REVAMP Clinical Trial Dataset

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Siedner. Mark, 2021, "REVAMP Clinical Trial Dataset", https://doi.org/10.7910/DVN/SKUUOP, Harvard Dataverse, V1, UNF:6:+8OM8WiRXHVT7hNESHIeWA== [fileUNF]

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Description	Data are derived from the Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa (REVAMP) clinical trial. The de-identified dataset includes include randomization allocation, baseline participant characteristics and primary and secondary outcomes. (2021-11-17)
Subject	Medicine, Health and Life Sciences
Keyword	HIV, resistance, virologic failure, africa
Related Publication	Siedner MJ, Moosa MS, McCluskey S, Gilbert RF, Pillay S, Aturinda I, Ard K, Muyindike W, Musinguzi N, Masette G, Pillay M, Moodley P, Brijkumar J, Rautenberg T, George G, Gandhi RT, Johnson BA, Sunpath H, Bwana MB, Marconi VC. Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa : An Unblinded Randomized Controlled Trial. Ann Intern Med. 2021 Oct 26. PMID: 34698502.doi: 10.7326/M21-2229
License/Data Use Agreement	Custom Dataset Terms

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	1 to 4 of 4 Files	Original Format Archival Format (.tab)
	REVAMP Clinical Trial Full Protocol Version 14 Dec 2020 Adobe PDF - 785.2 KB Published Dec 2, 2021 17 Downloads MD5: 12452f75a36fd5b96cdb10d6ca6b55b5 REVAMP Study Protocol	Preview "REVAMP Clinical Trial Full Protocol Version 14 Dec 2020" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation Download EndNote XML Download RIS Download BibTeX
	REVAMP Clinical Trial Primary Results Manuscript - Annals Internal Medicine Adobe PDF - 374.0 KB Published Dec 2, 2021 15 Downloads MD5: 98cd40cd68d0d4d0765f08be89f0d7f6 REVAMP Clinical Trail Manuscript	Preview "REVAMP Clinical Trial Primary Results Manuscript - Annals Internal Medicine" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation Download EndNote XML Download RIS Download BibTeX
	REVAMP Public Codebook Version 12nov2021.pdf Adobe PDF - 152.0 KB Published Dec 2, 2021 14 Downloads MD5: 3e5278b9a916c5595934304e45de2d13 REVAMP Codebook	Preview "REVAMP Public Codebook Version 12nov2021.pdf" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation Download EndNote XML Download RIS Download BibTeX
	revamp_public_dataset_7jul2021.tab Tabular Data - 64.8 KB Published Dec 2, 2021 17 Downloads 29 Variables, 840 Observations UNF:6:+8OM8WiRXHVT7hNESHIeWA== REVAMP Public Dataset	Preview "revamp_public_dataset_7jul2021.tab" Preview "revamp_public_dataset_7jul2021.tab" Access File File Access Public Download Options Comma Separated Values (Original File Format) Tab-Delimited RData Download Metadata DDI Codebook v2 Data File Citation Download EndNote XML Download RIS Download BibTeX Explore Options Data Explorer v2

Citation Metadata

Persistent Identifier	doi:10.7910/DVN/SKUUOP
Publication Date	2021-12-02
Title	REVAMP Clinical Trial Dataset
Alternative Title	Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa
Other Identifier	clinicaltrials.gov: NCT02787499
Author	MGH0000-0003-3506-842X
Point of Contact	Use email button above to contact. Siedner, Mark (MGH)
Description	Data are derived from the Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa (REVAMP) clinical trial. The de-identified dataset includes include randomization allocation, baseline participant characteristics and primary and secondary outcomes. (2021-11-17)
Subject	Medicine, Health and Life Sciences
Keyword	HIV, resistance, virologic failure, africa
Related Publication	Siedner MJ, Moosa MS, McCluskey S, Gilbert RF, Pillay S, Aturinda I, Ard K, Muyindike W, Musinguzi N, Masette G, Pillay M, Moodley P, Brijkumar J, Rautenberg T, George G, Gandhi RT, Johnson BA, Sunpath H, Bwana MB, Marconi VC. Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa : An Unblinded Randomized Controlled Trial. Ann Intern Med. 2021 Oct 26. PMID: 34698502. doi 10.7326/M21-2229 Reynolds Z, McCluskey SM, Moosa MYS, Gilbert RF, Pillay S, Aturinda I, Ard KL, Muyindike W, Musinguzi N, Masette G, Moodley P, Brijkumar J, Rautenberg T, George G, Johnson BA, Gandhi RT, Sunpath H, Marconi VC, Bwana MB, Siedner MJ. Who's slipping through the cracks? A comprehensive individual, clinical and health system characterization of people with virological failure on first-line HIV treatment in Uganda and South Africa. HIV Med. 2021 PMID: 34755438 doi 10.1111/hiv.13203 Rautenberg TA, George G, Bwana MB, Moosa MS, Pillay S, McCluskey SM, Aturinda I, Ard K, Muyindike W, Moodley P, Brijkumar J, Johnson BA, Gandhi RT, Sunpath H, Marconi VC, Siedner MJ. Comparative analyses of published cost effectiveness models highlight critical considerations which are useful to inform development of new models. J Med Econ. 2020 Mar;23(3):221-227. PMID: 31835974 doi 10.1080/13696998.2019 Siedner MJ, Bwana MB, Moosa MS, Paul M, Pillay S, McCluskey S, Aturinda I, Ard K, Muyindike W, Moodley P, Brijkumar J, Rautenberg T, George G, Johnson B, Gandhi RT, Sunpath H, Marconi VC. The REVAMP trial to evaluate HIV resistance testing in sub-Saharan Africa: a case study in clinical trial design in resource limited settings to optimize effectiveness and cost effectiveness estimates. HIV Clin Trials. 2017 07; 18(4):149-155. PMID: 28720039. doi 10.1080/15284336.2017.1349028
Funding Information	NIH/NIAID: R01AI124718
Depositor	Reynolds, Zahra
Deposit Date	2021-11-17
Date of Collection	Start Date: 2016-12-01; End Date: 2020-05-01
Data Type	survey data, clinical trial data

Geospatial Metadata

Geographic Coverage	Uganda, Mbarara South Africa, KwaZulu-Natal

Social Science and Humanities Metadata

Unit of Analysis	individuals
Universe	People in failing first-line HIV treatment in public health facilities in Uganda and South Africa
Data Collector	Mbarara University of Science and Technology, Africa Health Research Institute
Frequency	3 time points during the observation period
Target Sample Size	840
Collection Mode	In-person interview, laboratory and medical record reports
Type of Research Instrument	Structured interview

Life Sciences Metadata

Design Type	Parallel Group Design

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License/Data Use Agreement

Our Community Norms as well as good scientific practices expect that proper credit is given via citation. Please use the data citation shown on the dataset page.

Custom terms specific to this dataset Custom Dataset Terms - the following Custom Dataset Terms have been defined for this dataset.

Terms of Use I will use the dataset solely for statistical analysis and reporting of aggregated information, and not for investigation of specific individuals or organizations, except when identification is authorized in writing by the Distributor. I will not knowingly divulge any information that could be used to identify individual participants in the study, nor will I attempt to identify or contact any study participant, and I agree to use any precautions necessary to prevent such identification.

Citation Requirements I will make appropriate acknowledgment of the contributor of the dataset as well as the Distributor in any manuscript or presentation (published or unpublished) using the citation standard documented on this site.

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