Pilot Study of Financial Incentives for YMSM for HIV Testing and PrEP
This pilot, three-arm, randomized trial study involves 200 18-24-year-old young adult men-who-have-sex-with-men (YMSM) recruited through the internet. YMSM are eligible if they are 18-24 years-old, live in the United States, are not known to be HIV infected (self-report), have ever had condomless anal sex with another man, and have never taken HIV pre-exposure prophylaxis (PrEP). The aim of this pilot project is to compare the effect of financial incentives on encouraging YMSM to get tested for HIV and start PrEP for HIV.
Potential study participants will be recruited online through advertising on the internet and complete the study eligibility and consent procedures. Following provision of consent online, participants will be contacted via the email they provided and asked to confirm their willingness to participate. Email addresses are being collected as part of this study to help ensure that individuals do not attempt to participate more than once in this study. Study staff will review the email addresses for duplications. Anyone who attempts to enroll more than once will be disqualified from the study. Participants will not ask for their name as part of the study. Once study interest is confirmed, participants will be provided a study identification number and study arm assignment. They also will be provided with instructions specific to their study arm assignment for the study as well as online resources about HIV testing and PrEP, including options for paying for PrEP.
Participants will be randomly assigned to one of three study arms (no financial incentive, a fixed incentive ($25 Amazon.com gift card) or a lottery (20% for a $100 Amazon.com gift card). Participants in each study arm will be asked to contact the telehealth company PlushCare and make an appointment within two weeks. For this appointment, participants will speak with a PlushCare doctor about being tested for HIV and starting PrEP. They will provide PlushCare with their study identification number. As part of their services, PlushCare will obtain personal identifiers from participants but will not share this information with the study staff.
For this study, participants are asked to undergo an evaluation for PrEP through the PlushCare doctor, but will NOT be required to be tested for HIV nor start PrEP. It will be the participants choice whether or not to be tested for HIV and start or continue PrEP after consultation with the PlushCare doctor. For some participants, the PlushCare doctor might recommend against starting PrEP. PlushCare will follow usual standard-of-care practices for their evaluation, counseling and consideration of PrEP as well as provision and maintenance of services for PrEP. Using only the study identification numbers and not the participant's personal identifiers, PlushCare will provide the study staff with data on completion of the primary and secondary study outcomes.
Participants will be informed that they or their healthcare insurance will bear the costs of HIV testing and PrEP, but not the consultation with PlushCare. They will be provided with resources about how to pay for PrEP from the study as well as PlushCare.
Completion of the primary study outcome (completing an appointment with the telehealth provider PlushCare for a PrEP evaluation) and secondary outcomes (undergoing HIV testing, starting PrEP, time elapsed from study enrollment to PlushCare evaluation, time elapsed to HIV testing and PrEP initiation) will be compared by study arms.
調査の概要
研究の種類
入学 (予想される)
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: YMSM are eligible if they are 18-24 years-old, live in the United States, are not known to be HIV infected (self-report), have ever had condomless anal sex with another man, and have never taken PrEP.
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Exclusion Criteria: Not 18-24-years-old, do not live in the US, are known to be HIV infected, have never had condomless anal sex with another man, and have ever taken PrEP
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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 |
---|---|
介入なし:No financial incentive
No financial incentives will be provided for completing a PrEP evaluation
|
|
アクティブコンパレータ:Fixed incentive
A fixed incentive ($25 Amazon.com
gift card) will be provided for completing a PrEP evaluation
|
No financial incentive
|
アクティブコンパレータ:Lottery incentive
An entry into a lottery for a 20% chance to win a $100 Amazon.com
gift card will be provided for completing a PrEP evaluation
|
No financial incentive
|
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 |
---|---|---|
PrEP evaluation
時間枠:30 days
|
Completion of PrEP evaluation
|
30 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
その他の研究ID番号
- 2020P002907
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?
IPD プランの説明
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
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の臨床試験
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