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临床试验/NCT00253045
NCT00253045已完成不适用

Motivating HIV+ Women: Risk Reduction and ART Adherence

Emory University2 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2004年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
207
试验地点
2
主要终点
Adherence to antiretroviral therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Under 18 years of age
  • Transgender
  • 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

结局指标

主要结局

Adherence to antiretroviral therapy

时间窗: Baseline, 2 weeks, 3, 6, 9 months post intervention

Self report questionnaires, Electronic drug monitoring caps (MEMS)

Use of Risk Reduction Behaviors

时间窗: Baseline, 2 weeks, 3, 6, 9 months post intervention

Questionnaires about risky sexual behaviors, and substance use behaviors

Clinical indicators

时间窗: Baseline, 2 weeks, 3, 6, 9 months post intervention

CD4 and HIV viral load lab results from medical records

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcia McDonnell Holstad, DSN, FNP-BC

Principal Investigator

Emory University

研究点 (2)

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