Community-based Combination HIV Prevention in Tanzanian Women
Community-based Combination HIV Prevention in Tanzanian Women at Heightened Risk
調査の概要
状態
条件
詳細な説明
Combination HIV prevention demonstrates significant promise in reducing burden of disease. To maximize its effectiveness combination prevention must be tailored to a given context and population. From the beginning of the global HIV epidemic, female sex workers (FSWs) have been found to be at heightened risk for infection. More recently the role that sex work plays in ongoing HIV transmission dynamics has been more clearly established in generalized epidemics, where previously limited attention was paid to the role of key populations. The greater vulnerability of FSWs is now widely understood to be associated with social and structural factors including the intense stigma, discrimination and violence they often face and the unsafe environments in which they live and work. These factors are known to limit both protective sexual behaviors and engagement in HIV testing, care and treatment services. Comprehensive, community-based HIV prevention approaches addressing the aforementioned social and structural vulnerabilities to HIV infection among FSWs have been shown to be effective in South Asia and in Latin America. However, in sub-Saharan Africa where the impact of HIV is the greatest, no systematic efforts to develop and evaluate the feasibility and effectiveness of community-based combination HIV prevention among FSWs has occurred.
The investigators will conduct a two-arm Phase II community randomized controlled trial of a community-based combination HIV prevention intervention among FSWs in Iringa, Tanzania. The model was developed on the basis of prior formative research and mapping and utilizes an ongoing research infrastructure. The combination package will include integrated biomedical, behavioral and structural components: (1) mobile HIV testing and risk reduction counseling; (2) service navigation to facilitate access to treatment and retention in care; (3) sensitivity training for HIV clinical care providers; (4) SMS text messages to promote adherence to care and ART; (5) venue-based peer education and condom distribution; and (6) a community drop-in-center to promote cohesion and collective action to reduce stigma and discrimination. The investigators seek to establish base rates of key outcomes including HIV incidence and viral load suppression, examine the socio-structural and behavioral pathways of the intervention, assess feasibility, acceptability and safety, and document preliminary effectiveness. Should compelling indications of safety, feasibility, acceptability and initial effectiveness be found, study results will inform the first Phase III RCT of community-based combination HIV prevention among FSWs.
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
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-
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Iringa、タンザニア
- MUHAS
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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
説明
Inclusion Criteria:
- 18 years old, female, exchange sex for money in entertainment venue
- key informants working on HIV among sex workers in the region.
Exclusion Criteria:
- Psychiatric/psychological condition impeding 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
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:ダブル
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:Combination prevention
Community-based, combination HIV prevention intervention package
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The combination package will include integrated biomedical, behavioral and structural components: (1) mobile HIV testing and risk reduction counseling; (2) service navigation to facilitate access to treatment and retention in care; (3) sensitivity training for HIV clinical care providers; (4) SMS text messages to promote adherence to care and ART; (5) venue-based peer education and condom distribution; and (6) a community drop-in-center to promote cohesion and collective action to reduce stigma and discrimination.
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アクティブコンパレータ:Standard of care
Locally run standard of care HIV prevention, treatment and care services
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Locally available standard of care HIV prevention, treatment and care services
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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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HIV incidence
時間枠:18 months
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Biologic assessment of new infections among HIV-uninfected participants via blood draw
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18 months
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Viral load suppression
時間枠:18 months
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Biological assessment of viral suppression among HIV-infected participants via blood draw
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18 months
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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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Consistent condom use
時間枠:18 months
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Consistent condom use with clients among all participants via survey measures
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18 months
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Adherence to ART
時間枠:18 months
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Adherence to ART medication among those living with HIV via survey measures
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18 months
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協力者と研究者
捜査官
- 主任研究者:Deanna L Kerrigan, PhD, MPH、Johns Hopkins Bloomberg School of Public Health
出版物と役立つリンク
一般刊行物
- Kerrigan D, Mbwambo J, Likindikoki S, Davis W, Mantsios A, Beckham SW, Leddy A, Shembilu C, Mwampashi A, Aboud S, Galai N. Project Shikamana: Community Empowerment-Based Combination HIV Prevention Significantly Impacts HIV Incidence and Care Continuum Outcomes Among Female Sex Workers in Iringa, Tanzania. J Acquir Immune Defic Syndr. 2019 Oct 1;82(2):141-148. doi: 10.1097/QAI.0000000000002123.
- Kerrigan D, Mbwambo J, Likindikoki S, Beckham S, Mwampashi A, Shembilu C, Mantsios A, Leddy A, Davis W, Galai N. Project Shikamana: Baseline Findings From a Community Empowerment-Based Combination HIV Prevention Trial Among Female Sex Workers in Iringa, Tanzania. J Acquir Immune Defic Syndr. 2017 Jan 1;74 Suppl 1(Suppl 1):S60-S68. doi: 10.1097/QAI.0000000000001203.
- Beckham SW, Mantsios A, Galai N, Likindikoki S, Mbwambo J, Davis W, Kerrigan D. Acceptability of multiple modalities of pre-exposure prophylaxis (PrEP) among female sex workers in Tanzania: a mixed-methods study. BMJ Open. 2022 Aug 17;12(8):e058611. doi: 10.1136/bmjopen-2021-058611.
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 (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
キーワード
その他の研究ID番号
- R01MH104044 (米国 NIH グラント/契約)
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