Healthy Families Quantitative Datasets and Data Dictionaries (doi:10.7910/DVN/4U4TTL)

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Part 1: Document Description
Part 2: Study Description
Part 3: Data Files Description
Part 4: Variable Description
Part 5: Other Study-Related Materials
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Document Description

Citation

Title:

Healthy Families Quantitative Datasets and Data Dictionaries

Identification Number:

doi:10.7910/DVN/4U4TTL

Distributor:

Harvard Dataverse

Date of Distribution:

2023-01-31

Version:

1

Bibliographic Citation:

Matthews, Lynn T., 2023, "Healthy Families Quantitative Datasets and Data Dictionaries", https://doi.org/10.7910/DVN/4U4TTL, Harvard Dataverse, V1, UNF:6:GlRhyW59ObDxGvwK4VY0pA== [fileUNF]

Study Description

Citation

Title:

Healthy Families Quantitative Datasets and Data Dictionaries

Identification Number:

doi:10.7910/DVN/4U4TTL

Authoring Entity:

Matthews, Lynn T. (University of Alabama at Birmingham)

Distributor:

Harvard Dataverse

Access Authority:

Pratt, Madeline

Depositor:

Pratt, Madeline

Date of Deposit:

2023-01-31

Holdings Information:

https://doi.org/10.7910/DVN/4U4TTL

Study Scope

Keywords:

Medicine, Health and Life Sciences, HIV prevention, PrEP adherence, Serodifferent partnerships, Women, Safer conception

Abstract:

Background In Uganda, fertility rates and adult HIV prevalence are high, and many women conceive with partners living with HIV. PrEP reduces HIV acquisition for women and, therefore, infants. We developed the Healthy-Families-PrEP intervention to support PrEP use as part of HIV prevention during periconception-pregnancy periods. We conducted a longitudinal cohort study to evaluate oral PrEP use among women participating in the intervention. Methods and Findings We enrolled HIV-negative women with plans for pregnancy with a partner living, or thought to be living, with HIV (2017-2020) to evaluate PrEP use among women participating in the Healthy-Families intervention. Quarterly study visits through 9 months included HIV and pregnancy testing, and HIV prevention counseling. PrEP was provided in electronic pillboxes, providing the primary adherence measure (“high” adherence when pillbox was opened >80% of days). Enrollment questionnaires assessed factors associated with PrEP use. Plasma tenofovir (TFV) and intraerythrocytic TFV-diphosphate (TFV-DP) concentrations were determined quarterly for women who acquired HIV and a randomly selected subset of those who did not; concentrations TFV >40ng/mL and TFV-DP >600fmol/punch were categorized as “high”. Women who became pregnant were initially exited from the cohort by design; from April 2019, women with incident pregnancy remained in the study with quarterly follow-up until pregnancy outcome. Primary outcomes included (1) PrEP uptake (proportion who initiated PrEP) and (2) PrEP adherence (proportion of days with pillbox openings during the first 3 months following PrEP initiation). We used univariable and multivariable-adjusted linear regression to evaluate baseline predictors selected based on our conceptual framework of mean adherence over 3 months. We also assessed mean monthly adherence over 9 months of follow-up and during pregnancy. We enrolled 131 women with mean age 28.7 years (95% CI:27.8-29.5). Ninety-seven (74%) reported a partner with HIV and 79 (60%) reported condomless sex. Most women (N=118; 90%) initiated PrEP. Mean electronic adherence during the 3 months following initiation was 87% (95% CI:83%, 90%). No covariates were associated with 3-month pill-taking behavior. Concentrations of plasma TFV and TFV-DP were high among 66% and 47%, 56% and 41%, and 45% and 45% at months 3, 6, and 9, respectively. We observed 53 pregnancies among 131 women (1-year cumulative incidence 53% [95% CI:43%, 62%]) and one HIV-seroconversion in a non-pregnant woman. Mean pillcap adherence for PrEP users with pregnancy follow-up (N=17) was 98% (95% CI:97%, 99%). Study design limitations include lack of a control group. Conclusions Women in Uganda with PrEP indications and planning for pregnancy chose to use PrEP. By electronic pillcap, most were able to sustain high adherence to daily oral PrEP prior to and during pregnancy. Differences in adherence measures highlight challenges with adherence assessment; serial measures of TFV-dp in whole blood suggest 41-47% of women took sufficient periconception PrEP to prevent HIV. These data suggest that women planning for and with pregnancy should be prioritized for PrEP implementation, particularly in settings with high fertility rates and generalized HIV epidemics. Future iterations of this work should compare the outcomes to current standard of care.

Methodology and Processing

Sources Statement

Data Access

Other Study Description Materials

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Citation

Bibliographic Citation:

High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: a cohort study Lynn T Matthews, Esther C Atukunda, Moran Owembabazi, Kato Paul Kalyebera, Christina Psaros, Pooja Chitneni, Craig W Hendrix, Mark A Marzinke, Peter L Anderson, Oluwaseyi O Isehunwa, Kathleen E Wirth, Kara Bennett, Winnie Muyindike, David R Bangsberg, Jessica E Haberer, Jeanne M Marrazzo, Mwebesa Bosco Bwana medRxiv 2022.08.10.22278611; doi: https://doi.org/10.1101/2022.08.10.22278611

File Description--f6909119

File: manus_fig3a_plot_data_without ID.tab

  • Number of cases: 9

  • No. of variables per record: 6

  • Type of File: text/tab-separated-values

Notes:

UNF:6:94sk1R64Eu7aPQfRHQQHPg==

File Description--f6909113

File: manus_fig3b_data_without ID.tab

  • Number of cases: 6437

  • No. of variables per record: 2

  • Type of File: text/tab-separated-values

Notes:

UNF:6:wGQdLd9QouILO42uClSlVw==

File Description--f6909105

File: manus_fig3b_plot_data_without ID.tab

  • Number of cases: 12

  • No. of variables per record: 6

  • Type of File: text/tab-separated-values

Notes:

UNF:6:Lm1AFiiclZZ6i6ytoZPjZg==

Variable Description

List of Variables:

Variables

wisep_month

f6909119 Location:

Summary Statistics: StDev 2.7386127875258306; Max. 9.0; Valid 9.0; Mean 5.0; Min. 1.0

Variable Format: numeric

Notes: UNF:6:2opp6m0iOh74MhFjZVVqfg==

lb

f6909119 Location:

Summary Statistics: Min. 0.822; Max. 0.865; Valid 9.0; Mean 0.8395555555555555; StDev 0.015452435981999026

Variable Format: numeric

Notes: UNF:6:t/QL4xfz3D2jJGsUpi/MNw==

ub

f6909119 Location:

Summary Statistics: Min. 0.903; Mean 0.926; StDev 0.017277152543170967; Max. 0.948; Valid 9.0

Variable Format: numeric

Notes: UNF:6:jD81n/KcxJ4PxYn12H+Q6A==

x_num

f6909119 Location:

Summary Statistics: Max. 9.0; StDev 2.7386127875258306; Valid 9.0; Min. 1.0; Mean 5.0;

Variable Format: numeric

Notes: UNF:6:2opp6m0iOh74MhFjZVVqfg==

num_women

f6909119 Location:

Summary Statistics: StDev 22.776083947860748; Valid 9.0; Mean 76.0; Min. 48.0; Max. 107.0;

Variable Format: numeric

Notes: UNF:6:3rZCcrvlBF7F8GFBE7mQhA==

mean

f6909119 Location:

Summary Statistics: Min. 0.864; StDev 0.015634719199411444; Mean 0.8817777777777778; Valid 9.0; Max. 0.902

Variable Format: numeric

Notes: UNF:6:L+CZwNMWc223L5WGFj+EGQ==

wisep_outcome

f6909113 Location:

Summary Statistics: Min. 0.0; Mean 0.8799130029516844; Max. 1.0; StDev 0.3250884928243687; Valid 6437.0

Variable Format: numeric

Notes: UNF:6:AEXBgYgC1/4hS7WI7bijrQ==

preg_wisep_month

f6909113 Location:

Summary Statistics: StDev 2.9897787019376056; Max. 6.0; Min. -6.0; Mean -1.4199161099888011; Valid 6437.0

Variable Format: numeric

Notes: UNF:6:+aQVd906C7rPrRRVdW1ltw==

preg_wisep_month

f6909105 Location:

Summary Statistics: Valid 12.0; StDev 4.067610422035836; Max. 6.0; Mean 0.0; Min. -6.0

Variable Format: numeric

Notes: UNF:6:Tz+/xmU4INSxhRfstfXAgA==

num_women

f6909105 Location:

Summary Statistics: Min. 6.0; Valid 12.0; Max. 41.0; Mean 18.083333333333336; StDev 13.173377652974152

Variable Format: numeric

Notes: UNF:6:yAPLwZIRiuHhMITnj9ldYw==

x_num

f6909105 Location:

Summary Statistics: Min. -5.0; Max. 6.0; Valid 12.0; StDev 3.605551275463989; Mean 0.5;

Variable Format: numeric

Notes: UNF:6:gpmL76LD3zhKUNeiyGhfmQ==

lb

f6909105 Location:

Summary Statistics: StDev 0.08490797157136445; Max. 0.976; Min. 0.745; Valid 12.0; Mean 0.8705;

Variable Format: numeric

Notes: UNF:6:un0fublRROHbwzjv6tBk9A==

ub

f6909105 Location:

Summary Statistics: StDev 0.03695287744567601; Mean 0.9656666666666667; Max. 1.008; Min. 0.9; Valid 12.0

Variable Format: numeric

Notes: UNF:6:bthDI9XfPr739u+N6+vLlA==

mean

f6909105 Location:

Summary Statistics: Min. 0.819; Max. 0.99; Mean 0.9164166666666667; Valid 12.0; StDev 0.06182152954393409;

Variable Format: numeric

Notes: UNF:6:HNsp9ee3O1O7jMQVC11OCw==

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adhdbsplasma_3m_fig4_manus_codebook_without ID.csv

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text/csv

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adhdbsplasma_3m_fig4_manus_without ID.csv

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manus_fig3b_plot_data_codebook_without ID.csv

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prep3m_prepreg_table2_manus_codebook _without ID.csv

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wisep_prepreg_fig3a_manus_without ID.csv

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