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AzTrials

HIVCIPINCT01835574

Cambodia Integrated HIV and Drug Prevention Implementation Program

A study testing Conditional cash transfer and cognitive-behavioral aftercare in people with HIV, run by University of California, San Francisco at 1 site in Cambodia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HIV
What is being tested?
Conditional cash transfer and cognitive-behavioral aftercare
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,198 participants
Where
1 siteCambodia
Study dates
Apr 2013to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • male sex
  • under 18 years of age
  • unable to speak Khmer language
  • unable to consent

Trial locations and contacts

1 site in 1 country.

Cambodia1 site

  • Family Health International

    Phnom Penh

Other trials in Cambodia

About this study

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.

Read the 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.

Conditions
HIV
Being tested
Conditional cash transfer and cognitive-behavioral aftercare
Keywords
Amphetamine-type substance use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conditional cash transfer and cognitive-behavioral aftercareBehavioural

    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.

Study groups in NCT01835574
Study groupRoleWhat they receive
Conditional Cash Transfer and Cognitive-behavioral aftercareOtherPre- and post- CCT+AC intervention comparison
Receives: Behavioral: Conditional cash transfer and cognitive-behavioral aftercare

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sexual risk

    Change in number of sexual partners in the past 3 months (measured as a numeric variable).

    Measured: 6, 12 and 18 months

  2. Amphetamine type stimulant use (ATS)

    Change in ATS use as measured by urine toxicology screening.

    Measured: 6, 12, and 18 months

Secondary outcomes (6)

  1. Sexual risk 2

    Number of new sexual partners in the past 3 months.

    Measured: 6,12, and 18 months

  2. Sexual risk 3

    Biomarker outcome (prostate specific antigen (PSA)) indicating unprotected vaginal sex Biomarker outcome (prostate specific antigen (PSA)) indicating unprotected vaginal sex

    Measured: 6, 12 and 18 months

  3. Sexual risk 4

    Condom use with all paying partners

    Measured: 6,12, and 18 months

  4. Sexual risk 5

    Condom use with all non-paying partners

    Measured: 6,12, and 18 months

  5. ATS 2

    Self-reported ATS use using ASSIST

    Measured: 6,12 and 18 months

  6. ATS 3

    Self-reported binge use of ATS

    Measured: 6, 12, and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01835574
Sponsor's protocol ID
1R01DA033672
Acronym
CIPI
Status last verified
May 2017
First submitted
9 Apr 2013
Last updated
23 May 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: No plan to share individual level data at this time outside of study investigators.

Publications

  • 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.

    PubMed 27160844

  • 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.

    PubMed 26782667

  • 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.

    PubMed 26472570

  • Muth S, Len A, Evans JL, Phou M, Chhit S, Neak Y, Ngak S, Stein ES, Carrico AW, Maher L, Page K. HIV treatment cascade among female entertainment and sex workers in Cambodia: impact of amphetamine use and an HIV prevention program. Addict Sci Clin Pract. 2017 Sep 5;12(1):20. doi: 10.1186/s13722-017-0085-x.

    PubMed 28870232

Questions about this trial

What is this clinical trial studying?

A study testing Conditional cash transfer and cognitive-behavioral aftercare in people with HIV, run by University of California, San Francisco at 1 site in Cambodia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sexual risk (time frame: 6, 12 and 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01835574, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017; AzTrials last refreshed its copy on 27 Oct 2026.

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