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Motivating HIV+ Women: Risk Reduction and ART Adherence (KHARMA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcia McDonnell Holstad, DSN, FNP-BC, Emory University
ClinicalTrials.gov Identifier:
NCT00253045
First received: November 14, 2005
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to determine if a group motivational interviewing based intervention will increase adherence to antiretroviral medications and use of risk reduction behaviors.


Condition Intervention
HIV
AIDS
Behavioral: Motivational groups

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Motivating HIV+ Women: Risk Reduction and ART Adherence

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Adherence to antiretroviral therapy [ Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention ] [ Designated as safety issue: No ]
    Self report questionnaires, Electronic drug monitoring caps (MEMS)

  • Use of Risk Reduction Behaviors [ Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention ] [ Designated as safety issue: No ]
    Questionnaires about risky sexual behaviors, and substance use behaviors

  • Clinical indicators [ Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention ] [ Designated as safety issue: No ]
    CD4 and HIV viral load lab results from medical records


Secondary Outcome Measures:
  • Self-Efficacy [ Time Frame: Baseline, Immediate post follow-up, 3, 6, 9 months post intervention ] [ Designated as safety issue: No ]
  • Outcome Expectancy [ Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention ] [ Designated as safety issue: No ]
  • Personal Goals [ Time Frame: Immediate post follow-up, 3, 6, and 9 months post intervention ] [ Designated as safety issue: No ]

Enrollment: 207
Study Start Date: August 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational group
Group counseling using motivational interviewing
Behavioral: Motivational groups
Motivational interviewing in group format

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infected with HIV
  • Be on a new or different antiretroviral medication regimen or self report non-adherence to antiretroviral medications
  • Must be 18 years of age or older
  • Female by birth
  • Understand and speak English
  • Be willing to complete a screening interview to further determine if you are able to take part in the study
  • Be willing to follow study requirements and use a MEMS cap on one of your antiretroviral meds

Exclusion Criteria:

  • Under 18 years of age
  • Transgender
  • Males
  • HIV negative
  • Do not understand or speak English
  • Do not achieve a satisfactory score on the screening interview
  • Diagnosed as actively psychotic, severely depressed, or pose a risk of harm to themselves or others since these women may not be emotionally capable of sitting through lengthy, potentially emotional group or assessment sessions, or may be disruptive to other participants
  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: NCT00253045

Locations
United States, Georgia
Nell Hodgson Woodruff School of Nursing, Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Marcia McDonnell-Holstad, DSN,RN-C,FNP Nell Hodgson Woodruff School of Nursing, Emory University
Study Director: Bridget F. Jones, RN,MSN,BSEd Nell Hodgson Woodruff School of Nursing, Emory University
  More Information

Publications:
Responsible Party: Marcia McDonnell Holstad, DSN, FNP-BC, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00253045     History of Changes
Other Study ID Numbers: IRB00045905, 1-RO1-NR008094-01A1
Study First Received: November 14, 2005
Last Updated: September 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Motivational Interviewing
antiretroviral therapy
medication adherence
risk reduction behaviors
women
HIV
AIDS

ClinicalTrials.gov processed this record on November 23, 2014