南アフリカの思春期の少女と若い女性を HIV ワクチンの誤った情報から守る (PROTECT)
2026年8月7日 更新者：University of Pennsylvania
南アフリカでは、予防と治療プログラムの進歩が記録されているにもかかわらず、15～24歳の思春期の少女と若い女性（AGYW）がヒト免疫不全ウイルス（HIV）感染の矢面に立たされ続けている。
若い女性の HIV 感染に対する感受性は依然として高く、また、効果の高い暴露前予防 (PrEP) などの予防オプションの摂取が最適化されていないことにより、HIV 感染の重大なリスクにさらされている人々に利益をもたらす HIV ワクチンの必要性が生じています。
しかし、これまでのワクチン研究や最近の新型コロナウイルス感染症（COVID-19）ワクチンから得た教訓から、誤った情報の蔓延やワクチンへの躊躇など、ワクチン摂取に対する大きな障壁が浮き彫りになっている。
これらの課題により、将来の HIV ワクチンの導入の成功が脅かされています。
これらの洞察に基づいて、この研究は心理的接種理論を利用して、思春期の少女と若い女性の間での HIV ワクチンのメッセージを開発および評価します。
主な目的：心理的接種と行動経済学的ブーストを行ったグループと行わなかったグループで、誤った情報にさらされた後のHIVワクチン接種意向の変化を比較すること。
二次目的: (1) 心理的接種と行動経済学ブーストを行ったグループと行わなかったグループで、誤った情報の主張と、誤った情報に関連する動機付けの脅威の信憑性と説得力を比較する。
(2) HIV リスク、PrEP 歴、COVID-19 ワクチン歴、一般的なワクチンへの躊躇、情報回避など、関連する社会人口学的および行動的要因によるサブグループの影響を調査する。
研究者らは、南アフリカにおけるHIVワクチンに関する新たな神話や誤った情報に対処する2～3の接種メッセージの3群ランダム化対照試験を実施する予定だ。
参加者は、対照群または 2 つの介入群のいずれかにランダムに割り当てられます: (1) 接種メッセージ群、または (2) 行動経済学からの洞察を用いて接種メッセージを強化します。
調査の概要
研究の種類
介入
入学 (実際)
2163
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Johannesburg、南アフリカ
- Health Economics and Epidemiology Research Office, University of the Witwatersrand
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
包含基準:
- 女性
- 年齢 18 ～ 24 歳
- 過去 12 か月間の自己申告による性行為歴
- 自己申告による HIV 陰性状態または登録時の HIV 状態不明
- 書面によるインフォームドコンセントを提供する意欲と能力がある
- 英語を読んで理解できること
除外基準:
- 研究参加に同意したくない、または同意できない。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：コントロール
対照群に登録されている参加者は、接種メッセージと同じ長さの糖尿病と栄養トピックに関する無関係な情報を受け取ります。
このメッセージの構造の例については、付録6を参照してください。
これにより、コントロールグループが注意コントロールグループになり、調査結果が研究への参加により多くの時間と注意リソースを費やす介入グループによって混乱しないようにします。
|
対照群に登録されている参加者は、接種メッセージと同じ長さの糖尿病と栄養トピックに関する無関係な情報を受け取ります。
このメッセージの構造の例については、付録6を参照してください。
これにより、コントロールグループが注意コントロールグループになり、調査結果が研究への参加により多くの時間と注意リソースを費やす介入グループによって混乱しないようにします。
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他の：強化された接種メッセージ
強化された接種メッセージアームに登録されている参加者は、差し迫ったHIVワクチンの誤った情報について警告するメッセージを受け取り、それらの主張が虚偽または誤解を招く理由を説明します。
行動経済学の一環として、参加者は、一貫性とコミットメントプライムとしてワクチン接種を促進するメッセージを伴う小さなトークン（たとえば、ステッカー、バッジ、ブレスレットなど）を受け取ることを選択できます。
|
強化された接種メッセージアームに登録されている参加者は、差し迫ったHIVワクチンの誤った情報について警告するメッセージを受け取り、それらの主張が虚偽または誤解を招く理由を説明します。
行動経済学の一環として、参加者は、一貫性とコミットメントプライムとしてワクチン接種を促進するメッセージを伴う小さなトークン（たとえば、ステッカー、バッジ、ブレスレットなど）を受け取ることを選択できます。
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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 |
|---|---|---|
|
HIV Vaccine Intention, at the End of the Baseline Assessment
時間枠：At the end of the baseline assessment
|
Intention to get the HIV vaccine, measured after inoculation intervention and misinformation exposure The intention to get the vaccine will be measured on a 0-10 scale.
Higher score means they are more likely to get the HIV vaccine.
|
At the end of the baseline assessment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HIV Vaccine Intention, Follow-up
時間枠：2-4 weeks
|
Intention to get the HIV vaccine, measured at follow-up survey following misinformation exposure and intervention.
Measured on a 0-10 scale.
Higher score means they are more likely to get the HIV vaccine.
|
2-4 weeks
|
|
Recommend to Friends, at the End of the Baseline Assessment
時間枠：At the end of the baseline assessment
|
Intention to recommend the HIV vaccine to friends, measured at survey baseline following misinformation exposure and intervention.
Measured on a 0-10 scale.
Higher score means they are more likely to recommend the HIV vaccine to a friend.
|
At the end of the baseline assessment
|
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Recommend to Friends, Follow-up
時間枠：2-4 weeks
|
Intention to recommend the HIV vaccine to friends, measured at follow-up survey following misinformation exposure and intervention, controlling for baseline pre-intervention/exposure intention.
Measured on a 0-10 scale.
Higher score means they are more likely to recommend the HIV vaccine to a friend.
|
2-4 weeks
|
|
Credibility of Inoculated Exposure #1
時間枠：At the end of the baseline assessment
|
Extent to which claim #1 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #2
時間枠：At the end of the baseline assessment
|
Extent to which claim #2 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #3
時間枠：At the end of the baseline assessment
|
Extent to which claim #3 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #4
時間枠：At the end of the baseline assessment
|
Extent to which claim #4 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #5
時間枠：At the end of the baseline assessment
|
Extent to which claim #5 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #6
時間枠：At the end of the baseline assessment
|
Extent to which claim #6 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #1
時間枠：At the end of the baseline assessment
|
Extent to which claim #1 made the participants anxious or nervous about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #2
時間枠：At the end of the baseline assessment
|
Extent to which claim #2 made the participants anxious or nervous about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #3
時間枠：At the end of the baseline assessment
|
Extent to which claim #3 made the participants anxious or nervous about the HIV vaccine.
TThey were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #4
時間枠：At the end of the baseline assessment
|
Extent to which claim #4 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #5
時間枠：At the end of the baseline assessment
|
Extent to which claim #5 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #6
時間枠：At the end of the baseline assessment
|
Extent to which claim #6 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #1
時間枠：At the end of the baseline assessment
|
Extent to which claim #1 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #7
時間枠：At the end of the baseline assessment
|
Extent to which claim #7 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #3
時間枠：At the end of the baseline assessment
|
Extent to which claim #3 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #4
時間枠：At the end of the baseline assessment
|
Extent to which claim #4 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #5
時間枠：At the end of the baseline assessment
|
Extent to which claim #5 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #6
時間枠：At the end of the baseline assessment
|
Extent to which claim #6 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #1, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #1 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Credibility of Inoculated Exposure #2, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #2 made the participants believe the credibility of the information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Shareability of Inoculated Exposure #1, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #1 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of Inoculated Exposure #2, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #2 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Anxiousness of Inoculated Exposure #1, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #1 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Anxiousness of Inoculated Exposure #2, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #2 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Credibility of New Claims, Exposure #12, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #12 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Credibility of New Claims, Exposure #8, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #8 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Credibility of New Claims, Exposure #9, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #9 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Credibility of New Claims, Exposure #10, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #10 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Credibility of New Claims, Exposure #11, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #11 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Anxiousness o of New Claims, Exposure #12, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #12 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Anxiousness of New Claims, Claim #8, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #8 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #9, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #9 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #10, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #10 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #11, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #11 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #12, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #12 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #8, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #8 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #9, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #9 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #10, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #10 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #11, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #11 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
|
Credibility of Inoculated Exposure #7
時間枠：At the end of the baseline assessment
|
Extent to which claim #7 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #7
時間枠：At the end of the baseline assessment
|
Extent to which claim #7 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #2
時間枠：At the end of the baseline assessment
|
Extent to which claim #2 made the participants more likely to share information about the HIV vaccine.
They were provided information on this claim and how to recognize it as misinformation.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
At the end of the baseline assessment
|
|
Credibility of New Claims, Exposure #13, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #13 made the participants believe the credibility of the information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to believe the claim.
|
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #13, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #13 made the participants anxious or nervous about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number indicates more self-reported anxiousness.
|
2-4 weeks
|
|
Shareability of New Claims, Exposure #13, Follow-up
時間枠：2-4 weeks
|
Extent to which claim #13 made the participants more likely to share information about the HIV vaccine.
They were not provided prior information on this claim.
The scale is measured on 1-7.
Higher number means they are more likely to share the claim.
|
2-4 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年7月24日
一次修了 (実際)
2025年10月16日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2024年11月7日
QC基準を満たした最初の提出物
2024年11月18日
最初の投稿 (実際)
2024年11月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月28日
QC基準を満たした最後の更新が送信されました
2026年8月7日
最終確認日
2026年8月1日
詳しくは
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。