Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Youth Drug Abuse Prevention in Kazakhstan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01969305
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Columbia University
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE July 6, 2013
First Posted Date  ICMJE October 25, 2013
Last Update Posted Date May 22, 2019
Study Start Date  ICMJE January 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
Change in onset and 30-day alcohol and drug use from baseline to 6 months [ Time Frame: Up to 6-months ]
Measures will ask youth to report the frequency and quantity of alcohol and drug use in the past 30 days (number of alcoholic drinks, puffs of marijuana, or initiation of injection drug use). Substance use includes specific probes, including street names for alcohol, marijuana, ecstasy, cocaine, injecting drug use, heroin, inhalants, hallucinogens, and other drugs as appropriate to the context.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
Change in onset and sexual risk behaviors from baseline to 6 months [ Time Frame: Up to 6-months ]
Measures will ask youth to report a history of sexual intercourse and the age of onset, proportion of unprotected acts in past 30 days, frequency of condom use in past 30 days, condom use during the last episode, and number of sexual partners in past 30 days.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Youth Drug Abuse Prevention in Kazakhstan
Official Title  ICMJE A Computerized Family-Based Youth HIV and Drug Abuse Prevention in Kazakhstan
Brief Summary This pilot study will adapt and test the feasibility and estimate the effect size parameters of Kazakhstani Family Together (KFT), a family-based multi-media intervention designed to reduce sexual and drug-related risks for HIV infection among at-risk 14-17 year old females and males living in communities highly affected by heroin trade and use in Almaty, Kazakhstan.
Detailed Description

The purpose of this study is to adapt an evidence-based HIV and substance use prevention intervention for most at-risk adolescents and their caregivers (parents or other adult family members) from drug-risk communities in Kazakhstan. Located on major drug trafficking routes (between Afghanistan, the world's largest opium producer, and Russia), Central Asia and Kazakhstan, in particular, face one of the fastest growing rates of HIV infection in the world disproportionately affecting young people ages 15-29. Youth exposed to drugs at home and in the community are particularly at risk.

The country's HIV prevention efforts for youth are limited to a knowledge-based approach, which does not equip at-risk youth with skills required to deal with situations of risk exposure. Parents or other caregivers, who represent a significant protective force in a family-oriented culture of Central Asia, are largely excluded from youth prevention efforts in Kazakhstan.

KFT is a family-based multi-media intervention designed to reduce sexual and drug-related risks for HIV infection among at-risk adolescents. To address the dual risk of HIV and substance use, the proposed intervention combines empirically tested skills-based and family involvement approaches and utilizes multi-media computer technology to develop an engaging and potentially cost-effective tool with high fidelity and easy scalability. During each of the sessions, youth and caregivers will participate in interactive computer activities to learn skills and have conversations focused on risky behaviors.

During the development stage, the US and Kazakhstani investigative team will conduct formative research and will work closely with the local Community Collaborative Board to adapt the intervention to the cultural context of at-risk families in Kazakhstan.

Further, the KFT intervention will be tested in a pilot Randomized Controlled Trial with 248 adolescents and 248 of their caregivers. Intervention arm adolescent-caregiver pairs will receive three 45-minute interactive multi-media sessions with avatars customized to participants' gender that will focus on risk reduction self-efficacy, resistance to peer pressure, and caregiver-adolescent communication, support and monitoring. Adolescents from both intervention and control arms will receive the usual care services available for at-risk youth, which includes health education sessions on HIV and drug use delivered by peer educators and outreach workers.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Drug Use
Intervention  ICMJE
  • Behavioral: Kazakhstani Family Together
    Adolescent-caregiver pairs will receive three 45-minute interactive multi-media sessions with avatars customized to participants' gender that will focus on risk reduction self-efficacy, resistance to peer pressure, decision-making skills and caregiver-adolescent communication, support and monitoring to strengthen youth's relationships with caregivers and reduce youth's risks of drug use and sexual risk behaviors. Through the multimedia tool, participants will confront a series of sexual risks and substance use related situations and will practice their listening, empathy, assertiveness, refusal, and other interpersonal skills. Each caregiver-youth pair will work jointly and engage in discussions, exercises, and behavioral rehearsal as directed by the program.
  • Behavioral: Usual Care Alone

    Adolescents from both study arms will receive the usual care, a health education program about how to prevent drug use and HIV/STIs (sexually transmitted infections). The health education curriculum is delivered in a group format by trained peer educators and outreach workers. The curriculum consists of three 45-minute sessions that include lectures and interactive quizzes about drugs and HIV. These three sessions include information on the following topics:

    1. Facts and Myth about HIV. HIV/STIs modes of transmission;
    2. Prevention of HIV. Abstinence and Safe Sex. Attitudes and values about sexuality, sexual risk behaviors, and condom use;
    3. Knowledge, attitudes and beliefs about drinking and drug use. Risks and consequences of drug use.
Study Arms  ICMJE
  • Experimental: Kazakhstani Family Together (KFT)
    Usual Care Plus KFT: Family-based multi-media HIV and drug abuse prevention intervention
    Intervention: Behavioral: Kazakhstani Family Together
  • Experimental: Health education curriculum
    Usual Care Alone: Health education curriculum on HIV and drug use prevention
    Intervention: Behavioral: Usual Care Alone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2016)
181
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2013)
248
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Youth are between the ages of 14-17.
  2. Youth exhibits one of the following risk factors: substance-using peers or friends, parental history of drug use, parental history of alcohol problems, parental criminal history, adolescent's history of drug use, running away from home, school drop-out or history of sexual activity.
  3. You and caregiver are able to speak and read Russian.
  4. Both youth and caregiver (parent or other caregiving adult family member) can commit to study participation.
  5. Youth and caregiver do not plan to move in the next 6 months.

Exclusion Criteria:

  1. Youth are under the age of 14 or over the age of 17.
  2. Youth does not exhibit one of the aforementioned risk factors.
  3. Youth and caregiver do not speak and read Russian.
  4. Youth and caregiver are unable to commit to study participation.
  5. Youth or caregiver has plans to move within the next 6 months.
  6. Youth or caregiver has a cognitive impairment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01969305
Other Study ID Numbers  ICMJE IRB13-0841
R34DA033201 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Columbia University
Investigators  ICMJE
Principal Investigator: Leyla Ismayilova, PhD University of Chicago School of Social Service Administration
PRS Account University of Chicago
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP