NCT01969305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 22, 2019

Status Verified

September 1, 2018

Enrollment Period

1.7 years

First QC Date

July 6, 2013

Last Update Submit

May 20, 2019

Conditions

Keywords

KazakhstanCentral AsiaHIV preventionAdolescentsSexual risk behaviorsDrug abuse preventionMulti-media interventionDrug use

Outcome Measures

Primary Outcomes (1)

  • Change in onset and 30-day alcohol and drug use from baseline 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.

    Up to 6-months

Secondary Outcomes (1)

  • Change in onset and sexual risk behaviors from baseline to 6 months

    Up to 6-months

Study Arms (2)

Kazakhstani Family Together (KFT)

EXPERIMENTAL

Usual Care Plus KFT: Family-based multi-media HIV and drug abuse prevention intervention

Behavioral: Kazakhstani Family Together

Health education curriculum

EXPERIMENTAL

Usual Care Alone: Health education curriculum on HIV and drug use prevention

Behavioral: Usual Care Alone

Interventions

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.

Kazakhstani Family Together (KFT)

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.

Health education curriculum

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Youth are between the ages of 14-17.
  • 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.
  • You and caregiver are able to speak and read Russian.
  • Both youth and caregiver (parent or other caregiving adult family member) can commit to study participation.
  • Youth and caregiver do not plan to move in the next 6 months.

You may not qualify if:

  • Youth are under the age of 14 or over the age of 17.
  • Youth does not exhibit one of the aforementioned risk factors.
  • Youth and caregiver do not speak and read Russian.
  • Youth and caregiver are unable to commit to study participation.
  • Youth or caregiver has plans to move within the next 6 months.
  • Youth or caregiver has a cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Global Heath Research Center of Central Asia

Almaty, Kazakhstan

Location

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Leyla Ismayilova, PhD

    University of Chicago School of Social Service Administration

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2013

First Posted

October 25, 2013

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

May 1, 2016

Last Updated

May 22, 2019

Record last verified: 2018-09

Locations