Clinical trial NCT01835574: Cambodia Integrated HIV and Drug Prevention Implementation Program
Official title: Cambodia Integrated HIV and Drug Prevention Implementation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Amphetamine-type substance use
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 1198
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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 randomized stepped wedge trial: The Cambodia Integrated HIV and Drug Prevention Implementation \[CIPI) study. The CIPI study is embedded within the SMARTgirl HIV prevention program. The CIPI study aimed to recruit FESW from 10 provinces, assessing HIV risk exposures including ATS use. The CIPI study then tested sequentially delivered, behavioral interventions targeting ATS use. The trial combines a 12-week Conditional Cash Transfer (CCT) intervention with four-weeks of cognitive-behavioral group aftercare (AC) among FESW who use ATS. The primary goal of the CIPI study is to reduce ATS use and unprotected sex among FESW. The CCT+AC intervention is being implemented in ten provinces where order of delivery was randomized. Outcome assessments (OEs) including biomarkers and self-reported measures of recent sexual and ATS use behaviors are conducted prior to implementation, and at three 6-month intervals after completion. All women who are ATS negative at 6-months, including those who have completed the CCT+AC intervention are eligible to participate in a micro-enterprise (ME) opportunity. Consultation with multiple groups and stakeholders on implementation factors facilitated acceptance and operationalization 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. Dissemination of process indicators during the multi-year 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 discussions 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. Results will inform both CCT+AC implementation in low and middle-income countries and programs designed to reach FESW.

Detailed description: The CIPI Study is 16-week program that combines Conditional Cash Transfer (CCT) and group-based supportive After Care (AC) for moderate and high risk FESW ATS users using a stepped wedge randomized cluster design. The trial tests the CCT+AC intervention in 10 Cambodian provinces (clusters). Outcome Evaluation (OE) data is collected at 1 time-point prior to implementation of the CCT+AC program (Baseline), and 3 time-points after the intervention (OE-1, OE-2, and Post-OE) at 6, 12, and 18 months after baseline in each province. CCT+AC is followed by a linked economic capacity building opportunity. Women who are ATS-free, including those negative at baseline and those who successfully complete the CCT+AC intervention are eligible for referral to a MicroEnterprise (ME) program. The ME program combines financial literacy education and referral to a Cambodian registered microfinance organization (Chamroeun) for loan applications that may support alternate economic options for participating eligible women.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* biological female
* speaks Khmer language
* self reports 2 or more sex partners and/or transactional sex in last month
* able to provide informed consent

Exclusion Criteria:

* male sex
* under 18 years of age
* unable to speak Khmer language
* unable to consent

Primary outcomes:
measure: Sexual risk
timeFrame: 6, 12 and 18 months
measure: Amphetamine type stimulant use (ATS)
timeFrame: 6, 12, and 18 months
Secondary outcomes:
measure: Sexual risk 2
timeFrame: 6,12, and 18 months
measure: Sexual risk 3
timeFrame: 6, 12 and 18 months
measure: Sexual risk 4
timeFrame: 6,12, and 18 months
measure: Sexual risk 5
timeFrame: 6,12, and 18 months
measure: ATS 2
timeFrame: 6,12 and 18 months
measure: ATS 3
timeFrame: 6, 12, and 18 months
Other outcomes:
measure: Recent alcohol use
timeFrame: 6, 12, and 18 months
measure: Hazardous drinking
timeFrame: 6, 12, and 18 months
measure: HIV and STI service use
timeFrame: 6, 12 and 18 months
measure: Reproductive health outcomes
timeFrame: 6, 12 and 18 months
measure: Economic well being
timeFrame: 6,12, and 18 months
measure: Psychological distress
timeFrame: 6, 12, and 18 months
Locations:
city: Phnom Penh
country: Cambodia
facility: Family Health International
Study officials:
affiliation: University of New Mexico Health Sciences Center
name: Kimberly Page, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Page K, Stein ES, Carrico AW, Evans JL, Sokunny M, Nil E, Ngak S, Sophal C, McCulloch C, Maher L. 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. BMJ Open. 2016 May 9;6(5):e010854. doi: 10.1136/bmjopen-2015-010854.
citation: Carrico AW, Nil E, Sophal C, Stein E, Sokunny M, Yuthea N, Evans JL, Ngak S, Maher L, Page K. Behavioral interventions for Cambodian female entertainment and sex workers who use amphetamine-type stimulants. J Behav Med. 2016 Jun;39(3):502-10. doi: 10.1007/s10865-016-9713-2. Epub 2016 Jan 18.
citation: Dixon TC, Ngak S, Stein E, Carrico A, Page K, Maher L. Pharmacology, physiology and performance: occupational drug use and HIV risk among female entertainment and sex workers in Cambodia. Harm Reduct J. 2015 Oct 16;12:33. doi: 10.1186/s12954-015-0068-8.
citation: Muth S, Len A, Evans JL, Phou M, Chhit S, Neak Y, Ngak S, Stein ES, Carrico AW, Maher L, Page K. HIV treatment cascade among female entertainment and sex workers in Cambodia: impact of amphetamine use and an HIV prevention program. Addict Sci Clin Pract. 2017 Sep 5;12(1):20. doi: 10.1186/s13722-017-0085-x.