Page 326 - SAHCS HIVMed Journal Vol 20 No 1 2019

Page 2 of 7 Original Research

or EFV. Six patients switched ART regimens and all resolved to common statistical packages and (4) procedures for
within 2 years. In South Africa, a case study described a importing data from external sources. 9
1
prepubertal girl who developed pseudogynaecomastia 4
months after initiation onto EFV-based ART, with full resolution Data analysis
7
6 weeks following cessation of EFV. In another case, a 15-year-
old HIV-infected boy developed severe, bilateral breasts 2 All statistical analysis was performed by using STATA
10
years after changing to an EFV-containing regimen. 8 version 14 (Stata Corporation, College Station, TX, USA).
The prevalence of breast abnormality in this population of
HIV-infected adolescents on ART was determined.
The relationship between puberty and ART appears to affect
the characteristics of abnormal breast development and has Statistically significant associations between the extracted
implications on the short-term management of the breast patient characteristics and abnormal breast conditions were
abnormality and future long-term holistic management of tested using Fisher’s exact test for difference in proportions
the patient’s HIV care. Therefore, the aim of this study was to and the Student’s t-test for difference of means. A probability
establish the frequency and extent of breast abnormalities in value of p < 0.05 was designated for statistical significance.
adolescents receiving ART in South Africa and to determine Fisher’s exact test was chosen as the appropriate significance
whether there were associated ART drugs and comorbidities test as we expected values less than 9, making a Pearson’s
as well as the investigations and prescribed interventions chi-quared test not optimal.
used in this setting.

Methods Ethical consideration
Record review and data extraction Ethical clearance to conduct the study was obtained from the
Human Research Ethics Committee (Medical) University of
A retrospective review of routinely collected medical records the Witwatersrand (Ethical Clearance Number: M141134).
was performed at three public health facilities managing
adolescent HIV patients in Johannesburg, South Africa. In Results
order for patients’ records to be eligible for review, they had Patient characteristics
to be aged 10–19 years on ART and had to have presented to
their health facility during the study period, that is, 01 Over the three study sites, 45.9% (631/1376) of files of
January to 31 December 2014. The outcome of interest was adolescent patients were eligible for inclusion in the study.
whether an adolescent patient on ART had an abnormal The ART clinic characteristics of included records are shown
breast event. An abnormal event was defined in men as any in Table 1.
recorded breast development and in women as breast
development that was considered by the clinician, patient or Prevalence of breast abnormalities
caregiver to be abnormal. The number of files that reported breast abnormalities was
5.9% (37/631). Some patients had breast mentioned multiple
For eligible files, patient demographic profiles and current times in the file with 41 different abnormal breast events
ART regimen during the study period were recorded, if this being recorded for 37 patients.
information was present in the file. Patient records were
screened for breast-related events and for those identified, a Demographic characteristics for abnormal
comprehensive history of clinical follow-up and ART breast events
regimens at the time of the event, as well as details of the
actual breast condition were recorded. The description Table 2 shows the patient and breast characteristics for those
files in which abnormal breast events were recorded.
provided by the clinician was captured and used to classify Abnormal breast conditions were reported at a median of
the breast condition. Body mass index (BMI) was calculated 13.5 years (interquartile range [IQR]: 12.1–15.6 years). All
using weight (in kilograms) divided by height (in metres patients with recorded abnormal breast conditions were on
squared) . The result was plotted against data sourced from ART at the time of the reported event, for a median duration
2
World Health Organization growth charts. Body mass index of 4.9 years (IQR: 1.8–6.6) since initiation of ART and 2.0 years
(kg/m ) was plotted according to standard deviation per age since starting their current ART regimen (IQR: 1.2–4.6 years).
2
(years) for male and female adolescents separately.
TABLE 1: Antiretroviral therapy clinic characteristics (n = 631).
Data were collected and managed using the Research Characteristic Abnormal breast Normal or no breast
Electronic Data Capture (REDCap) tool hosted by the development development
N = 594
N = 37
9
University of the Witwatersrand. Research Electronic Data Age at most recent visit (years)† 15.7 (14.3, 16.9) 13.8 (11.8, 16.0)
Capture is a secure, web-based application designed to Age at ART initiation (years)†,‡ 8.3 (5.3, 11.0) 8.5 (5.3, 11.5)
support data capture for research studies, providing (1) an Duration of ART (years) †,§ 7.5 (4.4, 10.3) 5.6 (2.7, 8.3)
intuitive interface for validated data entry, (2) audit trails for ART, Antiretroviral therapy.
tracking data manipulation and export procedures, (3) †, Median (IQR).
‡, 616/631 (97.6%) with recorded age at ART initiation.
automated export procedures for seamless data downloads §, 625/631 (99.2%) with recorded ART initiation dates.
http://www.sajhivmed.org.za 319 Open Access