title: Assisted partner notification services to augment HIV testing and linkage to care in Kenya: study protocol for a cluster randomized trial.
abstract: BACKGROUND
  HIV case-finding and linkage to care are critical for control of HIV transmission. In Kenya, >50% of seropositive individuals are unaware of their status. Assisted partner notification is a public health strategy that provides HIV testing to individuals with sexual exposure to HIV and are at risk of infection and disease. This parallel, cluster-randomized controlled trial will evaluate the effectiveness, cost-effectiveness, and feasibility of implementing HIV assisted partner notification services at HIV testing sites (clusters) in Kenya.
  
  
  METHODS
  Eighteen sites were selected among health facilities in Kenya with well-established, high-volume HIV testing programs, to reflect diverse communities and health-care settings. Restricted randomization was used to balance site characteristics between study arms (n = 9 per arm). Sixty individuals testing HIV positive ('index partners') will be enrolled per site (inclusion criteria: ≥18 years, positive HIV test at a study site, willing to disclose sexual partners, and never enrolled for HIV care; exclusion criteria: pregnancy or high risk of intimate partner violence). Index partners provide names and contact information for all sexual partners in the past 3 years. At intervention sites, study staff immediately contact sexual partners to notify them of exposure, offer HIV testing, and link to care if HIV seropositive. At control sites, passive partner referral is performed according to national guidelines, and assisted partner notification is delayed by 6 weeks. Primary outcomes, assessed 6 weeks after index partner enrollment and analyzed at the cluster level, are the number of partners accepting HIV testing and number of HIV infections diagnosed and linked to care per index partner. Secondary outcomes are the incremental cost-effectiveness of partner notification and the costs of identifying >1 partner per index case. Participants are closely monitored for adverse outcomes, particularly intimate partner violence. The study is unblinded due to practical limitations.
  
  
  CONCLUSIONS
  This rigorously designed trial will inform policy decisions regarding implementation of HIV partner notification services in Kenya, with possible application to other parts of sub-Saharan Africa. Examination of effectiveness and cost-effectiveness in diverse settings will enable targeted application and define best practices.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01616420 .
authors.affiliation: Department of Research and Programs, Kenyatta National Hospital, Hospital Road, Upper Hill, Nairobi, 00202, Kenya. bwamuti@gmail.com.
authors.forename: Beatrice Muthoni
authors.initials: BM
authors.lastname: Wamuti
authors.affiliation: Department of Pediatrics, University of Toronto, Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada. laura.erdman@utoronto.ca.
authors.forename: Laura Kelly
authors.initials: LK
authors.lastname: Erdman
authors.affiliation: NASCOP, Ministry of Health, Government of Kenya, Kenyatta National Hospital Grounds, P.O. Box 19361-00202, Nairobi, Kenya. pcheru@uw.edu.
authors.forename: Peter
authors.initials: P
authors.lastname: Cherutich
authors.affiliation: Department of Epidemiology, University of Washington, 1959 NE Pacific Street, Health Sciences Building F-250, Seattle, WA, 98195-7236, USA. golden@uw.edu.|Department of Medicine, University of Washington, 1959 NE Pacific Street, RR-512 Health Sciences Building, Seattle, WA, 98195-6420, USA. golden@uw.edu.|Public Health-Seattle & King County HIV/STD Program, 401 5th Ave, Suite 1152, Seattle, WA, 98104, USA. golden@uw.edu.
authors.forename: Matthew
authors.initials: M
authors.lastname: Golden
authors.affiliation: Center for Studies in Demography and Ecology, University of Washington, 206 Raitt Hall, Seattle, WA, 98195-3412, USA. mddunbar@uw.edu.
authors.forename: Matthew
authors.initials: M
authors.lastname: Dunbar
authors.affiliation: VCT and HIV Prevention Unit, Kenyatta National Hospital, Hospital Road, Upper Hill, Nairobi, 00202, Kenya. davidbukusi@gmail.com.
authors.forename: David
authors.initials: D
authors.lastname: Bukusi
authors.affiliation: Department of Global Health, University of Washington, 1510 NE San Juan Road, Seattle, WA, 98195-7965, USA. barbrar@uw.edu.|Department of Biostatistics, University of Washington, F-600, Health Sciences Building, Seattle, WA, 98195-7232, USA. barbrar@uw.edu.|Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, Seattle, WA, 98109, USA. barbrar@uw.edu.
authors.forename: Barbra
authors.initials: B
authors.lastname: Richardson
authors.affiliation: NASCOP, Ministry of Health, Government of Kenya, Kenyatta National Hospital Grounds, P.O. Box 19361-00202, Nairobi, Kenya. annie@nascop.or.ke.
authors.forename: Anne
authors.initials: A
authors.lastname: Ng'ang'a
authors.affiliation: Department of Epidemiology, University of Washington, 1959 NE Pacific Street, Health Sciences Building F-250, Seattle, WA, 98195-7236, USA. rbarnaba@uw.edu.|Department of Medicine, University of Washington, 1959 NE Pacific Street, RR-512 Health Sciences Building, Seattle, WA, 98195-6420, USA. rbarnaba@uw.edu.|Department of Global Health, University of Washington, 1510 NE San Juan Road, Seattle, WA, 98195-7965, USA. rbarnaba@uw.edu.|Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, Seattle, WA, 98109, USA. rbarnaba@uw.edu.
authors.forename: Ruanne
authors.initials: R
authors.lastname: Barnabas
authors.affiliation: VCT and HIV Prevention Unit, Kenyatta National Hospital, Hospital Road, Upper Hill, Nairobi, 00202, Kenya. pmaingi08@gmail.com.
authors.forename: Peter Maingi
authors.initials: PM
authors.lastname: Mutiti
authors.affiliation: NASCOP, Ministry of Health, Government of Kenya, Kenyatta National Hospital Grounds, P.O. Box 19361-00202, Nairobi, Kenya. macharia.m.paul@gmail.com.
authors.forename: Paul
authors.initials: P
authors.lastname: Macharia
authors.affiliation: Department of Research and Programs, Kenyatta National Hospital, Hospital Road, Upper Hill, Nairobi, 00202, Kenya. jmabz86@gmail.com.
authors.forename: Mable
authors.initials: M
authors.lastname: Jerop
authors.affiliation: Department of Research and Programs, Kenyatta National Hospital, Hospital Road, Upper Hill, Nairobi, 00202, Kenya. fabuna@yahoo.com.
authors.forename: Felix Abuna
authors.initials: FA
authors.lastname: Otieno
authors.affiliation: Department of Global Health and Population, Harvard University, 655 Huntington Avenue, Boston, MA, 02115, USA. danielle.n.poole@gmail.com.
authors.forename: Danielle
authors.initials: D
authors.lastname: Poole
authors.affiliation: Department of Epidemiology, University of Washington, 1959 NE Pacific Street, Health Sciences Building F-250, Seattle, WA, 98195-7236, USA. cfarq@uw.edu.|Department of Medicine, University of Washington, 1959 NE Pacific Street, RR-512 Health Sciences Building, Seattle, WA, 98195-6420, USA. cfarq@uw.edu.|Department of Global Health, University of Washington, 1510 NE San Juan Road, Seattle, WA, 98195-7965, USA. cfarq@uw.edu.
authors.forename: Carey
authors.initials: C
authors.lastname: Farquhar
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods; D000328:Adult; D002985:Clinical Protocols; D016358:Contact Tracing / Q000379:methods*; D003362:Cost-Benefit Analysis; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000628:therapy; D006801:Humans; D000066511:Intimate Partner Violence / Q000517:prevention & control; D007630:Kenya; D008297:Male; D015397:Program Evaluation; D012747:Sexual Partners