Table 3. Mapping qualitative findings to the TDF and COM-B frameworks and BCW.

Findings	Review findings	COM-B and TDF mapping	Actor	Potential intervention type based on BCW	Examples of how implementation strategies could be operationalised or actual implementation strategies used
1	Women have a limited appetite for risk during pregnancy or lactation	Psychological Capability (Memory, Attention and Decision processes); Reflective Motivation (Beliefs about Consequences)	Pregnant and lactating women, health workers, and research staff	Education, Persuasion, Enablement, Training	1) For health workers, provide access to credible resources of empirical evidence or proof related to risks, benefits, side-effects, how past and ongoing medical complications might be affected by trial intervention, and probability and implications of possible interactions between current medications and the experimental product being tested through the trial that can support addressing fear, uncertainty, and provision of clinical advice around medication use during pregnancy. 2) Provide training to researchers on how to humanise engagement between the study team and participants through all trial stages. Training could include how to apply an individualised approach to recruitment that considers women’s medical conditions, their individual and family situations, and preferences for engagement. Additionally, develop mechanisms for obtaining and integrating participant feedback on interpersonal engagement through all trial stages. 3) For women, see review finding 1.2.
2	Making trade-offs between risk and severity of the condition and risk-benefit ratio of intervention	Psychological Capability (Memory, Attention, and Decision processes); Reflective Motivation (Beliefs about Consequences, Optimism)	Pregnant and lactating women and research staff	Education, Training, Enablement	1) For pregnant and lactating women, share information transparently about safety, risks, benefits, and side effects of the trial intervention, and encourage personalised discussions about how these aspects relate to women’s own perceptions about participation and their individual situations to increase their knowledge and understanding. Inform women about the number of participants that have already enrolled in the trial and if the intervention has been tested in other settings. Engage prior trial participants to discuss personal experiences of trial participation. 2) For research staff, see review finding 1.1.
3	Benefits to health arising from participation	Reflective Motivation (Beliefs about Consequences, Optimism)	Pregnant and lactating women	Education	For pregnant and lactating women, consider how sharing information about the trial can be tailored to their personal circumstances, for example, with the assistance of a decision-analysis tool. See also review finding 1.2.
4	Experiences and expectations of high-quality care motivate participation	Reflective Motivation (Intentions, Beliefs about Consequences); Automatic Motivation (Emotion)	Pregnant and lactating women	Education, Enablement	Consider how trusted resources, such as the woman’s care provider, could help to communicate with women about benefits and risks of trial participation.
5	Knowledge of the rationale for study design features	Psychological Capability (Knowledge); Reflective Motivation (Beliefs about Consequences); Automatic Motivation (Emotion)	Pregnant and lactating women and research staff	Education, Training, Enablement	Provide clear explanations for the trial design features in plain language in the recruitment materials, informed consent form, and through discussion with women. Ensure research staff can clearly explain the rationale for different trial design features using plain language.
6	Acceptability of the intervention is key to pregnant and lactating women’s willingness to participate in a trial, and for research staff to recruit for a trial	Psychological Capability (Knowledge); Reflective Motivation (Beliefs about Consequences, Optimism)	Pregnant and lactating women and research staff	Education, Training, Enablement	Conduct formative research before the start of the trial to assess the acceptability of different intervention components, and what components may need adjustments. Consider how trial procedures and intervention components can be simplified or streamlined to improve acceptability.
7	Fears around data sharing and use	Psychological Capability (Knowledge); Reflective Motivation (Beliefs about Consequences); Physical Opportunity (Environmental Context and Resources); Social Opportunity (Social Influences)	Pregnant and lactating women and community leaders/members	Education, Training, Enablement, Environmental restructuring	Ensure that data management plans include efforts to preserve data confidentiality. Train all health workers and research staff on the importance of maintaining confidentiality. Consider how research materials (e.g., forms, packaging) and the research environment (e.g., signposting, area of health facility) can be structured to prevent disclosure of stigmatising health conditions. Community engagement and outreach can also help to de-stigmatise health conditions.
8	Altruistic motivations	Reflective Motivation (Intentions, Beliefs about Consequences)	Pregnant and lactating women	Education	Provide information about the potential societal benefits of the research to women during recruitment and throughout the trial.
9	Financial incentives	Automatic Motivation (Reinforcement)	Pregnant and lactating women	Enablement	Conduct formative research before the start of the trial to consider different perspectives on appropriate and ethical remuneration for trial participation. Consider how nonfinancial remuneration may also be acceptable (e.g., providing childcare during trial visits, providing transportation vouchers).
10	Roles of trust and power in the medical and research ecosystem	Psychological Capability (Knowledge, Memory, Attention and Decision process); Reflective Motivation (Beliefs about Consequences, Optimism)	Pregnant and lactating women and health workers	Education, Training, Enablement	Provide training to health workers involved in the trial that elaborates on the trial rationale, potential benefits, and where the trial fits into existing evidence. Ensure that women clearly understand the context of a trial and that participation may not yield therapeutic benefit. Where benefit is demonstrated in a trial, consider how participants randomised to a control group may receive the intervention at a later stage, or how scale-up could happen in control sites.
11	The role of therapeutic hope and optimism	Reflective Motivation (Social/Professional Role and Identity); Social Opportunity (Social Influences)	Pregnant and lactating women, family members and community members	Education, Enablement, Persuasion	Provide training to health workers involved in the trial that elaborates on the trial rationale, potential benefits, and where the trial fits into existing evidence. Ensure that women clearly understand the context of a trial and that participation may not yield therapeutic benefit. Where benefit is demonstrated in a trial, consider how participants randomised to a control group may receive the intervention at a later stage, or how scale-up could happen in control sites.
12	Expectations of women’s roles as mothers and caregivers	Psychological Capability (Knowledge, Memory, Attention, and Decision process); Reflective Motivation (Beliefs about Consequences, Optimism)	Pregnant and lactating women, health workers, and research staff	Education, Training, and Enablement	Ensure that information about the trial considers gendered aspects of motherhood and balances gendered beliefs and responsibilities with clear information about trial participation. Provide educational materials about pregnancy and the trial to women to share with their partners/spouses and family members.
13	Role of bodily autonomy in decision-making	Reflective Motivation (Beliefs about Capabilities); Social Opportunity (Social Influences)	Pregnant and lactating women, family members, health workers, research staff, ethics committee members, and regulators	Education, Enablement	Develop training materials for ethics committee members and regulators about the ethical conduct of interventional research with women during pregnancy. Consider societal norms in the trial context to ensure that women are provided with the opportunity to accept or decline participation without undue influence from other people.
14	Relationship dynamics, gender roles, and norms are key to women’s attitudes to partner involvement and paternal consent	Reflective Motivation (Beliefs about Consequences); Social Opportunity (Social Influences)	Pregnant and lactating women and partners	Education, Enablement	Prior to trial recruitment, ensure that research staff have a clear picture of social and gender norms around women’s healthcare-seeking behaviours during pregnancy and birth. Engage with patient advocates and women’s groups to ensure that trial procedures and recruitment processes are respectful of and responsive to social and gender norms. Develop decision aids and educational materials that can be used to foster discussion about participation between a woman and her spouse/partner and family, as appropriate.
15	Developing trusting and reciprocal relationships with the community as part of the research process	Automatic Motivation (Emotion); Physical Opportunity (Environmental Context and Resources); Social Opportunity (Social Influences)	Pregnant and lactating women, community members, health workers, and research staff	Training, Enablement, Environmental restructuring	Engage with patient advocate and women’s groups throughout the trial to improve design, recruitment, implementation, and dissemination efforts. Patient advocate and women’s groups can help to improve the person-centredness and inclusivity of research and develop strategies to address stigma or mistrust associated with clinical trials. Depending on context, engaging with community health workers or community leaders may help to align trial activities with community norms and beliefs.
16	Increasing visibility and awareness of the trial	Psychological Capability (Knowledge); Physical Opportunity (Environmental Context and Resources)	Pregnant and lactating women, health workers, and community members	Enablement, Environmental restructuring	Develop promotional materials to promote trial activities that are appropriate for the setting, such as radio advertisements and written materials provided at health facilities. Consider how the physical environment where recruitment takes place can be designed to improve person-centredness.
17	Inadequate resources	Physical Opportunity (Environmental Context and Resources)	Study investigators, research staff, and health workers	Enablement, Environmental restructuring	Engage with health workers in the study health facilities to understand any barriers to recruitment given their context. Consider whether it is more appropriate to engage with research staff who are not employed by the health facility for research tasks, such as a research midwife. Ensure that research staffs are compensated fairly for their roles and that trial activities do not interfere with clinical responsibilities.
18	Engaging health workers in trials	Psychological Capability (Knowledge, Cognitive/Interpersonal Skills); Reflective Motivation (Beliefs about Consequences, Social/Professional Role and Identity, Optimism)	Health workers and research staff	Training, Education, Enablement, Persuasion	Depending on the context, health workers may benefit from general training about the utility of trials in maternal health, and how trials relate to evidence-based practice, clinical protocols, and guidelines. Either during formative research before the trial or when training health workers on trial activities, provide ample time for discussion to understand potential barriers to trial implementation and engagement in their setting to assuage fears and ensure benefits are understood.
19	Research staff’s emotional orientations towards clinical trials	Reflective Motivation (Goals, Beliefs about Capabilities); Physical Opportunity (Environmental Context and Resources); Social Opportunity (Social Influences)	Research staff	Enablement, Incentivisation, Education, Environmental restructuring	Set feasible, achievable, and clear goals for trial recruitment for each site. Provide recognition and appreciation for research staff to celebrate milestones, achievements, and successful recruitment outcomes. Provide ongoing training to strengthen skills of research staff, offer opportunities for professional development and career growth, and ensure they feel confident and well-equipped for their roles. Consider if establishing performance-based bonuses or rewards are appropriate and could enhance recruitment without negative impacts. Ensure research staff understand the big picture of the significance of their work in advancing knowledge and the broader mission or vision of an organisation or community.
20	Women-centred approach encourages participation	Psychological Capability (Knowledge, Memory, Attention, and Decision process); Reflective Motivation (Beliefs about Consequences); Automatic Motivation (Emotion); Physical Opportunity (Environmental Context and Resources)	Pregnant and lactating women, research staff and health workers	Education, Training, Enablement, Environmental restructuring	See finding 1.2. Also consider the most appropriate timing to approach women for trial recruitment, to align and not conflict with timing around their own clinical care.
21	Recruitment for intrapartum research	Psychological Capability (Knowledge, Memory, Attention, and Decision process); Reflective Motivation (Beliefs about Consequences); Automatic Motivation (Emotion); Physical Opportunity (Environmental Context and Resources)	Pregnant and lactating women, partners, research staff, and health workers	Education, Training, Enablement, Environmental restructuring	Timing of intervening for women’s participation in research addressing intrapartum interventions is important. If trial information is given to women too early during antenatal care, it may be forgotten during labour. Some women may be distressed in labour, but many women are comfortable in early labour and if they have adequate pain management. Seek input from patient advocates or women’s groups, and consider if it is feasible to have a multi-staged approach to providing information about trial participation. For example, women could be sensitised to ongoing trials during antenatal care, with specific recruitment details provided late in pregnancy or when admitted for birth.
22	Factors affecting motivation of study investigators	Psychological Capability (Knowledge); Reflective Motivation (Goals, Beliefs about Consequences, Social/Professional Role and Identity); Social Opportunity (Social Influences)	Study investigators	Education, Persuasion, Incentivisation, Enablement	Work towards creating a research-friendly environment within health facilities. Engage with hospital leadership to promote buy-in, and create research committees. Provide dedicated research space within health facilities (offices, meeting rooms, labs), and invest in research infrastructure (data storage, research information systems). Hire and train research support staff (e.g., research midwives), and provide continuous learning and professional development about conducting research. Where possible, allocate budget for research activities, including small grants, research fellowships, or internal funding for pilot projects. Encourage collaboration between hospital departments, academic institutions, and other research entities, and foster networking opportunities. Hold regular research seminars and journal clubs to promote knowledge exchange. Develop a formal research mentorship scheme for students, trainees, and junior staff. Establish awards or recognition for research achievements. Collaborate with organisations in the facility catchment area to ensure women and community members are involved in research, and research is responsive and relevant to community needs.
23	Challenges in gaining ethical approvals for trials with pregnant women	Reflective Motivation (Optimism [Pessimism], Belief about Consequences); Physical Opportunity (Environmental Context and Resources)	Study investigators, ethics committee members, and regulators	Education, Persuasion, Enablement, Environmental restructuring	1) Educate IRB committee members and regulators about the health consequences of excluding pregnant women from research and the opportunities and approaches for estimating and monitoring risks associated with trial inclusion. 2) Provide training on developing a shared institutional commitment to safe and responsible inclusion of pregnant women in biomedical research as the standard, and develop a common institutional understanding of regulatory guidelines and associated documentation such as standard operating procedures, worksheets, and checklists to facilitate consistency in guideline application by institutional ethics committees and researchers. 3) Promote collaboration, discussion, and consensus-building with ethics committee members in locations where the trials are initiated and implemented, colleagues across different specialties and geographical locations and community representatives through protocol development and study design stages to determine mutually acceptable approaches to trial design.
24	Role of funders	Reflective Motivation (Belief about Consequences); Physical Opportunity (Environmental Context and Resources)	Funders and research staff	Education, Persuasion, Enablement, Incentivisation, Environmental Restructuring	Awareness-raising for funders about the importance of funding trials with pregnant and lactating women is urgently needed. This should include a clear discussion that if the research is not conducted with these populations, then the responsibility for decision-making about therapeutics is left to health workers and pregnant women: this is an unfair transfer of responsibility. Educational materials could be developed as core funder resources for “how to include pregnant and lactating women” in trials conducted by researchers receiving funds from a given funder.