title: Abbreviated HIV counselling and testing and enhanced referral to care in Uganda: a factorial randomised controlled trial.
abstract: BACKGROUND
  HIV counselling and testing and linkage to care are crucial for successful HIV prevention and treatment. Abbreviated counselling could save time; however, its effect on HIV risk is uncertain and methods to improve linkage to care have not been studied.
  
  
  METHODS
  We did this factorial randomised controlled study at Mulago Hospital, Uganda. Participants were randomly assigned to abbreviated or traditional HIV counselling and testing; HIV-infected patients were randomly assigned to enhanced linkage to care or standard linkage to care. All study personnel except counsellors and the data officer were masked to study group assignment. Participants had structured interviews, given once every 3 months. We compared sexual risk behaviour by counselling strategy with a 6·5% non-inferiority margin. We used Cox proportional hazards analyses to compare HIV outcomes by linkage to care over 1 year and tested for interaction by sex. This trial is registered with ClinicalTrials.gov (NCT00648232).
  
  
  RESULTS
  We enrolled 3415 participants; 1707 assigned to abbreviated counselling versus 1708 assigned to traditional. Unprotected sex with an HIV discordant or status unknown partner was similar in each group (232/823 [27·9%] vs 251/890 [28·2%], difference -0·3%, one-sided 95% CI 3·2). Loss to follow-up was lower for traditional counselling than for abbreviated counselling (adjusted hazard ratio [HR] 0·61, 95% CI 0·44-0·83). 1003 HIV-positive participants were assigned to enhanced linkage (n=504) or standard linkage to care (n=499). Linkage to care did not have a significant effect on mortality or receipt of co-trimoxazole. Time to treatment in men with CD4 cell counts of 250 cells per μL or fewer was lower for enhanced linkage versus standard linkage (adjusted HR 0·60, 95% CI 0·41-0·87) and time to HIV care was decreased among women (0·80, 0·66-0·96).
  
  
  CONCLUSIONS
  Abbreviated HIV counselling and testing did not adversely affect risk behaviour. Linkage to care interventions might decrease time to enrolment in HIV care and antiretroviral treatment and thus might affect secondary HIV transmission and improve treatment outcomes.
  
  
  BACKGROUND
  US National Institute of Mental Health.
authors.affiliation: Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda. Electronic address: rwanyenze@hotmail.com.
authors.forename: Rhoda K
authors.initials: RK
authors.lastname: Wanyenze
authors.affiliation: Department of Medicine, Makerere University School of Medicine, Kampala, Uganda.
authors.forename: Moses R
authors.initials: MR
authors.lastname: Kamya
authors.affiliation: Department of Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Robin
authors.initials: R
authors.lastname: Fatch
authors.affiliation: Department of Medicine, Makerere University School of Medicine, Kampala, Uganda.
authors.forename: Harriet
authors.initials: H
authors.lastname: Mayanja-Kizza
authors.affiliation: Department of Medicine, Makerere University School of Medicine, Kampala, Uganda.
authors.forename: Steven
authors.initials: S
authors.lastname: Baveewo
authors.affiliation: Division of Infectious Diseases, University of California Los Angeles David Geffen School of Medicine, Los Angeles, CA, USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: Szekeres
authors.affiliation: Massachusetts General Hospital Center for Global Health and Harvard Medical School, Boston, MA, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Bangsberg
authors.affiliation: Division of Infectious Diseases, University of California Los Angeles David Geffen School of Medicine, Los Angeles, CA, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Coates
authors.affiliation: Department of Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Hahn
mesh_terms: D000328:Adult; D018791:CD4 Lymphocyte Count; D003376:Counseling / Q000379:methods*; D019468:Disease Management; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000628:therapy; D006801:Humans; D008297:Male; D016016:Proportional Hazards Models; D012017:Referral and Consultation; D018570:Risk Assessment; D012309:Risk-Taking; D012737:Sex Factors; D012725:Sexual Behavior; D061665:Time-to-Treatment; D014454:Uganda; D047568:Unsafe Sex; D055815:Young Adult
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