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| Name | Class |
|---|---|
| Infectious Diseases Research Collaboration, Uganda | OTHER |
| Makerere University | OTHER |
| Kenya Medical Research Institute | OTHER |
| Gilead Sciences |
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The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP) in the context of universal treatment and streamlined care. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".
The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP) in the context of universal treatment and streamlined care. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st: universal test and treat; 2nd: targeted PrEP and cascade | Experimental | Intervention arm first phase: annual universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery Intervention arm second phase: baseline universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery + targeted PrEP, and targeted HIV testing interventions |
|
| 1st: baseline community testing; 2nd: None | Active Comparator | Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Universal ART in a streamlined care model | Other | immediate ART start for all HIV+ in community with streamlined care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative HIV Incidence | Cumulative 3 year HIV incidence in men and women ages ≥15 years after the start of Phase I intervention. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up |
| HIV Incidence | HIV incidence rate in men and women ages ≥15 years after the start of Phase II intervention (started after 3 years of Phase I). | 3 years follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Incident TB Associated With HIV | Cumulative incidence of TB or death due to illness among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up |
| Overall Mortality |
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Community Level Inclusion Criteria:
Individual Level Inclusion Criteria:
Community Level Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Havlir, MD | University of California, San Francisco | Study Chair |
| Moses Kamya, MBChB, PhD | Makerere University | Principal Investigator |
| Maya Petersen, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nyanza Province Kenya | Nyanza Province | Kenya | ||||
| Eastern Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25421503 | Background | Balzer LB, Petersen ML, van der Laan MJ; SEARCH Consortium. Adaptive pair-matching in randomized trials with unbiased and efficient effect estimation. Stat Med. 2015 Mar 15;34(6):999-1011. doi: 10.1002/sim.6380. Epub 2014 Nov 25. | |
| 26959355 | Background | Camlin CS, Seeley J, Viljoen L, Vernooij E, Simwinga M, Reynolds L, Reis R, Plank R, Orne-Gliemann J, McGrath N, Larmarange J, Hoddinott G, Getahun M, Charlebois ED, Bond V. Strengthening universal HIV 'test-and-treat' approaches with social science research. AIDS. 2016 Mar 27;30(6):969-70. doi: 10.1097/QAD.0000000000001008. No abstract available. |
| Label | URL |
|---|---|
| SEARCH Collaboration website | View source |
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32 communities were enrolled and randomized to the intervention and control (16 per arm in each stage). We enrolled 150,395 community residents aged 15+ years at study baseline in Stage 1. At the start of Stage 2, 184,091 community residents (including in-migrants) aged 15+ years were enrolled. The analytic population for each endpoint is detailed in the Outcomes section.
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Intervention arm first stage: annual universal community-based HIV and multi-disease testing; ART for all HIV+; ART delivery using streamlined patient-centered care Intervention arm second stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care; targeted population-level PrEP |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2018 | Jun 17, 2021 |
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| INDUSTRY |
| World Bank | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| United States President's Emergency Plan for AIDS Relief | FED |
| Bill and Melinda Gates Foundation | OTHER |
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| Annual Community Health Campaigns | Other | HIV and multi-disease testing for all community members |
|
| Targeted PrEP and Targeted testing interventions | Other |
|
| Baseline community-based HIV and multi-disease testing | Other | HIV and multi-disease testing for all community members at baseline only |
|
Mortality risk among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
| 3 years follow up |
| HIV-free Infant Survival | Probability of an infant born to an HIV+ mother remaining alive and HIV uninfected. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up |
| Percent of HIV+ Adults With HIV RNA <=500 c/mL | Percent of HIV+ adults with HIV RNA <=500 c/mL. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up |
| Time in Care for HIV+ Adults With Baseline Viremia | Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia | 3 years follow up |
| Cumulative Incidence of ART-initiation | Proportion of baseline HIV+ ART-naive persons who initiate ART Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up |
| Hypertension Control | hypertension control (greater than or equal to 140 mg Hg systolic or 90 mg Hg diastolic after 3 repeated readings) at year 3 among adults aged >= 30 years with hypertension. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up |
| Adherence to PrEP Treatment | Number of patients with adherence to PrEP treatment (self reported adherence at >=1 visit) | 3 years follow up |
| Average Adults' on- and Off-farm Employment | HIV+ adults with on- and off-farm employment | 3 years follow up |
| Year 3 Viremia Among ART-experienced Persons With Baseline Viremia | Plasma HIV RNA <400 cps/ml Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up |
| Linkage to Care | Proportion of Persons Attending an HIV Clinic Visit by 30 Days After HIV Test Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 30 days after HIV test |
| HIV Incidence Rate | HIV incidence rates during the first and third year of follow up; Results from the Control arm are not provided because annual HIV incidence was not measured in the control arm (annual HIV testing was only conducted in the intervention arm). | 3 years follow up |
| Prevalence of Transmitted HIV Drug-resistance Mutations | HIV NNRTI drug-resistance mutations found at baseline | Baseline |
| Prevalence of Chronic Kidney Disease (CKD) | Percentage of participants with chronic kidney disease (CKD) | 3 years follow up |
| Total Costs of Programming (ART) | Cost of ART streamlined care delivery amount HIV+ persons | Follow up year 3 |
| Mbale/Tororo Region |
| Uganda |
| Southwestern Uganda | Mbarara Region | Uganda |
| 28406269 | Background | SEARCH Collaboration. Evaluating the feasibility and uptake of a community-led HIV testing and multi-disease health campaign in rural Uganda. J Int AIDS Soc. 2017 Mar 30;20(1):21514. doi: 10.7448/IAS.20.1.21514. |
| 27436797 | Background | Balzer LB, van der Laan MJ, Petersen ML; SEARCH Collaboration. Adaptive pre-specification in randomized trials with and without pair-matching. Stat Med. 2016 Nov 10;35(25):4528-4545. doi: 10.1002/sim.7023. Epub 2016 Jul 19. |
| 28124579 | Background | Balzer L, Staples P, Onnela JP, DeGruttola V. Using a network-based approach and targeted maximum likelihood estimation to evaluate the effect of adding pre-exposure prophylaxis to an ongoing test-and-treat trial. Clin Trials. 2017 Apr;14(2):201-210. doi: 10.1177/1740774516679666. Epub 2017 Jan 26. |
| 28885271 | Background | Tram KH, Mwangwa F, Atukunda M, Owaraganise A, Ayieko J, Plenty A, Kwariisima D, Clark TD, Petersen ML, Charlebois ED, Kamya MR, Chamie G, Havlir DV, Marquez C; SEARCH Collaboration. Isoniazid Preventive Therapy Completion in the Era of Differentiated HIV Care. J Acquir Immune Defic Syndr. 2017 Dec 15;76(5):e115-e117. doi: 10.1097/QAI.0000000000001540. No abstract available. |
| 31725431 | Background | Puryear SB, Balzer LB, Ayieko J, Kwarisiima D, Hahn JA, Charlebois ED, Clark TD, Cohen CR, Bukusi EA, Kamya MR, Petersen ML, Havlir DV, Chamie G. Associations between alcohol use and HIV care cascade outcomes among adults undergoing population-based HIV testing in East Africa. AIDS. 2020 Mar 1;34(3):405-413. doi: 10.1097/QAD.0000000000002427. |
| 31697383 | Background | Balzer LB, Havlir DV, Kamya MR, Chamie G, Charlebois ED, Clark TD, Koss CA, Kwarisiima D, Ayieko J, Sang N, Kabami J, Atukunda M, Jain V, Camlin CS, Cohen CR, Bukusi EA, Van Der Laan M, Petersen ML. Machine Learning to Identify Persons at High-Risk of Human Immunodeficiency Virus Acquisition in Rural Kenya and Uganda. Clin Infect Dis. 2020 Dec 3;71(9):2326-2333. doi: 10.1093/cid/ciz1096. |
| 32347446 | Background | Marcus JL, Sewell WC, Balzer LB, Krakower DS. Artificial Intelligence and Machine Learning for HIV Prevention: Emerging Approaches to Ending the Epidemic. Curr HIV/AIDS Rep. 2020 Jun;17(3):171-179. doi: 10.1007/s11904-020-00490-6. |
| 32452912 | Background | Balzer LB, Ayieko J, Kwarisiima D, Chamie G, Charlebois ED, Schwab J, van der Laan MJ, Kamya MR, Havlir DV, Petersen ML. Far from MCAR: Obtaining Population-level Estimates of HIV Viral Suppression. Epidemiology. 2020 Sep;31(5):620-627. doi: 10.1097/EDE.0000000000001215. |
| 33770065 | Background | Jewell BL, Balzer LB, Clark TD, Charlebois ED, Kwarisiima D, Kamya MR, Havlir DV, Petersen ML, Bershteyn A. Predicting HIV Incidence in the SEARCH Trial: A Mathematical Modeling Study. J Acquir Immune Defic Syndr. 2021 Aug 1;87(4):1024-1031. doi: 10.1097/QAI.0000000000002684. |
| 22916256 | Result | Chamie G, Kwarisiima D, Clark TD, Kabami J, Jain V, Geng E, Petersen ML, Thirumurthy H, Kamya MR, Havlir DV, Charlebois ED; SEARCH Collaboration. Leveraging rapid community-based HIV testing campaigns for non-communicable diseases in rural Uganda. PLoS One. 2012;7(8):e43400. doi: 10.1371/journal.pone.0043400. Epub 2012 Aug 20. |
| 23169332 | Result | Thirumurthy H, Chamie G, Jain V, Kabami J, Kwarisiima D, Clark TD, Geng E, Petersen ML, Charlebois ED, Kamya MR, Havlir DV; SEARCH Collaboration. Improved employment and education outcomes in households of HIV-infected adults with high CD4 cell counts: evidence from a community health campaign in Uganda. AIDS. 2013 Feb 20;27(4):627-34. doi: 10.1097/QAD.0b013e32835c54d8. |
| 23243180 | Result | Jain V, Liegler T, Kabami J, Chamie G, Clark TD, Black D, Geng EH, Kwarisiima D, Wong JK, Abdel-Mohsen M, Sonawane N, Aweeka FT, Thirumurthy H, Petersen ML, Charlebois ED, Kamya MR, Havlir DV; SEARCH Collaboration. Assessment of population-based HIV RNA levels in a rural east African setting using a fingerprick-based blood collection method. Clin Infect Dis. 2013 Feb;56(4):598-605. doi: 10.1093/cid/cis881. Epub 2012 Dec 12. |
| 23899683 | Result | Namusobya J, Semitala FC, Amanyire G, Kabami J, Chamie G, Bogere J, Jain V, Clark TD, Charlebois E, Havlir DV, Kamya M, Geng EH. High retention in care among HIV-infected patients entering care with CD4 levels >350 cells/muL under routine program conditions in Uganda. Clin Infect Dis. 2013 Nov;57(9):1343-50. doi: 10.1093/cid/cit490. Epub 2013 Jul 29. |
| 24146022 | Result | Jain V, Byonanebye DM, Liegler T, Kwarisiima D, Chamie G, Kabami J, Petersen ML, Balzer LB, Clark TD, Black D, Thirumurthy H, Geng EH, Charlebois ED, Amanyire G, Kamya MR, Havlir DV; SEARCH Collaboration. Changes in population HIV RNA levels in Mbarara, Uganda, during scale-up of HIV antiretroviral therapy access. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):327-32. doi: 10.1097/QAI.0000000000000021. |
| 24392124 | Result | Chamie G, Kwarisiima D, Clark TD, Kabami J, Jain V, Geng E, Balzer LB, Petersen ML, Thirumurthy H, Charlebois ED, Kamya MR, Havlir DV. Uptake of community-based HIV testing during a multi-disease health campaign in rural Uganda. PLoS One. 2014 Jan 2;9(1):e84317. doi: 10.1371/journal.pone.0084317. eCollection 2014. |
| 24321133 | Result | Kotwani P, Kwarisiima D, Clark TD, Kabami J, Geng EH, Jain V, Chamie G, Petersen ML, Thirumurthy H, Kamya MR, Charlebois ED, Havlir DV; SEARCH Collaboration. Epidemiology and awareness of hypertension in a rural Ugandan community: a cross-sectional study. BMC Public Health. 2013 Dec 9;13:1151. doi: 10.1186/1471-2458-13-1151. |
| 24495307 | Result | Kotwani P, Balzer L, Kwarisiima D, Clark TD, Kabami J, Byonanebye D, Bainomujuni B, Black D, Chamie G, Jain V, Thirumurthy H, Kamya MR, Geng EH, Petersen ML, Havlir DV, Charlebois ED; SEARCH Collaboration. Evaluating linkage to care for hypertension after community-based screening in rural Uganda. Trop Med Int Health. 2014 Apr;19(4):459-68. doi: 10.1111/tmi.12273. Epub 2014 Feb 3. |
| 25022596 | Result | Jain V, Byonanebye DM, Amanyire G, Kwarisiima D, Black D, Kabami J, Chamie G, Clark TD, Rooney JF, Charlebois ED, Kamya MR, Havlir DV; SEARCH Collaboration. Successful antiretroviral therapy delivery and retention in care among asymptomatic individuals with high CD4+ T-cell counts above 350 cells/mul in rural Uganda. AIDS. 2014 Sep 24;28(15):2241-9. doi: 10.1097/QAD.0000000000000401. |
| 27232186 | Result | Kwarisiima D, Balzer L, Heller D, Kotwani P, Chamie G, Clark T, Ayieko J, Mwangwa F, Jain V, Byonanebye D, Petersen M, Havlir D, Kamya MR. Population-Based Assessment of Hypertension Epidemiology and Risk Factors among HIV-Positive and General Populations in Rural Uganda. PLoS One. 2016 May 27;11(5):e0156309. doi: 10.1371/journal.pone.0156309. eCollection 2016. |
| 26939734 | Result | Chamie G, Clark TD, Kabami J, Kadede K, Ssemmondo E, Steinfeld R, Lavoy G, Kwarisiima D, Sang N, Jain V, Thirumurthy H, Liegler T, Balzer LB, Petersen ML, Cohen CR, Bukusi EA, Kamya MR, Havlir DV, Charlebois ED. A hybrid mobile approach for population-wide HIV testing in rural east Africa: an observational study. Lancet HIV. 2016 Mar;3(3):e111-9. doi: 10.1016/S2352-3018(15)00251-9. Epub 2016 Jan 26. |
| 26908725 | Result | Katrak S, Day N, Ssemmondo E, Kwarisiima D, Midekisa A, Greenhouse B, Kamya M, Havlir D, Dorsey G. Community-wide Prevalence of Malaria Parasitemia in HIV-Infected and Uninfected Populations in a High-Transmission Setting in Uganda. J Infect Dis. 2016 Jun 15;213(12):1971-8. doi: 10.1093/infdis/jiw057. Epub 2016 Feb 10. |
| 27258399 | Result | Kadede K, Ruel T, Kabami J, Ssemmondo E, Sang N, Kwarisiima D, Bukusi E, Cohen CR, Liegler T, Clark TD, Charlebois ED, Petersen ML, Kamya MR, Havlir DV, Chamie G; SEARCH team. Increased adolescent HIV testing with a hybrid mobile strategy in Uganda and Kenya. AIDS. 2016 Sep 10;30(14):2121-6. doi: 10.1097/QAD.0000000000001180. |
| 26632823 | Result | Jain V, Chang W, Byonanebye DM, Owaraganise A, Twinomuhwezi E, Amanyire G, Black D, Marseille E, Kamya MR, Havlir DV, Kahn JG. Estimated Costs for Delivery of HIV Antiretroviral Therapy to Individuals with CD4+ T-Cell Counts >350 cells/uL in Rural Uganda. PLoS One. 2015 Dec 3;10(12):e0143433. doi: 10.1371/journal.pone.0143433. eCollection 2015. |
| 27087478 | Result | Balzer LB, Petersen ML, van der Laan MJ; SEARCH Collaboration. Targeted estimation and inference for the sample average treatment effect in trials with and without pair-matching. Stat Med. 2016 Sep 20;35(21):3717-32. doi: 10.1002/sim.6965. Epub 2016 Apr 18. |
| 27421056 | Result | Thirumurthy H, Jakubowski A, Camlin C, Kabami J, Ssemmondo E, Elly A, Mwai D, Clark T, Cohen C, Bukusi E, Kamya M, Petersen M, Havlir D, Charlebois ED. Expectations about future health and longevity in Kenyan and Ugandan communities receiving a universal test-and-treat intervention in the SEARCH trial. AIDS Care. 2016;28 Suppl 3(Suppl 3):90-8. doi: 10.1080/09540121.2016.1178959. |
| 27421052 | Result | Maeri I, El Ayadi A, Getahun M, Charlebois E, Akatukwasa C, Tumwebaze D, Itiakorit H, Owino L, Kwarisiima D, Ssemmondo E, Sang N, Kabami J, Clark TD, Petersen M, Cohen CR, Bukusi EA, Kamya M, Havlir D, Camlin CS; SEARCH Collaboration. "How can I tell?" Consequences of HIV status disclosure among couples in eastern African communities in the context of an ongoing HIV "test-and-treat" trial. AIDS Care. 2016;28 Suppl 3(Suppl 3):59-66. doi: 10.1080/09540121.2016.1168917. |
| 27421053 | Result | Camlin CS, Ssemmondo E, Chamie G, El Ayadi AM, Kwarisiima D, Sang N, Kabami J, Charlebois E, Petersen M, Clark TD, Bukusi EA, Cohen CR, R Kamya M, Havlir D; SEARCH Collaboration. Men "missing" from population-based HIV testing: insights from qualitative research. AIDS Care. 2016;28 Suppl 3(Suppl 3):67-73. doi: 10.1080/09540121.2016.1164806. |
| 27989576 | Result | Jain V, Petersen ML, Liegler T, Byonanebye DM, Kwarisiima D, Chamie G, Sang N, Black D, Clark TD, Ladai A, Plenty A, Kabami J, Ssemmondo E, Bukusi EA, Cohen CR, Charlebois ED, Kamya MR, Havlir DV; SEARCH Collaboration. Population levels and geographical distribution of HIV RNA in rural Ugandan and Kenyan communities, including serodiscordant couples: a cross-sectional analysis. Lancet HIV. 2017 Mar;4(3):e122-e133. doi: 10.1016/S2352-3018(16)30220-X. Epub 2016 Dec 16. |
| 27603290 | Result | Brown LB, Havlir DV, Ayieko J, Mwangwa F, Owaraganise A, Kwarisiima D, Jain V, Ruel T, Clark T, Chamie G, Bukusi EA, Cohen CR, Kamya MR, Petersen ML, Charlebois ED; SEARCH Collaboration. High levels of retention in care with streamlined care and universal test and treat in East Africa. AIDS. 2016 Nov 28;30(18):2855-2864. doi: 10.1097/QAD.0000000000001250. |
| 27741031 | Result | Chang W, Chamie G, Mwai D, Clark TD, Thirumurthy H, Charlebois ED, Petersen M, Kabami J, Ssemmondo E, Kadede K, Kwarisiima D, Sang N, Bukusi EA, Cohen CR, Kamya M, Havlir DV, Kahn JG. Implementation and Operational Research: Cost and Efficiency of a Hybrid Mobile Multidisease Testing Approach With High HIV Testing Coverage in East Africa. J Acquir Immune Defic Syndr. 2016 Nov 1;73(3):e39-e45. doi: 10.1097/QAI.0000000000001141. |
| 28394821 | Result | Brown LB, Ayieko J, Mwangwa F, Owaraganise A, Kwarisiima D, Jain V, Ruel T, Clark T, Black D, Chamie G, Bukusi EA, Cohen CR, Kamya MR, Petersen ML, Charlebois ED, Havlir DV. Predictors of Retention in HIV Care Among Youth (15-24) in a Universal Test-and-Treat Setting in Rural Kenya. J Acquir Immune Defic Syndr. 2017 Sep 1;76(1):e15-e18. doi: 10.1097/QAI.0000000000001390. No abstract available. |
| 27741032 | Result | Ssemmondo E, Mwangwa F, Kironde JL, Kwarisiima D, Clark TD, Marquez C, Charlebois ED, Petersen ML, Kamya MR, Havlir DV, Chamie G; SEARCH Collaboration. Implementation and Operational Research: Population-Based Active Tuberculosis Case Finding During Large-Scale Mobile HIV Testing Campaigns in Rural Uganda. J Acquir Immune Defic Syndr. 2016 Nov 1;73(3):e46-e50. doi: 10.1097/QAI.0000000000001142. |
| 28586888 | Result | Petersen M, Balzer L, Kwarsiima D, Sang N, Chamie G, Ayieko J, Kabami J, Owaraganise A, Liegler T, Mwangwa F, Kadede K, Jain V, Plenty A, Brown L, Lavoy G, Schwab J, Black D, van der Laan M, Bukusi EA, Cohen CR, Clark TD, Charlebois E, Kamya M, Havlir D. Association of Implementation of a Universal Testing and Treatment Intervention With HIV Diagnosis, Receipt of Antiretroviral Therapy, and Viral Suppression in East Africa. JAMA. 2017 Jun 6;317(21):2196-2206. doi: 10.1001/jama.2017.5705. |
| 28384841 | Result | Zheng W, Balzer L, van der Laan M, Petersen M; SEARCH Collaboration. Constrained binary classification using ensemble learning: an application to cost-efficient targeted PrEP strategies. Stat Med. 2018 Jan 30;37(2):261-279. doi: 10.1002/sim.7296. Epub 2017 Apr 6. |
| 29291251 | Result | Mwangwa F, Chamie G, Kwarisiima D, Ayieko J, Owaraganise A, Ruel TD, Plenty A, Tram KH, Clark TD, Cohen CR, Bukusi EA, Petersen M, Kamya MR, Charlebois ED, Havlir DV, Marquez C. Gaps in the Child Tuberculosis Care Cascade in 32 Rural Communities in Uganda and Kenya. J Clin Tuberc Other Mycobact Dis. 2017 Dec;9:24-29. doi: 10.1016/j.jctube.2017.10.003. |
| 29210185 | Result | Camlin CS, Charlebois ED, Geng E, Semitala F, Wallenta J, Getahun M, Kampiire L, Bukusi EA, Sang N, Kwarisiima D, Clark TD, Petersen ML, Kamya MR, Havlir DV. Redemption of the "spoiled identity:" the role of HIV-positive individuals in HIV care cascade interventions. J Int AIDS Soc. 2017 Dec;20(4):e25023. doi: 10.1002/jia2.25023. |
| 29741594 | Result | Koss CA, Ayieko J, Mwangwa F, Owaraganise A, Kwarisiima D, Balzer LB, Plenty A, Sang N, Kabami J, Ruel TD, Black D, Camlin CS, Cohen CR, Bukusi EA, Clark TD, Charlebois ED, Petersen ML, Kamya MR, Havlir DV; SEARCH Collaboration. Early Adopters of Human Immunodeficiency Virus Preexposure Prophylaxis in a Population-based Combination Prevention Study in Rural Kenya and Uganda. Clin Infect Dis. 2018 Nov 28;67(12):1853-1860. doi: 10.1093/cid/ciy390. |
| 31955361 | Result | Camlin CS, Koss CA, Getahun M, Owino L, Itiakorit H, Akatukwasa C, Maeri I, Bakanoma R, Onyango A, Atwine F, Ayieko J, Kabami J, Mwangwa F, Atukunda M, Owaraganise A, Kwarisiima D, Sang N, Bukusi EA, Kamya MR, Petersen ML, Cohen CR, Charlebois ED, Havlir DV. Understanding Demand for PrEP and Early Experiences of PrEP Use Among Young Adults in Rural Kenya and Uganda: A Qualitative Study. AIDS Behav. 2020 Jul;24(7):2149-2162. doi: 10.1007/s10461-020-02780-x. |
| 31940346 | Result | Heller DJ, Balzer LB, Kazi D, Charlebois ED, Kwarisiima D, Mwangwa F, Jain V, Kotwani P, Chamie G, Cohen CR, Clark TD, Ayieko J, Byonanabye DM, Petersen M, Kamya MR, Havlir D, Kahn JG. Hypertension testing and treatment in Uganda and Kenya through the SEARCH study: An implementation fidelity and outcome evaluation. PLoS One. 2020 Jan 15;15(1):e0222801. doi: 10.1371/journal.pone.0222801. eCollection 2020. |
| 31809357 | Result | Brown LB, Balzer LB, Kabami J, Kwarisiima D, Sang N, Ayieko J, Chen Y, Chamie G, Charlebois ED, Camlin CS, Cohen CR, Bukusi E, Kamya MR, Moody J, Havlir DV, Petersen ML. The Influence of Social Networks on Antiretroviral Therapy Initiation Among HIV-Infected Antiretroviral Therapy-Naive Youth in Rural Kenya and Uganda. J Acquir Immune Defic Syndr. 2020 Jan 1;83(1):9-15. doi: 10.1097/QAI.0000000000002199. |
| 31490343 | Result | Olilo WA, Petersen ML, Koss CA, Wafula E, Kwarisiima D, Kadede K, Clark TD, Cohen CR, Bukusi EA, Kamya MR, Charlebois ED, Havlir DV, Ayieko J; SEARCH Collaboration. Pre-exposure Prophylaxis (PrEP) Uptake Among Older Individuals in Rural Western Kenya. J Acquir Immune Defic Syndr. 2019 Dec 1;82(4):e50-e53. doi: 10.1097/QAI.0000000000002150. No abstract available. |
| 31589172 | Result | Chamie G, Kamya MR, Petersen ML, Havlir DV. Reaching 90-90-90 in rural communities in East Africa: lessons from the Sustainable East Africa Research in Community Health Trial. Curr Opin HIV AIDS. 2019 Nov;14(6):449-454. doi: 10.1097/COH.0000000000000585. |
| 31314966 | Result | Havlir DV, Balzer LB, Charlebois ED, Clark TD, Kwarisiima D, Ayieko J, Kabami J, Sang N, Liegler T, Chamie G, Camlin CS, Jain V, Kadede K, Atukunda M, Ruel T, Shade SB, Ssemmondo E, Byonanebye DM, Mwangwa F, Owaraganise A, Olilo W, Black D, Snyman K, Burger R, Getahun M, Achando J, Awuonda B, Nakato H, Kironde J, Okiror S, Thirumurthy H, Koss C, Brown L, Marquez C, Schwab J, Lavoy G, Plenty A, Mugoma Wafula E, Omanya P, Chen YH, Rooney JF, Bacon M, van der Laan M, Cohen CR, Bukusi E, Kamya MR, Petersen M. HIV Testing and Treatment with the Use of a Community Health Approach in Rural Africa. N Engl J Med. 2019 Jul 18;381(3):219-229. doi: 10.1056/NEJMoa1809866. |
| 31181961 | Result | Tram KH, Mwangwa F, Chamie G, Atukunda M, Owaraganise A, Ayieko J, Jain V, Clark TD, Kwarisiima D, Petersen ML, Kamya MR, Charlebois ED, Havlir DV, Marquez C; SEARCH collaboration. Predictors of isoniazid preventive therapy completion among HIV-infected patients receiving differentiated and non-differentiated HIV care in rural Uganda. AIDS Care. 2020 Jan;32(1):119-127. doi: 10.1080/09540121.2019.1619661. Epub 2019 Jun 10. |
| 31060545 | Result | Kwarisiima D, Atukunda M, Owaraganise A, Chamie G, Clark T, Kabami J, Jain V, Byonanebye D, Mwangwa F, Balzer LB, Charlebois E, Kamya MR, Petersen M, Havlir DV, Brown LB. Hypertension control in integrated HIV and chronic disease clinics in Uganda in the SEARCH study. BMC Public Health. 2019 May 6;19(1):511. doi: 10.1186/s12889-019-6838-6. |
| 31037845 | Result | Mayer CM, Owaraganise A, Kabami J, Kwarisiima D, Koss CA, Charlebois ED, Kamya MR, Petersen ML, Havlir DV, Jewell BL. Distance to clinic is a barrier to PrEP uptake and visit attendance in a community in rural Uganda. J Int AIDS Soc. 2019 Apr;22(4):e25276. doi: 10.1002/jia2.25276. |
| 31152972 | Result | Camlin CS, Akullian A, Neilands TB, Getahun M, Bershteyn A, Ssali S, Geng E, Gandhi M, Cohen CR, Maeri I, Eyul P, Petersen ML, Havlir DV, Kamya MR, Bukusi EA, Charlebois ED. Gendered dimensions of population mobility associated with HIV across three epidemics in rural Eastern Africa. Health Place. 2019 May;57:339-351. doi: 10.1016/j.healthplace.2019.05.002. Epub 2019 May 29. |
| 30807481 | Result | Ayieko J, Petersen ML, Charlebois ED, Brown LB, Clark TD, Kwarisiima D, Kamya MR, Cohen CR, Bukusi EA, Havlir DV, Van Rie A. A Patient-Centered Multicomponent Strategy for Accelerated Linkage to Care Following Community-Wide HIV Testing in Rural Uganda and Kenya. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):414-422. doi: 10.1097/QAI.0000000000001939. |
| 30673744 | Result | Brown LB, Getahun M, Ayieko J, Kwarisiima D, Owaraganise A, Atukunda M, Olilo W, Clark T, Bukusi EA, Cohen CR, Kamya MR, Petersen ML, Charlebois ED, Havlir DV, Camlin CS. Factors predictive of successful retention in care among HIV-infected men in a universal test-and-treat setting in Uganda and Kenya: A mixed methods analysis. PLoS One. 2019 Jan 23;14(1):e0210126. doi: 10.1371/journal.pone.0210126. eCollection 2019. |
| 30134294 | Result | Shade SB, Osmand T, Luo A, Aine R, Assurah E, Mwebaza B, Mwai D, Owaraganise A, Mwangwa F, Ayieko J, Black D, Brown LB, Clark TD, Kwarisiima D, Thirumurthy H, Cohen CR, Bukusi EA, Charlebois ED, Balzer L, Kamya MR, Petersen ML, Havlir DV, Jain V. Costs of streamlined HIV care delivery in rural Ugandan and Kenyan clinics in the SEARCH Studys. AIDS. 2018 Sep 24;32(15):2179-2188. doi: 10.1097/QAD.0000000000001958. |
| 31995631 | Result | Marquez C, Atukunda M, Balzer LB, Chamie G, Kironde J, Ssemmondo E, Ruel TD, Mwangwa F, Tram KH, Clark TD, Kwarisiima D, Petersen M, Kamya MR, Charlebois ED, Havlir DV. The age-specific burden and household and school-based predictors of child and adolescent tuberculosis infection in rural Uganda. PLoS One. 2020 Jan 29;15(1):e0228102. doi: 10.1371/journal.pone.0228102. eCollection 2020. |
| 32091179 | Result | Havlir D, Lockman S, Ayles H, Larmarange J, Chamie G, Gaolathe T, Iwuji C, Fidler S, Kamya M, Floyd S, Moore J, Hayes R, Petersen M, Dabis F; (Universal Test, Treat Trials) UT3 Consortium. What do the Universal Test and Treat trials tell us about the path to HIV epidemic control? J Int AIDS Soc. 2020 Feb;23(2):e25455. doi: 10.1002/jia2.25455. |
| 32130245 | Result | Muiru AN, Charlebois ED, Balzer LB, Kwarisiima D, Elly A, Black D, Okiror S, Kabami J, Atukunda M, Snyman K, Petersen M, Kamya M, Havlir D, Estrella MM, Hsu CY. The epidemiology of chronic kidney disease (CKD) in rural East Africa: A population-based study. PLoS One. 2020 Mar 4;15(3):e0229649. doi: 10.1371/journal.pone.0229649. eCollection 2020. |
| 32087152 | Result | Koss CA, Charlebois ED, Ayieko J, Kwarisiima D, Kabami J, Balzer LB, Atukunda M, Mwangwa F, Peng J, Mwinike Y, Owaraganise A, Chamie G, Jain V, Sang N, Olilo W, Brown LB, Marquez C, Zhang K, Ruel TD, Camlin CS, Rooney JF, Black D, Clark TD, Gandhi M, Cohen CR, Bukusi EA, Petersen ML, Kamya MR, Havlir DV; SEARCH Collaboration. Uptake, engagement, and adherence to pre-exposure prophylaxis offered after population HIV testing in rural Kenya and Uganda: 72-week interim analysis of observational data from the SEARCH study. Lancet HIV. 2020 Apr;7(4):e249-e261. doi: 10.1016/S2352-3018(19)30433-3. Epub 2020 Feb 19. |
| 32507985 | Result | Chamie G, Hickey MD, Kwarisiima D, Ayieko J, Kamya MR, Havlir DV. Universal HIV Testing and Treatment (UTT) Integrated with Chronic Disease Screening and Treatment: the SEARCH study. Curr HIV/AIDS Rep. 2020 Aug;17(4):315-323. doi: 10.1007/s11904-020-00500-7. |
| 32472768 | Result | Kabami J, Balzer LB, Saddiki H, Ayieko J, Kwarisiima D, Atukunda M, Charlebois ED, Clark TD, Koss CA, Ruel T, Bukusi EA, Cohen CR, Musoke P, Petersen ML, Havlir DV, Kamya MR, Chamie G. Population-level viral suppression among pregnant and postpartum women in a universal test and treat trial. AIDS. 2020 Jul 15;34(9):1407-1415. doi: 10.1097/QAD.0000000000002564. |
| 32991337 | Result | Hickey MD, Ayieko J, Kwarisiima D, Opel FJ, Owaraganise A, Balzer LB, Chamie G, Jain V, Peng J, Camlin C, Charlebois ED, Cohen CR, Bukusi EA, Kamya MR, Petersen ML, Havlir DV. Improved Viral Suppression With Streamlined Care in the SEARCH Study. J Acquir Immune Defic Syndr. 2020 Dec 15;85(5):571-578. doi: 10.1097/QAI.0000000000002508. |
| 33283986 | Result | Camlin CS, Charlebois ED, Getahun M, Akatukwasa C, Atwine F, Itiakorit H, Bakanoma R, Maeri I, Owino L, Onyango A, Chamie G, Clark TD, Cohen CR, Kwarisiima D, Kabami J, Sang N, Kamya MR, Bukusi EA, Petersen ML, V Havlir D. Pathways for reduction of HIV-related stigma: a model derived from longitudinal qualitative research in Kenya and Uganda. J Int AIDS Soc. 2020 Dec;23(12):e25647. doi: 10.1002/jia2.25647. |
| 33561143 | Result | Koss CA, Havlir DV, Ayieko J, Kwarisiima D, Kabami J, Chamie G, Atukunda M, Mwinike Y, Mwangwa F, Owaraganise A, Peng J, Olilo W, Snyman K, Awuonda B, Clark TD, Black D, Nugent J, Brown LB, Marquez C, Okochi H, Zhang K, Camlin CS, Jain V, Gandhi M, Cohen CR, Bukusi EA, Charlebois ED, Petersen ML, Kamya MR, Balzer LB. HIV incidence after pre-exposure prophylaxis initiation among women and men at elevated HIV risk: A population-based study in rural Kenya and Uganda. PLoS Med. 2021 Feb 9;18(2):e1003492. doi: 10.1371/journal.pmed.1003492. eCollection 2021 Feb. |
| 33544717 | Result | Nyabuti MN, Petersen ML, Bukusi EA, Kamya MR, Mwangwa F, Kabami J, Sang N, Charlebois ED, Balzer LB, Schwab JD, Camlin CS, Black D, Clark TD, Chamie G, Havlir DV, Ayieko J. Characteristics of HIV seroconverters in the setting of universal test and treat: Results from the SEARCH trial in rural Uganda and Kenya. PLoS One. 2021 Feb 5;16(2):e0243167. doi: 10.1371/journal.pone.0243167. eCollection 2021. |
| 33821821 | Result | Shade SB, Osmand T, Kwarisiima D, Brown LB, Luo A, Mwebaza B, Mwesigye AR, Kwizera E, Imukeka H, Mwanga F, Ayieko J, Owaraganise A, Bukusi EA, Cohen CR, Charlebois ED, Black D, Clark TD, Petersen ML, Kamya MR, Havlir DV, Jain V. Costs of integrating hypertension care into HIV care in rural East African clinics. AIDS. 2021 May 1;35(6):911-919. doi: 10.1097/QAD.0000000000002834. |
| 33945526 | Result | Chamie G, Kwarisiima D, Ndyabakira A, Marson K, Camlin CS, Havlir DV, Kamya MR, Thirumurthy H. Financial incentives and deposit contracts to promote HIV retesting in Uganda: A randomized trial. PLoS Med. 2021 May 4;18(5):e1003630. doi: 10.1371/journal.pmed.1003630. eCollection 2021 May. |
| 41848412 | Derived | Charlebois ED, Gutin SA, Neilands TB, Getahun M, Akullian A, Maeri I, Eyul P, Omoding D, Okiring J, Cohen CR, Gandhi M, Bukusi EA, Kamya MR, Camlin CS. Geospatial mobility, non-local partners, concurrent sexual partnerships, and gender influence longitudinal STI prevalence in rural eastern Africa. Int J STD AIDS. 2026 Jun;37(7):757-767. doi: 10.1177/09564624261427053. Epub 2026 Mar 18. |
| 41762058 | Derived | Balzer LB, van der Laan MJ, Petersen ML. Machine learning to optimize precision in the analysis of randomized trials: A journey in pre-specified, yet data-adaptive learning. Clin Trials. 2026 Jun;23(3):289-296. doi: 10.1177/17407745261417227. Epub 2026 Feb 28. |
| 40327268 | Derived | Camlin CS, Gutin SA, Charlebois ED, Neilands TB, Balzer LB, Petersen ML, Chamie G, Cohen CR, Bukusi EA, Kamya MR, Havlir DV, Ayieko J. Metrics of Mobility by Sex are Associated with HIV Incidence in Rural Kenya and Uganda. AIDS Behav. 2025 Sep;29(9):2869-2881. doi: 10.1007/s10461-025-04743-6. Epub 2025 May 6. |
| 38824440 | Derived | Abbott R, Landsiedel K, Atukunda M, Puryear SB, Chamie G, Hahn JA, Mwangwa F, Kakande E, Petersen ML, Havlir DV, Charlebois E, Balzer LB, Kamya MR, Marquez C. Incident Tuberculosis Infection Is Associated With Alcohol Use in Adults in Rural Uganda. Clin Infect Dis. 2025 Mar 17;80(3):562-565. doi: 10.1093/cid/ciae304. |
| 38226445 | Derived | Marquez C, Atukunda M, Nugent J, Charlebois ED, Chamie G, Mwangwa F, Ssemmondo E, Kironde J, Kabami J, Owaraganise A, Kakande E, Ssekaynzi B, Abbott R, Ayieko J, Ruel T, Kwariisima D, Kamya M, Petersen M, Havlir DV, Balzer LB. Community-Wide Universal HIV Test and Treat Intervention Reduces Tuberculosis Transmission in Rural Uganda: A Cluster-Randomized Trial. Clin Infect Dis. 2024 Jun 14;78(6):1601-1607. doi: 10.1093/cid/ciad776. |
| 37992063 | Derived | Ayieko J, Charlebois ED, Maeri I, Owino L, Thorp M, Bukusi EA, Petersen ML, Kamya MR, Havlir DV, Camlin CS. Improving care engagement for mobile people living with HIV in rural western Kenya. PLoS One. 2023 Nov 22;18(11):e0288087. doi: 10.1371/journal.pone.0288087. eCollection 2023. |
| 37220015 | Derived | Puryear SB, Ayieko J, Hahn JA, Mucunguzi A, Owaraganise A, Schwab J, Balzer LB, Kwarisiima D, Charlebois ED, Cohen CR, Bukusi EA, Petersen ML, Havlir DV, Kamya MR, Chamie G. Universal HIV Testing and Treatment With Patient-Centered Care Improves ART Uptake and Viral Suppression Among Adults Reporting Hazardous Alcohol Use in Uganda and Kenya. J Acquir Immune Defic Syndr. 2023 Sep 1;94(1):37-45. doi: 10.1097/QAI.0000000000003226. |
| 36628879 | Derived | Maeri I, Eyul P, Getahun M, Hatchett K, Owino L, Akatukwasa C, Itiakorit H, Gutin SA, Johnson-Peretz J, Ssali S, Cohen CR, Bukusi EA, Kamya MR, Charlebois ED, Camlin CS. Nothing about us without us: Community-based participatory research to improve HIV care for mobile patients in Kenya and Uganda. Soc Sci Med. 2023 Feb;318:115471. doi: 10.1016/j.socscimed.2022.115471. Epub 2022 Oct 28. |
| 36201226 | Derived | Camlin CS, Getahun M, Koss CA, Owino L, Akatukwasa C, Itiakorit H, Onyango A, Bakanoma R, Atwine F, Maeri I, Ayieko J, Atukunda M, Owaraganise A, Mwangwa F, Sang N, Kabami J, Kaplan RL, Chamie G, Petersen ML, Cohen CR, Bukusi EA, Kamya MR, Havlir DV, Charlebois ED. Providers' Attitudes and Experiences with Pre-Exposure Prophylaxis Implementation in a Population-Based Study in Kenya and Uganda. AIDS Patient Care STDS. 2022 Oct;36(10):396-404. doi: 10.1089/apc.2022.0084. Epub 2022 Oct 5. |
| 34919862 | Derived | Jakubowski A, Kabami J, Balzer LB, Ayieko J, Charlebois ED, Owaraganise A, Marquez C, Clark TD, Black D, Shade SB, Chamie G, Cohen CR, Bukusi EA, Kamya MR, Petersen M, Havlir DV, Thirumurthy H. Effect of universal HIV testing and treatment on socioeconomic wellbeing in rural Kenya and Uganda: a cluster-randomised controlled trial. Lancet Glob Health. 2022 Jan;10(1):e96-e104. doi: 10.1016/S2214-109X(21)00458-7. |
| 34841945 | Derived | Mwangwa F, Getahun M, Itiakorit H, Jain V, Ayieko J, Owino L, Akatukwasa C, Maeri I, Koss CA, Chamie G, Clark TD, Kabami J, Atukunda M, Kwarisiima D, Sang N, Bukusi EA, Kamya MR, Petersen ML, Cohen CR, Charlebois ED, Havlir DV, Camlin CS. Provider and Patient Perspectives of Rapid ART Initiation and Streamlined HIV Care: Qualitative Insights From Eastern African Communities. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211053518. doi: 10.1177/23259582211053518. |
| 34543267 | Derived | Hickey MD, Ayieko J, Owaraganise A, Sim N, Balzer LB, Kabami J, Atukunda M, Opel FJ, Wafula E, Nyabuti M, Brown L, Chamie G, Jain V, Peng J, Kwarisiima D, Camlin CS, Charlebois ED, Cohen CR, Bukusi EA, Kamya MR, Petersen ML, Havlir DV. Effect of a patient-centered hypertension delivery strategy on all-cause mortality: Secondary analysis of SEARCH, a community-randomized trial in rural Kenya and Uganda. PLoS Med. 2021 Sep 20;18(9):e1003803. doi: 10.1371/journal.pmed.1003803. eCollection 2021 Sep. |
| 34152067 | Derived | Ayieko J, Petersen ML, Kabami J, Mwangwa F, Opel F, Nyabuti M, Charlebois ED, Peng J, Koss CA, Balzer LB, Chamie G, Bukusi EA, Kamya MR, Havlir DV. Uptake and outcomes of a novel community-based HIV post-exposure prophylaxis (PEP) programme in rural Kenya and Uganda. J Int AIDS Soc. 2021 Jun;24(6):e25670. doi: 10.1002/jia2.25670. |
| 33783495 | Derived | Kamya MR, Petersen ML, Kabami J, Ayieko J, Kwariisima D, Sang N, Clark TD, Schwab J, Charlebois ED, Cohen CR, Bukusi EA, Peng J, Jain V, Chen YH, Chamie G, Balzer LB, Havlir DV. SEARCH Human Immunodeficiency Virus (HIV) Streamlined Treatment Intervention Reduces Mortality at a Population Level in Men With Low CD4 Counts. Clin Infect Dis. 2021 Oct 5;73(7):e1938-e1945. doi: 10.1093/cid/ciaa1782. |
| 30161172 | Derived | Ayieko J, Brown L, Anthierens S, Van Rie A, Getahun M, Charlebois ED, Petersen ML, Clark TD, Kamya MR, Cohen CR, Bukusi EA, Havlir DV, Camlin CS. "Hurdles on the path to 90-90-90 and beyond": Qualitative analysis of barriers to engagement in HIV care among individuals in rural East Africa in the context of test-and-treat. PLoS One. 2018 Aug 30;13(8):e0202990. doi: 10.1371/journal.pone.0202990. eCollection 2018. |
| 30027668 | Derived | Camlin CS, Akullian A, Neilands TB, Getahun M, Eyul P, Maeri I, Ssali S, Geng E, Gandhi M, Cohen CR, Kamya MR, Odeny T, Bukusi EA, Charlebois ED. Population mobility associated with higher risk sexual behaviour in eastern African communities participating in a Universal Testing and Treatment trial. J Int AIDS Soc. 2018 Jul;21 Suppl 4(Suppl Suppl 4):e25115. doi: 10.1002/jia2.25115. |
| 29944678 | Derived | Jakubowski A, Snyman K, Kwarisiima D, Sang N, Burger R, Balzer L, Clark T, Chamie G, Shade S, Cohen C, Bukusi E, Charlebois E, Kamya M, Petersen M, Havlir D, Thirumurthy H. High CD4 counts associated with better economic outcomes for HIV-positive adults and their HIV-negative household members in the SEARCH Trial. PLoS One. 2018 Jun 26;13(6):e0198912. doi: 10.1371/journal.pone.0198912. eCollection 2018. |
| 28770596 | Derived | Kwarisiima D, Kamya MR, Owaraganise A, Mwangwa F, Byonanebye DM, Ayieko J, Plenty A, Black D, Clark TD, Nzarubara B, Snyman K, Brown L, Bukusi E, Cohen CR, Geng EH, Charlebois ED, Ruel TD, Petersen ML, Havlir D, Jain V. High rates of viral suppression in adults and children with high CD4+ counts using a streamlined ART delivery model in the SEARCH trial in rural Uganda and Kenya. J Int AIDS Soc. 2017 Jul 21;20(Suppl 4):21673. doi: 10.7448/IAS.20.5.21673. |
| FG001 | Control | Active Comparator arm first stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care Active Comparator arm second stage |
| COMPLETED |
|
| NOT COMPLETED |
|
| Stage 2 |
|
|
Persons who were residents and aged 15+ years at baseline.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Intervention arm first stage: Annual universal community- based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care |
| BG001 | Control | Active Comparator arm first stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Marital Status | Marital status not reported by all participants | Count of Participants | Participants |
| |||||||||||||||
| Marital status - polygamous marriage | Polygamous marriage status was not reported by all participants | Count of Participants | Participants |
| |||||||||||||||
| Education | Education was not reported by all participants | Count of Participants | Participants |
| |||||||||||||||
| Occupation | A formal sector occupation was defined as a teacher, student, government worker, military worker, health worker, or factory worker. A high-risk informal sector occupation was defined as a fishmonger, fisher, bar owner, bar worker, transportation worker, or tourism worker. A low-risk informal sector occupation was defined as a farmer, shopkeeper, market vendor, hotel worker, homemaker, household worker, construction worker, or miner. | Occupation not reported by all participants | Count of Participants | Participants |
| ||||||||||||||
| Household wealth index quintile | Quintiles were based on a principle components analysis of the household wealth survey and were calculated at the level of the household. | Household wealth survey data was not collected on all households. | Count of Participants | Participants |
| ||||||||||||||
| Stable residents | Stable residents were defined as residents who had spent at least 6 months of the previous year in the trial community. | Two participants did not have data recorded to determine as stable resident. | Count of Participants | Participants |
| ||||||||||||||
| Residents living with HIV | HIV status was not available for all participants | Count of Participants | Participants |
| |||||||||||||||
| Residents with prevalent hypertension | Previous or current self-report of prior diagnosis OR previous or current systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg on all 3 measurements at the health campaign or on all measures if < 3 measurements done | Adults 30 years of age or older were included in the analysis. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative HIV Incidence | Cumulative 3 year HIV incidence in men and women ages ≥15 years after the start of Phase I intervention. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | Baseline HIV- stable adult (15+years) residents | Posted | Mean | 95% Confidence Interval | cumulative events per 100 persons | 3 years follow up | Communities | Communities |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | HIV Incidence | HIV incidence rate in men and women ages ≥15 years after the start of Phase II intervention (started after 3 years of Phase I). | Intervention population consists of persons aged 15+ years who initiated PrEP in Phase II intervention communities. The comparator population consists of propensity score matched historical controls from Phase I intervention communities. HIV testing was not comprehensively conducted during Phase 2. | Posted | Number | 95% Confidence Interval | Incident HIV per 100 person-year | 3 years follow up |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incident TB Associated With HIV | Cumulative incidence of TB or death due to illness among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | Adults without active TB and with HIV at baseline | Posted | Mean | 95% Confidence Interval | cumulative events per 100 persons | 3 years follow up | Communities | Communities |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Mortality | Mortality risk among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | Known HIV+ at baseline | Posted | Mean | 95% Confidence Interval | cumulative events per 100 persons | 3 years follow up | Communities | Communities |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HIV-free Infant Survival | Probability of an infant born to an HIV+ mother remaining alive and HIV uninfected. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | Infants born in study period to women with HIV | Posted | Mean | 95% Confidence Interval | cumulative events per 100 persons | 3 years follow up | Communities | Communities |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of HIV+ Adults With HIV RNA <=500 c/mL | Percent of HIV+ adults with HIV RNA <=500 c/mL. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | HIV+ adults at year 3, including those out of care or without a prior HIV diagnosis | Posted | Mean | 95% Confidence Interval | cumulative events per 100 persons | 3 years follow up | Communities | Communities |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time in Care for HIV+ Adults With Baseline Viremia | Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia | HIV+ adults linked to care with baseline HIV RNA >=500 c/mL | Posted | Mean | 95% Confidence Interval | percentage of days | 3 years follow up |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of ART-initiation | Proportion of baseline HIV+ ART-naive persons who initiate ART Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | Baseline HIV+ without previous or current ART | Posted | Mean | 95% Confidence Interval | cumulative events per 100 persons | 3 years follow up | Communities | Communities |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hypertension Control | hypertension control (greater than or equal to 140 mg Hg systolic or 90 mg Hg diastolic after 3 repeated readings) at year 3 among adults aged >= 30 years with hypertension. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | Hypertensive adults (aged 30+) at year 3 | Posted | Mean | 95% Confidence Interval | cumulative events per 100 persons | 3 years follow up | Communities | Communities |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adherence to PrEP Treatment | Number of patients with adherence to PrEP treatment (self reported adherence at >=1 visit) | Persons who initiated PrEP eligible for a follow-up visit. No data were collected for the second stage in the control arm due to DSMB approved design modification. | Posted | Count of Participants | Participants | 3 years follow up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Adults' on- and Off-farm Employment | HIV+ adults with on- and off-farm employment | Subsample of baseline HIV+ working-age adults (18-65) | Posted | Mean | 95% Confidence Interval | cumulative events per 100 persons | 3 years follow up |
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| Secondary | Year 3 Viremia Among ART-experienced Persons With Baseline Viremia | Plasma HIV RNA <400 cps/ml Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | HIV+ ART experienced adults linked to care with baseline HIV RNA >=500 c/mL | Posted | Mean | 95% Confidence Interval | cumulative events per 100 persons | 3 years follow up | Communities | Communities |
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| Secondary | Linkage to Care | Proportion of Persons Attending an HIV Clinic Visit by 30 Days After HIV Test Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | Persons testing HIV+ and not in care | Posted | Mean | 95% Confidence Interval | cumulative events per 100 persons | 30 days after HIV test | Communities | Communities |
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| Secondary | HIV Incidence Rate | HIV incidence rates during the first and third year of follow up; Results from the Control arm are not provided because annual HIV incidence was not measured in the control arm (annual HIV testing was only conducted in the intervention arm). | HIV-negative adults in stage 1 intervention arm who had repeat HIV testing | Posted | Number | 95% Confidence Interval | per 100 person-years | 3 years follow up |
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| Secondary | Prevalence of Transmitted HIV Drug-resistance Mutations | HIV NNRTI drug-resistance mutations found at baseline | ART naive HIV+ persons at baseline | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Prevalence of Chronic Kidney Disease (CKD) | Percentage of participants with chronic kidney disease (CKD) | participants (age >=18) who had a home visit during follow up year 3 | Posted | Count of Participants | Participants | 3 years follow up |
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| Secondary | Total Costs of Programming (ART) | Cost of ART streamlined care delivery amount HIV+ persons | Units are Intervention clinics using streamlined care; participants are HIV+ with at least one streamlined care visit | Posted | Mean | 95% Confidence Interval | USD per person year | Follow up year 3 | Clinics | Clinics |
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Phase I: 3 years Phase II: 3 years
This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm Stage 1 | Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care Adverse events monitored among persons initiating ART outside of National guidelines | 1,217 | 79,818 | 89 | 1,671 | 80 | 1,671 |
| EG001 | Intervention Arm Stage II | Baseline universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care; targeted population-level PrEP Adverse events monitored among persons initiating PrEP | 18 | 5,447 | 50 | 5,447 | 17 | 5,447 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | DAIDS Vers Nov 2014 | Systematic Assessment |
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| Altered Mental Status | Psychiatric disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Chest Pain | Cardiac disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Cutaneous Eruption | Skin and subcutaneous tissue disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Deep Vein Thrombosis | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Dehydration | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Diarrhea | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Elevated ALT | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Elevated AST | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Elevated Creatinine | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Fatigue | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Genital Ulcer | Infections and infestations | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Hemoptysis | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Hemorrhage | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Incontinence | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Intoxication | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Neuromuscular weakness | Nervous system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Pain | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Pre-term Labor | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Seizure | Nervous system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Soft Tissue Injury | Musculoskeletal and connective tissue disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Spontaneous Abortion | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Temperature | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Unintentional Weight Loss | Metabolism and nutrition disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Urticaria | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| UTI | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Vomiting | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Wound | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Fetal Demise | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Fever | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Blood clot in brain | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Cesarean Infant Delivery | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Head Injury | Nervous system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Uterine Fibroids | Reproductive system and breast disorders | DAIDS Vers Nov 2014 | Systematic Assessment |
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| Injury | Musculoskeletal and connective tissue disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Pulmonary Tuberculosis | Respiratory, thoracic and mediastinal disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Ruptured Ectopic Pregnancy | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Sepsis | Infections and infestations | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Seroconversion | Infections and infestations | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Stillbirth | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Uterine Prolapse | Reproductive system and breast disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Typhoid | Infections and infestations | NIH DAIDS Nov 2014 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | DAIDS Vers Nov 2014 | Systematic Assessment |
| |
| Altered Mental Status | Psychiatric disorders | DAIDS Vers Nov 2014 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | DAIDS Vers Nov 2014 | Systematic Assessment |
| |
| Dehydration | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Dizziness | Ear and labyrinth disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Eye Discharge | Eye disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Elevated ALT | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Elevated AST | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Elevated Creatinine | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Fatigue | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Fever | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Hyperglycemia | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Hyperkalemia | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Hyponatraemia | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
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| Leucopenia | Blood and lymphatic system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Neutropenia | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Pain | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Spontaneous Abortion | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Thrombocytopenia | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Unintentional Weight Loss | Metabolism and nutrition disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Vomiting | General disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Elevated Bilirubin | Renal and urinary disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | DAIDS Vers Nov 2014 | Systematic Assessment |
| |
| Uterine Bleeding | Reproductive system and breast disorders | DAIDS Vers Nov 2014 | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Dizzinesss | Nervous system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
| |
| Headache | Nervous system disorders | NIH DAIDS Nov 2014 | Systematic Assessment |
|
In the second stage, following re-randomization, there was a DSMB approved study modification due to policy changes in standard of care. As a result, outcomes were only assessed among participants in the intervention arm who were offered PrEP. No data were collected in the control arm.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara Clark | University of California, San Francisco | 628-206-8790 | Tamara.Clark@ucsf.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 27, 2017 | Jun 17, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
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