Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01835574
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2013-04-09
Brief Title:
Cambodia Integrated HIV and Drug Prevention Implementation Program
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Cambodia Integrated HIV and Drug Prevention Implementation Program
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIPI
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 CCTAC 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 CCTAC 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 CCTAC 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 CCTAC intervention in 10 Cambodian provinces clusters Outcome Evaluation OE data is collected at 1 time-point prior to implementation of the CCTAC 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 CCTAC 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 CCTAC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None