博茨瓦纳联合预防项目 (BCPP)
2022年11月9日 更新者：Centers for Disease Control and Prevention
博茨瓦纳联合预防项目： - 评估方案（方案 #1）：研究设计和影响评估 - 封闭临床队列方案（方案 #3）在博茨瓦纳农村和城郊社区实施、监测和评估艾滋病毒综合预防干预措施
BCPP 研究旨在检验以下假设，即实施包括向所有参与者提供 ART 在内的强化组合预防方案，无论 CD4 计数或 HIV 疾病的严重程度如何，将通过显着降低人口水平、累积 HIV 来影响 HIV/AIDS 流行。 3 年内确定的地理区域内的发病率，并且具有成本效益。
研究概览
研究类型
介入性
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Multiple
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Multiple Locations、Multiple、博茨瓦纳
- Botswana communities and Botswana Ministry of Health clinics
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 64年 (成人、孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 方案 #1 - 基线家庭调查 (BHS)：30 个研究社区中任何一个的永久或兼职研究社区居民；博茨瓦纳公民或博茨瓦纳公民的配偶；如果年满 18 岁，则能够提供知情同意，或者如果是未成年人（16 或 17 岁），则能够提供同意以补充监护人的许可。
- 方案 #3 - 扩大治疗队列：尚未接受抗逆转录病毒治疗的联合预防社区中的 HIV 感染者如果年满 18 岁则能够提供知情同意，或者如果未成年人能够提供同意以补充监护人的许可（ 16 或 17 岁）。
排除标准：
- 不符合纳入标准的人。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：平行线
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：联合预防
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ACTIVE_COMPARATOR：加强护理
增强型护理社区将在个人接受 HIV 护理和治疗的所有当地诊所获得质量管理和数据系统方面的指导和改进的技术支持。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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人口水平的艾滋病毒累积发病率
大体时间：3年
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人口水平的累积 HIV 发病率将在每年跟踪的 30 个研究社区中从 20% 的符合条件的家庭样本中确定的 HIV 阴性人群中进行测量。
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3年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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2. HIV 检测和咨询 (HTC)、ART、VL 抑制、男性包皮环切术 (MC) 和 PMTCT 服务的人群接受程度
大体时间：3年
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将通过对 30 个研究社区中 20% 的符合条件的家庭样本进行年度调查，并通过对常规项目监测数据的分析来衡量每项干预措施在人群层面的采用情况。
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3年
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避免额外感染的成本
大体时间：3年
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3年
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Janet S Moore, PhD、Centers for Disease Control and Prevention
- 首席研究员：Myron Essex, DVM, PhD、Harvard School of Public Health (HSPH)
- 首席研究员：Refeletswe Lebelonyane, MD、Botswana Ministry of Health
- 首席研究员：Shenaaz El Halabi, MPH、Botswana Ministry of Health
- 首席研究员：Joseph Makhema, MBChB, FRCP、Botswana Harvard AIDS Institute Partnership
- 首席研究员：Eric Tchetgen Tchetgen, PhD、Harvard School of Public Health (HSPH)
- 首席研究员：Molly Pretorius Holme, MS、Harvard School of Public Health (HSPH)
- 首席研究员：Pam Bachanas, PhD、Centers for Disease Control and Prevention
- 首席研究员：Tafireyi Marukutira, MD、Centers for Disease Control and Prevention
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Moyo S, Gaseitsiwe S, Mohammed T, Pretorius Holme M, Wang R, Kotokwe KP, Boleo C, Mupfumi L, Yankinda EK, Chakalisa U, van Widenfelt E, Gaolathe T, Mmalane MO, Dryden-Peterson S, Mine M, Lebelonyane R, Bennett K, Leidner J, Wirth KE, Tchetgen Tchetgen E, Powis K, Moore J, Clarke WA, Lockman S, Makhema JM, Essex M, Novitsky V. Cross-sectional estimates revealed high HIV incidence in Botswana rural communities in the era of successful ART scale-up in 2013-2015. PLoS One. 2018 Oct 24;13(10):e0204840. doi: 10.1371/journal.pone.0204840. eCollection 2018.
- Novitsky V, Gaolathe T, Mmalane M, Moyo S, Chakalisa U, Yankinda EK, Marukutira T, Holme MP, Sekoto T, Gaseitsiwe S, Musonda R, van Widenfelt E, Powis KM, Khan N, Dryden-Peterson S, Bennett K, Wirth KE, Tchetgen ET, Bachanas P, Mills LA, Lebelonyane R, El-Halabi S, Makhema J, Lockman S, Essex M. Lack of Virological Suppression Among Young HIV-Positive Adults in Botswana. J Acquir Immune Defic Syndr. 2018 Aug 15;78(5):557-565. doi: 10.1097/QAI.0000000000001715.
- Moyo S, Gaseitsiwe S, Powis KM, Pretorius Holme M, Mohammed T, Zahralban-Steele M, Yankinde EK, Maphorisa C, Abrams W, Lebelonyane R, Manyake K, Sekoto T, Mmalane M, Gaolathe T, Wirth KE, Makhema J, Lockman S, Clarke W, Essex M, Novitsky V. Undisclosed antiretroviral drug use in Botswana: implication for national estimates. AIDS. 2018 Jul 17;32(11):1543-1546. doi: 10.1097/QAD.0000000000001862.
- Novitsky V, Prague M, Moyo S, Gaolathe T, Mmalane M, Yankinda EK, Chakalisa U, Lebelonyane R, Khan N, Powis KM, Widenfelt E, Gaseitsiwe S, Dryden-Peterson SL, Holme MP, De Gruttola V, Bachanas P, Makhema J, Lockman S, Essex M. High HIV-1 RNA Among Newly Diagnosed People in Botswana. AIDS Res Hum Retroviruses. 2018 Mar;34(3):300-306. doi: 10.1089/AID.2017.0214. Epub 2018 Jan 17.
- Moyo S, Mohammed T, Wirth KE, Prague M, Bennett K, Holme MP, Mupfumi L, Sebogodi P, Moraka NO, Boleo C, Maphorisa CN, Seraise B, Gaseitsiwe S, Musonda RM, van Widenfelt E, Powis KM, Gaolathe T, Tchetgen Tchetgen EJ, Makhema JM, Essex M, Lockman S, Novitsky V. Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable. J Clin Microbiol. 2016 Dec;54(12):3050-3055. doi: 10.1128/JCM.01594-16. Epub 2016 Oct 12.
- Gaolathe T, Wirth KE, Holme MP, Makhema J, Moyo S, Chakalisa U, Yankinda EK, Lei Q, Mmalane M, Novitsky V, Okui L, van Widenfelt E, Powis KM, Khan N, Bennett K, Bussmann H, Dryden-Peterson S, Lebelonyane R, El-Halabi S, Mills LA, Marukutira T, Wang R, Tchetgen EJ, DeGruttola V, Essex M, Lockman S; Botswana Combination Prevention Project study team. Botswana's progress toward achieving the 2020 UNAIDS 90-90-90 antiretroviral therapy and virological suppression goals: a population-based survey. Lancet HIV. 2016 May;3(5):e221-30. doi: 10.1016/S2352-3018(16)00037-0. Epub 2016 Mar 24.
- Novitsky V, Zahralban-Steele M, McLane MF, Moyo S, van Widenfelt E, Gaseitsiwe S, Makhema J, Essex M. Correction for Novitsky et al., Long-Range HIV Genotyping Using Viral RNA and Proviral DNA for Analysis of HIV Drug Resistance and HIV Clustering. J Clin Microbiol. 2016 Apr;54(4):1175. doi: 10.1128/JCM.00190-16. No abstract available.
- Perriat D, Balzer L, Hayes R, Lockman S, Walsh F, Ayles H, Floyd S, Havlir D, Kamya M, Lebelonyane R, Mills LA, Okello V, Petersen M, Pillay D, Sabapathy K, Wirth K, Orne-Gliemann J, Dabis F; Universal Test and Treat Trials Consortium (UT3C). Comparative assessment of five trials of universal HIV testing and treatment in sub-Saharan Africa. J Int AIDS Soc. 2018 Jan;21(1):e25048. doi: 10.1002/jia2.25048.
- Novitsky V, Zahralban-Steele M, Moyo S, Nkhisang T, Maruapula D, McLane MF, Leidner J, Bennett K; PANGEA Consortium; Wirth KE, Gaolathe T, Kadima E, Chakalisa U, Pretorius Holme M, Lockman S, Mmalane M, Makhema J, Gaseitsiwe S, DeGruttola V, Essex M. Mapping of HIV-1C Transmission Networks Reveals Extensive Spread of Viral Lineages Across Villages in Botswana Treatment-as-Prevention Trial. J Infect Dis. 2020 Nov 15;222(10):1670-1680. doi: 10.1093/infdis/jiaa276. Epub 2020 Jun 3.
- Lebelonyane R, Mills LA, Mogorosi C, Ussery F, Marukutira T, Theu J, Kapanda M, Matambo S, Block L, Raizes E, Makhema J, Lockman S, Bachanas P, Moore J, Jarvis JN. Advanced HIV disease in the Botswana combination prevention project: prevalence, risk factors, and outcomes. AIDS. 2020 Dec 1;34(15):2223-2230. doi: 10.1097/QAD.0000000000002627.
- Lockman S, Holme MP, Makhema J, Bachanas P, Moore J, Wirth KE, Lebelonyane R, Essex M. Implementation of Universal HIV Testing and Treatment to Reduce HIV Incidence in Botswana: the Ya Tsie Study. Curr HIV/AIDS Rep. 2020 Oct;17(5):478-486. doi: 10.1007/s11904-020-00523-0.
- Lebelonyane R, Bachanas P, Block L, Ussery F, Abrams W, Roland M, Theu J, Kapanda M, Matambo S, Lockman S, Gaolathe T, Makhema J, Moore J, Jarvis JN. Rapid antiretroviral therapy initiation in the Botswana Combination Prevention Project: a quasi-experimental before and after study. Lancet HIV. 2020 Aug;7(8):e545-e553. doi: 10.1016/S2352-3018(20)30187-9.
- Alwano MG, Bachanas P, Block L, Roland M, Sento B, Behel S, Lebelonyane R, Wirth K, Ussery F, Bapati W, Motswere-Chirwa C, Abrams W, Ussery G, Miller JA, Bile E, Fonjungo P, Kgwadu A, Holme MP, Del Castillo L, Gaolathe T, Leme K, Majingo N, Lockman S, Makhema J, Bock N, Moore J. Increasing knowledge of HIV status in a country with high HIV testing coverage: Results from the Botswana Combination Prevention Project. PLoS One. 2019 Nov 25;14(11):e0225076. doi: 10.1371/journal.pone.0225076. eCollection 2019.
- Kebaabetswe P, Manyake K, Kadima E, Auletta-Young C, Chakalisa U, Sekoto T, Dintwa OM, Mmalane M, Makhema J, Lebelonyane R, Bachanas P, Plank R, Gaolathe T, Lockman S, Holme MP. Barriers and facilitators to linkage to care and ART initiation in the setting of high ART coverage in Botswana. AIDS Care. 2020 Jun;32(6):722-728. doi: 10.1080/09540121.2019.1640843. Epub 2019 Jul 12.
- Chakalisa U, Wirth K, Bennett K, Kadima E, Manyake K, Gaolathe T, Bachanas P, Marukutira T, Lebelonyane R, Dryden-Peterson S, Butler L, Mmalane M, Makhema J, Roland ME, Pretorius-Holme M, Essex M, Lockman S, Powis KM. Self-reported risky sexual practices among adolescents and young adults in Botswana. South Afr J HIV Med. 2019 Jun 26;20(1):899. doi: 10.4102/sajhivmed.v20i1.899. eCollection 2019.
- Moyo S, Gaseitsiwe S, Zahralban-Steele M, Maruapula D, Nkhisang T, Mokaleng B, Mohammed T, Ditlhako TR, Bareng OT, Mokgethi TP, van Widenfelt E, Pretorius-Holme M, Mine MO, Raizes E, Yankinda EK, Wirth KE, Gaolathe T, Makhema JM, Lockman S, Essex M, Novitsky V. Low rates of nucleoside reverse transcriptase inhibitor and nonnucleoside reverse transcriptase inhibitor drug resistance in Botswana. AIDS. 2019 May 1;33(6):1073-1082. doi: 10.1097/QAD.0000000000002166.
- Lasry A, Bachanas P, Suraratdecha C, Alwano MG, Behel S, Pals S, Block L, Moore J. Cost of Community-Based HIV Testing Activities to Reach Saturation in Botswana. AIDS Behav. 2019 Apr;23(4):875-882. doi: 10.1007/s10461-019-02408-9.
- Molebatsi K, Gabaitiri L, Mokgatlhe L, Moyo S, Gaseitsiwe S, Wirth KE, DeGruttola V, Tchetgen Tchetgen E. Efficient estimation of human immunodeficiency virus incidence rate using a pooled cross-sectional cohort study design. Stat Med. 2020 Oct 30;39(24):3255-3271. doi: 10.1002/sim.8661. Epub 2020 Sep 1.
- Bareng OT, Seselamarumo S, Seatla KK, Choga WT, Bakae B, Maruapula D, Kelentse N, Moraka NO, Mokaleng B, Mokgethi PT, Ditlhako TR, Pretorius-Holme M, Mbulawa MB, Lebelonyane R, Bile EC, Gaolathe T, Shapiro R, Makhema JM, Lockman S, Essex M, Novitsky V, Mpoloka SW, Moyo S, Gaseitsiwe S. Doravirine-associated resistance mutations in antiretroviral therapy naive and experienced adults with HIV-1 subtype C infection in Botswana. J Glob Antimicrob Resist. 2022 Dec;31:128-134. doi: 10.1016/j.jgar.2022.08.008. Epub 2022 Aug 13.
- Bhebhe L, Moyo S, Gaseitsiwe S, Pretorius-Holme M, Yankinda EK, Manyake K, Kgathi C, Mmalane M, Lebelonyane R, Gaolathe T, Bachanas P, Ussery F, Letebele M, Makhema J, Wirth KE, Lockman S, Essex M, Novitsky V, Ragonnet-Cronin M. Epidemiological and viral characteristics of undiagnosed HIV infections in Botswana. BMC Infect Dis. 2022 Aug 28;22(1):710. doi: 10.1186/s12879-022-07698-4.
- Marukutira T, Ussery F, Kadima E, Mills LA, Moore J, Block L, Bachanas P, Davis S, Schissler T, Mosha R, Komotere O, Diswai T, Ntsuape C, Lebelonyane R, Bock N. Male circumcision uptake during the Botswana Combination Prevention Project. PLoS One. 2022 Jun 15;17(6):e0269178. doi: 10.1371/journal.pone.0269178. eCollection 2022.
- Ussery F, Bachanas P, Alwano MG, Lebelonyane R, Block L, Wirth K, Ussery G, Sento B, Gaolathe T, Kadima E, Abrams W, Segolodi T, Hader S, Lockman S, Moore J. HIV Incidence in Botswana Rural Communities With High Antiretroviral Treatment Coverage: Results From the Botswana Combination Prevention Project, 2013-2017. J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):9-16. doi: 10.1097/QAI.0000000000003017.
- Bareng OT, Moyo S, Zahralban-Steele M, Maruapula D, Ditlhako T, Mokaleng B, Mokgethi P, Choga WT, Moraka NO, Pretorius-Holme M, Mine MO, Raizes E, Molebatsi K, Motswaledi MS, Gobe I, Mohammed T, Gaolathe T, Shapiro R, Mmalane M, Makhema JM, Lockman S, Essex M, Novitsky V, Gaseitsiwe S. HIV-1 drug resistance mutations among individuals with low-level viraemia while taking combination ART in Botswana. J Antimicrob Chemother. 2022 Apr 27;77(5):1385-1395. doi: 10.1093/jac/dkac056.
- Magosi LE, Zhang Y, Golubchik T, DeGruttola V, Tchetgen Tchetgen E, Novitsky V, Moore J, Bachanas P, Segolodi T, Lebelonyane R, Pretorius Holme M, Moyo S, Makhema J, Lockman S, Fraser C, Essex MM, Lipsitch M; Botswana Combination Prevention Project and PANGEA consortium. Deep-sequence phylogenetics to quantify patterns of HIV transmission in the context of a universal testing and treatment trial - BCPP/Ya Tsie trial. Elife. 2022 Mar 1;11:e72657. doi: 10.7554/eLife.72657.
- Seatla KK, Maruapula D, Choga WT, Morerinyane O, Lockman S, Novitsky V, Kasvosve I, Moyo S, Gaseitsiwe S. Limited HIV-1 Subtype C nef 3'PPT Variation in Combination Antiretroviral Therapy Naive and Experienced People Living with HIV in Botswana. Pathogens. 2021 Aug 13;10(8):1027. doi: 10.3390/pathogens10081027.
- Resch SC, Foote JHA, Wirth KE, Lasry A, Scott JA, Moore J, Shebl FM, Gaolathe T, Feser MK, Lebelonyane R, Hyle EP, Mmalane MO, Bachanas P, Yu L, Makhema JM, Holme MP, Essex M, Alwano MG, Lockman S, Freedberg KA. Health Impact and Cost-Effectiveness of HIV Testing, Linkage, and Early Antiretroviral Treatment in the Botswana Combination Prevention Project. J Acquir Immune Defic Syndr. 2022 Aug 1;90(4):399-407. doi: 10.1097/QAI.0000000000002996. Epub 2022 Apr 14.
- Lebelonyane R, Bachanas P, Block L, Ussery F, Alwano MG, Marukutira T, El Halabi S, Roland M, Abrams W, Ussery G, Miller JA, Lockman S, Gaolathe T, Holme MP, Hader S, Mills LA, Wirth K, Bock N, Moore J. To achieve 95-95-95 targets we must reach men and youth: High level of knowledge of HIV status, ART coverage, and viral suppression in the Botswana Combination Prevention Project through universal test and treat approach. PLoS One. 2021 Aug 10;16(8):e0255227. doi: 10.1371/journal.pone.0255227. eCollection 2021.
- Bachanas P, Alwano MG, Lebelonyane R, Block L, Behel S, Raizes E, Ussery G, Wang H, Ussery F, Pretorius Holme M, Sexton C, Pals S, Lasry A, Del Castillo L, Hader S, Lockman S, Bock N, Moore J. Finding, treating and retaining persons with HIV in a high HIV prevalence and high treatment coverage country: Results from the Botswana Combination Prevention Project. PLoS One. 2021 Apr 21;16(4):e0250211. doi: 10.1371/journal.pone.0250211. eCollection 2021.
- Wirth KE, Gaolathe T, Pretorius Holme M, Mmalane M, Kadima E, Chakalisa U, Manyake K, Matildah Mbikiwa A, Simon SV, Letlhogile R, Mukokomani K, van Widenfelt E, Moyo S, Bennett K, Leidner J, Powis KM, Lebelonyane R, Alwano MG, Jarvis J, Dryden-Peterson SL, Kgathi C, Moore J, Bachanas P, Raizes E, Abrams W, Block L, Sento B, Novitsky V, El-Halabi S, Marukutira T, Mills LA, Sexton C, Pals S, Shapiro RL, Wang R, Lei Q, DeGruttola V, Makhema J, Essex M, Lockman S, Tchetgen Tchetgen EJ. Population uptake of HIV testing, treatment, viral suppression, and male circumcision following a community-based intervention in Botswana (Ya Tsie/BCPP): a cluster-randomised trial. Lancet HIV. 2020 Jun;7(6):e422-e433. doi: 10.1016/S2352-3018(20)30103-X.
- Marukutira T, Block L, Alwano MG, Behel S, Jarvis JN, Chakalisa U, Powis K, Novitsky V, Bapati W, Wang H, Ussery F, Lebelonyane R, Mills LA, Moore J, Bachanas P. Comparison of knowledge of HIV status and treatment coverage between non-citizens and citizens: Botswana Combination Prevention Project (BCPP). PLoS One. 2019 Aug 29;14(8):e0221629. doi: 10.1371/journal.pone.0221629. eCollection 2019.
- Makhema J, Wirth KE, Pretorius Holme M, Gaolathe T, Mmalane M, Kadima E, Chakalisa U, Bennett K, Leidner J, Manyake K, Mbikiwa AM, Simon SV, Letlhogile R, Mukokomani K, van Widenfelt E, Moyo S, Lebelonyane R, Alwano MG, Powis KM, Dryden-Peterson SL, Kgathi C, Novitsky V, Moore J, Bachanas P, Abrams W, Block L, El-Halabi S, Marukutira T, Mills LA, Sexton C, Raizes E, Gaseitsiwe S, Bussmann H, Okui L, John O, Shapiro RL, Pals S, Michael H, Roland M, DeGruttola V, Lei Q, Wang R, Tchetgen Tchetgen E, Essex M, Lockman S. Universal Testing, Expanded Treatment, and Incidence of HIV Infection in Botswana. N Engl J Med. 2019 Jul 18;381(3):230-242. doi: 10.1056/NEJMoa1812281.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年10月30日
初级完成 (实际的)
2018年7月26日
研究完成 (实际的)
2018年7月26日
研究注册日期
首次提交
2013年10月16日
首先提交符合 QC 标准的
2013年10月16日
首次发布 (估计)
2013年10月18日
研究记录更新
最后更新发布 (实际的)
2022年11月14日
上次提交的符合 QC 标准的更新
2022年11月9日
最后验证
2022年11月1日
更多信息
与本研究相关的术语
其他研究编号
- CDC-CGH-6475
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.