Cambodia Integrated HIV and Drug Prevention Implementation Program

HIV Clinical Trial

— CIPI  

Official title:

Cambodia Integrated HIV and Drug Prevention Implementation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835574
• Other study ID #: 1R01DA033672
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: May 19, 2017
• Start date: April 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1198
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Cambodia	Family Health International	Phnom Penh

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

Cambodia, 

References & Publications (3)

Carrico AW, Nil E, Sophal C, Stein E, Sokunny M, Yuthea N, Evans JL, Ngak S, Maher L, Page K. Behavioral interventions for Cambodian female entertainment and sex workers who use amphetamine-type stimulants. J Behav Med. 2016 Jun;39(3):502-10. doi: 10.1007/s10865-016-9713-2. Epub 2016 Jan 18. — View Citation

Dixon TC, Ngak S, Stein E, Carrico A, Page K, Maher L. Pharmacology, physiology and performance: occupational drug use and HIV risk among female entertainment and sex workers in Cambodia. Harm Reduct J. 2015 Oct 16;12:33. doi: 10.1186/s12954-015-0068-8. — View Citation

Page K, Stein ES, Carrico AW, Evans JL, Sokunny M, Nil E, Ngak S, Sophal C, McCulloch C, Maher L. Protocol of a cluster randomised stepped-wedge trial of behavioural interventions targeting amphetamine-type stimulant use and sexual risk among female entertainment and sex workers in Cambodia. BMJ Open. 2016 May 9;6(5):e010854. doi: 10.1136/bmjopen-2015-010854. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recent alcohol use	Self-reported alcohol use as measured by ASSIST	6, 12, and 18 months
Other	Hazardous drinking	Self-reported alcohol use as measured by AUDIT-C	6, 12, and 18 months
Other	HIV and STI service use	HIV testing and STI diagnoses	6, 12 and 18 months
Other	Reproductive health outcomes	(i) visits to reproductive health clinics, (ii) birth control use, (iii) pregnancy termination	6, 12 and 18 months
Other	Economic well being	(i) income, (ii) housing instability, (iii) food insecurity, (iv) number of electronic devices in the home	6,12, and 18 months
Other	Psychological distress	Kessler 10 scale score	6, 12, and 18 months
Primary	Sexual risk	Change in number of sexual partners in the past 3 months (measured as a numeric variable).	6, 12 and 18 months
Primary	Amphetamine type stimulant use (ATS)	Change in ATS use as measured by urine toxicology screening.	6, 12, and 18 months
Secondary	Sexual risk 2	Number of new sexual partners in the past 3 months.	6,12, and 18 months
Secondary	Sexual risk 3	Biomarker outcome (prostate specific antigen (PSA)) indicating unprotected vaginal sex Biomarker outcome (prostate specific antigen (PSA)) indicating unprotected vaginal sex	6, 12 and 18 months
Secondary	Sexual risk 4	Condom use with all paying partners	6,12, and 18 months
Secondary	Sexual risk 5	Condom use with all non-paying partners	6,12, and 18 months
Secondary	ATS 2	Self-reported ATS use using ASSIST	6,12 and 18 months
Secondary	ATS 3	Self-reported binge use of ATS	6, 12, and 18 months