Motivating HIV+ Women: Risk Reduction and ART Adherence

NCT00253045 | Completed DMC

• 2 other identifiers: IRB000459051R01NR008094-01A1
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; AIDS

Keywords

Motivational Interviewing; antiretroviral therapy; medication adherence; risk reduction behaviors; women; HIV; AIDS

Outcome Measures

Primary Outcomes (3)

• Adherence to antiretroviral therapy

  Self report questionnaires, Electronic drug monitoring caps (MEMS)

  Baseline, 2 weeks, 3, 6, 9 months post intervention

• Use of Risk Reduction Behaviors

  Questionnaires about risky sexual behaviors, and substance use behaviors

  Baseline, 2 weeks, 3, 6, 9 months post intervention

• Clinical indicators

  CD4 and HIV viral load lab results from medical records

  Baseline, 2 weeks, 3, 6, 9 months post intervention

Secondary Outcomes (3)

• Self-Efficacy

  Baseline, Immediate post follow-up, 3, 6, 9 months post intervention

• Outcome Expectancy

  Baseline, 2 weeks, 3, 6, 9 months post intervention

• Personal Goals

  Immediate post follow-up, 3, 6, and 9 months post intervention

Study Arms (1)

Motivational group

EXPERIMENTAL

Group counseling using motivational interviewing

Behavioral: Motivational groups

Interventions

Motivational groups BEHAVIORAL

Motivational interviewing in group format

Motivational group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Nell Hodgson Woodruff School of Nursing, Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (3)

• Holstad MM, DiIorio C, Magowe MK. Motivating HIV positive women to adhere to antiretroviral therapy and risk reduction behavior: the KHARMA Project. Online J Issues Nurs. 2006 Jan 31;11(1):5.

  PMID: 16629499 BACKGROUND

• Holstad MM, DiIorio C, Kelley ME, Resnicow K, Sharma S. Group motivational interviewing to promote adherence to antiretroviral medications and risk reduction behaviors in HIV infected women. AIDS Behav. 2011 Jul;15(5):885-96. doi: 10.1007/s10461-010-9865-y.

  PMID: 21165692 RESULT

• Holstad MM, Diiorio C, McCarty F. Adherence, sexual risk, and viral load in HIV-infected women prescribed antiretroviral therapy. AIDS Patient Care STDS. 2011 Jul;25(7):431-8. doi: 10.1089/apc.2010.0331. Epub 2011 Jun 11.

  PMID: 21663541 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marcia McDonnell-Holstad, DSN,RN-C,FNP

  Nell Hodgson Woodruff School of Nursing, Emory University

  PRINCIPAL INVESTIGATOR

• Bridget F. Jones, RN,MSN,BSEd

  Nell Hodgson Woodruff School of Nursing, Emory University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 15, 2005
• Study Start: August 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

US (1)