NCT00831883

Brief Summary

The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

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

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

1.9 years

First QC Date

January 28, 2009

Last Update Submit

December 3, 2012

Conditions

Sexually Transmitted DiseasesSubstance-Related Disorders

Keywords

AdolescentAdolescent behaviorHealth behaviorSexual BehaviorIncarcerationBehavioral InterventionRisk Reduction Behavior

Outcome Measures

Primary Outcomes (1)

  • lower levels of sex-related HIV risk behavior

    3 months

Secondary Outcomes (4)

  • knowledge about STI transmission

    3 months

  • partner-specific perceptions of STI risks

    3 months

  • social norms, expectations and personal attitudes regarding partner-specific sexual behavior

    3 months

  • partner-specific behavioral and communication skills

    3 months

Study Arms (2)

Partner Specific IMB

EXPERIMENTAL

partner-specific HIV risk reduction intervention

Behavioral: Partner-Specific IMB-based HIV risk reduction intervention

HLS

PLACEBO COMPARATOR

5 session psychoeducational group, designed to provide equivalent time and attention, that focuses on the importance of maintaining a good diet, exercise, and developing health skills.

Behavioral: Healthy Lifestyle

Interventions

Partner-Specific IMB-based HIV risk reduction interventionBEHAVIORAL

5 session partner-specific HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model.

Partner Specific IMB
Healthy LifestyleBEHAVIORAL

5 session psychoeducational group, designed to provide equivalent time and attention, that focuses on the importance of maintaining a good diet, exercise, and developing health skills.

HLS

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • English-speaking ability
  • unprotected vaginal, anal, or oral intercourse at least once in the 6 months prior to incarceration or placement
  • marijuana use disorders, other non-injection drug use disorders, or substance use by a sexual partner during a sexual episode in the six months prior to incarceration or placement
  • sentence or placement length between 2 and 12 months
  • must plan to remain in the area for the 6 months following their release from the facility
  • must be willing to provide two pieces of contact information for follow-up

You may not qualify if:

  • signs of psychosis (assessed through clinical assessment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Sexually Transmitted DiseasesSubstance-Related DisordersAdolescent BehaviorHealth BehaviorSexual BehaviorRisk Reduction Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cynthia Rosengard, PhD, MPH

    Women & Infants of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cynthia Rosengard, Ph.D.

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

US(1)