PROJECT ACCEPT PERFORMANCE FEEDBACK

7/29/2019 PROJECT ACCEPT PERFORMANCE FEEDBACK

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NIMH Project Accept

(HPTN 043)A CLUSTER-RANDOMIZED TRIAL OF COMMUNITY

MOBILIZATION, MOBILE HIV TESTING, POST-TEST SUPPORT

SERVICES, AND REAL-TIME PERFORMANCE FEEDBACK FOR

HIV PREVENTION IN ENTIRE COMMUNITIES


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10 Years Work

presented in

10 MinutesA CLUSTER-RANDOMIZED TRIAL OF COMMUNITY





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The AIDS Free Generation

Depends on You

(Mike Cohen)A CLUSTER-RANDOMIZED TRIAL OF COMMUNITY





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HIV PREVENTION NEEDS TO

Encourage

widespreadHIV testing

Behavioralrisk reduction

Mobilize

Communities

Accessstrategies

and devices


Access careand treatment

HIV Uninfected HIV Infected

Providesupport


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NIMH PROJECT ACCEPT (HPTN 043) STUDY SITES

Vulindlela, South Africa

Chiang Mai, Thailand

Kisarawe, Tanzania

Soweto, South Africa

Mutoko, Zimbabwe


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Communities were randomized to 2 approaches

Mobilization, Testing, Support, and

Access to Services

Community-based VCT(CBVCT N = 24 communities)

1. Community preparation,outreach, mobilization

2. Mobile VCT

3. Post-test support services

a. Stigma-reduction skills training

b. Coping effectiveness training

c. Ongoing counseling

4. Ongoing data feedback and field

adjustments

Standard VCT(SVCT N = 24 communities)

1. Clinic-based VCT2. Standard VCT services

normally provided in that

community

Van Rooyen et al, AIDS and

Behavior, 2012


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The joint efforts that make Project AFIKI


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THE COMPLETE INTERVENTION PACKAGE

FOR COMMUNITY BASED VCT (CBVCT)

Community

Mobilization

Mobile VCTbrought to

where peopleare

TestingSupportServices

TSS club guests receive

stigma and HIV/AIDS

info: Mobilized for testing

Participants receive risk

reduction information andmobilize partners for testing

Community

members mobilized:Social networks,

door-to-door, mob

talks, community

events

Social networks are

identified and secured forinformation sessions

Update from community

members around

caravan

Participants tested, move on to

TSS for support and referrals

DATA


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Study Design: Timeline

Pilot studies in

Zimbabwe and Thailand

Community

Selection,Recruitment,

Funding

Baseline

Survey

2001 20042003 2005 2006 2007 20082002 2009 2010 2011

INTERVENTION

CommunityRandom-

izationPost-

Intervention

Assessment

Qualitative Cohort

Probability sample of 18-32 year olds Survey only

Total N =48 communities24 intervention / 24 control

Assessment of a random sample of18-32 year olds in each intervention andcontrol community

Behavioral survey Biologic assays to estimate HIV incidence


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The goal was to affect the entire community and not

just a study cohort

Anyone in the community could participate in any of

the community events including mobile testing

Outcomes were evaluated at the end of the

intervention among a probability sample of 54,326

community residents 18 to 32 years of age (89%

response rate)

Incident infections were estimated using a multi-assay

algorithm (MAA) developed by the HPTN Core Lab at

Hopkins and the Core Statistical Unit at SCHARP and

Charles University (Prague)

Primary outcome = HIV incidence,

evaluated at the community level


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ALL OF THIS RESULTED IN:

86,720 HIV tests

50,000 individuals

when repeat tests are excluded

69,987

in CBVCT

communities

7,636

in SVCT

communities

140,755 post-test support visits

Sweat et al, Lancet ID, 2011


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There has been gender equity in uptake for CBVCT

47.8 45.9

59.8

50.2 47.1

52.2 54.1

40.2

49.8 52.9

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Thailand Zimbabwe Tanzania Soweto Vulindlela

Percent

Male Female

Lancet Infectious Diseases, 2011


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We Have Reached a Relatively Young Group of Clients

36

28

30

28

21

05

10

15

20

25

30

35

40

Thailand Zimbabwe Tanzania Soweto Vulindlela

Me

dianAge(Years)

Project Sites

Lancet Infectious Diseases, 2011


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Proportion of the Population

Using Mobile VCT

Country CBVCT

SVCT Ratio

South Africa--Soweto 17% 1% 14.8

South Africa--Vulindlela 20% 1% 16.8

Zimbabwe 25% 8% 3.07

Tanzania 21% 7% 2.93

Thailand 35% 1% 35.0


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Testing Uptake: 12 Months

Effecta

95% CI p-value

All sites 1.06 1.03 1.09 0.0001

Thailand 1.09 1.02 1.16Zimbabwe 1.07 1.00 1.13

Tanzania 1.05 1.01 1.09

Vulindlela 1.07 0.97 1.18

Soweto 1.01 0.88 1.15

SVCT-B SVCT-P CBVCT-B CBVCT-P Ratio P-Value

Overall 16% 26% 14% 32% 1.25 0.0003

Thailand 17% 15% 17% 24% 1.56

Zimbabwe 7% 26% 3% 32% 1.20

Tanzania 15% 32% 16% 37% 1.13

Vulindlela 20% 35% 19% 40% 1.14

Soweto 33% 37% 31% 41% 1.10


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The interventionincreased HIV testing by

45% among men and

15% among women

Improvements in testing

rates were highest among

men and young people

Many women had been

tested in antenatal clinics

but the increase was still

significant

Increased

testingespecially

among men


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Testing Uptake Men: 12 Months

Effecta

95% CI p-value

All sites 1.06 1.03 1.09 0.0001

Thailand 1.09 1.02 1.16Zimbabwe 1.07 1.00 1.13

Tanzania 1.05 1.01 1.09


Soweto 1.01 0.88 1.15


Overall 8% 16% 9% 24% 1.45


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Testing Uptake Women: 12 Months

Effecta

95% CI p-value

All sites 1.06 1.03 1.09 0.0001

Thailand 1.09 1.02

1.16Zimbabwe 1.07 1.00 1.13

Tanzania 1.05 1.01 1.09


Soweto 1.01 0.88 1.15


Overall 22% 34% 19% 39% 1.15 0.01

Thailand 21% 20% 21% 28% 1.56

Zimbabwe 10% 37% 4% 36% 1.20

Tanzania 23% 44% 26% 45% 1.03

Vulindlela 28% 46% 25% 47% 1.03

Soweto 45% 46% 45% 54% 1.17


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Prevalence and Estimated IncidenceCountry Prevalence

Incidence Population Size

South Africa--Soweto 14.1 1.2152,000

(8 communities)

South Africa--Vulindlela 30.8 3.967,200

(8 communities)

Zimbabwe 12.9 0.993,300

(8 communities)

Tanzania 5.9 0.854,900

(10 communities)

Thailand 1.0


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Incidence Differences:

Intervention vs. Control CommunitiesSubgroup

(N of Incident Infections)Effect

a95% CI p-value

All participants 49 (464) 0.86 0.73 1.02 0.0822

Women (316)

Men (148)

0.88

0.81

0.73 1.06

0.57 1.15

0.1691

0.1934

Age 18-24 years (271)

Age 25-32 years (193)

0.98

0.75

0.80 1.22

0.54 1.04

0.8554

0.0777

Women, age 18-24 years (201)Women, age 25-32 years (115)

1.000.70

0.78 1.280.54 0.90

0.98330.0085

Men, age 18-24 years (69)

Men, age 25-32 years (79)

0.95

0.78

0.64 1.40

0.41 1.47

0.6934

0.3914

a

Relative risk of infection (CBVCT vs. SVCT); weighted incidence ratio


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The intervention producedan almost 4-fold increase

in the detection of

previously undiagnosed

HIV cases

This was true at all of the

3 sites where differential

utilization could be

assessed

Increased

HIV CaseFinding

Sweat et al, Lancet ID, 2011


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Number of sexual partnersreported by HIV-infected

individuals lower by 8% 95% CI:1% - 15%, p = 0.03

Number of sexual partners

among HIV-positive men

lower by 18% (95% CI = 5% to 28%,p = .009).

Reductions

in SexualRisk


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Multiple sexual partnerslower by 30% 95% CI: 0.54 0.92, p = 0.01

Multiple sexual partnersamong HIV-infected men

lower by 29% 95% CI: 0.57to 0.89, p = .0006

Reductions

in SexualRisk


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No increase observed innegative effects of the

intervention in

communities

No increasein violence towards women

as a result of learning

their HIV status

TheIntervention

was Safe


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HIV PREVENTION NEEDS TO

EncouragewidespreadHIV testing


Mobilize

Communities

Accessstrategies

and devices


Access careand treatment

HIV Uninfected HIV Infected

Provide

support


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NIMH Project Accept (HPTN 043)demonstrated that it is possible to:

Produce modest reductions in

HIV incidence

This suggests that the additionof other components referraland maintenance in care, earlytreatment, male circumcision,pre-exposure prophylaxis might be successful in achievinggreater reductions in HIV

incidence in entire communities.

Implications


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Principal Investigators

Soweto, South Africa: Thomas Coates / Glenda Gray

Tanzania: Michael Sweat / Jessie Mbwambo

Thailand: David Celentano / Suwat Chariyalertsak

Vulindlela, South Africa: Thomas Coates / Linda Richter /

Heidi van Rooyen

Zimbabwe: Steve Morin / Alfred Chingono

NIMH Cooperative Agreement Project Officer: Chris Gordon

Core Lab: Susan Eshleman/Estelle Piwowar-Manning

Statistical Core: Michal Kulich, Deborah Donnell

Collaborators:

NIMH Project Accept (HPTN 043)


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ACKNOWLEDGEMENTS

Sponsored by NIMH under the following Cooperative Agreements: U01MH066687 (Johns Hopkins University: David Celentano, PI)

U01MH066688 (Medical University of South Carolina: Michael Sweat, PI)

U01MH066701 (University of California, Los Angeles: Thomas J. Coates, PI)

U01MH066702 (University of California, San Francisco: Stephen F. Morin, PI)

Also Sponsored by the Division of AIDS at NIAID and the Office of AIDS Research ofthe NIH, as HPTN Protocol 043:

U01AI068613/UM1AI068613 (HPTN Network Laboratory: Susan Eshleman, PI)

U01AI068617/UM1AI068617 (SCHARP: Deborah Donnell, PI)

U01AI068619/UM1AI068619 (HIV Prevention Trials Network: Sten Vermund, PI)


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We thank the communities that partnered with us in conducting

this research, and all study participants for their contributions.

We also thank study staff and volunteers at all participating

institutions for their work and dedication.

Acknowledgements

PROJECT ACCEPT PERFORMANCE FEEDBACK

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