NATIONAL INSTITUTES OF HEALTH:National Institute of Allergy and Infectious Diseases

National Institute of Mental HealthNational Institute on Drug Abuse

Dynamic Partnerships Across Community, Academic and Policy

Sectors: HPTN 071The PopART Study

Helen Ayles, on behalf of the HPTN071 study team

Universal voluntary HIV testing

with appropriate combination

prevention offered to all those

testing HIV negative - in addition

to immediate ART for all those

testing HIV positive - will have a

substantial impact on HIV

incidence at population level

Hypothesis

ART initiation according to current national guidelines*

PopART intervention

except

3 arm cluster-randomised trial with 21 communities (N ≈ 1.2million total population)

Full PopARTintervention

including

immediate ART irrespective of CD4

count

Standard of care at current service provision levels

including

ART initiation according to current national guidelines*

Arm A Arm B Arm C

• Average of ~50,000 in each cluster (~ 50% adults)• Incidence measured in Population Cohort:

2,500 adults in each cluster, followed up after 1, 2 and 3 years

Trial Design

Health centre

VMMC facility

Universal testing: annual door-to-door HBT

Follow-up on referral Support for:

- Retention in care- Adherence to treatment

CHiPs: Community HIV-care ProvidersPMTCT: Prevention of Mother to Child TransmissionVMMC: Voluntary Medical Male CircumcisionTB: TuberculosisSTI: Sexually Transmitted Infections

Service promotion and referral for- HIV care for HIV +ve

including PMTCT- VMMC- TB - STI

Universal treatment for HIV +ve

irrespective of CD4 count

Facilitated by CHiPs

PopART Intervention Package

• HPTN071 is a huge community randomised trial, involving– Over 1 million participants– 21 communities– 8 district health authorities– 5 provincial health authorities– 4 Ministries/Departments of Health (SA Cape Town City

health Dept., Government of W. Cape Health Directorate , Z Ministry of Health, Ministry of Community Development Mother and Child Health)

– 3 USG agencies– 6 implementation partners– Study team of more than 800

HPTN071: Lessons in Partnership

PEPFARNIAIDNIDANIMH

HPTN

CDC

LSHTM

BMGF

3IE

NIAID USAID

ZPCTIICIDRZZAMBART

SCMS

SCMS

Zambian Ministry of Health and Ministry of Community Development Mother and Child Health

Zambia

Research ImplementationFunding Flows

• Vital!• Designed structures at all levels giving

representation to all stakeholders– District health authorities, community and implementers– National health authorities, implementers, USG

agencies, community– National policy makers (MOH, MCDMCH), reps of

international agencies (UNAIDS, WHO, PEPFAR), USG (CDC, USAID), civil society, community

– International Advisory Group- reps from academia, civil society, international policy makers

Coordination

Trial oversight DSMB/SMC/DAIDS-NIAID

PROTOCOL TEAM

SOUTH AFRICA PopART Study Team (DTTC)

Zambia Trial Management Committee (Z-TMC)

Funders

ZAMBIA PopART Study team (ZAMBART)

Zambia Intervention management team (Z-IMT)

South Africa Trial Management team (SA-TMC)

Zambia District intervention management teams (Z-DIMT)

South Africa District/Sub district intervention coordination teams (CWICT & CMICT)

International Advisory Group

Implementing partners

Community advisory boards

ZAMBART district staff

MOH staff

South Africa Intervention management team (SA-IMT)

DOH

Implementing partners

Community advisory boards

 

DTTC district staff

Community partnership

platform

• 21 “ communities”- geographical catchment area of one health facility– Not necessarily a natural community, may be part of

a community or made up of many communities

• Communities of PLWH– How do they fit into the trial communities?

• Communities of health implementers– Government health providers– NGO health providers– Community based organisations– Faith based organisations

What is “Community”?

Community stakeholder

reps

Opinion leaders/ G keepers

Community Advisory

Board (CAB)

Z-DIMT

CBO reps

National Community

Advisory Board

(NCAB)

Community partners platform

Zambia Implementation Management Team (Z-IMT)

Zambia Trial Management Committee (Z-

TMC)

Com

mun

ity a

nd D

istr

ict

Leve

ls Nat

iona

l Lev

el

Community Engagement

• Partnerships evolve– First discussions with community and national health authorities

several years prior to trial being funded– Discussions with all partners prior to submission of proposal– Some partnerships develop more slowly than others, some happen

spontaneously, some have to be worked at– Changing relationships as the trial progresses

• We may not all be natural partners– Different language ( even if many of us use “English”)– Different cultures– Different skills– Different education and socio-economic status– Different power balances– Different expectations

Dynamism

ACKNOWLEDGEMENTS

• Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) under Cooperative Agreements # UM1 AI068619, UM1-AI068617, and UM1-AI068613

• Funded by:

– The U.S. President's Emergency Plan for AIDS Relief (PEPFAR)

– The International Initiative for Impact Evaluation (3ie) with support from the Bill & Melinda Gates Foundation

– NIAID, the National Institute of Mental Health (NIMH), and the National Institute on Drug Abuse (NIDA) all part of the U.S. National Institutes of Health (NIH)

The HPTN 071 Study Team, led by:Dr. Richard Hayes

Dr. Sarah FidlerDr. Helen Ayles

Dr. Nulda Beyers

PEPFARImplementing

Partners

Implementing Partners:

Government Agencies:

• All research participants and their families

• The 21 research communities and their religious, traditional, secular and civil leadership structures

• Volunteers in the community advisory board structures

With thanks to: