Table 4.

Summary of Findings and Possible Implications for HIV Cure-Related Research

Themes	Possible implications
Decisions to participate in research	• HIV cure researchers should recognize that people living with HIV may join trials for a variety of reasons.
• ACTG 5366 participants joined the study for a combination of reasons, including societal and altruistic benefits of contributing to science, and the desire to personally benefit.	• People living with HIV, and women in particular, may need to consult with important people in their lives before making decisions to participate.
Understanding of the study	• The word “cure” should be avoided in all study-related documents. Precise terms that describe study mechanisms may go a long way in setting realistic expectations.
• Most ACTG 5366 participants understood the study as helping advance HIV cure-related science. Some women showed a sophisticated understanding of the study.	• Biomedical HIV cure researchers should ensure adequate comprehension of study participants. This may require repeated communication during study follow-up.
• Over half thought the study would personally benefit their personal health.	• Increasing the readability of informed consent forms or using informed decision-making checklists could be helpful in enhancing understanding.
• We noted minor misunderstandings about the study in a subset of participants.	• The psychological aspects of research participation should be appreciated. Study participants should also be provided with adequate psychological counseling and support.
• A small number believed the study could possibly result in a cure.	• Ascertaining the existence of therapeutic or curative misconception requires in-depth probing of study participations.
	• Further empirical research is needed to examine how participants understand various HIV cure studies and interventions.
Perceptions of risks and benefits	• Biomedical HIV cure research teams should simplify risk information during the informed consent process, and provide refreshers during study visits.
• The majority of ACTG 5366 participants understood that some risks were involved, but had difficulty naming specific clinical risks.	• Biomedical HIV cure research teams should ascribe value to the lived experiences of study participants. This is particularly important for research involving women.
• ACTG 5366 participants valued the likelihood of health and psychological benefits, while the informed consent form emphasized there would be no direct benefit.	• Attention should be paid to how risks and benefits are communicated to study participants.
	• Information should be collected on how participants perceive and understand risks and benefits of research, with the close involvement of social scientists in a multi-disciplinary research effort.
	• Biomedical HIV cure research teams should emphasize the incremental nature of scientific discovery and that initial studies will not be curative.
	• While biomedical HIV cure research teams can explain to participants that they will be closely monitored, it should be emphasized that experimental study interventions are not meant to benefit participants's health directly, but to advance biomedical science.
Meaning of the study and altruism	• Biomedical HIV cure research teams should foster a healthy sense of altruism, while ensuring altruistic outlook does not unduly distort risk perceptions.
• Several ACTG 5366 participants gave altruistic reasons for joining the study. These altruistic motivations were also mixed with the desire for personal benefit.	• Future HIV cure studies should explore how participants weigh various motivations—including altruistic intentions versus self-oriented motivations.
	• In-depth empirical research is needed to precisely characterize the type of altruism witnessed in HIV cure-related study participants.
Self-image and perceived stigma	• Biomedical HIV cure research teams should appreciate that, despite being otherwise healthy, participants may still need to cope with various layers of stigma in daily life.
• Stigma remains a pervasive reality in the lives of several women who volunteered for the ACTG 5366 study, and appears to have played a role in decisions to join the study.	• More research is needed to better understand the role of stigma and self-image in decisions to participate or stay involved in research.
Role of compensation	• Monetary compensation may be a motivational factor for women, particularly in overcoming barriers to research participation (e.g., transportation), although it should not be construed as a benefit according to ethical guidelines.
• Compensation was cited as facilitating participation by at least one third of participants, and played a role in decisions to participate for some women.
Exit survey	• It is possible to recruit women in HIV cure-related research, if attention is paid up front to protocol design.
• Almost all ACTG 5366 participants would recommend the study to others and would volunteer again.	• HIV cure researchers should help women reduce barriers and enhance facilitators to participation. This would help ensure that decisions are based on participant preferences and autonomy, instead of systemic barriers.
• Only few women reported problems with research participation (e.g., finding the research difficult to understand, stigma, parking problem, and too much blood drawn).	• Exit surveys are helpful to understand factors affecting participant satisfaction and practical challenges encountered.

ACTG, AIDS Clinical Trials Group.