Ethical review
Prior to study initiation, ethical approval was obtained from the University of Miami Institutional Review Board, the University of Zambia Biomedical Research Ethics Committee, and the Zambian National Health Research Authority. All procedures were followed in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) following the Helsinki Declaration of 1975, as revised in 2000. All participants provided written informed consent to participate in the study at enrollment. The LFLS protocol was registered on clinicaltrials.gov under trial number NCT04119414.

Sites received S&S+LFLS training. The CHCs selected 2 VCT/ANC counselors/staff (or equivalent) to receive training to conduct the S&S+LFLS intervention. S&S training commenced with a 2 day intensive review of the S&S program manual followed by supervised “on the job” training sessions with a S&S staff trainer. The trainees participated in three 4 session S&S groups and five 2 session LFLS couple interventions. The first S&S/LFLS group and couple sessions were led by a study staff member with trainee(s) observing; second and third group sessions were co-led by trainee and study staff; fourth S&S session were led by trainee, with study staff observing. A similar pattern took place with the couple sessions. Following completion of the S&S+LFLS training, study staff reviewed trainee’s performance for both interventions and recommended certification, or additional training on either or both interventions.

Theory of reasoned action.
The proposed EIMC pilot study was also guided by the theories of reasoned action (intentions influence attitudes and subjective norms, i.e., perceptions of social norms, motivation to comply, which influence beliefs about behavior [32] and planned behavior (perceived behavioral control influences intentions and behavior [33]) as predictors of EIMC [34]. Within this model, it was hypothesized that EIMC intentions and EIMC-related knowledge would result in higher EIMC uptake.

The EIMC intervention incorporated factors associated with couples’ decision making [35] and leveraged the current MOH promotion of male engagement during pregnancy to increase EIMC uptake [18]. Potential factors and influential others (family members and peers who are decision makers, e.g., in-laws, aunts, uncles, grandfathers, brothers and sisters in law, friends) contributing to EIMC decision making include the father’s circumcision status, paternal grandparents’ circumcision attitudes, peer circumcision attitudes, father’s HIV status, mother’s HIV status, and circumcision attitudes. In session 2, couples were invited to bring an influential other to be included in the EIMC decision-making process.

Session 1 focused on the immediate benefits associated with EIMC: Cost effective, faster wound healing, easier to circumcise, less chance of adverse events, easier to clean the penis, reduced urinary tract infections. Masculine cultural norms related to potential pain, sexual performance, and pleasure were addressed during the S&S program; couples learned that potential pain is diminished if the procedure is completed during infancy. Pregnancy heightens awareness of danger and safety for the infant, and the desire to protect the infant. Couples were encouraged to weigh both present and future benefits and risks for the male child, utilizing a cost/benefit approach that incorporates cultural norms regarding the health and wellbeing of all family members. Session 1 included a testimonial from a medical practitioner with EIMC experience, and at the end of the session, couples were invited to return to Session 2 with an influential other, if desired. EIMC brochures were distributed.

Topics included: Why undergo EIMC? What are the benefits? Why now? When is the best time for EIMC? Information: What happens? How long does it take? Is it painful, how is pain controlled? What happens next? How long is healing, cleaning during healing? What happens to the foreskin? What are the risks? Is it safe? Who should be involved in the decision? Any additional questions or concerns about EIMC? The feasibility and acceptability of LFLS was assessed by assessing participants about the utility of each of these topics during their last assessment (see Table 2).

Funding: This study was funded by the National Institutes of Health/National Institute of Mental Health (NIH/NIMH; R34MH121111 and R01MH095539), with support from the University of Miami Miller School of Medicine Center for AIDS Research funded by NIH/National Institute of Allergy and Infectious Diseases (NIAID) (P30AI073961). VJR’s work on this study was also supported by a Ford Foundation Fellowship, administered by the National Academies of Sciences, Engineering, and Medicine (NASEM), a PEO Scholar Award from the PEO Sisterhood, and NIMH R36MH127838. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Funding: This study was funded by the National Institutes of Health/National Institute of Mental Health (NIH/NIMH; R34MH121111 and R01MH095539), with support from the University of Miami Miller School of Medicine Center for AIDS Research funded by NIH/National Institute of Allergy and Infectious Diseases (NIAID) (P30AI073961). VJR’s work on this study was also supported by a Ford Foundation Fellowship, administered by the National Academies of Sciences, Engineering, and Medicine (NASEM), a PEO Scholar Award from the PEO Sisterhood, and NIMH R36MH127838. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.