Effectiveness of Enhanced Counseling and Observed Therapy on Antiretroviral Adherence in People With HIV
ART Adherence: Enhanced Counseling and Observed Therapy
調査の概要
状態
条件
詳細な説明
HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. Antiretroviral therapy (ART) has proven to be an effective treatment for inhibiting the replication of HIV, allowing for improved quality of life and survival. However, the long-term effectiveness of ART depends on strict adherence to a prescribed medication regimen. Previous studies have indicated that observing patients while they take their medications for a period of time can improve adherence to their prescribed drug regimens. This study will evaluate the effectiveness of enhanced counseling (EC) alone versus EC combined with modified directly observed therapy (mDOT) at improving medication adherence in people with HIV.
Participants in this 48-week study will be randomly placed into one of the following three treatment groups:
- Group 1 participants will receive standard care, which will involve the care that the clinic staff normally provide to all patients on HIV therapy.
- Group 2 participants will receive EC.
- Group 3 participants will receive EC with mDOT.
All participants will continue to take the anti-HIV medication regimen prescribed by their health care provider. However, participants will be asked to keep one medication type in a bottle that has a special Micro-Electro-Mechanical System (MEMS) cap. This electronic cap will record each time the participant opens the bottle. Participants will meet with study staff for MEMS cap data collection once weekly for the first 4 weeks, every 2 weeks up to Week 12, and then every 4 weeks thereafter.
EC will consist of 30- to 45-minute counseling sessions about medication adherence. Participants will meet in person with a counselor for the first five sessions, occurring at baseline and Weeks, 1, 2, 6, and 11. An additional five counseling sessions will be conducted by phone during Weeks 4, 9, 15, 19, and 23. Participants receiving mDOT will have their doses of HIV medication delivered to them by an mDOT worker for the first 24 weeks of treatment. Participants will select a time and location to meet with an mDOT staff member, who will then provide the daily doses of drugs and observe participants taking those drugs. Participants will meet with an mDOT worker 5 times a week from baseline to Week 16. Starting at Week 17, the number of weekly meetings will gradually taper until Week 24 when there will be no meeting and participants will return to obtaining and taking their HIV medications as done prior to study enrollment.
Evaluation visits will occur for all participants at baseline and Weeks 12, 24, 36, and 48. Evaluation sessions will last 45 minutes to 1 hour and will include questionnaires about adherence, knowledge and attitudes about HIV and HIV therapy, quality of life, support systems, health status, medical history, drug and alcohol use, and satisfaction with HIV care. Blood samples will also be taken to measure CD4 cell count and amount of virus in the blood.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Kansas
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Kansas City、Kansas、アメリカ、66160
- Kansas University Medical Center ID Clinic
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Missouri
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Kansas City、Missouri、アメリカ、64108
- Truman Medical Center ID Clinic
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Kansas City、Missouri、アメリカ、64110
- Kansas City Free Health Clinic
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Kansas City、Missouri、アメリカ、641128
- Kansas City Veterans Administration Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patient at participating clinical site
- English-speaking
- Initiating new ART (new or change in therapy) or nonadherent to ART as documented by care provider's assessment, patient self-report, and consistent HIV RNA laboratory results
- Lives within 45-mile radius of participating clinical site or able to participate in observed therapy procedures
Exclusion Criteria:
- Pregnancy
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Enhanced Counseling
Participants meet with a counselor trained in motivational interviewing and cognitive behavioral techniques
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Counseling sessions are completed face-to-face or by telephone at baseline and Weeks 1, 2, 4, 6, 9, 11, 15, 19, and 23.
Counselors are trained in motivational interview technique and focus on ART medication adherence.
他の名前:
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介入なし:Standard Care
Participants receive usual clinical care provided by health care providers and they participate only in evaluation components of the study
|
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実験的:Enhanced Counseling/Modified Directly Observed Therapy
Participants receive their ART medications delivered to them by study staff and they receive the enhanced counseling
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Counseling sessions are completed face-to-face or by telephone at baseline and Weeks 1, 2, 4, 6, 9, 11, 15, 19, and 23.
Counselors are trained in motivational interview technique and focus on ART medication adherence.
他の名前:
From baseline to Week 16, Monday through Friday, study staff meet the participants daily to observe one dose of their ART and to leave with the participants all other doses needed until the next observed dose.
The frequency of observed doses begins to taper at Week 17 through to Week 24.
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Adherence with ART as measured by Micro-Electro-Mechanical Systems (MEMS)
時間枠:Measured at Week 48
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Measured at Week 48
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二次結果の測定
結果測定 |
時間枠 |
---|---|
HIV RNA suppression
時間枠:Measured at Week 48
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Measured at Week 48
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協力者と研究者
捜査官
- 主任研究者:Kathy Goggin, PhD、University of Missouri, Kansas City
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- R01MH068197 (米国 NIH グラント/契約)
- DAHBR 9A-ASGA
- PA 01 0173
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HIV感染症の臨床試験
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
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Hospital Clinic of Barcelona完了
-
University of WashingtonNational Institute of Mental Health (NIMH)募集