The Aim of This Study is to Determine the Effectiveness of a Motivational Enhancement Intervention in Reducing Risk Behaviors (Drug and Alcohol Use, Sexual Risk Behavior, Poor Adherence to Medications) Among HIV+ Youth. - 1

NCT ID: NCT00227825

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2005-08-31

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).

Detailed Description

The proposed study is a randomized clinical trial with a wait-list control. The sample will be 60 HIV+ young adults between the ages of 16 to 24 years recruited from the DMC Horizons Project and other community based HIV programs. Self referred persons meeting the diagnostic criteria of HIV+ will also be accepted. There are no exclusion criteria. Subjects will be randomly assigned to one of 2 groups: MET NOW or MET LATER. MET LATER is the wait list control group. The only difference between the groups is the timing of the intervention and data collection. All subjects will complete 5 research visits and 4 MET therapy sessions. Research visits consists of an interview, completion of self-report questionnaires, a 20cc blood drawn for complete blood count (CBC), viral load and CD4 count, and adherence rating completed by the physician. Established questionnaires are used to measure health behaviors, sexual risk behaviors, substance use, self-efficacy, stage of change, social support, health beliefs, and mental health status. Research visits take about 1 = hours. Therapy sessions consist of MET provided by a trained therapist. Sessions last about 1 hour and focus on changing behavior to improve health, increase medical adherence, and/or reduce risk. Subjects choose the behaviors they want to change. There are a total of 4 sessions over 3 months. The MET NOW group will begin session immediately after the first (baseline) research visit and the MET LATER group will begin therapy sessions approximately 9 months after the first research visit. All subjects will be paid $25.00 for the first research visit with a $5 increase for each subsequent research visit, a total of $175.00 for the 5 research visits. Subjects will receive $10 gift certificate at each therapy session. Cab vouchers or parking fees will be provided for each therapy or research session.

Conditions

Adherence; HIV Risk Behaviors; Alcohol & Drug Use; Health Behaviors; Sexual Risk Behaviors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Motivational interviewing

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Naar-King, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Detroit Medical Center-CHM and UHC

Detroit, Michigan, United States

Countries

United States

Central Contacts

Phebe K Lam, M.A.

Role: CONTACT

plam@med.wayne.edu

(313)745-4213

Other Identifiers

R21-14710-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-14710-1

Identifier Type: -

Identifier Source: org_study_id