Motivating HIV+ Women: Risk Reduction and ART Adherence
Condition: HIV; AIDS
Study type: Interventional

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.
    

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.
    

Intervention name(s): Motivational groups
Intervention type(s): Behavioral
Intervention description(s): Motivational interviewing in group format
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Motivational Interviewing; antiretroviral therapy; medication adherence; risk reduction behaviors; women; HIV; AIDS