Descriptions of risks and benefits of HIV vaccine trials in low-and middle-income countries (LMICs): an integrative review.

Human immunodeficiency virus (HIV) vaccine trials are needed in efforts to prevent infection and acquired immunodeficiency syndrome (AIDS). Like other types of research, HIV vaccine trials present benefits and risks that may or may not be anticipated by participants. Perceptions of risks and benefits often vary with contextual factors, such as sociocultural and economic variables, which are important in low- and middle-income countries (LMICs).

Aims: This integrative review aimed to determine the risks and benefits of HIV vaccine trial participation reported in the LMICs from 1995 to 2024. The risks and benefits were reported by participants and potential participants during trial preparations, recruitment, actual trial participation or after trial participation. In this review we assessed on how the risks and benefits were described by the authors of the reviewed studies. We also sought to categorize these risks and benefits, consider ethical implications, identify gaps for further research, and recommend actions for policy improvement.

Methods: The integrative review screened studies from four databases (CINAHL, Embase, MEDLINE and Web of Science). Studies were eligible if they involved interactions with human subjects and were written in English. Covidence software was used to organize the search outcomes.

Results and discussion: Twenty-five studies met inclusion criteria. Identified benefits included a sense of altruism, free healthcare, financial incentives and HIV education. Risks included stigma and discrimination associated with vaccine-induced seropositivity, perceived racism and fear of delayed harms. Important descriptions of risks and benefits (e.g., magnitude and likelihood) were missing. Free healthcare and financial incentives may render participants too influenced to enter consent, which is an important ethical concern in LMICs.

Conclusion: The literature was scant, highlighting a need for research on how participants in LMICs are informed about weighing risks and benefits of HIV vaccine trial participation. More in-depth description of risks and benefits is warranted. Standardized risk/benefit assessment frameworks tailored to the context of these trials in LMICs are needed.