Cambodia Integrated HIV and Drug Prevention Implementation Program (CIPI)

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Conditional cash transfer and cognitive-behavioral aftercare

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.

• Study Type: Interventional
• Enrollment (Actual): 1198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cambodia
  • Phnom Penh, Cambodia
    • Family Health International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Conditional Cash Transfer and Cognitive-behavioral aftercare; Pre- and post- CCT+AC intervention comparison

Behavioral: Conditional cash transfer and cognitive-behavioral aftercare; The intervention combines a 12-week conditional cash transfer (CCT) intervention with 4-weeks of cognitive-behavioral group aftercare (AC) among women who use ATS. CCT includes thrice weekly urine screening for 12 weeks; participants receive $ for ATS-negative screens. Those with 3 negative screens in a week participants receive a cash bonus, which increase per month to mitigate habituation to the CCT reward schedule. Women who complete >=50% of ATS negative screening visits may participate in a 4-week, cognitive-behavioral AC group delivered immediately after CCT, which includes: 1) experiential group exercises; 2) didactic recovery skills training; 3) meditation and relaxation training; and 4) a ''lucky draw'' which is a form of CCT that provides positive reinforcement for group attendance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual risk	Change in number of sexual partners in the past 3 months (measured as a numeric variable).	6, 12 and 18 months
Amphetamine type stimulant use (ATS)	Change in ATS use as measured by urine toxicology screening.	6, 12, and 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual risk 2	Number of new sexual partners in the past 3 months.	6,12, and 18 months
Sexual risk 3	Biomarker outcome (prostate specific antigen (PSA)) indicating unprotected vaginal sex Biomarker outcome (prostate specific antigen (PSA)) indicating unprotected vaginal sex	6, 12 and 18 months
Sexual risk 4	Condom use with all paying partners	6,12, and 18 months
Sexual risk 5	Condom use with all non-paying partners	6,12, and 18 months
ATS 2	Self-reported ATS use using ASSIST	6,12 and 18 months
ATS 3	Self-reported binge use of ATS	6, 12, and 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recent alcohol use	Self-reported alcohol use as measured by ASSIST	6, 12, and 18 months
Hazardous drinking	Self-reported alcohol use as measured by AUDIT-C	6, 12, and 18 months
HIV and STI service use	HIV testing and STI diagnoses	6, 12 and 18 months
Reproductive health outcomes	(i) visits to reproductive health clinics, (ii) birth control use, (iii) pregnancy termination	6, 12 and 18 months
Economic well being	(i) income, (ii) housing instability, (iii) food insecurity, (iv) number of electronic devices in the home	6,12, and 18 months
Psychological distress	Kessler 10 scale score	6, 12, and 18 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Kimberly Page, PhD., University of New Mexico Health Sciences Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: April 9, 2013
• First Submitted That Met QC Criteria: April 16, 2013
• First Posted (ESTIMATE): April 19, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Amphetamine-type substance use
• Other Study ID Numbers: 1R01DA033672 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual level data at this time outside of study investigators.