- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00253045
Motivating HIV+ Women: Risk Reduction and ART Adherence (KHARMA)
Study Overview
Detailed Description
Women are the fastest growing group of persons with AIDS. They are often diagnosed later in the disease, when antiretroviral therapy (ART) is strongly indicated. Currently ART involves the use of multiple medications that must be taken under strict conditions at regular time intervals up to as many as 4 different times a day. Some medications must be taken on an empty stomach, some with high fat food, some with low fat food, and all of these must be coordinated throughout the day. It is extremely important for patients to take ART exactly as prescribed and not miss any doses in order to reduce the amount of HIV virus in the bloodstream, increase the CD4 cell counts, prevent the serious consequences of AIDS, hospitalizations, and development of drug resistant strains. These regimen-related problems and the high care-taking burden placed on HIV+ women for their children and partners make near perfect adherence difficult to achieve. And, as women on ART begin to feel better and resume their normal activities, including sexual activities, adherence to behaviors that contribute to reducing the risk of spreading HIV (RRB), such as condom use and safe needle use in injection drug users becomes crucial. Researches have shown that only about 11% to 63% of HIV+ women use condoms consistently.
The primary purpose of this randomized controlled behavioral trial is to test the effect of a nurse led group motivational intervention for HIV+ women on adherence to ART and RRB. The secondary purpose is to examine the mediator effect of 3 variables that have been shown to be important in behavior change: self-efficacy, outcome expectancy, and personal goals. The Motivational Group + Usual Care (MG+UC) intervention builds on the usual care provided at the agencies and has Motivational Interviewing (MI) as a central component. It consists of 8 90 minute sessions, 1 week apart, led by a specially trained nurse, to motivate women to adhere to both ART and RRB. The intervention will be compared to an 8 session health promotion program (HPP+UC) that is led by a nurse health educator. These sessions will focus on nutrition, exercise, stress management, and women's health issues. These sessions will also be 90 minutes in length and meet weekly for 8 weeks. Both groups will receive beauty and pampering incentives such as beauty makeovers, skin care instruction, and massages after several of the sessions, as well as child care, transportation tokens, and monetary incentives of $10 for attendance at each of the first 4 groups and $15 for attendance at each of the last 4 groups. Snacks appropriate for ART and immune status will be supplied to the MG+UC group, and fruits, vegetables, and other nutritious snacks will be provided to the HPP+UC group. Groups will be held at AID Atlanta, the Infectious Disease Program of the Grady Health System, and at the Infectious Disease Clinic of Emory Crawford Long.
In order to be eligible to participate, the women must be HIV+, over 18 years of age, be on a new or different ART or have self-reported nonadherence to her current ART regimen, speak and understand English, and be mentally stable as determined by a screening assessment. All participants will complete a baseline assessment, and follow-up assessments immediately, 3, 6, and 9 months after the end of the group. Participants will be paid $25 for each assessment. We expect 300 women to be randomized and participate; pregnant women will not be excluded.
We hypothesize that the women who are randomized to the MG+UC group, will, on the immediate, 3, 6, and 9 month follow-up assessments have higher mean adherence rates to ART, report more frequent use of RRB, have higher CD4 counts, and lower mean viral loads than those randomized to the HPP+UC group. We also hypothesize that the effects of the intervention on adherence to ART and RRB will be brought about by higher mean levels of self-efficacy, more positive expected outcomes, and more specific and effective personal goals.
As noted above, MI forms the basis for the intervention. MI is a client-focused method of counseling used to help clients deal with ambivalence about changing behavior. MI principles include expressing empathy, developing discrepancy, rolling resistance, and supporting self-efficacy. It has been used primarily with individuals, but some MI groups have been described with substance users. Our application in a group format with HIV+ women is new and innovative.
All participants will receive the usual care plus either the Health Promotion Program or the Motivational Interviewing Intervention. How the usual care is administered varies by agency but in general for ART consists of prescription of new or different ART regimen based on established clinical criteria and guidelines by the Panel on Clinical Practices for Treatment of HIV infection, education about the medications (including actions, side effects, special requirements), setting up the medication schedule, and follow-up regarding medication taking. The usual RRB education includes information about risk reduction practices such as condom use, sexual practices, needle cleansing, and needle sharing. Depending on the agency, the usual care may be formalized and administered by health care providers, nurses, social workers, and/or health educators.
This innovative project is designed to promote adherence to both ART and RRB, something that has not been described so far in the literature. Adherence to ART promotes health and reduces infectiousness, including transmission of HIV from mother to fetus. Adherence to RRB reduces the spread of HIV. Thus, if effective, the intervention will promote health of HIV+ women and reduce the spread of HIV.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Nell Hodgson Woodruff School of Nursing, Emory University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivational group
Group counseling using motivational interviewing
|
Motivational interviewing in group format
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to antiretroviral therapy
Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention
|
Self report questionnaires, Electronic drug monitoring caps (MEMS)
|
Baseline, 2 weeks, 3, 6, 9 months post intervention
|
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
|
Baseline, 2 weeks, 3, 6, 9 months post intervention
|
Clinical indicators
Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention
|
CD4 and HIV viral load lab results from medical records
|
Baseline, 2 weeks, 3, 6, 9 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-Efficacy
Time Frame: Baseline, Immediate post follow-up, 3, 6, 9 months post intervention
|
Baseline, Immediate post follow-up, 3, 6, 9 months post intervention
|
Outcome Expectancy
Time Frame: Baseline, 2 weeks, 3, 6, 9 months post intervention
|
Baseline, 2 weeks, 3, 6, 9 months post intervention
|
Personal Goals
Time Frame: Immediate post follow-up, 3, 6, and 9 months post intervention
|
Immediate post follow-up, 3, 6, and 9 months post intervention
|
Collaborators and Investigators
Sponsor
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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00045905
- 1R01NR008094-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecruitingHIV | HIV Testing | HIV Linkage to Care | HIV TreatmentUnited States
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement and other collaboratorsUnknownHIV | HIV-uninfected Children | Children Exposed to HIVCameroon
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationCompletedPartner HIV Testing | Couple HIV Counseling | Couple Communication | HIV IncidenceCameroon, Dominican Republic, Georgia, India
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
CDC FoundationGilead SciencesUnknownHIV Preexposure Prophylaxis | HIV ChemoprophylaxisUnited States
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... and other collaboratorsRecruiting
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); Fenway Community Health; Tuberculosis...CompletedHIV/STI Risk | HIV/STI IncidenceUnited States, India
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Hospital Clinic of BarcelonaCompletedIntegrase Inhibitors, HIV; HIV PROTEASE INHIBSpain
-
University of WashingtonNational Institute of Mental Health (NIMH)RecruitingHIV Prevention | HIV Preexposure Prophylaxis | ImplementationKenya
Clinical Trials on Motivational groups
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Necmettin Erbakan UniversityCompleted
-
Barcelonabeta Brain Research Center, Pasqual Maragall...CompletedAlzheimer's DiseaseSpain
-
Assistance Publique - Hôpitaux de ParisNational Research Agency, FranceCompletedRheumatoid Arthritis | Uveitis | Vasculitis | Type 1 Diabetes | Crohn's Disease | Myositis | Healthy Volunteer | Ankylosing Spondylitis | FMF | Systemic Lupus Erythematosus/Antiphospholipid Syndrome | Cryopyrin-Associated Periodic Syndromes /TNF-receptor Associated Periodic Syndrome | Ulcerative Rectocolitis | Unclassified...France
-
Gazi UniversityCompletedGingival Recession
-
Seventh Medical Center of PLA General HospitalActive, not recruiting
-
Hasan Kalyoncu UniversityCompleted
-
Sandra BucciUniversity of Edinburgh; NHS Lothian; Manchester University NHS Foundation Trust and other collaboratorsCompletedChild Sexual Abuse, Confirmed, SequelaUnited Kingdom
-
Gia MuddWest Virginia UniversityCompletedAdverse Childhood ExperiencesUnited States
-
National Institute of Mental Health (NIMH)CompletedSchizophreniaUnited States