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治験 NCT07125235 (reSTART)（対象：Behavioral Intervention、Viral Suppression of HIV Infection、ART遵守）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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カリフォルニア大学サンフランシスコ校Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) Clinical Trial 270 遠隔参加
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07125235 (reSTART) は 介入研究 臨床試験 で、Behavioral Intervention、Viral Suppression of HIV Infection、ART遵守 に関するものです。現在は 募集中 で、2026年2月9日 から開始しています。270 名の参加者 の募集が計画されています。この試験は カリフォルニア大学サンフランシスコ校 によって主導され、2028年7月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月13日 です。
概要
Men who are living with HIV and use stimulants face many challenges and barriers that may interfere with remembering to take their HIV medication. Forgetting to take HIV medication puts men living with HIV at a greater risk of becoming virally unsuppressed. Researchers are doing this study to test if a remote intervention can help participants improve remembering to take their HIV medications and reduce the HIV viral...もっと見る
詳細説明
A resurgent stimulant epidemic among men living with HIV could compromise the U.S. Ending the HIV Epidemic goals by interfering with HIV care engagement, adherence, and virologic suppression among men living with HIV. Prominent multi-level factors interfere with HIV virologic suppression for men living with HIV, particularly among those who use stimulants. This study is a nested randomized clinical trial to test a mu...もっと見る
公式タイトル
Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial
疾患名
Behavioral InterventionViral Suppression of HIV InfectionART遵守その他の研究識別子
- reSTART
- 25-44467
- UH3DA058304 (米国NIHの助成金/契約)
NCT番号
開始日
2026-02-09
最終更新日
2026-03-13
終了予定日
2028-07-30
目標参加者数
270
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
HIV
Stimulant Use
mHealth
Stimulant Use
mHealth
主目的
その他
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的reSTART Intervention The reSTART intervention will be administered to this group and includes: (1) adherence self-monitoring tools delivered during a single baseline motivational interviewing session; (2) the urine tenofovir point-of-care self-test with adherence feedback and visualizations with motivational messages; (3) a positive affect intervention delivered via a mobile health application which supports stimulant-using men in reduci...もっと見る | reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention The reSTART intervention integrates a mobile health application, a urine tenofovir point-of-care self-test, and adherence feedback with motivational messages to increase HIV medication intake, reduce stimulant use, and improve HIV virologic suppression. urine tenofovir point-of-care self-test urine tenofovir point-of-care self-test |
非介入Standard of Care The control group will receive standard of care and will not receive the reSTART intervention. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR | The primary endpoint will be change in viral suppression comparing baseline to post-intervention viral load results measured by HIV-1 RNA, Quantitative, Real-Time PCR. Viral suppression is defined as viral load results that yield less than 50 copies/mL. | Baseline to 6-months post-intervention |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Stimulant Use measured quantitatively by stimulant levels in hair | Stimulant levels will be compared pre- and post-intervention and measured quantitatively using liquid chromatography-mass spectrometry laboratory techniques. | Baseline to 6-months post-intervention |
Long-term Viral Suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR. | As a secondary endpoint, long-term viral suppression will be measured at 12-months and compared to baseline viral load results from HIV-1 RNA, Quantitative, Real-Time PCR. Viral suppression is defined as viral load results that yield less than 50 copies/mL. | Baseline to 12-months post-intervention |
Adherence to Tenofovir-based antiretroviral therapy | Urine tenofovir levels measured by the urine tenofovir point-of-care self-test lateral flow assay at baseline and 6-months post-intervention will be compared to assess the presence or absence of tenofovir and changes in adherence to HIV medications. | Baseline to 6-months post-intervention |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
男性
- Prescribed antiretroviral therapy (ART) with a tenofovir-based regimen.
- Documented virologic non-suppression, urine tenofovir testing without tenofovir detected, or self-reported adherence <100%.
- Reports stimulant use.
- Has a mailing address within the U.S.
- Currently has a smartphone with photo capabilities.
- Have any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions.
- Not prescribed ART.
- Unwilling to perform urine self-testing or to attend a local Quest site for viral load monitoring.
- Unable to provide a hair sample of ~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length
カリフォルニア大学サンフランシスコ校701 件のアクティブな治験を探索試験中央連絡先
連絡先: Shivani Mahuvakar, 415-878-6384, [email protected]
連絡先: Kevin Sassaman
1 1カ国の場所
California
University of California, San Francisco, San Francisco, California, 94110, United States
Matthew Spinelli, MD, MAS, 連絡先, 415-806-8554, [email protected]
募集中