WISSPR研究の混合メソッドプロトコル (WiSSPr)
WISSPR研究のための混合メソッドプロトコル：ザンビアの曝露前予防に対する性的仕事、スティグマ、心理社会的障壁の女性
WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH).
調査の概要
詳細な説明
WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH). The study will administer a one-time psychosocial survey vetted by the CAB and follow 300 WESW in the electronic medical record for three months to measure PrEP initiation (#/% ever taking PrEP) and persistence (immediate discontinuation and a medication possession ratio). The study will conduct in-depth interviews with a purposive sample of 18 women, including 12 WESW and 6 peer navigators who support routine HIV screening and PrEP delivery, in two community hubs serving KPs since October 2021. The study seeks to value KP communities as equal contributors to the knowledge production process by actively engaging KP-CSOs throughout the research process. Expected outcomes include quantitative measures of PrEP initiation and persistence among WESW, and qualitative insights into the enablers and barriers to PrEP use informed by participants' lived experiences. https://doi.org/10.1136/bmjopen-2023-080218
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Lusaka、ザンビア
- Centre for Infectious Disease Research Zambia
-
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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
受講資格のある性別
サンプリング方法
調査対象母集団
The study population is composed of adult WESW who are living or working within the catchment areas of two community hubs located within urban Lusaka. Based on CIDRZ's prior published work, we anticipate that the study population will be comprised largely (63%) of younger women (18 - 29 years old).
説明
Inclusion Criteria
Participants must meet all of the following criteria:
- Identify as a cisgender or transgender woman.
- Be 18 years of age or older.
- Earn a significant amount of income from exchanging sex for money or goods within the last 3 months.
- Be HIV-negative and eligible for PrEP according to national guidelines.
- Not be planning to transfer care to another site within the next 30 days.
- Speak English, ChiNyanja, or IchiBemba.
- Be willing and able to provide written informed consent.
Exclusion Criteria
Participants will be excluded if they meet any of the following criteria:
- Do not identify as a woman.
- Are under 18 years of age.
- Have not earned a significant amount of income from exchanging sex for money or goods, or have done so for less than 3 months.
- Are HIV-positive, have an unknown HIV status, or are ineligible for PrEP.
- Are planning to transfer care to another site within the next 30 days.
- Are unable to speak English, ChiNyanja, or IchiBemba.
- Are unwilling or unable to provide written informed consent.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
PrEP initiators
women who initiate on PrEP |
oral PrEP |
|
PrEP refusers
women who refuse PrEP |
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 initiation (#/% ever taken PrEP)
時間枠：3 months
|
PrEP initiation (Number or percentage of Women Engaging in Sex Work (WESW) initiating on PrEP) |
3 months
|
|
PrEP Persistence (#/ % eligible refills obtained until first discontinuation)
時間枠：3 months
|
PrEP persistence. Number or percentage of women engaging in sex work with high levels of stigma who will persist on PrEP |
3 months
|
協力者と研究者
捜査官
- 主任研究者：Ramya Kumar, PhD, MPH、University of Washington
出版物と役立つリンク
便利なリンク
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
その他の研究ID番号
- UJMT Fogarty Fellowship 2023
- D43TW009340 (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
Vulnerable population of sex workers in a country where sex work is largely criminalized, and there is a risk of harm if the data is identifiable even with common identifiers like name is removed.
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。