MSM における PrEP の持続性を高め、意思決定を改善するための簡単な介入
医療提供者と患者の視点（男性とセックスをする男性）から見た、PrEPの要求、申し出、受け入れ、継続の決定における認知バイアスの役割
Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality that requires individuals to take a daily tablet to prevent themselves acquiring HIV. In South Africa while this is freely available in the public sector, persistence (that is continuation after initiation) is low amongst vulnerable populations, including men who have sex with men (MSM).
This study is a feasibility and acceptability study of a behavioral economics informed intervention to improve persistence amongst MSM newly initiating PrEP in South Africa. The goal of this study is to show that this approach is possible in a routine setting and gather the necessary data for a fully powered effectiveness trial.
Study participants will complete a baseline questionnaire and then be randomized to either receive standard of care (control) or to receive the intervention. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. The intervention package aims to address present bias, optimism bias and salience. The intervention is delivered and the enrollment visit and then through mobile phone reminders / text messages. There is no further in person interaction after the initial interaction. Participants may be contacted for a telephonic enplane questionnaire. Outcome data is obtained from passive followup through routine medical record review with the primary end point being persistence at 3 months.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
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:
- Not currently on pre exposure prophylaxis (PrEP); no PrEP within the last 12 months
- Initiating PrEP on the date of enrolment
- Access to a mobile phone
- Willing and able to provide written informed consent in English
Exclusion Criteria:
- PrEP status unknown
- Previous PrEP experience within the last year (12 months from enrolment)
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：ヘルスサービス研究
- 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 |
|---|---|
|
実験的：Intervention group
Participants randomized into this group will receive a behavioral economics informed intervention to improve persistence among amongst high risk men newly initiating PrEP in South Africa. |
A light touch, once off, low cost. lay counsellor led intervention, designed to focus decision making around HIV prevention addressing present bias, salience and over optimism. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. |
|
介入なし：Control group
Usual care for high risk men newly initiating PrEP in South Africa. |
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 |
|---|---|---|
|
Target population recruitment (feasibility)
時間枠：5 months
|
The percent of participants enrolled from those that meet eligibility criteria and are offered will be assessed from screening log. |
5 months
|
|
Fidelity to intervention
時間枠：5 months
|
Percent of intervention interactions that are delivered in the first 3 months (Max interactions in 3 months = 2 visit reminders and 24 text messages (2 per week) = 26 total interactions). |
5 months
|
|
Acceptability by intervention participants
時間枠：5 months
|
The percent of participants that accept to participate in the intervention (set reminders/receive text messages) after being randomized to the intervention arm. |
5 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PrEP persistence at 3 months
時間枠：4 months
|
PrEP persistence is defined as having at least a specific number of months of PrEP dispensed after study enrolment. The outcome is determined at the subsequent month to allow for variable timing around return visits. For example persistence at 3 months is defined as having at least 90 days of PrEP dispensed by 4 months. |
4 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Lawrence C Long, PhD MCom、Boston University School of Public Health,Global Health
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
- H-45113
- 1K01MH119923-01A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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