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

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ClinicalTrials.gov Identifier: NCT00253045
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV AIDS Behavioral: Motivational groups

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Motivating HIV+ Women: Risk Reduction and ART Adherence
Study Start Date : August 2004
Primary Completion Date : January 2008
Study Completion Date : January 2008

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: Motivational group
Group counseling using motivational interviewing
Behavioral: Motivational groups
Motivational interviewing in group format


Outcome Measures

Primary Outcome Measures :
  1. Adherence to antiretroviral therapy [ Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention ]
    Self report questionnaires, Electronic drug monitoring caps (MEMS)

  2. Use of Risk Reduction Behaviors [ Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention ]
    Questionnaires about risky sexual behaviors, and substance use behaviors

  3. Clinical indicators [ Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention ]
    CD4 and HIV viral load lab results from medical records


Secondary Outcome Measures :
  1. Self-Efficacy [ Time Frame: Baseline, Immediate post follow-up, 3, 6, 9 months post intervention ]
  2. Outcome Expectancy [ Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention ]
  3. Personal Goals [ Time Frame: Immediate post follow-up, 3, 6, and 9 months post intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes 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

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): 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