NCT00675610

Brief Summary

The goal of this research is to improve communication between the patients with HIV and their health care providers. The overall purpose of doing so is to reduce disparities in medication self-efficacy, adherence to therapy, and HIV viral load suppression. The investigators will conduct a randomized controlled trial to test the effectiveness of a combined provider and patient communication intervention conducted at two separate visits compared to usual care in improving the quality of patient-provider communication, patients' medication self-efficacy, patient adherence to therapy, and HIV RNA suppression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P25-P50 for phase_3 hiv-infections

Timeline
Completed

Started May 2008

Shorter than P25 for phase_3 hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

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

May 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

May 7, 2008

Last Update Submit

March 31, 2015

Conditions

Keywords

communicationHIV/AIDSTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • patient-provider communication

    1 day- 3 months

Study Arms (2)

usual care

NO INTERVENTION

providers are not trained and patients are not coached

intervention arm

EXPERIMENTAL

providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers

Behavioral: communication training

Interventions

providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers

intervention arm

Eligibility Criteria

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

You may qualify if:

  • Currently providing primary care to at least 10 HIV-infected patients in the clinic
  • Physician, Nurse-Practitioner, or Physician-Assistant
  • Agree to give written informed consent.
  • HIV-infected patient of one of the participating providers
  • Has had at least one prior visit with that provider
  • Currently taking antiretroviral therapy
  • Capable of understanding and giving written informed consent
  • Age \> 20 years old
  • English-speaking
  • African-American (or people of African descent living in the United States), Hispanic, or non-Hispanic White race/ethnicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Saint Lukes-Roosevelt

New York, New York, 10023, United States

Location

Oregon Health Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

HIV InfectionsCommunicationAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mary Catherine Beach, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 9, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2010

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations