Assisted Partner Notification to Augment HIV Treatment and Prevention in Kenya (APS)
The main purpose of this implementation science study is to find out if providing aPS at 18 different Ministry of Health (MOH) VCT clinics in Kenya works and is cost-effective. This would enable co-investigators in the Kenyan MOH to justify funding to scale-up these services.
The primary aim of the study is to find out whether providing aPS to sexual partners of newly tested HIV-infected individuals can result in more sexual partners getting counseled and HIV tested and linked to HIV care programs for initiation of ART if appropriate. The investigators hypothesize that aPS will increase rates of case-finding, linkages to care, and ART initiation and will not result in social harm.
The second aim is whether aPS is cost-effective in the Kenyan setting. The investigators will estimate how much it costs (when compared to standard methods) to identify and link HIV-infected persons into care. The investigators will also determine how successful aPS is at preventing future HIV transmission events and other outcomes associated with untreated HIV infection. The investigators hypothesize that HIV prevalence among partners in the immediate aPS arm will be high enough to make this approach cost-effective from the payer and societal perspective.
Finally, with the Kenya MOH, the investigators want to establish a nationwide monitoring system to evaluate why Kenyans are testing for HIV. In the future, when aPS is rolled out nationally, this will help Kenyan public health officials define the contribution of aPS to HIV case-finding. The investigators hypothesize that the proportion of newly tested HIV-infected individuals who report testing because of known exposure to a person with HIV will represent a significant proportion of new cases and the investigators will be able to identify places in Kenya where aPS will have the greatest impact on HIV treatment and prevention.
調査の概要
詳細な説明
Diagnosing HIV soon after infection can benefit individuals and also has important public health benefits. It has been shown that starting antiretroviral therapy (ART) before HIV has progressed results in a better response to treatment and gives the person a better chance of long-term survival with HIV. Treating HIV can also reduce the risk that someone will transmit HIV to his or her sexual partners. The first step in achieving these individual and population level benefits is testing people for HIV. Unfortunately, in many parts of the world, including Kenya where we plan to conduct this study, many people are not tested regularly and do not know that they are infected. This study involves providing a public health service, notification of an exposure to a communicable disease and HIV testing, to sexual partners of those who test HIV-positive at voluntary counseling and testing (VCT) clinics in Kenya. Sexual partners are identified voluntarily by the person who tests at the VCT. A public health provider then goes to the home of the sexual partners to offer them HIV counseling and testing. This process is called provision of assisted partner services (aPS).
We propose a cluster randomized clinical trial which will be conducted in collaboration with the Kenya Ministry of Health (MOH) at 18 rural and urban voluntary counseling and testing (VCT) facilities across Kenya. Proposed activities will assess the effectiveness and cost-effectiveness of providing aPS, improve capacity for program implementation in Kenya, and lay the foundation for evaluating the program's impact at the national level.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Kiambu、ケニア
- Karuri VCT
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Kiambu、ケニア
- Kiambu Hospital VCT
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Kiambu、ケニア
- Kirwara VCT
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Kisumu、ケニア
- Chulaimbo Health Centre
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Kisumu、ケニア
- Joo Trh Vct
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Kisumu、ケニア
- Kisumu East District Hospital
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Kisumu、ケニア
- Kombewa VCT
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Maseno、ケニア
- Maseno Mission
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Nairobi、ケニア
- Baba Dogo VCT
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Nairobi、ケニア
- Casino VCT
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Nairobi、ケニア
- Huruma Lions
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Nairobi、ケニア
- Kariobangi VCT
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Nairobi、ケニア
- Kenyatta National Hospital (KNH) VCT
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Nairobi、ケニア
- Mama Lucy Kibaki VCT
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Nairobi、ケニア
- Mbagathi VCT
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Nairobi、ケニア
- Pumwani VCT
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Siaya、ケニア
- Abidha Health Centre
-
Siaya、ケニア
- Ongielo Health Centre
-
-
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:
- Written informed consent is required of all participants. All participants must be 18 years or older.
- Index case participants must be HIV-seropositive, and willing and able to provide locator information for sexual partners in the past three years.
Exclusion Criteria:
- Index cases will be excluded from participation if they are pregnant, or have reported intimate partner violence during the last month. There is no exclusion criteria for partner participants.
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 |
|---|---|
|
介入なし：Delayed aPS
|
|
|
実験的：Immediate aPS
|
Assisted-partner notification services (aPS) is a public health service which notifies the partners of those who test positive for a communicable disease of their exposure.
他の名前：
|
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 |
|---|---|---|
|
Number of partners testing for HIV
時間枠：6 week period following index case enrollment
|
The number of partners of an index participant that were tested for HIV (offset will be the number of partners with locator information provided by the index participant).
|
6 week period following index case enrollment
|
|
Newly tested HIV-infected partners
時間枠：6 week period following index case enrollment
|
The number of partners of an index participant identified as HIV-infected (offset will be the number of partners of that index participant who were HIV tested).
|
6 week period following index case enrollment
|
|
Number of partners linking to HIV care
時間枠：6 week period following index case enrollment
|
The number of partners of an index participant who were linked to HIV care (offset will be the number of partners of an index participant identified as HIV-infected and analysis will be limited to index participants with at least one HIV-infected partner.)
|
6 week period following index case enrollment
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incremental cost-effectiveness from payer and societal perspectives
時間枠：6 week period following index case enrollment
|
6 week period following index case enrollment
|
|
Proportion of individuals with newly diagnosed HIV infection who report testing because of known exposure to a person with HIV
時間枠：6 week period after index case enrollment
|
6 week period after index case enrollment
|
|
Costs of identifying >1 partner per index case
時間枠：6 week period after index case enrollment
|
6 week period after index case enrollment
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Carey Farquhar, MD, MPH、University of Washington
- スタディチェア：Peter Cherutich, MBChB, MPH、Kenya Ministry of Health
- スタディチェア：Matthew Golden, MD, MPH、University of Washington
出版物と役立つリンク
一般刊行物
- Cherutich P, Golden MR, Wamuti B, Richardson BA, Asbjornsdottir KH, Otieno FA, Ng'ang'a A, Mutiti PM, Macharia P, Sambai B, Dunbar M, Bukusi D, Farquhar C; aPS Study Group. Assisted partner services for HIV in Kenya: a cluster randomised controlled trial. Lancet HIV. 2017 Feb;4(2):e74-e82. doi: 10.1016/S2352-3018(16)30214-4. Epub 2016 Nov 30.
- Wamuti BM, Erdman LK, Cherutich P, Golden M, Dunbar M, Bukusi D, Richardson B, Ng'ang'a A, Barnabas R, Mutiti PM, Macharia P, Jerop M, Otieno FA, Poole D, Farquhar C. Assisted partner notification services to augment HIV testing and linkage to care in Kenya: study protocol for a cluster randomized trial. Implement Sci. 2015 Feb 13;10:23. doi: 10.1186/s13012-015-0212-6.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
- 43628
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