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

10 Years Work presented in 10 Minutes

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

The AIDS Free Generation Depends on You (Mike Cohen)

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

HIV PREVENTION NEEDS TO

Mobilize Communities

Encourage widespread HIV testing

HIV Uninfected
HIV Infected

Behavioral risk reduction Access strategies and devices Provide support

Behavioral risk reduction

Access care and treatment

NIMH PROJECT ACCEPT (HPTN 043) STUDY SITES

Chiang Mai, Thailand

Kisarawe, Tanzania Mutoko, Zimbabwe Soweto, South Africa Vulindlela, South Africa

Communities were randomized to 2 approaches Mobilization, Testing, Support, and Access to Services
Community-based VCT
(CBVCT N = 24 communities)

Standard VCT
(SVCT N = 24 communities) 1. Clinic-based VCT 2. Standard VCT services normally provided in that community

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

Van Rooyen et al, AIDS and Behavior, 2012

The joint efforts that make Project AFIKI

THE COMPLETE INTERVENTION PACKAGE FOR COMMUNITY BASED VCT (CBVCT)

Social networks are identified and secured for information sessions Community members mobilized: Social networks, door-to-door, mob talks, community events

TSS club guests receive stigma and HIV/AIDS info: Mobilized for testing

Testing Support Services

Community Mobilization

Participants tested, move on to TSS for support and referrals

Mobile VCT brought to where people are

Update from community members around caravan

DATA
Participants receive risk reduction information and mobilize partners for testing

Study Design: Timeline

Total N = 48 communities 24 intervention / 24 control

Qualitative Cohort Community Selection, Recruitment, Funding Pilot studies in Zimbabwe and Thailand INTERVENTION
Community Randomization

Baseline Survey

PostIntervention Assessment

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

Probability sample of 18-32 year olds Survey only

Assessment of a random sample of 18-32 year olds in each intervention and control community Behavioral survey Biologic assays to estimate HIV incidence

Primary outcome = HIV incidence, evaluated at the community level

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)

ALL OF THIS RESULTED IN:

86,720 HIV tests

69,987 in CBVCT communities 50,000 individuals
when repeat tests are excluded

7,636 in SVCT communities

140,755 post-test support visits

Sweat et al, Lancet ID, 2011

There has been gender equity in uptake for CBVCT

100% 90% 80%
52.2 40.2 54.1 49.8

70%

52.9

Percent

60% 50% 40% 30%

47.8 59.8 45.9 50.2

20% 10% 0%
Thailand

47.1

Zimbabwe

Tanzania

Soweto

Vulindlela

Male

Female

Lancet Infectious Diseases, 2011

We Have Reached a Relatively Young Group of Clients

40 35
36 30 28 28

Median Age (Years)

30 25

21

20 15 10 5 0
Thailand Zimbabwe Tanzania
Project Sites

Soweto

Vulindlela

Lancet Infectious Diseases, 2011

Proportion of the Population Using Mobile VCT

Country South Africa--Soweto South Africa--Vulindlela CBVCT 17% 20% SVCT 1% 1% Ratio 14.8 16.8

Zimbabwe

25%

8%

3.07

Tanzania

21%

7%

2.93

Thailand

35%

1%

35.0

Testing Uptake: 12 Months

SVCT-B
Overall All sites Thailand

SVCT-P 26%

CBVCT-B

Effect

CBVCT-P

Ratio

P-Value
p-value

95% CI
1.02 1.16

16%

14% 1.06 32% 1.03 1.09 1.25

1.09

0.0003 0.0001

Thailand

Zimbabwe
Tanzania

17%

15% 26% 32% 35% 37%

17% 3% 16% 19% 31%

1.07
1.05

24%

1.00 1.13

1.01 1.09

1.56

Vulindlela Zimbabwe 7%

1.07 32% 0.97 1.18 1.20

Soweto

1.01

0.88 1.15

Tanzania Vulindlela Soweto

15% 20% 33%

37% 40% 41%

1.13 1.14 1.10

Increased testing especially among men

The intervention increased 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

Testing Uptake Men: 12 Months

SVCT-B
Overall sites 8% All Thailand

SVCT-P 16%

CBVCT-B 9%

Effect
1.09

CBVCT-P

Ratio

P-Value
p-value

95% CI
1.02 1.16

1.45 1.06 24%1.03 1.09

1.07
1.05

<0.0001 0.0001

Thailand

Zimbabwe
Tanzania

11%

11%

13%

19%

1.00 1.13

1.01 1.09

1.56

Vulindlela3% Zimbabwe

16%
6% 21% 25%

3%
16% 11% 19%

Soweto

1.07 25% 0.97 1.18 1.20 1.01 0.88 1.15

Tanzania Vulindlela Soweto

6% 9% 18%

26% 30% 25%

1.13 1.41 0.96

Testing Uptake Women: 12 Months

SVCT-B
Overall All sites Thailand

SVCT-P 34%

CBVCT-B

Effect

CBVCT-P

Ratio

P-Value
p-value

95% CI
1.02 1.16

22%

19% 1.06 39%1.03 1.09 1.15

1.09

0.01 0.0001

Zimbabwe

1.07

1.00 1.13

Thailand Tanzania
Soweto

21%

20% 37% 44% 46%

21% 1.05 28%1.01 1.09 1.56 4% 26% 25%

1.07

Vulindlela Zimbabwe 10%

36%0.97 1.18 1.20

0.88 1.15

1.01

Tanzania Vulindlela

23% 28%

45% 47%

1.03 1.03

Soweto

45%

46%

45%

54%

1.17

Prevalence and Estimated Incidence

Country Prevalence Incidence Population Size 152,000
(8 communities)

South Africa--Soweto

14.1

1.2

South Africa--Vulindlela

30.8

3.9

67,200
(8 communities)

Zimbabwe

12.9

0.9

93,300
(8 communities)

Tanzania

5.9

0.8

54,900
(10 communities)

Thailand

1.0

<0.1

103,200
(14 communities)

Incidence Differences: Intervention vs. Control Communities

Subgroup (N of Incident Infections) Effect
a

95% CI

p-value

All participants 49 (464)

Women (316) Men (148) Age 18-24 years (271) Age 25-32 years (193)

0.86
0.88 0.81 0.98 0.75

0.73 1.02
0.73 1.06 0.57 1.15 0.80 1.22 0.54 1.04

0.0822
0.1691 0.1934 0.8554 0.0777

Women, age 18-24 years (201) Women, age 25-32 years (115)
Men, age 18-24 years (69) Men, age 25-32 years (79)
a

1.00 0.70
0.95 0.78

0.78 1.28 0.54 0.90

0.64 1.40 0.41 1.47

0.9833 0.0085
0.6934 0.3914

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

Increased HIV Case Finding

The intervention produced an 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

Sweat et al, Lancet ID, 2011

Reductions in Sexual Risk

Number of sexual partners reported 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).

 Multiple sexual partners lower by 30% 95% CI: 0.54

0.92, p = 0.01

Reductions in Sexual Risk

Multiple sexual partners among HIV-infected men lower by 29% 95% CI: 0.57
to 0.89, p = .0006

The Intervention was Safe

No increase observed in negative effects of the intervention in communities

No increase in violence towards women as a result of learning their HIV status

HIV PREVENTION NEEDS TO

Mobilize Communities

Encourage widespread HIV testing

HIV Uninfected
HIV Infected

Behavioral risk reduction Access strategies and devices Provide support

Behavioral risk reduction

Access care and treatment

Implications

NIMH Project Accept (HPTN 043) demonstrated that it is possible to: Produce modest reductions in HIV incidence
This suggests that the addition of other components referral and maintenance in care, early treatment, male circumcision, pre-exposure prophylaxis might be successful in achieving greater reductions in HIV incidence in entire communities.

Collaborators: NIMH Project Accept (HPTN 043)

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

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 of the 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)

Acknowledgements
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.