Cambodia Integrated HIV and Drug Prevention Implementation Program (CIPI)

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2014 by University of California, San Francisco

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01835574

First received: April 9, 2013

Last updated: July 2, 2014

Last verified: July 2014

History of Changes

Purpose

The Cambodia Integrated HIV and Drug Prevention Implementation Program project will implement and evaluate an integrated combination HIV prevention intervention: SMARTgirl Plus for Cambodian female entertainment and sex workers where non-injection use of amphetamine type stimulant (ATS) is high and significantly contributing to HIV risk. SMARTgirl Plus will add demonstrated approaches to ATS and HIV prevention (conditional cash transfer (CCT) and microfinance (MF) opportunities) into an existing widely disseminated program (SMARTgirl), using a stepped wedge randomized cluster design, and assess impacts on HIV related risk behavior. Adding CCT and MF to existing HIV prevention programs will broaden the scope of the current prevention model which focuses principally on reducing sexual risk through condom use and STI care, and uptake of reproductive health services.

Condition	Intervention
HIV	Behavioral: Contingency Cash Transfer


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Cambodia Integrated HIV and Drug Prevention Implementation Program

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

Primary Outcome Measures:

HIV risk behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

amphetamine use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cross-sectional behavioral risk data will be collected from approximately 1200 eligible participants at 6 timepoints (2 prior to implementation of a substance-use reduction program, two during the program, and two following the program). HIV risk behavior is to be measured by protected versus unprotected sex by partner types.


Estimated Enrollment:	1200
Study Start Date:	April 2013
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	September 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Contingency Cash Transfer	Behavioral: Contingency Cash Transfer Behavioral: Contingency Cash Transfer Active amphetamine substance users will be enrolled into a 16-week Contingency Cash Transfer intervention designed to reduce use of amphetamine.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders 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

Contacts


Contact: Ellen S Stein, MPH	(415) 597-9299	estein@epi.ucsf.edu

Locations


Cambodia
Family Health International	Recruiting
Phnom Penh, Cambodia
Sub-Investigator: Song Ngak

Sponsors and Collaborators

University of California, San Francisco

National Institutes of Health (NIH)

Investigators


Principal Investigator:	Kimberly Page, PhD.	University of California, San Franciscco

More Information

No publications provided


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01835574 History of Changes
Other Study ID Numbers:	1R01DA033672, 5R01DA033672
Study First Received:	April 9, 2013
Last Updated:	July 2, 2014
Health Authority:	United States: Federal Government

Keywords provided by University of California, San Francisco:


Amphetamine-type substance use

ClinicalTrials.gov processed this record on March 03, 2015

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