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.

Conditional cash transfer (CCT) and cognitive-behavioral treatments are evidence-based approaches to reduce stimulant use and sexual risk taking. We describe the adaptation and implementation of sequential behavioral interventions for Cambodian female entertainment and sex workers (FESW) who use amphetamine-type stimulants (ATS): (1) a 12-week CCT intervention; and (2) a 4-week cognitive-behavioral aftercare (AC) group. An ongoing cluster randomized stepped wedge trial in 10 Cambodian provinces is enrolling FESW with confirmed recent ATS use to examine the effectiveness of CCT + AC. In the first six provinces, 138 of the 183 eligible FESW (75 %) enrolled in CCT and completed a median of 25 (interquartile range 9-32) of the 36 urine screening visits. Of the 84 participants who were eligible for AC, 79 completed at least one session (94 %) and 57 completed three or more sessions (68 %). Culturally tailored behavioral interventions to reduce ATS use and optimize HIV prevention are feasible in resource-limited settings.