NCT00227825

Brief Summary

The purpose of this study is to conduct a pilot study of Motivational Enhancement Therapy (MET), an empirically validated behavioral change strategy, with young adults who are HIV +. The aim is to determine if MET is effective in increasing general health promotion behaviors, adherence to HIV+ specific medical treatment over and above taking medication, and decreasing risky behaviors in young adults who are HIV positive. The longer-term objective is to identify and way to decrease HIV transmission rates, disease progression, illness episodes, and hospitalizations in this high-risk population. Hypotheses: 1)Youth receiving the motivational intervention plus referrals will report greater reductions in risky behaviors than youth in the control group receiving standard care plus referrals at 3-months post-baseline. This hypothesis will first be tested in the whole sample using an overall risk index. Then, the hypothesis will be tested with each behavior (reduced drug and alcohol use, condom use, taking medications,) within the subgroups reporting problem levels of that behavior; 2)Youth in the intervention group will demonstrate improved viral loads, will report greater improvement in perceived health status, depression, general psychological distress, disclosure to sexual partners, and will demonstrate greater attendance of medical and support service appointments than youth in the control group at 3 months post-baseline; 3)Youth in the intervention group will report greater reductions in temptation to engage in risky behaviors, increased self-efficacy, and improvements in readiness to change their behavior than youth in the control group at 3 months post-baseline; 4)The differences between the intervention and control group from pre- to post- intervention will be maintained at 6, 9, 12, and 15 months post-baseline (3, 6, 9, and 12 months after intervention completion).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
Last Updated

January 11, 2017

Status Verified

September 1, 2005

First QC Date

September 27, 2005

Last Update Submit

January 10, 2017

Conditions

Keywords

Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

  • Reduction of Risk Behaviors (Sexual, Drug, & Health), Viral Burden & CD4+ T Cell Count

Secondary Outcomes (1)

  • SES, health beliefs, physical and mental status, self-efficacy, stages of change, service utilization, HIV stigma

Interventions

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A sample of 60 HIV+youth, ages 16-24, will be recruited from the four health care sites in the Michigan Title IV Project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Medical Center-CHM and UHC

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersHealth Behavior

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sylvie Naar-King, Ph.D.

    Wayne State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phebe K Lam, M.A.

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 28, 2005

Study Start

January 1, 2002

Study Completion

August 1, 2005

Last Updated

January 11, 2017

Record last verified: 2005-09

Data Sharing

IPD Sharing
Will not share

Locations