title: Effect of community-based voluntary counselling and testing on HIV incidence and social and behavioural outcomes (NIMH Project Accept; HPTN 043): a cluster-randomised trial.
abstract: BACKGROUND
  Although several interventions have shown reduced HIV incidence in clinical trials, the community-level effect of effective interventions on the epidemic when scaled up is unknown. We investigated whether a multicomponent, multilevel social and behavioural prevention strategy could reduce HIV incidence, increase HIV testing, reduce HIV risk behaviour, and change social and behavioural norms.
  
  
  METHODS
  For this phase 3 cluster-randomised controlled trial, 34 communities in four sites in Africa and 14 communities in Thailand were randomly allocated in matched pairs to receive 36 months of community-based voluntary counselling and testing for HIV (intervention group) or standard counselling and testing alone (control group) between January, 2001, and December, 2011. The intervention was designed to make testing more accessible in communities, engage communities through outreach, and provide support services after testing. Randomisation was done by a computer-generated code and was not masked. Data were collected at baseline (n=14 567) and after intervention (n=56.683) by cross-sectional random surveys of community residents aged 18-32 years. The primary outcome was HIV incidence and was estimated with a cross-sectional multi-assay algorithm and antiretroviral drug screening assay. Thailand was excluded from incidence analyses because of low HIV prevalence. This trial is registered at ClinicalTrials.gov, number NCT00203749.
  
  
  RESULTS
  The estimated incidence of HIV in the intervention group was 1.52% versus 1.81% in the control group with an estimated reduction in HIV incidence of 13.9% (relative risk [RR] 0.86, 95% CI 0.73-1.02; p=0.082). HIV incidence was significantly reduced in women older than 24 years (RR=0.70, 0.54-0.90; p=0.0085), but not in other age or sex subgroups. Community-based voluntary counselling and testing increased testing rates by 25% overall (12-39; p=0.0003), by 45% (25-69; p<0·0001) in men and 15% (3-28; p=0.013) in women. No overall effect on sexual risk behaviour was recorded. Social norms regarding HIV testing were improved by 6% (95% CI 3-9) in communities in the intervention group.
  
  
  CONCLUSIONS
  These results are sufficiently robust, especially when taking into consideration the combined results of modest reductions in HIV incidence combined with increases in HIV testing and reductions in HIV risk behaviour, to recommend the Project Accept approach as an integral part of all interventions (including treatment as prevention) to reduce HIV transmission at the community level.
  
  
  BACKGROUND
  US National Institute of Mental Health, the Division of AIDS of the US National Institute of Allergy and Infectious Diseases, and the Office of AIDS Research of the US National Institutes of Health.
authors.affiliation: University of California, Los Angeles, UCLA Center for World Health, Los Angeles, CA, USA. Electronic address: tcoates@mednet.ucla.edu.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Coates
authors.affiliation: Charles University, Faculty of Mathematics and Physics, Prague, Czech Republic.
authors.forename: Michal
authors.initials: M
authors.lastname: Kulich
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, MD, USA.
authors.forename: David D
authors.initials: DD
authors.lastname: Celentano
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, MD, USA.
authors.forename: Carla E
authors.initials: CE
authors.lastname: Zelaya
authors.affiliation: Chiang Mai University, Research Institute for Health Sciences, Chiang Mai, Thailand.
authors.forename: Suwat
authors.initials: S
authors.lastname: Chariyalertsak
authors.affiliation: University of Zimbabwe, College of Health Sciences, Harare, Zimbabwe.
authors.forename: Alfred
authors.initials: A
authors.lastname: Chingono
authors.affiliation: University of the Witwatersrand, Chris Hani Baragwanath Hospital, Faculty of Health Sciences, Perinatal HIV Research Unit, Soweto, South Africa.
authors.forename: Glenda
authors.initials: G
authors.lastname: Gray
authors.affiliation: Muhimbili University of Health and Allied Sciences, Muhimbili University Teaching Hospital, Dar es Salaam, Tanzania.
authors.forename: Jessie K K
authors.initials: JK
authors.lastname: Mbwambo
authors.affiliation: University of California, San Francisco, Center for AIDS Prevention Studies, San Francisco, CA, USA.
authors.forename: Stephen F
authors.initials: SF
authors.lastname: Morin
authors.affiliation: Human Sciences Research Council, Dalbridge, South Africa.
authors.forename: Linda
authors.initials: L
authors.lastname: Richter
authors.affiliation: Medical University of South Carolina, Family Services Research Center, Charleston, SC, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Sweat
authors.affiliation: Human Sciences Research Council, Durban, South Africa.
authors.forename: Heidi
authors.initials: H
authors.lastname: van Rooyen
authors.affiliation: University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: Nuala
authors.initials: N
authors.lastname: McGrath
authors.affiliation: University of California, Los Angeles, UCLA Center for World Health, Los Angeles, CA, USA.
authors.forename: Agnès
authors.initials: A
authors.lastname: Fiamma
authors.affiliation: Johns Hopkins University School of Medicine, Department of Medicine, Baltimore, MD, USA; The National Institutes of Health, Bethesda, MD, USA.
authors.forename: Oliver
authors.initials: O
authors.lastname: Laeyendecker
authors.affiliation: Department of Pathology, Baltimore, MD, USA.
authors.forename: Estelle
authors.initials: E
authors.lastname: Piwowar-Manning
authors.affiliation: University of California, Los Angeles, UCLA Center for World Health, Los Angeles, CA, USA.
authors.forename: Greg
authors.initials: G
authors.lastname: Szekeres
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Donnell
authors.affiliation: Department of Pathology, Baltimore, MD, USA.
authors.forename: Susan H
authors.initials: SH
authors.lastname: Eshleman
mesh_terms: D000293:Adolescent; D000328:Adult; D000349:Africa / Q000453:epidemiology; D019058:Community Networks; D003376:Counseling; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control; D015438:Health Behavior; D006801:Humans; D015994:Incidence; D008297:Male; D017063:Outcome Assessment, Health Care; D010342:Patient Acceptance of Health Care; D040242:Risk Reduction Behavior; D013785:Thailand / Q000453:epidemiology; D055815:Young Adult
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