Transcript Slide 1

Community-Level HIV Incidence
Outcomes of NIMH Project Accept
(HPTN 043)
Glenda Gray for the
Project Accept Study Team
IAS 2013
2 July 2013
Kuala Lumpur, Malaysia
Context matters… in 2002/3
• Majority of persons
unaware of HIV status
– Low testing motivation
• Limitations to individual
clinic-based VCT:
– Passive, inaccessible to
certain groups
• HIV silent and hidden
• ART slowly rolled out
nationally and globally
NIMH
Project
Accept
(HPTN 043)
• The first communityrandomized trial designed to:
– test a combination of social,
behavioral, and structural
approaches for HIV prevention
– assess the impact of an
integrated strategy for HIV
prevention on HIV incidence
– assess the impact of an
integrated strategy for HIV
prevention on behavioral and
social outcomes at the
community level.
Rationale
for
NIMH
Project
Accept
(HPTN 043)
• Community-level approach
chosen because earlier VCT
research in Africa found that
while it lead to increased
information and risk
reduction, many avoided
testing as it was not
normative, because of stigma
and no available support
services or effective
treatment for those testing
positive.
Objective
• To determine whether communities
that received at least 36 months of
intervention would have lower HIV
incidence, increased rate of HIV
testing, lower rates of sexual risk
behavior and lower stigma compared
to control communities
48 communities in 5 study sites
Chiang Mai, Thailand
Kisarawe, Tanzania
Mutoko, Zimbabwe
Soweto, South Africa
Vulindlela, South Africa
Trial Design
• Phase III cluster community (pair)
randomized trial of a community-level
behavioral intervention to reduce HIV
incidence:
– 8 in rural Zimbabwe, 10 in rural Tanzania, 8 in
Soweto and 8 in rural KwaZulu Natal, South
Africa, and 14 in rural northern Thailand
– Thailand data not included due to low
prevalence (<1%) and negligible incidence
Communities randomized to 2
VCT approaches
Community-based VCT
Standard VCT
(CBVCT N = 24 communities)
(SVCT 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
1. Clinic-based VCT
2. Standard VCT services
normally provided in that
community
The COMPLETE INTERVENTION PACKAGE for
community based VCT (CBVCT)
Social networks are
identified and secured for
information sessions
TSS club guests receive
stigma and HIV/AIDS
info: Mobilized for testing
Testing
Support
Services
Community
members mobilized:
Social networks,
door-to-door, mob
talks, community
events
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
2002
2003
Community
Randomization
PostIntervention
Assessment
Baseline
Survey
Pilot studies in
Zimbabwe and Thailand
2001
INTERVENTION
2004
2005
• Probability sample of 18-32 year olds
• Survey only (N=14,567)
2006
2007
2008
2009
2010
2011
• Assessment of a random sample of
18-32 year olds in each intervention and
control community
• Behavioral survey (N=56,683).
• Biologic assays to estimate HIV incidence
Primary outcome = HIV incidence,
evaluated at community level
• Goal was to impact entire community, not just a
study cohort
• Intervention: provided to anyone in the community
could participate
• Outcomes: evaluated among probability sample of
54,326 community residents 18 to 32 years of age
(89% response rate)
• Incident infections: used a multi-assay algorithm
(MAA) developed by HPTN Core Lab at Hopkins
and the Core Statistical Unit at SCHARP and
Charles University (Prague)
Primary outcome = HIV incidence,
evaluated at community level
• HIV incidence estimated using a cross-sectional
laboratory-based measure that was extensively
validated by the HPTN Central Laboratory
• No HIV testing done at baseline, since HIV testing
was the mechanism by which we anticipated a
reduction in HIV incidence (i.e., we could not
“contaminate” the communities)
• HIV was not evaluated based on participation in the
intervention – rather, it was measured on a random
sample (at the community level) who may or may
not have participated in any intervention activities
Prevalence and Estimated Incidence
Country
Prevalence
Incidence
South Africa--Soweto
14.1
1.2
South Africa--Vulindlela
30.8
3.9
Zimbabwe
12.9
0.9
Tanzania
5.9
0.8
Thailand
1.0
<0.1
Population
Size
152,000
(8 communities)
67,200
(8 communities)
93,300
(8 communities)
54,900
(10 communities)
103,200
(14 communities)
Incidence Differences:
Intervention vs. Control Communities
Subgroup
(N of Incident Infections)
Effect
a
95% CI
p-value
All participants (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)
1.00
0.70
0.78 – 1.28
0.54 – 0.90
0.9833
0.0085
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
Conclusions
• Our findings among older
women suggest that their risk
may have been reduced due to
the risk reduction reported by
men, especially those who were
found to be HIV-negative
Conclusions
• Our modest reductions in HIV
incidence at a population level:
– Provides a benchmark
– The addition of other
components — linkage and
retention in care, early ART
treatment, male circumcision,
pre-exposure prophylaxis —
might be successful in
achieving greater reductions in
HIV incidence in entire
communities
Major
challenges in
prevention
science
• Important to understand what
happens in entire communities
and not just in study cohorts
participating in experiments
• Bridge from clinical trials
proving the concept to
intervention studies
demonstrating effectiveness
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
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.