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Completed

NCT Number: NCT01835574

Cambodia Integrated HIV and Drug Prevention Implementation Program

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Family Health International

Phnom Penh, Cambodia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Sexual risk

    Time frame: 6, 12 and 18 months

    Change in number of sexual partners in the past 3 months (measured as a numeric variable).

  2. Amphetamine type stimulant use (ATS)

    Time frame: 6, 12, and 18 months

    Change in ATS use as measured by urine toxicology screening.

Secondary outcomes

  1. Sexual risk 2

    Time frame: 6,12, and 18 months

    Number of new sexual partners in the past 3 months.

  2. Sexual risk 3

    Time frame: 6, 12 and 18 months

    Biomarker outcome (prostate specific antigen (PSA)) indicating unprotected vaginal sex Biomarker outcome (prostate specific antigen (PSA)) indicating unprotected vaginal sex

  3. Sexual risk 4

    Time frame: 6,12, and 18 months

    Condom use with all paying partners

  4. Sexual risk 5

    Time frame: 6,12, and 18 months

    Condom use with all non-paying partners

  5. ATS 2

    Time frame: 6,12 and 18 months

    Self-reported ATS use using ASSIST

  6. ATS 3

    Time frame: 6, 12, and 18 months

    Self-reported binge use of ATS

Other outcomes

  1. Recent alcohol use

    Time frame: 6, 12, and 18 months

    Self-reported alcohol use as measured by ASSIST

  2. Hazardous drinking

    Time frame: 6, 12, and 18 months

    Self-reported alcohol use as measured by AUDIT-C

  3. HIV and STI service use

    Time frame: 6, 12 and 18 months

    HIV testing and STI diagnoses

  4. Reproductive health outcomes

    Time frame: 6, 12 and 18 months

    (i) visits to reproductive health clinics, (ii) birth control use, (iii) pregnancy termination

  5. Economic well being

    Time frame: 6,12, and 18 months

    (i) income, (ii) housing instability, (iii) food insecurity, (iv) number of electronic devices in the home

  6. Psychological distress

    Time frame: 6, 12, and 18 months

    Kessler 10 scale score

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: CIPI

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 19, 2013
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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