Cambodia Integrated HIV and Drug Prevention Implementation Program

NCT01835574 | Completed DMC

• 1 other identifier: 1R01DA033672
• Study Type: interventional
• Target: 1,198
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Amphetamine-type substance use

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Sexual risk 2

  6,12, and 18 months

• Sexual risk 3

  6, 12 and 18 months

• Sexual risk 4

  6,12, and 18 months

• Sexual risk 5

  6,12, and 18 months

• ATS 2

  6,12 and 18 months

Other Outcomes (6)

• Recent alcohol use

  6, 12, and 18 months

• Hazardous drinking

  6, 12, and 18 months

• HIV and STI service use

  6, 12 and 18 months

Study Arms (1)

Conditional Cash Transfer and Cognitive-behavioral aftercare

OTHER

Pre- and post- CCT+AC intervention comparison

Behavioral: Conditional cash transfer and cognitive-behavioral aftercare

Interventions

Conditional cash transfer and cognitive-behavioral aftercare BEHAVIORAL

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.

Conditional Cash Transfer and Cognitive-behavioral aftercare

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Family Health International

Phnom Penh, Cambodia

Location

Related Publications (4)

• 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.

  PMID: 27160844 BACKGROUND

• 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.

  PMID: 26782667 BACKGROUND

• 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.

  PMID: 26472570 BACKGROUND

• 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.

  PMID: 28870232 DERIVED

Study Officials

• Kimberly Page, PhD.

  University of New Mexico Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 19, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)