Improving Choice And Use Of Biomedical HIV Prevention For Women In Uganda: A Couples-based Approach (CUPID)
調査の概要
詳細な説明
This is a hybrid type 1 effectiveness-implementation study designed to refine, evaluate effectiveness, and assess implementation of a couples-based shared decision-making intervention (CUPID) within public health settings where HIV pre-exposure prophylaxis (PrEP) choice is offered to women in Uganda. The following are the aims of the study:
Aim 1: Refine CUPID intervention content and implementation to support women's PrEP choice and use in public health settings.
Aim 2: Assess the effectiveness of the CUPID intervention on PrEP use (uptake, persistence, and adherence) among Ugandan women.
Aim 3: Assess CUPID intervention implementation outcomes, and barriers and strategies to address them, to inform the adoption and integration of CUPID to support women's PrEP uptake and use.
The study population will include (Aim 1): PrEP delivery staff, Peer navigators & stakeholders; and (Aims 2 and 3): Women accessing PrEP and their sexual partners; PrEP delivery staff.
Sites will be drawn from high-volume health facilities providing PrEP choice in Uganda, including Gulu Regional Referral Hospital, Namakwekwe Health Centre III, Kitgum Hospital, Bison Health Centre III, Mukono Hospital and Wakiso Health Center IV. Sites will include health facilities and the community catchment areas where services are delivered.
The CUPID decision tool offers a patient-centered approach to encourage an informed and active role in decision making by providing couples with knowledge about available PrEP options, encouraging shared responsibility for HIV prevention, and helping to clarify their needs and values relevant to prevention decisions.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Kampala、ウガンダ
- 募集
- Makerere University-Johns Hopkins University Research Collaboration MU-JHU Care
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コンタクト：
- Dr. Brenda Gati Mirembe, MBChB, MSc
- 電話番号：(+256) 200 404 100
- メール：bgati@mujhu.org
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
All Aims:
- Able and willing to provide written informed consent
- Fluent in English or the dominant language spoken in the health facility's region.
Aim 1:
- Age ≥18 years
Meets one of the following criteria:
- Performs tasks related to PrEP outreach and/or delivery in former CATALYST study areas. This may include clinic and non-clinic positions.
- Is a member of one of the three regional CATALYST CABs
- Willing to participate in a focus group discussion
Aim 2:
- Aged 18 years or older
- Attending a PrEP follow-up visit
- Able and willing to complete all study procedures.
Aim 3:
- Age ≥18 years
Meets one of the following criteria:
- CUPID couples' decision tool user
- A CUPID intervention provider (member of a CHT or other PrEP Provider)
- A provider offering PrEP choice through a health facility where CUPID is implemented
- MOH or District Health Official
- Willing to complete a questionnaire and participate in a qualitative interview (individual or dyadic)
Exclusion Criteria:
All Aims: Participants will be excluded who have any condition that, in the opinion of the MPI or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Aim 2:
Exclusion criteria: Participants aged 15-17 years
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：なし
- 介入モデル：順次割り当て
- 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：CUPID shared decision-making counseling intervention
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The CUPID shared decision-making counseling intervention involves delivery of a paper-based, shared decision-making tool in community and clinic settings by PrEP delivery staff and Community Health Teams affiliated with each health facility.
The intervention is designed as a single session in which a couple will go through the decision tool, guided by a trained member of a Community Health Team (which can include Community Health Extension Workers, Peer Educators, PrEP Ambassadors, Village Health Teams, or other personnel affiliated with MOH clinics trained to operate in communities), with onsite support, as needed, from a PrEP delivery staff, counselors, or other health providers.
The CUPID shared decision-making model provides a patient-centered approach to encourage an informed and active role in decision making by providing couples with knowledge about the available options and helping to clarify their needs and values relevant to the decision.
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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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PrEP persistence
時間枠：Weekly for 48 weeks
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Number of PrEP refill/administration visits by women per week: 2nd refill visits for oral PrEP, PrEP ring and injectable cabotegravir (~3 month persistence); 1st refill (at 6 months) for injectable lenacapavir
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Weekly for 48 weeks
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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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PrEP uptake
時間枠：Weekly for 64 weeks
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Number of PrEP initiations by women per week
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Weekly for 64 weeks
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6-month PrEP persistence
時間枠：Weekly for 36 weeks
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Number of 6-month PrEP refill/administration visits per week
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Weekly for 36 weeks
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PrEP use: Objective adherence
時間枠：Weekly for 48 weeks
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Percentage of adherence objective markers collected at the PrEP refill/administration visit per week demonstrating adherent PrEP use.
PrEP refill visits will be 2nd refill visits for oral PrEP, PrEP ring and injectable cabotegravir (~3 months after initiation); 1st refill (at 6 months) for injectable lenacapavir
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Weekly for 48 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Brenda Gati Mirembe, MBChB, MSc、Makerere University-Johns Hopkins Research Collaboration /MU-JHU CARE LTD
- 主任研究者：Carolyne A Akello, MBChB, MSc、MU-JHU Research Collaboration/ Ministry of Health
- 主任研究者：Alexandra M Minnis, PhD, MPH、RTI International
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
- R01MH137873 (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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- ICF
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。