"If it benefits someone, it will be good:" perspectives on research participation from pregnant women living with HIV.

Pregnant women living with HIV (PWLHIV) are becoming increasingly involved in HIV research; however, the ethical concerns regarding their decision-making related to research participation are understudied. This qualitative study aimed to understand the perspectives and lived research experiences of PWLHIV, intending to identify important considerations to inform best practices. This study used semi-structured interviews (SSIs) of PWLHIV who participated in research studies in Eldoret, Kenya. All interviews were audio-recorded, transcribed, and translated. Qualitative analyses were performed, with line-by-line coding, constant comparison, axial coding, and triangulation to identify central concepts. Twelve PWLHIV participated. Overall, participants had positive experiences with HIV research. Most participants had difficulty distinguishing the differences between the research process and enhanced clinical care. They reported a willingness to participate in future HIV research studies and indicated altruism as the primary motivator. Participants identified their preferences and experiences with recruitment, consenting, reimbursement, and enrolment of infants in HIV research. The largest barrier for participating in HIV research was identified as a concern that participation would lead to HIV disclosure. By understanding the lived experiences of PWLHIV who participate in HIV research, future researchers can design studies and consenting processes to optimize ethical research practices.

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

BACKGROUND: The proper and ethical inclusion of PWLHIV and their young children in research is paramount to ensure valid evidence is generated to optimize treatment and care. Little empirical data exists to inform ethical considerations deemed most critical to these populations. Our study aimed to systematically review the empiric literature regarding ethical considerations for research participation of PWLHIV and their young children. METHODS: We conducted this systematic review in partnership with a medical librarian. A search strategy was designed and performed within the following electronic databases: Ovid MEDLINE, Embase and CINAHL. We screened titles and abstracts using the following inclusion criteria: (1) a study population of PWLHIV or children under 5 years of age; and (2) collection of qualitative or quantitative data regarding ethics of research participation. Excluded were reviews, commentaries, policy statements, clinical care-related ethics concerns, abstracts, case studies, or studies unrelated to HIV research. Studies were appraised for quality, data were extracted, and studies were qualitatively analyzed using a principle-based ethical framework within the Belmont Report. RESULTS: Of the 7470 titles identified, 538 full-text articles were reviewed for eligibility and only three articles met full criteria for inclusion within this review. While we allowed for inclusion of studies involving young children born to mothers with HIV, only articles focused on PWLHIV were identified. Within the results of these studies, four themes emerged: (1) adequacy of informed consent; (2) consideration of paternal involvement; (3) balancing risks; and (4) access to research and treatment. A strength of this review is that it included perspectives of international research investigators, community leaders, and male partners. However, only two studies collected empiric data from PWLHIV regarding their experiences participating in research CONCLUSION: Researchers and funding agencies should be aware of these considerations and appreciate the value of and critical need for formative research to ensure clinical trials involving PWLHIV promote ethical, well-informed research participation and, ultimately, improve care outcomes. More research is needed to create a comprehensive ethical framework for researchers when conducting studies with PWLHIV.

A Rare Case of Cardiac Tamponade Induced by Chronic Lymphocytic Leukemia.

While cardiac tamponade is a commonly recognized complication in solid organ malignancies and acute leukemias, instances of cardiac involvement in the context of chronic hematologic malignancies, such as chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), are rarely observed. A 66-year-old male, with a history of stage IV CLL/SLL, presented with three weeks of worsening edema, orthopnea, and dyspnea. Two days after admission, an echocardiogram revealed a large circumferential pericardial effusion. Given the concern about early signs of pericardial tamponade, the patient underwent emergent pericardiocentesis with the removal of 700 cc of sanguineous fluid. A pericardial biopsy and flow cytometry of the pericardial fluid confirmed the diagnosis of CLL/SLL with pericardial involvement. There were no signs of large cell lymphoma transformation at that point. This rare case demonstrates the importance of considering cardiac complications in CLL/SLL patients who present with worsening edema, orthopnea, and dyspnea.