Community-Level HIV Incidence Outcomes of NIMH Project Accept
(HPTN 043)Glenda Gray for the
Project Accept Study TeamIAS 2013
2 July 2013Kuala Lumpur, Malaysia
• 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
Context matters… in 2002/3
• The first community-randomized 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.
NIMHProject 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.
Rationale for
NIMHProject Accept
(HPTN 043)
• 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
Objective
48 communities in 5 study sites
Vulindlela, South Africa
Chiang Mai, Thailand
Kisarawe, Tanzania
Soweto, South AfricaMutoko, Zimbabwe
• 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
Trial Design
Communities randomized to 2 VCT approaches
Community-based VCT (CBVCT N = 24 communities)
1. Community preparation, outreach, mobilization
2. Mobile VCT3. Post-test support services
a. Stigma-reduction skills trainingb. Coping effectiveness trainingc. 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
The COMPLETE INTERVENTION PACKAGE for community based VCT (CBVCT)
CommunityMobilization
Mobile VCT brought to
where people are
Testing Support ServicesTSS club guests receive
stigma and HIV/AIDS info: Mobilized for testing
Participants receive risk reduction information and mobilize partners for testing
Community members mobilized:
Social networks, door-to-door, mob talks, community
events
Social networks are identified and secured for information sessions
Update from community members around caravan
Participants tested, move on to TSS for support and referrals
DATA
Study Design: Timeline
Pilot studies in Zimbabwe and Thailand
Community Selection,
Recruitment, Funding
Baseline Survey
2001 20042003 2005 2006 2007 20082002 2009 2010 2011
INTERVENTIONCommunity
Random-ization
Post-Intervention Assessment
Qualitative Cohort
• Probability sample of 18-32 year olds• Survey only (N=14,567)
Total N = 48 communities24 intervention / 24 control
• 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
• 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
Primary outcome = HIV incidence, evaluated at community level
Prevalence and Estimated IncidenceCountry Prevalence Incidence Population Size
South Africa--Soweto 14.1 1.2 152,000 (8 communities)
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) Effecta 95% CI p-value
All participants (464) 0.86 0.73 – 1.02 0.0822
Women (316)Men (148)
0.880.81
0.73 – 1.060.57 – 1.15
0.16910.1934
Age 18-24 years (271)Age 25-32 years (193)
0.980.75
0.80 – 1.220.54 – 1.04
0.85540.0777
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)
0.950.78
0.64 – 1.400.41 – 1.47
0.69340.3914
a Relative risk of infection (CBVCT vs. SVCT); weighted incidence ratio
• 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
Conclusions
• 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
Major challenges in
prevention science
• 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)
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
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