男性の ART と PrEP の取り込みを改善するためのセルフテスト戦略とリンケージ インセンティブ
調査の概要
状態
詳細な説明
目的 1 では、研究のパイロット、コミュニティの選択、および準備に続いて、研究者は、研究に適格な男性の人口を特定するために、研究コミュニティで国勢調査/BMU レジストリの検証を実施します。 この研究では、参加するためのインフォームド コンセントを提供する適格な男性を選別し、募集し、登録します。その後、彼らの親密なソーシャル ネットワークを測定し、ネットワーク中心の高度に接続された男性 (「プロモーター」) を特定し、彼らの親密なソーシャル ネットワーク (クラスター) を 1 に無作為化します。 :1 介入群と対照群。 捜査官はその後、ベースライン調査を実施して、社会人口統計学的およびベースラインの性的行動データを、密接なソーシャル ネットワーク内の男性から収集します。 このベースライン データの収集に続いて、すべてのプロモーターにトレーニングが提供されます。 介入グループのプロモーターは、HIVST トレーニング、他の男性に配布するための複数の HIVST、および少額の報酬を受け取ります。 対照群のプロモーターは、研究に関する基本的な HIV 教育とトレーニングを受け、近隣の医療施設で HIV 検査 (標準または無料の HIVST キット) と交換できるバウチャーが提供されます。 フォローアップ調査データを使用して、研究者は、対照と比較して、介入を受けたネットワークの男性で3か月後にHIV検査の割合が高くなるという仮説を検証します.
目的 2 では、研究者は、ネットワーク中心のプロモーターが、親密なソーシャル ネットワーク内の男性の HIV 検査後に ART および PrEP へのリンケージを強化できるかどうかをテストします。 目標 1 の介入グループのプロモーターは、HIV 自己検査を親密なソーシャル ネットワークで男性に配布する際に、ART または PrEP の情報を配布し、バウチャーを輸送するよう求められます。 治験責任医師は臨床データを使用して、介入によりARTまたはPrEPへの連鎖率が高くなるという主要な仮説を検証します(陽性の場合は確認検査とARTへの紹介、陰性の場合はPrEPスクリーニング)。 治験責任医師は、介入群で 3 か月以内 (+ 約 1 か月) 以内に ART と PrEP の取り込みが増加するという仮説も検証します。
目的 3 では、治験責任医師は、ウイルス負荷試験と新しいポイント オブ ケア PrEP アドヒアランス アッセイ (尿中のテノホビル レベルの測定を可能にする抗体ベースのアッセイ) を使用して、6 か月の VL と 6 か月のテノホビル レベルを測定し、仮説を検証します。介入群では、HIV に感染した男性ではより高い割合でウイルス学的抑制が観察され、感染していない男性では PrEP の順守が観察される。 ウイルス量の測定は、MOH ウイルス量モニタリングのために予定されている定期的な採血中に追加の静脈血を採取することによって実施されます(また、毎年の VL テスト標準治療期間外に発生する予定の予約中に追加の採血を行います)。 PrEPアドヒアランスは、6か月で研究尿アッセイを利用して測定されます。 HIV治療の順守は、3回および6回の定期的な診療所訪問中の順守評価によって測定されます。
すべての目的にわたって、研究者は質的および混合方法を使用して介入行動の経路を評価します。 研究者は、目標 1、2、3 に組み込まれた定量的および定性的な評価を定性的および混合方法を使用して、アクションのメカニズム、ソーシャル ネットワークおよびインセンティブ介入の実装の障壁とファシリテーターを特定します。 データ収集アプローチには、両方のグループの参加者への詳細なインタビュー、ネットワーク中心のプロモーターへの重要な情報提供者へのインタビュー、および HIV ステータスと研究グループによって層別化された研究参加者とのフォーカス グループ ディスカッションが含まれます。 データは、目標 1 ~ 3 の定量的結果測定のタイミングに対応するベースラインおよび 3 つのフォローアップ期間で収集されます。
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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Siaya、ケニア
- Impact Research Development Organization
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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
説明
包含基準:
- 大人(18歳以上)
- 男
- 漁師または漁業関連の職業
- -参加のためのインフォームドコンセントを提供する意思と能力
- HIV検査、治療および/または予防に関連する別の調査研究に参加していない
除外基準:
- 18歳未満
- 女性
- HIV/AIDS に関する別の介入研究に含まれる
- -研究チームの裁量により、計画された研究手順を完了するための不十分な認知および/または聴覚能力
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:防止
- 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:プロモーター トレーニング、複数のセルフテスト キット、インセンティブ
介入グループのプロモーターは、HIVST トレーニング、他の男性に配布するための複数の HIVST、および自分自身とネットワーク内の男性に配布するための少額の報酬 (輸送券) を受け取ります。
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参加者には複数の Oraquick Advance HIV-1/2 テスト キットが提供され、より頻繁に自分自身をテストしたり、ソーシャル ネットワークの男性のためにテストしたりできます。
少額のインセンティブ バウチャー (約 5 ドル) を使用して、確認テストへのリンクを促進します。
メッセージは動機付けになり、識別情報は含まれず、「健康を維持してください」などの一般的なテキストが含まれ、ARV を服用している HIV 陽性の個人と HIV 陰性の個人の両方に有効なステータス中立的な言葉遣いに対応します。アドヒアランスサポートが必要な可能性のある PrEP について。
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介入なし:短いトレーニングとテストの紹介
コントロール グループのプロモーターは、HIV の予防と治療の基本に関する短いトレーニングを受け、地元の医療施設での標準治療検査のためにネットワーク内の男性を紹介することが奨励されます。利用可能なものに応じて、地元の診療所からのテスト。
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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自己報告されたHIV検査
時間枠:最大3か月
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過去3か月以内にHIV検査(はい/いいえ)を自己報告する参加者の割合は、3か月のフォローアップで測定されました。
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最大3か月
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3か月以内に研究に関連したクリニックにリンクした参加者の割合
時間枠:最大3か月
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介入ベースラインから3か月以内に、HIV治療またはケアのために研究に所属するクリニックに参加した参加者の割合
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最大3か月
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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準備へのリンク
時間枠:最大3か月
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事前処方を開始するPREPに適格のHIV陰性参加者の割合(はい/いいえ)、確認検査と適格性スクリーニング(組み合わせ)後の3か月間
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最大3か月
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準備の順守(尿中の検出可能なテノフォビルの%)
時間枠:最大6か月
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準備:PREP開始後6か月でPREP(TFVレベル> = 1500 ng/ml)に従うことに従うことに固執するPREPTAKING HIV陰性参加者の割合。
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最大6か月
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芸術への順守
時間枠:最大6か月
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ART:ウイルス抑制(HIV RNA <400 c/ml)を達成したHIV陽性の参加者の割合、ART開始後6か月後。
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最大6か月
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協力者と研究者
協力者
捜査官
- 主任研究者:Harsha Thirumurthy, PhD、University of Pennsylvania
- 主任研究者:Carol S Camlin, MPH, PhD、University of California, San Francisco
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