the epidemic
Realized that no single intervention alone significantly reduce the number of new infections in AGYW
but that a comprehensive package of interventions is more likely to reduce infections than any single intervention
So PEPFAR launched DREAMS on WAD in 2014, which is a program designed to keep AGYW HIV free by making them determined, resilient, empowered, AIDS-free, mentored and SAFE
Tries to holistically address HIV prevention through structural, behavioral and biomedical interventions
DREAMS is currently being implemented in 15 countries with the highest HIV burden in this population

11. PrEP is a rapidly expanding intervention
In more than 20 PEPFAR countries and counting
PEPFAR has initiated thousands of girls and women on PrEP in SSA
Structural challenges include:
Restrictive policies in some settings, lack of implementation of policies, low resources for PrEP, demand creation and general awareness of PrEP
Individual challenges include:
daily pill burden, side-effects, stigma and discrimination, IPV, lack of adolescent friendly health services, etc.
From the Previous slide, you saw that PrEP is a crucial part of the biomedical interventions within the DREAMS Core package
The number of countries where oral PrEP is approved for use has increased significantly since 2016
Currently PrEP is being delivered in more than 20 pepfar countries
However, there are challenges with PrEP at several level, especially at the structural and individual levels

12. USAID Microbicide Program Approach to Addressing Challenges
These structural and individual barriers prevent effective use of the only government approved biomedical product that we have available
USAID recognizes all of these challenges and tries to address them through the USAID Microbicide Program which focuses introduction and access to new and existing biomedical prevention products and research and development of new HIV prevention products that women can use to protect themselves
The Microbicide Program defines a microbicide as any biomedical prevention products, whether systemic or topical, that a woman can use to protect herself from HIV
Photo Credit: OPTIONS/ FHI 360

13. The USAID Microbicide Program’s Approach to Expanding Product Introduction
Microbicide Product Introduction Initiative (MPii): Expansion of HIV prevention products occur primarily through a set of interconnected research projects focused on introduction and access for women and girls
Policy and Systems Approach
OPTIONS: Offers targeted support to expedite and sustain access to HIV prevention products
Examples: Plan4PrEP Toolkit; Communications Accelerator; PrEP4Youth PSAs, Costing Guidelines; TWG Support and Collaboration with WHO/UNAIDS
Innovations in PrEP Implementation
POWER: Diverse service models for PrEP delivery
Examples: Mobile services, youth clinics and FP clinics; improved recruitment, retention, adherence approaches for AGYW
EMOTION: HCD approach to deliver an enhanced delivery experience that increases uptake and adherence in AGYW
Examples: The ‘V’ brand discreet pill carriers, The ‘V’ Experience
Measuring unintended consequences of PrEP
GEMS: Monitor/characterize resistance for DVR and oral PrEP failure
Examples: Establish resistance monitoring in national guidelines; Protocols implemented in 3 PEPFAR-DREAMs countries.
CHARISMA: Assess risk for IPV to mitigate violence issues with PrEP uptake
Examples: HEART tool; counseling
The Microbicide programs approach to expanding product introduction occurs primarily through 5 Microbicide production introduction initiatives (MPii)
Set of 5 interconnected projects focused on introduction and access to ARV-based prevention products for women and girls
For ease of understanding, we’ve bucketed them into categories based on their goals
The 1st bucket is a policy and systems approach
In this bucket is OPTIONS which uses a policy and systems approach which offers support to expedite and sustain access to HIV prevention products
The 2nd bucket is innovations in PrEP implementation
This bucket contains POWER which tries to understand, through research how diverse delivery models for PrEP can lead to improved recruitment and retention
Also here is EMOTION which used HCD to enhance PrEP delivery experience that increases uptake and adherence of PrEP in AGYW
The 3rd bucket is measuring unintended consequences of PrEP which contains GEMS and CHARISMA
GEMS monitors and characterizes HIV resistance for oral PrEP and DVR
CHARISMA tries to understand, through research, how to better identify candidates for IPV counseling when girls and women are using PrEP 13

14. The USAID Microbicide Program’s Approach to Expanding Product Options for Women
Portfolio takes a strategic forward-looking approach to invest in products that fill identified gaps in the achievable range of prevention options
Support research on products with novel characteristics that are expected to significantly increase acceptability and effective use by women at high risk
Investments prioritize affordability and product characteristics that reduce burden on strained healthcare systems. Equity and community acceptability will also be considered.
MIC program will continue to invest in prevention products, that address identified gaps that prevent effective use
We are specifically focused on supporting research and development of products that contain a range of desirable characteristics that are expected to increase acceptability and effective use for women at high risk of HIV
Affordability, accessibility and ability to be delivered in a way that will reduce the burden on already strained HCS are key

15. USAID Microbicide Program-Supported Prevention Product Pipeline
Biodegradable Implant
Target Dosing: months
Active Ingredient: TAF, CAB, contraceptive (MPT)
Key Features: long-acting, low user burden, discreet, reversible, low HCS burden
Microarray Patch
Target Dosing: at least 1 month
Active Ingredient: CAB
Key Features: short wear/long acting, low user burden, low HCS burden, discreet, painless
Next-Generation Ring
Target Dosing: at least 1 month
Active Ingredient: Dapivirine, Tenofovir, contraceptive (MPT)
Key Features: low HCS Burden, low user burden, discreet, painless, long-acting, reversible
All of this development requires an understanding of the key issues blocking effective use of prevention products
These are just a few of the types of products that we in the Microbide Program are supporting the development of
add something linking back to the needs of AGYW

16. USAID remains supportive of researchers throughout the world working together to achieve epidemic control