5 research outputs found

    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

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    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

    Qualitative research and implementation science: Informing the acceptability and implementation of a trial of a conditional cash transfer intervention designed to reduce drug use and HIV risk

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    HIV risk remains high among Cambodian female entertainment and sex workers, driven by amphetamine-type substance use and sexual risk. Conditional cash transfer is an evidence-based approach to reduce stimulant use and optimize HIV/AIDS prevention, but questions remain regarding implementation in resource-limited settings. We conducted formative qualitative research to enhance acceptability of a conditional cash transfer intervention aimed at reducing amphetamine-type substance use and HIV risk among female entertainment/sex workers and inform implementation as part of a large cluster randomized trial. We conducted in-depth interviews with 30 female entertainment/sex workers. Interviews were digitally recorded and conducted and transcribed in Khmer. English transcripts were read for emerging themes and an initial coding scheme was developed. Data were coded using open and axial coding to clarify and consolidate initial themes. While most participants expressed enthusiasm for the intervention, financial and transportation issues emerged as key barriers to participation. The proposed incentive of USD$1 per screen was regarded as unacceptable and participants identified a need for transportation assistance. Participants also expressed concerns about directly observed urine specimen collection. Finally, while most participants found the 4-week aftercare program acceptable, the need for enjoyable as well as educational content was emphasized. Revisions to the protocol taking these data into account were made to optimize the acceptability of the intervention and the implementation of the trial. Findings identified key concerns and preferences that were taken into account in the final trial protocol. In particular, financial and transportation issues were identified as critical barriers to participation, with the potential to impact both intervention uptake and trial feasibility. Results demonstrate the value of formative qualitative research for clinical trial planning and implementation, particularly in settings where little is known about acceptability of interventions or willingness to participate
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