title: Protocol of a cluster randomised stepped-wedge trial of behavioural interventions targeting amphetamine-type stimulant use and sexual risk among female entertainment and sex workers in Cambodia.
abstract: HIV risk among female entertainment and sex workers (FESW) remains high and use of amphetamine-type stimulants (ATS) significantly increases this risk. We designed a cluster randomised stepped wedge trial (The Cambodia Integrated HIV and Drug Prevention Implementation (CIPI) study) to test sequentially delivered behavioural interventions targeting ATS use.
  
  
  
  The trial combines a 12-week Conditional Cash Transfer (CCT) intervention with 4 weeks of cognitive-behavioural group aftercare (AC) among FESW who use ATS. The primary goal is to reduce ATS use and unprotected sex among FESW. The CCT+AC intervention is being implemented in 10 provinces where order of delivery was randomised. Outcome assessments (OEs) including biomarkers and self-reported measures of recent sexual and drug use behaviours are conducted prior to implementation, and at three 6-month intervals after completion. Consultation with multiple groups and stakeholders on implementation factors facilitated acceptance and operationalisation of the trial. Statistical power and sample size calculations were based on expected changes in ATS use and unprotected sex at the population level as well as within subjects.
  
  
  
  Ethical approvals were granted by the Cambodia National Ethics Committee; University of New Mexico; University of California, San Francisco; and FHI360. The trial is registered with ClinicalTrials.gov. Dissemination of process indicators during the multiyear trial is carried out through annual in-country Stakeholder Meetings. Provincial 'Close-Out' forums are held at the conclusion of data collection in each province. When analysis is completed, dissemination meetings will be held in Cambodia with stakeholders, including community-based discussion sessions, policy briefs and results published and presented in the HIV prevention scientific journals and conferences.
  
  
  
  CIPI is the first trial of an intervention to reduce ATS use and HIV risk among FESW in Cambodia.
  
  
  
  Will inform both CCT+AC implementation in low and middle-income countries and programmes designed to reach FESW.
  
  
  
  NCT01835574; Pre-results.
authors.affiliation: Division of Epidemiology, Biostatistics and Preventive Medicine, Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Page
authors.affiliation: Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, California, USA.
authors.forename: Ellen S
authors.initials: ES
authors.lastname: Stein
authors.affiliation: Department of Community Health Systems, School of Nursing, University of California San Francisco, San Francisco, California, USA.
authors.forename: Adam W
authors.initials: AW
authors.lastname: Carrico
authors.affiliation: Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, California, USA.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Evans
authors.affiliation: FHI360 Cambodia, Phnom Penh, Cambodia.
authors.forename: Muth
authors.initials: M
authors.lastname: Sokunny
authors.affiliation: FHI360 Cambodia, Phnom Penh, Cambodia.
authors.forename: Ean
authors.initials: E
authors.lastname: Nil
authors.affiliation: FHI360 Cambodia, Phnom Penh, Cambodia.
authors.forename: Song
authors.initials: S
authors.lastname: Ngak
authors.affiliation: Department of Mental Health and Substance Abuse, Ministry of Health, Phnom Penh, Cambodia.
authors.forename: Chhit
authors.initials: C
authors.lastname: Sophal
authors.affiliation: Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, California, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: McCulloch
authors.affiliation: Kirby Institute for Infection and Immunity, UNSW Australia, Sydney, New South Wales, Australia.
authors.forename: Lisa
authors.initials: L
authors.lastname: Maher
mesh_terms: D000293:Adolescent; D000359:Aftercare; D019969:Amphetamine-Related Disorders / Q000628:therapy* / Q000652:urine; D015415:Biomarkers / Q000652:urine; D002160:Cambodia; D015928:Cognitive Behavioral Therapy; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D009042:Motivation; D017063:Outcome Assessment, Health Care; D012107:Research Design; D060386:Sex Workers; D047568:Unsafe Sex / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D015415:Biomarkers