NCT01383837

Brief Summary

Adolescents with substance use disorders (SUD) are at substantial risk for contracting HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction interventions have been developed to meet their unique needs, and none use a family-based intervention approach, which the literature recommends as the focus for intervention for youth. Current state policies neither require providers in clinics delivering substance use treatment to offer HIV/STI sexual risk reduction nor offer providers tools or training for HIV/STI prevention. There is clear public health need to develop innovative methods of service delivery and effective strategies of HIV/STI sexual risk reduction that address multiple contexts of risk (i.e. family) for this high risk population. The current proposal addresses this need by developing a provider-delivered HIV sexual risk reduction intervention to be implemented in outpatient SUD treatment that: 1) builds the clinics' capacity to help families under their care to more comfortably address the adolescent's sexuality; 2) promotes youth's safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents with SUD in care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P75+ for phase_1 hiv

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_1 hiv

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

Study Start

First participant enrolled

August 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

4.8 years

First QC Date

August 18, 2010

Last Update Submit

August 27, 2015

Conditions

HIVSexually Transmitted Diseases

Keywords

HIV/STIPreventionAdolescentsSubstance Use DisordersFamily-based intervention

Outcome Measures

Primary Outcomes (1)

  • Unprotected vaginal or anal sex occasions

    3-months look back

Secondary Outcomes (4)

  • Caregiver-youth communication about sex

    3-months look back

  • Caregiver-youth communication about sexual risk behaviors

    5-minutes

  • Feasibility of conducting the intervention

    3-months

  • Acceptability of the intervention

    3 months

Study Arms (2)

STYLEnS

EXPERIMENTAL

Multifamily Group HIV/STI Prevention intervention or Single Family Dyad (youth and a parent)

Behavioral: STYLEnS

Health Promotion

ACTIVE COMPARATOR

Health Promotion Intervention - Adolescents only

Behavioral: Health Promotion

Interventions

STYLEnSBEHAVIORAL

Multifamily group HIV/STI Prevention Intervention or Single Family Dyad (youth and a parent)

STYLEnS
Health PromotionBEHAVIORAL

Health Promotion Intervention

Health Promotion

Eligibility Criteria

Age13 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • are in care at the pilot sites;
  • are ages 13-24 years;
  • meet criteria for (Diagnostic Statistical Manual) DSM-IV substance abuse diagnosis (patient record);
  • have a caregiver who will consent to their study participation,
  • have a parent/family member willing to enter treatment and participate in study

You may not qualify if:

  • have mental retardation or pervasive developmental disorder as primary diagnosis;
  • have a medical or psychiatric illness requiring hospitalization;
  • have current psychotic features, or current suicidality;
  • are not English- or Spanish-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Lukes-Roosevelt Hospital

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Sexually Transmitted DiseasesSubstance-Related Disorders

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Milton L Wainberg, MD

    New York State Psychiatric Institute, Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2010

First Posted

June 28, 2011

Study Start

August 1, 2010

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations

US(1)