Cambodia Integrated HIV and Drug Prevention Implementation Program (CIPI)
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ClinicalTrials.gov Identifier: NCT01835574 |
Recruitment Status
:
Completed
First Posted
: April 19, 2013
Last Update Posted
: May 23, 2017
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Condition or disease | Intervention/treatment | Phase |
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HIV | Behavioral: Conditional cash transfer and cognitive-behavioral aftercare | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1198 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Cambodia Integrated HIV and Drug Prevention Implementation Program |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Conditional Cash Transfer and Cognitive-behavioral aftercare
Pre- and post- CCT+AC intervention comparison
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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.
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- 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.
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835574
Cambodia | |
Family Health International | |
Phnom Penh, Cambodia |
Principal Investigator: | Kimberly Page, PhD. | University of New Mexico Health Sciences Center |
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 ) |
First Posted: | April 19, 2013 Key Record Dates |
Last Update Posted: | May 23, 2017 |
Last Verified: | May 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 |