Clinical trial NCT01969305: Youth Drug Abuse Prevention in Kazakhstan
Official title: A Computerized Family-Based Youth HIV and Drug Abuse Prevention in Kazakhstan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use
Keywords: Kazakhstan
Central Asia
HIV prevention
Adolescents
Sexual risk behaviors
Drug abuse prevention
Multi-media intervention
Drug use
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Columbia University
First posted: 2013-10-25
Enrollment: 181
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in onset and 30-day alcohol and drug use from baseline to 6 months
timeFrame: Up to 6-months
Secondary outcomes:
measure: Change in onset and sexual risk behaviors from baseline to 6 months
timeFrame: Up to 6-months
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Columbia University Global Heath Research Center of Central Asia
Study officials:
affiliation: University of Chicago School of Social Service Administration
name: Leyla Ismayilova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ismayilova L, Terlikbayeva A. Building Competencies to Prevent Youth Substance Use in Kazakhstan: Mixed Methods Findings From a Pilot Family-Focused Multimedia Trial. J Adolesc Health. 2018 Sep;63(3):301-312. doi: 10.1016/j.jadohealth.2018.04.005. Epub 2018 Jul 10.
citation: Ismayilova L, Terlikbayeva A, Rozental Y. Computerized intervention to prevent drug use among at-risk adolescents in Central Asia: Preliminary family-level findings from a pilot mixed methods trial. Int J Drug Policy. 2019 Jun;68:75-85. doi: 10.1016/j.drugpo.2019.03.022. Epub 2019 Apr 16.