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

IntroductionHIV 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 analysisThe 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 disseminationEthical 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.ConclusionsCIPI is the first trial of an intervention to reduce ATS use and HIV risk among FESW in Cambodia.ResultsWill inform both CCT+AC implementation in low and middle-income countries and programmes designed to reach FESW.Trial registration numberNCT01835574; Pre-results.

HIV treatment cascade among female entertainment and sex workers in Cambodia: impact of amphetamine use and an HIV prevention program

“…The SMARTgirl club and membership therein may be providing a larger platform for engagement and social mobilization [ 34 ] and which could be operationalizing broadly as a empowerment opportunity [ 35 ]. The broad reach of SMARTgirl could potentially be further leveraged as a platform to reach higher risk women, as has been done with the CIPI project [ 26 ], to implement multicomponent HIV prevention and care interventions.…”

“…Women with HIV infection who use stimulants in the U.S. are also more likely to report engaging in HIV transmission risk behavior [ 23 , 24 ], resulting in increased odds of onward HIV transmission where viral load is greater than 200 copies/mL [ 25 ]. We examine CoC outcomes among a sample of HIV-positive FESW participating in the Cambodia Integrated HIV and Drug Prevention Implementation (CIPI) Study being implemented in ten provinces in Cambodia [ 26 , 27 ].…”

“…The CIPI Study targeted women at high risk of HIV infection in 10 provinces of Cambodia: female entertainment and sex workers (FESW). Specifics on the population and methods have been described in detail in a previous publication defining the protocol for the CIPI Study [ 26 ]. In brief, the study recruited and enrolled FESW who: (1) were biologically female; (2) aged ≥18 years; (3) reported ≥2 different sexual partners and/or transactional sex within the last month; (4) understood spoken Khmer language; and (5) were able to provide voluntary informed consent.…”

“…The CIPI Study was implemented within the SMARTgirl HIV prevention platform [ 26 , 27 ], a widely disseminated ‘standard of care’ program launched nationally in 2008 to reduce HIV risk in women working in the high-risk entertainment sector [ 28 ]. SMARTgirl clubs exist in most provinces, and local community-based organizations maintain them and provide outreach to local women.…”

“…The SMARTgirl program uses targeted communication tools and club events to disseminate health information, conduct and promote HIV testing, and referrals to health services including HIV care, sexually transmitted infection and reproductive health services. The CIPI Study integrated an ATS intervention and microenterprise opportunity within the existing SMARTgirl platform (described in [ 26 , 27 ]).…”