We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Provider Counseling Interventions in HIV Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00538993
Recruitment Status : Unknown
Verified September 2007 by Johns Hopkins University.
Recruitment status was:  Active, not recruiting
First Posted : October 3, 2007
Last Update Posted : October 3, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Hypothesis: HIV clinicians trained to deliver brief counseling messages and receiving cues from a brief computer survey on risk behaviors of their patients can counsel have an impact on patient's risk behaviors.

Condition or disease Intervention/treatment
HIV Infections Behavioral: Stage based counseling

Detailed Description:
This is a randomized controlled study. The purpose of this study is to assess the impact of the cue sheet as an aid to targeted provider behavioral counseling. All enrolled participants are HIV+ adults seen for regular medical care at a site affiliated with the Johns Hopkins AIDS Service. After consenting, participants will take an audio-assisted computer interviews to collect patient risk assessment data. For participants randomized to the intervention arm, the printed output on risk behaviors is then given to the provider along with cues for staged-based counseling for use during the same visit. Participants in the control arm take the same computerized risk assessment but there are no printed cue sheets. Risk behaviors of all participants are assessed at entry, at 6 months, and at 12 months. The main outcome measure is change in HIV transmission behaviors at 12 months for those in the intervention arm compared to the control arm.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 425 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Study Start Date : September 2003
Estimated Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Provider receives cue sheet to assist with counseling.
Behavioral: Stage based counseling
No Intervention: 2
Provider does not receive cue sheet.


Outcome Measures

Primary Outcome Measures :
  1. Disclosure of HIV status to sex partners; unprotected sexual encounters. [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV seropositive
  • English speaking

Exclusion Criteria:

  • Cannot give informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538993


Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
University of California, San Francisco
Investigators
Principal Investigator: Emily Erbelding, M.D. Johns Hopkins University
More Information

ClinicalTrials.gov Identifier: NCT00538993     History of Changes
Other Study ID Numbers: H97HA01144
First Posted: October 3, 2007    Key Record Dates
Last Update Posted: October 3, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases