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Cambodia Integrated HIV and Drug Prevention Implementation Program (CIPI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01835574
First received: April 9, 2013
Last updated: May 19, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
HIV Behavioral: Conditional cash transfer and cognitive-behavioral aftercare

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cambodia Integrated HIV and Drug Prevention Implementation Program

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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).

  • Amphetamine type stimulant use (ATS) [ Time Frame: 6, 12, and 18 months ]
    Change in ATS use as measured by urine toxicology screening.


Secondary Outcome Measures:
  • Sexual risk 2 [ Time Frame: 6,12, and 18 months ]
    Number of new sexual partners in the past 3 months.

  • 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

  • Sexual risk 4 [ Time Frame: 6,12, and 18 months ]
    Condom use with all paying partners

  • Sexual risk 5 [ Time Frame: 6,12, and 18 months ]
    Condom use with all non-paying partners

  • ATS 2 [ Time Frame: 6,12 and 18 months ]
    Self-reported ATS use using ASSIST

  • ATS 3 [ Time Frame: 6, 12, and 18 months ]
    Self-reported binge use of ATS


Other Outcome Measures:
  • Recent alcohol use [ Time Frame: 6, 12, and 18 months ]
    Self-reported alcohol use as measured by ASSIST

  • Hazardous drinking [ Time Frame: 6, 12, and 18 months ]
    Self-reported alcohol use as measured by AUDIT-C

  • HIV and STI service use [ Time Frame: 6, 12 and 18 months ]
    HIV testing and STI diagnoses

  • Reproductive health outcomes [ Time Frame: 6, 12 and 18 months ]
    (i) visits to reproductive health clinics, (ii) birth control use, (iii) pregnancy termination

  • 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

  • Psychological distress [ Time Frame: 6, 12, and 18 months ]
    Kessler 10 scale score


Enrollment: 1198
Study Start Date: April 2013
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835574

Locations
Cambodia
Family Health International
Phnom Penh, Cambodia
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kimberly Page, PhD. University of New Mexico Health Sciences Center
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01835574     History of Changes
Other Study ID Numbers: 1R01DA033672 ( U.S. NIH Grant/Contract )
Study First Received: April 9, 2013
Last Updated: May 19, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual level data at this time outside of study investigators.

Keywords provided by University of California, San Francisco:
Amphetamine-type substance use

ClinicalTrials.gov processed this record on September 21, 2017