Motivating HIV+ Women: Risk Reduction and ART Adherence

HIV Clinical Trial

— KHARMA  

Official title:

Motivating HIV+ Women: Risk Reduction and ART Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253045
• Other study ID #: IRB00045905
• Secondary ID: 1-RO1-NR008094-0
• Status: Completed
• Phase: N/A
• First received: November 14, 2005
• Last updated: September 13, 2013
• Start date: August 2004
• Est. completion date: January 2008

Study information

• Verified date: September 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• AIDS
• HIV

Intervention

Behavioral:
• Motivational groups
Motivational interviewing in group format

Locations

Country	Name	City	State
United States	Nell Hodgson Woodruff School of Nursing, Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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- — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to antiretroviral therapy	Self report questionnaires, Electronic drug monitoring caps (MEMS)	Baseline, 2 weeks, 3, 6, 9 months post intervention	No
Primary	Use of Risk Reduction Behaviors	Questionnaires about risky sexual behaviors, and substance use behaviors	Baseline, 2 weeks, 3, 6, 9 months post intervention	No
Primary	Clinical indicators	CD4 and HIV viral load lab results from medical records	Baseline, 2 weeks, 3, 6, 9 months post intervention	No
Secondary	Self-Efficacy		Baseline, Immediate post follow-up, 3, 6, 9 months post intervention	No
Secondary	Outcome Expectancy		Baseline, 2 weeks, 3, 6, 9 months post intervention	No
Secondary	Personal Goals		Immediate post follow-up, 3, 6, and 9 months post intervention	No