Motivating HIV+ Women: Risk Reduction and ART Adherence



Status:Archived
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011

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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.


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.


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