Table 1 Study characteristics
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% |