Data for: "Impact of micro- and macronutrient status on the incidence of tuberculosis: an examination of an African cohort initiating antiretroviral therapy" – Data codebook

Permanent identifier

10.17037/DATA.00003506

Description

Nutritional Support for Africans Starting Antiretroviral Therapy (NUSTART) was a two-center (Lusaka, Zambia and Mwanza, Tanzania) randomized controlled trial funded by the European and Developing Countries Clinical Trials Partnership and sponsored by the London School of Hygiene & Tropical Medicine. The project addressed mortality resulting from malnutrition in an African cohort after starting combination antiretroviral therapy (cART) for HIV/AIDS by investigating whether nutritional supplementation can improve survival.

Data collection methods

The following trial publications provide information on the data capture and analysis process:

Effects on mortality of a nutritional intervention for malnourished HIV-infected adults referred for antiretroviral therapy: a randomised controlled trial. https://doi.org/10.1186/s12916-014-0253-8
Effects on anthropometry and appetite of vitamins and minerals given in lipid nutritional supplements for malnourished HIV-infected adults referred for antiretroviral therapy: results from the NUSTART randomized controlled trial. https://doi.org/10.1097/QAI.0000000000000483
Changes in serum phosphate and potassium and their effects on mortality in malnourished African HIV-infected adults starting antiretroviral therapy and given vitamins and minerals in lipid-based nutritional supplements: secondary analysis from the Nutritional Support for African Adults Starting Antiretroviral Therapy (NUSTART) trial. https://doi.org/10.1017/S0007114517000721

Project information

Project name	Funder/sponsor	Grant number
NUSTART	European and Developing Countries Clinical Trials Partnership	IP.2009.33011.004

Data codebook

The NUSTART trial dataset is not held in the LSHTM digital repository.

Researchers wishing to access the data should contact the trial Principal Investigator, Professor Suzanne Filteau (Suzanne.Filteau@lshtm.ac.uk), providing information on their research objectives. Professor Filteau will advise on the relevant ethical approval that must be obtained, including the process for obtaining approval from the research committees in Tanzania and Zambia, and any contractual conditions that may need to be met.

A list of variables contained within the dataset are outlined below.

Variable name	Variable description	Answer code	Answer label	Variable type
id	Patient ID			Numeric
admitted	Hospitalised due to referral	0	No	Numeric
		1	Yes
date_arv	ARV start date			Date
arv	Patient started ART	0	No	Numeric
		1	Yes
cd4gp	Baseline CD4 count group	0	<100	Numeric
		1	100-200
		2	>=200
cd4100	Baseline CD4 <100	0	No	Numeric
		1	Yes
ses5	5 quantiles of SES score	1	First quantile (lowest)	Numeric
		2	Second quantile
		3	Third quantile
		4	Fourth quantile
		5	Fifth quantile (highest)
date_rect	Recruitment date			Date
sex	Sex	0	Female	Numeric
		1	Male
site	Study site	1	Lusaka	Numeric
		2	Mwanza
bmigp	BMI group	0	17-18.5	Numeric
		1	16-16.9
		2	<16
xreason1	Reason for exiting study	1	Completed 12 weeks follow-up	Numeric
		2	Died
		4	Lost to follow-up
		5	Withdrew
arm	Randomisation arm	0	Placebo	Numeric
		1	Active
died	Patient died	0	No	Numeric
		1	Yes
newtb	Incident TB disease	0	No	Numeric
		1	Yes
date_exit	Date of censoring from study			Date
ses3	3 quantiles of SES score	1	Low	Numeric
		2	Mid
		3	High
crpgp	Baseline CRP group	0	<10	Numeric
		1	10-160
		2	160+
religion2	Religion regrouped	1	None/Other	Numeric
		2	Christian
occupation2	Occupation regrouped	1	Salaried employed	Numeric
		2	Self employed
		3	Housewife/Student/Unemployed
education2	Education regrouped	1	No education	Numeric
		2	Primary (1-7 Grades)
		3	Secondary/Tertiary/University
mstatus2	Marital status regrouped	1	Married/cohabiting	Numeric
		2	Widowed/Divorced/Separated
		3	Single - Never married
hbgp2	Hb regrouped	0	<80 severe anaemia	Numeric
		1	80-109 moderate anaemia
		2	>=110 mild anaemia/normal
agegp2	Age regrouped	0	18-29	Numeric
		1	30-44
		2	45+
xreason2	Simplified exit reason LTFU	0	Completed 12 weeks follow-up or expiry	Numeric
		1	Died of non-TB
		2	LFTU/withdrew
dob	Date of birth			Date
newtb_death	Incident death due to TB	0	No	Numeric
		1	Yes