NCT00602758

Brief Summary

This study will compare the effectiveness of enhanced counseling alone versus enhanced counseling combined with observed therapy at improving medication adherence in people with HIV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

4 active sites

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

December 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

4.7 years

First QC Date

January 4, 2008

Last Update Submit

May 19, 2016

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Keywords

AIDSAdherenceAntiretroviral TherapyHIV

Outcome Measures

Primary Outcomes (1)

  • Adherence with ART as measured by Micro-Electro-Mechanical Systems (MEMS)

    Measured at Week 48

Secondary Outcomes (1)

  • HIV RNA suppression

    Measured at Week 48

Study Arms (3)

Enhanced Counseling

EXPERIMENTAL

Participants meet with a counselor trained in motivational interviewing and cognitive behavioral techniques

Behavioral: Motivational interviewing with cognitive behavioral therapy

Standard Care

NO INTERVENTION

Participants receive usual clinical care provided by health care providers and they participate only in evaluation components of the study

Enhanced Counseling/Modified Directly Observed Therapy

EXPERIMENTAL

Participants receive their ART medications delivered to them by study staff and they receive the enhanced counseling

Behavioral: Motivational interviewing with cognitive behavioral therapyBehavioral: Modified directly observed therapy

Interventions

Motivational interviewing with cognitive behavioral therapyBEHAVIORAL

Counseling sessions are completed face-to-face or by telephone at baseline and Weeks 1, 2, 4, 6, 9, 11, 15, 19, and 23. Counselors are trained in motivational interview technique and focus on ART medication adherence.

Also known as: Enhanced counseling (EC)
Enhanced CounselingEnhanced Counseling/Modified Directly Observed Therapy
Modified directly observed therapyBEHAVIORAL

From baseline to Week 16, Monday through Friday, study staff meet the participants daily to observe one dose of their ART and to leave with the participants all other doses needed until the next observed dose. The frequency of observed doses begins to taper at Week 17 through to Week 24.

Also known as: OT, Modified observed therapy (MDOT)
Enhanced Counseling/Modified Directly Observed Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient at participating clinical site
  • English-speaking
  • Initiating new ART (new or change in therapy) or nonadherent to ART as documented by care provider's assessment, patient self-report, and consistent HIV RNA laboratory results
  • Lives within 45-mile radius of participating clinical site or able to participate in observed therapy procedures

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kansas University Medical Center ID Clinic

Kansas City, Kansas, 66160, United States

Location

Truman Medical Center ID Clinic

Kansas City, Missouri, 64108, United States

Location

Kansas City Free Health Clinic

Kansas City, Missouri, 64110, United States

Location

Kansas City Veterans Administration Medical Center

Kansas City, Missouri, 641128, United States

Location

Related Publications (1)

  • Goggin K, Liston RJ, Mitty JA. Modified directly observed therapy for antiretroviral therapy: a primer from the field. Public Health Rep. 2007 Jul-Aug;122(4):472-81. doi: 10.1177/003335490712200408.

    PMID: 17639650BACKGROUND

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Motivational InterviewingCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesBehavior TherapyPsychotherapy

Study Officials

  • Kathy Goggin, PhD

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 28, 2008

Study Start

December 1, 2004

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 20, 2016

Record last verified: 2016-05

Locations

US(4)