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Table 1 Study characteristics

From: Ethical considerations for research involving pregnant women living with HIV and their young children: a systematic review of the empiric literature and discussion

References Country Study design Sample size Relevant data collection methods Key results Notes Themes Quality Assessment using STROBE guidelines
Corneli et al. [13] Malawi Qualitative cross-sectional study Total: N = 185
HIV positive mothers of infants less than one year old: n = 40
Mothers of undisclosed HIV status with an infant below the age of one: n = 35
Pregnant women: n = 25
Grandmothers of grandchildren less than one year: n = 26
Fathers of infants less than one year: n = 26
Health providers: n = 19
Traditional birth:
n = 7
Semi-structured interviews
Focus group discussions
The mothers did not fully understand the goals of the study, raising concern to the informed consent process
Randomization as a study technique does not make sense to the women participating in the study
Women participating in studies often feel compelled to share study interventions, such as medications and food supplements, with partners and families
Current study nested within The Breastfeeding, Antiretroviral and Nutrition (BAN) Study Balancing risks
Adequate informed consent
60%
Krubiner et al. [5] United States
South Africa
Botswana
Malawi
Qualitative cross-sectional study Total N = 62 HIV investigators and clinicians Focus group discussions
Semi-structured interviews
Unclear guidance on the level of risk and benefit of the research for the woman and fetus, as determined by the ethical review boards. This uncertainty may cause investigators to exclude this population to enable other aspects of the study to progress with great efficiency
Researchers are unsure who to include in the enrolment process because of the complex relationship of mother, fetus, and father
The consequences for errors in research with pregnant women are grave (e.g. authors cite thalidomide study), which dis-incentivizes research with this population
The financial costs for including pregnant women are much higher compared to research with other populations, due to the need for extended follow up
Current study nested within Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Balancing Risks
Consideration of paternal involvement
Access to research and treatment
32%
Sullivan et al. [14] United States
Malawi
Qualitative cross-sectional study Total: N = 140 women with HIV or at high risk for HIV
United States: n = 70
Malawi: n = 70
Semi-structured interviews Results were primary focused on reasons in promoting/opposing a paternal consent requirement for HIV research involving pregnant women
The rights of the father, protection of the fetus if something to were happen to the mother, and paternalistic gender dynamics were cited by women as reasons in favor of paternal consent requirement
Maternal rights, protecting interests of fetus, and controlling partners were cited by women as reasons to oppose paternal consent requirements
Current study nested within Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Balancing risks
Consideration of paternal involvement
86%
  1. BAN Breastfeeding, Antiretroviral and Nutrition Study, PHASES Pregnancy and HIV/AIDS: Seeking Equitable Study, STROBE The Strengthening the Reporting of Observational Studies in Epidemiology