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