Improving Provider Counseling Interventions in HIV Practice

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2007 by Johns Hopkins University.
Recruitment status was: Active, not recruiting

Sponsor:

Collaborator:

University of California, San Francisco

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00538993

First received: October 1, 2007

Last updated: NA

Last verified: September 2007

History: No changes posted

Purpose

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	Intervention
HIV Infections	Behavioral: Stage based counseling


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

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


Estimated Enrollment:	425
Study Start Date:	September 2003
Estimated Study Completion Date:	October 2007

Arms	Assigned Interventions
Experimental: 1 Provider receives cue sheet to assist with counseling.	Behavioral: Stage based counseling
No Intervention: 2 Provider does not receive cue sheet.

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.

Eligibility


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	October 1, 2007
Last Updated:	October 1, 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

ClinicalTrials.gov processed this record on August 17, 2017

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