Inclusion of Women in HIV (Including Cure) Clinical Research
Inclusion of Women in HIV (Including Cure) Clinical Studies:. Researchers should ensure broad representation, clear definitions, and accurate capture of gender identities. Inclusion can also be driven by the local and global epidemiology, scientific questions, and proactive enrollment goals. Common Challenges to Including Women in HIV Cure Clinical Research: There are multiple common challenges to including women in HIV cure research, including protocol-level challenges, medical and practical-level challenges, psychosocial challenges and institutional challenges. Research teams should prioritize to proactively reduce as many of these common challenges as possible, and design and implement HIV cure trials through the lenses of intersectionality.
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Meaningful Participation of Women in HIV (Including Cure) Research
Successful Trial Examples: The following were highlighted in some trials as successful tools in enrolling women in trials: the insistence and requirement to include women, respectful and holistic engagement of women, focus on scientific issues that matter for women, and trial design specific to a population aimed at answering a scientific question.
Steps to Facilitate More Equitable Participation of Women:
Protocol-level strategies were including women in research planning stages, having more lenient eligibility criteria, preparing clear enrollment plans for women, setting very intentional enrollment goals and implementing enrollment freezes when necessary.
Implementation strategies include having frequent recruitment updates to research teams, reducing trial burdens as much as possible, and valuing women’s unique lived experiences.
Institution-level strategies include involving sites that have adequate infrastructure and populations, recruiting women where they receive HIV care, involving primary care doctors, and having representation of women at all levels.
Community engagement and outreach-related strategies include involving peer navigators, outreach workers or case managers, involving community members and CBOs as partners, using simple language, and sharing research results back to the community.
Disaggregating Scientific Data by Sex and Gender: Data disaggregation by sex should occur as early as possible in the research process. There should be more standardized requirements for scientific abstracts and publications, and peer reviewers should recognize their role in making sure diligent reporting occurs. Data disaggregation is important to close scientific gaps and disparities, to help answer scientific questions, and to make people feel included in research.
Testing Interventions in Women: Biological sex is an important variable when testing HIV cure interventions, particularly for host-directed therapies. Willingness to Undergo Invasive Procedures (e.g., biopsies): Women may be willing to undergo biopsies, and several factors affect willingness to donate biopsies (e.g., information about why biopsies are needed, level of invasiness, frequency, level of pain or pain medications involved, sedation, recovery time, and compensation for biopsies and for research-related injuries). People Who Can Bear Children: People should be given autonomy to make decisions with informed consent, and there should be robust pre-clinical data to understand potential reproductive risks. Researchers should follow recommendations to make contraceptive requiremens more person- and women-centered (55) – for example, thinking carefully about these requirements for people from the LGTBQAI+ community.
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Women and HIV Treatment Interruptions
Women’s Willingness to Interrupt HIV Treatment: Facilitators to HIV treatment interruptions included frequent clinical monitoring, helping ensure representation of women, and long-term side effects of study interventions. Potential ATI concerns were viral rebound, CD4 count decrease, inflammation, immune activation, health regression, contradicting ART adherence messages, having to relearn ART adherence after an ATI, changes in ART regimens, and challenges for women trying to conceive. Considerations for Women Undergoing ATIs centered around avoiding risks related to pregnancy and/or breast/chest-feeding, establishing relationships of trust and mechanisms for communication, involving primary care doctors in conversations, and adopting a holistic approach to ATIs (e.g., mental health checks). Considerations related to partner protections included understanding partnership status, offering adequate counseling and disclosure support, and adopting principles of trauma-informed research.
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Additional Considerations
Logistical Aspects for Women: Logistical considerations included offering transportation, childcare, customized support, flexibility with study visits (including home visits), meaningful financial incentives, minimized paperwork, birth control, mental health support, and linkages with CBOs who can offer wrap-around services outside of clinical trials if needed. Transgender and Gender Diverse Individuals: Attention should be paid to the role of sex hormones and gender-affirming care, as well as social factors (e.g., discrimination, stigma, stress, violence, economic vulnerabilities).
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