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HIV/AIDS
Protocol
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
  1. Kimberly Page1,
  2. Ellen S Stein2,
  3. Adam W Carrico3,
  4. Jennifer L Evans2,
  5. Muth Sokunny4,
  6. Ean Nil4,
  7. Song Ngak4,
  8. Chhit Sophal5,
  9. Charles McCulloch2,
  10. Lisa Maher6
  1. 1Division of Epidemiology, Biostatistics and Preventive Medicine, Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA
  2. 2Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, California, USA
  3. 3Department of Community Health Systems, School of Nursing, University of California San Francisco, San Francisco, California, USA
  4. 4FHI360 Cambodia, Phnom Penh, Cambodia
  5. 5Department of Mental Health and Substance Abuse, Ministry of Health, Phnom Penh, Cambodia
  6. 6Kirby Institute for Infection and Immunity, UNSW Australia, Sydney, New South Wales, Australia
  1. Correspondence to Dr Kimberly Page; Pagek{at}salud.unm.edu

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

Conclusions CIPI is the first trial of an intervention to reduce ATS use and HIV risk among FESW in Cambodia.

Results Will inform both CCT+AC implementation in low and middle-income countries and programmes designed to reach FESW.

Trial registration number NCT01835574; Pre-results.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2015-010854

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