1. Combination Prevention of HIV: What is it and where are we now?
Farley R, Cleghorn MD, MPH – Futures Group
Chief Knowledge Officer & Global Health Practice Leader
USAID Mini-University

2. WHAT IS COMBINATION HIV PREVENTION?
“Combination HIV Prevention is the strategic, simultaneous use of different classes of prevention activities and interventions (biomedical, behavioral, social/structural) that operate on multiple levels (individual, relationship/network, community and societal) to respond to the specific needs of particular key groups and modes of transmission (key or vulnerable populations) and to make efficient use of resources through prioritization, partnership and engagement of affected communities.”
UNAIDS 2010

3. The social ecological model of health promotion
Mitigate both
Proximal and
Contributing risk
Factors for HIV
Transmission.

4. Most HIV prevention and treatment strategies have focused on the individual level, assuming individuals will defy or overcome social, economic and political constraints.
Individuals
Social and sexual networks
Community, Organizations
Society
Inter-governmental, Global
Need to mitigate both
Proximal and
Contributing risk
Factors for HIV
Transmission.
Individuals

5. IMPLEMENTATION (PROGRAM) SCIENCE IN HEALTH “PILOTITIS”
Population level outcomes
Program level efforts
Models & Pilot Studies
Research
Concepts
Implementation
Science Gap
Impact
Resources
What intervention mix do country programs invest in for impact?

6. HEALTH: PROGRAM SUCCESS
Doing enough (the right dose) of the right thing at the right time for the right people
Coverage, quality and intensity of proven interventions
Missing science on how these combine across sectors in programs, e.g. health & education
Health markets include all sectors – public, middle and private

7. ARV prophylaxis SEXUAL HIV PREVENTION Medical Male circumcision
Auvert B, PloS Med 2005
Gray R, Lancet 2007
Bailey R, Lancet 2007
Treatment of STIs
Grosskurth H, Lancet 2000
Microbicides
for women & some gay men
Abdool Karim Q, Science 2010
Female Condoms
Male Condoms
SEXUAL HIV
PREVENTION
Grant R, NEJM 2010 (MSM)
Baeten J , 2011 (Couples)
Thigpen M, 2011 (Heterosexuals)
Choopanya K, 2013 (IDU)
Oral Pre-exposure prophylaxis (PrEP)
HIV Counselling and Testing
Coates T, Lancet 2000
Sweat M, Lancet 2011
Post Exposure
prophylaxis (PEP)
Scheckter M, 2002
Behavioural Change
Treatment as prevention
Cohen M, NEJM 2011
Donnell D, Lancet 2010
Tanser F, Science 2013
Note: PMTCT, Screening transfusions, Harm reduction, Universal precautions, etc. have not been included – this is focused on reducing sexual transmission

8. The core transmission dynamics distinction
Epidemics CONCENTRATED if effective SW (sex worker), MSM (men-having-sex-with-men) and IDU (injection drug user) programs would prevent wider epidemic
Epidemics GENERALIZED if epidemics would persist despite effective SW, MSM and IDU programs
Epidemics MIXED if transmission sustained BOTH by SW, MSM and IDU and wider population

9. Concentrated, generalized and mixed epidemics
Mixed/uncertain

10. Defining Combination Prevention: Ongoing trials in sub-Saharan Africa
NIH’s Methods for Prevention Packages Program – MP3 I
NIH’s Methods for Prevention Packages Program – MP3 II
PEPFAR-funded effectiveness trials
Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings
Gender-specific HIV packages for male and female youth delivered using community-based mobile health teams
Kenya
Methods for Prevention Packages Program
Home-based HIV testing and targeted referrals for VMMC, ART, STI treatment, couples counseling and oral PrEP plus topical PrEP (if effective)
South Africa and Uganda
Johns Hopkins University with USAID funding
Evaluation of the impact on HIV incidence of expanding population coverage of an integrated set of HIV prevention interventions DISCONTINUED
Tanzania
An HIV Prevention Package for Mochudi
Behavioral interventions: VCT, partner notification, concurrency reduction, VMMC, condoms and ART for those with high viral load
Botswana
Acute Infection in Heterosexuals
Standard vs. enhanced counseling vs. behavioral intervention plus 12-week ART to reduce viral load
Malawi
Comprehensive HIV Prevention Package for MSM in Southern Africa
Package of behavioral, biomedical and community-level interventions
Zambia and South Africa
PopART/HPTN 071
A strategy linking household-based HIV testing to universal community-based HIV treatment
South Africa and Zambia
Enhance Prevention in Couples
Behavioral counseling, ART for prevention
(CD4<500) plus couples counseling, VMMC
Lesotho
Harvard School of Public Health
with US CDC funding
Evaluation of the impact on HIV incidence of expanding population coverage of an integrated set of HIV prevention interventions
Botswana
CHAMPS: Choices for Adolescent Methods of
Prevention in South Africa
Potentially PrEP, microbicides, HCT and circumcision—plus messaging and social marketing around these approaches
South Africa
In addition to the trials pictured, there are also evaluations ongoing in Europe, North and South America. For a complete list, visit avac.org/pxrd.
AVAC Report 2012: Achieving the End – One year and counting. www,avac.org/report2012

11. PopART: Model structure for infected individuals.
Cori A, Ayles H, Beyers N, Schaap A, Floyd S, et al. (2014) HPTN 071 (PopART): A Cluster-Randomized Trial of the Population Impact of an HIV Combination Prevention Intervention Including Universal Testing and Treatment: Mathematical Model. PLoS ONE 9(1): e doi: /journal.pone

12. Progam Results – Proposed Logic Model

14. SHIPP Chronology Leadership - Permanent Chief of Party in Place:
Initial CoP rejected by USAID
Dr. Farley Cleghorn of Futures as Interim CoP from contract award until May 2011
Dr. Kevin Bellis hired through stakeholder approved recruitment process and lasted until September 2012
Dr. Doris Macharia hired in November 2012 and performing at high level
Partner/Subcontractor Performance
Closure of Engender Health South Africa office in Year 1
Staff relocated within SHIPP and managed by Futures
Amicable withdrawal of WRHI in Year 3
Expanding portfolio of PEPFAR work in HIV/AIDS treatment and implementation science
Biomedical research orientation meant less interest in design and delivery of programmes at scale
All activities subsumed under Futures
Dr. Kevin Kelly left CADRE during Year 3
Need for research in later project years diminished
SHIPP team capacity now available in research
National and Provincial level agreement on key HIV prevention priorities elusive:
Normative confusion on what sexual prevention activities to support in the National Strategic plan and what constitutes a responsive HIV prevention programme
Enormous capacity issues at sub-district levels:
Lack of information inability to plan, implement and manage programme activities, and mismatch between resources and expectations
Finding Key Technical Staff
High turnover in key technical staff and small pool of potential candidates at high cost
Much effort and cost in recruitment and compensation
Staff placed within SAG agencies at all levels “lost” to SHIPP management
To address supply side barriers to postnatal care NSP now being operationalized
Combination HIV prevention will Improve service delivery models at local level, help to define action plans, and improve supply of prevention services
Community based service delivery model that can address social, financial, and cultural barriers will improve demand and help shift community cultural norms
SHIPP team now at full capacity in Year 4
Structure and functioning of team matches the scope of work
Staff placed within four line ministries, SANAC and in 13 sub-districts
Integrated team providing technical assistance in combination prevention and building capacity for more and better prevention services

15. SHIPP Mid-term Evaluation Key Reccomendations
Scale up alternative LEAP process such as the DPSA’s Local Assessment Model based on KYE/KYR to inform optimal HIV combination packages at the local level
Build on the capacity developed for DACs, LACs and WACs to enable them to identify, implement, monitor, and coordinate optimal HIV prevention packages
In collaboration with SAG operationalize combination prevention packages for the SHIPP-supported districts based on an understanding of the local epidemic
Support the demonstration of optimal combination HIV prevention packages in geographical areas where SHIPP/SAG has generated local epidemic information based on the Local Epidemic Assessment Model accepted in SA.

16. What more do we need to know?
How do we prioritize non-biomedical interventions based on the evidence?
How do these interventions combine with accepted biomedical interventions into coherent programming?
How do we construct programmes at district/sub-district/community level so that these roll up into scale for impact?

17. Addressing the Implementation Science Gap
Local Epidemic Assessment for Prevention (LEAP): An excel-based tool developed by the Health Policy Project & SHIPP that uses mathematical modeling (Impact matrix) to convert different intervention scenarios into changes in the incidence and prevalence of a local HIV epidemic
LEAP distributes the relevant population by geography and risk groups and allows the user to
Attribute different risk behaviors to these risk groups
Develop interventions for specifically for key populations and target interventions for the general population by geography

18. LEAP – Population Risk Groups

19. LEAP in Mozambique
Beira is an MOH priority district in Central Mozambique for both prevention and treatment interventions
Located in a province with an estimated 15% HIV prevalence
City population mostly divided into urban and peri-urban areas
Focal point in the Central Transport Corridor
District level data available:
Demographic
Behavioral
Epidemiologic
Programmatic

20. Using LEAP in Beira, Mozambique
Policymakers using LEAP are be able to determine:
Impact of combinations of interventions on HIV prevalence and incidence
Most effective package of interventions based on:
Type of interventions used (ie ART, VMMC, Community Mobilization, GBV programs)
Tailored coverage for the general population, via geography
Tailored coverage for key populations
Most cost-effective interventions
Develop an evidence-based package of interventions tailored to the local context
Assess as they go

21. HIV Incidence by Year & Scenario
Incidence per year as % of susceptible population 15-64
Ulundi: Max. 0.7% (Status Quo) Region G: Max. 0.8% (Status Quo)
Min. 0.4% (New Combination) Min. 0.6% (New Combination)

22. Copyright © 2015 American Medical Association. All rights reserved.
From: Human Immunodeficiency Virus Transmission at Each Step of the Care Continuum in the United States
JAMA Intern Med. Published online February 23, doi: /jamainternmed
Figure Legend:
Estimated Number of Human Immunodeficiency Virus (HIV) Transmissions Along the HIV Care ContinuumART indicates antiretroviral therapy; MSM-IDU, male-to-male sexual contact and injection drug use. Retained in care is defined as attending at least 1 visit with a medical care provider from January to April Viral suppression is defined as the most recent viral load documented as undetectable or 200 copies/mL or less. In A, error bars represent 95% simulation intervals. In D, estimates for persons 13 to 24 years old were not calculated because the Medical Monitoring Project and the National HIV Behavioral Surveillance System collect data only on persons 18 years or older, and the base population size estimated from the National HIV Surveillance System prevalence could not be determined by smaller age strata owing to sample size limitations.
Date of download: 2/24/2015
Copyright © 2015 American Medical Association. All rights reserved.

23. Conclusions
While results from specific combination trials in specific settings are forthcoming, countries and programs have enough information to implement combination programs for HIV prevention today.
There is enough of an evidence base, tools, and solutions to support HIV prevention programs.
Research and analytical technical assistance can provide continuing guidance to refine such programs to get to the goal of zero HIV transmission.