Increasing Early Infant Male Circumcision Uptake in Zambia: Like Father Like Son
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice, Health Risk Behaviors
Sponsor: University of Miami

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1) Protocol Title: Increasing early infant male circumcision uptake in 
Zambia: Like Father Like Son 
2) Clinical Trials Number: NCT04119414    
3) Version #: 1.2    
 
 
 

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INSTRUCTIONS: 
4) Protocol Title 
Increasing early infant male circumcision uptake in Zambia: Like Father Like Son 
5) IRB Review History* 
This protocol is being submitted to another review board, the University of 
Zambia Biomedical Research Ethics Committee (UZBREC). As an international 
study, it does not require single IRB review.  
Objectives* 
Objectives 
Specific Aims: Voluntary medical male circumcision (VMMC) has proven to be 
effective in decreasing the risk of HIV infection for men in Southern and Eastern Africa 
by 51-60% (Bailey et al., 2007, Auvert, et al., 2005, Gray et al., 2007). Post-
circumcision, long-term studies have reported increased levels of protection (up to 67-
73%) (Bailey et al., 2010; Mehta et al., 2013, Gray et al., 2012; Siegfried et al., 2009). 
Zambia has high HIV prevalence (19.7% urban) and incidence (4% urban), and a low rate 
of male circumcision (23%). The Republic of Zambia Ministry of Health (RZMOH) 
established a National Operational Plan for the Scale-up of Voluntary Medical Male 
Circumcision (RZMOH, 2016-2020) with the goal of performing 2 million VMMCs by 
2020. While most men surveyed in several sub-Saharan African countries expressed 
willingness to consider circumcision, (Westerkamp et al., 2007) over 80% of Zambian 
males expressed no interest in undergoing VMMC (Zambia Sex Behav Survey, 2010).  
 
The Spear & Shield 1 (S&S1) comprehensive adult HIV risk reduction program 
conducted by this research team significantly increased VMMC rates among Zambian 
men who initially had no interest in undergoing the procedure. This clinical trial 
established that substantial increases in VMMC rates were attributable to the combination 
of the Spear & Shield behavioral intervention plus increased VMMC availability. 
Currently, the Spear & Shield 2 (S&S2; R01MH095539) dissemination and 
implementation program has expanded this Community Health Center (CHC)-based 
program to 96 CHCs in four Zambian Provinces with high rates of HIV and low 
prevalence of male circumcision. To date, ~20,000 men and women have attended the 
S&S2 program at 72 clinics since the study began almost 3 years ago.  
 
The Government of the Republic of Zambia, as well as several other Sub-Saharan 
countries, has identified Early Infant Male Circumcision (EIMC) as an important 
component of the overall program to increase male circumcision at the population level. 
Consequently, as VMMC promotion progressed, the GRZ Ministry of Health (MOH) 
began development of an EIMC program as a long-term HIV prevention solution for the 
~360,000 male neonates born yearly. EIMC is a safer, simpler and less expensive 
procedure than adult VMMC, with shorter healing times (Weiss et al., 2010; Binagwaho 
2010; WHO/UNAIDS 2007). By increasing the availability and acceptability of both 
EIMC and VMMC, the overall population health benefit of male circumcision could be 
realized in less than one generation. In addition to offering lifetime protection from 
several diseases and disorders, EIMC is associated with improved penile hygiene and 

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fewer urinary tract infections, which are prevalent in uncircumcised infants. Yet, despite 
widespread agreement that EIMC would convey considerable short- and long-term health 
advantages, only about 0.3% of male infants have been circumcised (National VMMC 
Program Officer, 2018).  
 
This study proposes to conduct a 3-year pilot to explore the barriers and facilitators 
associated with EIMC acceptability, and the feasibility and acceptability of providing a 
novel EIMC strategy, “Like Father, Like Son” (LFLS) plus S&S, in CHCs in Lusaka, the 
Zambian capital. This pilot study would expand the impact of S&S by adopting a family-
oriented approach to encourage pregnant couples to consider both EIMC for their 
neonates and VMMC for fathers and other uncircumcised males in the household. This 
study proposes to 1) match 8 clinics on past 12 month VMMC/EIMC rates and catchment 
size and randomize to intervention (n = 4 clinics, S&S+LFLS + VMMC/EIMC training) 
or observation conditions (n = 4 clinics, VMMC/EIMC training only), 2) utilize 
collaborative input from community stakeholders (n = 144; CHC Community Advisory 
Boards, patient focus groups, EIMC experts) at the 4 Experimental CHCs to develop 
study protocol, assessments, and LFLS intervention sessions, 2) establish formative, 
process and outcome evaluation criteria to assess feasibility and guide the 
implementation of the LFLS sessions, 3) enroll 300 pregnant couples (75 per 
experimental clinic over 18 months recruitment), 3) conduct baseline, pre- and 
immediately post-partum and 6-month post-partum assessments, and 4) evaluate 
acceptability and feasibility of S&S+LFLS at the CHC level, and the effect of S&S+ 
LFLS on uptake of VMMC and EIMC. This study proposes to conduct a 3-year pilot 
study to explore the barriers and facilitators associated with early infant male 
circumcision (EIMC) acceptability, and the feasibility and acceptability of providing a 
novel EIMC strategy, “Like Father, Like Son” (LFLS) plus Spear & Shield (an evidence-
based intervention), in community health centers (CHCs) in Lusaka, the Zambian capital. 
This pilot study would expand the impact of Spear & Shield by adopting a family-
oriented approach to encourage pregnant couples to consider both early infant male 
circumcision (EIMC) for their neonates and voluntary medical male circumcision 
(VMMC) for fathers and other uncircumcised males in the household.  
 
Aim 1. Develop, pilot and conduct formative, process and outcome evaluations to assess 
the CHC level feasibility and acceptability of S&S+LFLS. 
Aim 2. Assess the intrapersonal, interpersonal, structural, and sociocultural factors 
relevant to the “Like Father, Like Son(s)” intervention, and develop program components 
to respond to these factors. 
Hypothesis 2. Father’s circumcision status, paternal grandparent’s circumcision 
attitudes, peer circumcision attitudes, father’s HIV status, and mother’s HIV status will 
be indirectly related to the decision to elect EIMC through the father’s circumcision 
attitudes. A mother’s circumcision attitudes will be influenced by her HIV status, and her 
attitudes will also influence the father’s circumcision attitudes. 
Aim 3. Assess whether the combined S&S + LFLS pilot program will increase uptake of 
EIMC at the clinic level.  
Hypothesis 3. The S&S + LFLS experimental condition clinics will have higher 
numbers of EIMC in comparison with observation condition clinics. 

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6) Background* 
Voluntary medical male circumcision (VMMC). Randomized clinical trials 
involving over 11,000 adult men in Uganda, Kenya and South Africa have confirmed that 
voluntary medical male circumcision (VMMC) provides upwards of 60-73% protection 
for men from HIV infection (Auvert et al., 2005; Bailey et al., 2007; Gray et al., 2007; 
Weiss et al., 2000). Yet, despite these encouraging findings, the majority of Zambian men 
remain reluctant to circumcise (Weiss et al., 2015; Zulu et al., 2015; Republic of Zambia 
Ministry of Health (RZMOH, 2016). Zambia has the lowest level of MC acceptability 
among the 10 Sub-Saharan African countries with high HIV incidence. To attain the 
Zambian national goal of 2 million VMMCs by 2020, innovative “demand generation” 
strategies will be required to increase the acceptability of VMMC, and thereby, to reach 
the desired increases in the rates of circumcision nationally (RZMOH), 2016).  
 
Zambia, population 17.61m, has a low rate of circumcision nationally (22%), 
even though cultural groups in the Northwestern and Western Provinces (the Luvale, 
Lunda, Luchazi, Chokwe), practice traditional male circumcision as a rite of passage for 
adolescent males (UNAIDS, 2018). The Government of the Republic of Zambia (GRZ) 
has demonstrated political will and support for VMMC services, but, as in Zimbabwe 
(Hatzold et al., 2014), challenges to VMMC uptake remain, e.g., fear of pain, adverse 
events, reduced sexual performance, misinformation about sexual abstinence during 
healing, MC-stigma associated with traditional circumcisers, and concerns regarding 
women’s preferences for a specific circumcision status (Makawa, 2012). The Spear & 
Shield clinical trial conducted by this team from 2010-2015 (R01MH095539) found men 
who were better informed regarding VMMC protection, who perceived greater VMMC 
cultural acceptability, and who had female partners with greater VMMC acceptability 
were more likely to undergo VMMC (Jones, Cook et al., 2014; Redding et al., 2015; 
Weiss et al., 2015; Cook et al., 2015). 
 
The Spear & Shield Program. Evidence-based community-level sexual risk 
reduction programs can increase VMMC acceptability and convince “hard to reach” 
uncircumcised Zambian men that VMMC is their best means of reducing risk of HIV 
infection if highly consistent condom use is not an option (De Cock et al., 2012). The 
original Spear & Shield program (S&S1; Weiss et al., 2015) was designed to increase 
both availability and acceptability of VMMC. Currently being disseminated and 
implemented in 96 community health centers (CHCs) in four Zambian Provinces, Spear 
& Shield 2 (S&S2) is a comprehensive sexual risk reduction intervention program that 
trains HIV Voluntary Counseling and Testing (VCT) counselors to conduct the S&S 
intervention and trains CHC biomedical staff to perform VMMCs. The intervention 
encourages use of multiple prevention strategies (Vermund & Hayes, 2013; de Bruyn et 
al., 2010) while emphasizing the unique lifetime HIV risk-reduction characteristic of 
VMMC, as well as other health-related benefits  [(e.g., reduced HPV/cervical cancer risk 
for female partners, chancroid sexually transmitted infections (STIs), penile cancer) 
(Auvert et al., 2009; Gray et al., 2007; White et al., 2008; Weiss et al., 2006; Tobian et 
al., 2009; Sobngwi-Tambekou et al., 2009)]. The S&S1 program was effective in 
increasing the likelihood of men opting for VMMC by 2.5 times in comparison with the 
Control condition and by 8.5 times in comparison with an Observation-Only condition. 

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Increased condom use among the those in the Experimental group who underwent 
VMMC was also observed, countering concerns of behavioral disinhibition following 
VMMC (Weiss et al., 2015). If implemented on a nationwide scale, results could have a 
major public health impact on HIV prevention. 
 
Women and VMMC. Men participating in S&S were encouraged to invite their 
female partners to participate, as the national Zambia Sexual Behaviour Survey found 
men viewed their partners’ potential preference for an uncircumcised penis as an 
impediment to considering VMMC (Central Statistical Office, MOH, University of 
Zambia, and MEASURE Evaluation, 2010). The S&S intervention, with female 
participation of 80%, found a 6% increase in uptake of VMMC among Experimental 
participants attributable to positive shifts in women’s preferences (see Preliminary 
Studies, Cook et al., 2015). To optimize women’s influence on VMMC decision-making, 
the comparable women’s intervention focused on VMMC attitudes and beliefs and 
highlighted VMMC health benefits for women (Westercamp et al., 2012; Lanham et al., 
2012).  
 
Early Infant Male Circumcision (EIMC, performed during the first 60 days of 
life). EIMC is a safer, simpler and less expensive procedure with shorter healing times 
than adult VMMC (Weiss et al., 2010; Binagwaho 2010; WHO/UNAIDS 2007). In 
addition to offering lifetime protection from several disorders/diseases, EIMC is 
associated with improved penile hygiene and fewer of the urinary tract infections (UTIs) 
that are prevalent in uncircumcised infants. By increasing the availability and 
acceptability of both EIMC and VMMC, the overall population health benefit of male 
circumcision could be realized in less than one generation. Consequently, as VMMC 
promotion began, the Ministry of Health began development of an EIMC program as a 
longterm HIV prevention solution for the ~360,000 male neonates born yearly in Zambia 
(GRZ Central Statistics Office, 2018). However, a study by Waters et al (2013) of 2000 
Zambian pregnant women provided with information on EIMC, found although 97% 
agreed they would circumcise their infant if they had a boy, only 11% actually did so. 
More recently, the Zambia Operational Plan for VMMC 2016-2020 (RZMOH, 2016) 
reported that significantly lower uptake of infant MC had been achieved than originally 
targeted. In fact, as of October 1, only 1,181 of the 362,078 newborn males in 2018 
underwent EIMC (GRZ Central Statistics Office, 2018; clinic data); in EIMC trained 
clinics in Lusaka, only ~0.02% of male infants were circumcised in 2018 (clinic data). 
 
The proposed study seeks to address this discordance by developing and testing 
an innovative “father and son” biobehavioral demand generation strategy, providing on-
site availability of EIMC and VMMC services embedded in the Spear & Shield 
behavioral intervention. The program, entitled “Like Father, Like Son” (LFLS), will 
evaluate the feasibility and acceptability of offering combined EIMC and VMMC 
services and behavioral interventions, building on successful implementation strategies 
utilized in S&S1 and 2. 
 
Factors underlying EIMC Decision Making. Acceptability underlies uptake of 
both EIMC and VMMC (Sekhon et al., 2017) and the primary determinant of EIMC is 

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the father’s MC status (Mavhu et al., 2011). Challenges to acceptability of EIMC have 
been identified among both women and men in Malawi, Zambia, Zimbabwe, Botswana, 
Uganda, South Africa, and Kenya. Barriers reported by men include availability of EIMC 
services, cultural/religious considerations, and lack of knowledge  about EIMC 
(Chilimampunga et al., 2017; Mavhu et al., 2015); challenges to uptake identified by both 
women and men include religious/cultural issues, parental concern for son’s autonomy, 
men as decision makers in the family (Jarrett et al., 2014), concerns regarding pain 
(Waters et al., 2012; Mavhu et al., 2011; Young et al., 2016), and access to services 
(Jarrett et al., 2014). Other barriers included skepticism regarding EIMC’s protection 
against HIV, adverse side effects, and the perception that infant penises were too fragile 
for EIMC (Mavhu et al., 2012). Uptake increased when parents were reassured that 
infants could safely undergo EIMC (Waters et al., 2013). Women, including pregnant 
women, were generally receptive to EIMC (Chilimampunga et al., 2017; Waters et al., 
2012; 2013; Mavhu et al., 2012; Plank et al., 2010; Kankaka et al., 2017). Women with 
more HIV knowledge were more receptive to EIMC, and women expressing high 
VMMC acceptability also endorsed high EIMC acceptability (Mavhu et al., 2011). 
Overall, women’s MC perceptions were more positive than men’s, both before and after 
receiving EIMC information, especially regarding younger boys (Albert et al., 2011). 
Following EIMC, mothers in Uganda and Zimbabwe reported satisfaction with the 
outcome (Mavhu et al., 2015; Kankaka et al., 2017).  
 
Little research has evaluated the impact of demand creation on EIMC uptake. 
However, studies that evaluated uptake in response to information on EIMC (Waters et 
al., 2013; Mavhu et al., 2015; Mavhu et al., 2016; Kankaka et al., 2017; Plank et al., 
2013) found EIMC uptake did not reflect reported acceptability. This discrepancy 
between theoretical acceptability and actual uptake has not been addressed. Barriers to 
EIMC suggest that poor uptake may arise from the bottleneck created by the final 
decision resting with husbands; 85% of women indicated that husbands’ agreement is 
important, and only 10% of women identified as sole decision makers (Albert et al., 
2011). Parents were more willing to accept EIMC if fathers were circumcised, if mothers 
were more educated, if couples were serodiscordant, or if parents were aware of the 
benefits of EIMC (Waters et al., 2013; Mugwanya et al., 2011; Young et al., 2016). 
While 83% of mothers in South Africa accepted EIMC, many refused the procedure as 
they were required to first discuss it with their husband and/or family (Young et al., 
2016). Decisions governing sons are traditionally the purview of the father in most 
African societies, although the opinions of mothers and paternal family members may 
also be solicited (Mavhu et al., 2017). In addition, studies suggest that fathers “need to be 
provided with information directly, not just through their wives” (Mavhu et al., 2017; 
GRZ 2018). The proposed study will attempt to bridge the gap between hypothetical 
acceptability and low uptake by creating an intervention to increase acceptability and 
availability of EIMC and VMMC during the perinatal period, focusing on both parents 
and the option of a shared father-son circumcision experience. As such, pregnancy 
provides a “window of opportunity” to encourage the participation of both members of 
the couple in a culturally tailored informational/motivational HIV prevention program.  
 

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Based on the IMB Model (information, motivation, behavioral skills) and the 
theory of planned behavior addressing normative behaviors (Ajzen & Fishbein, 1980) this 
exploratory study will examine the factors (e.g., father’s circumcision and HIV status, 
paternal grandparents’ and peer circumcision attitudes, mother’s HIV status and 
circumcision attitudes) that underlie the decision to engage in VMMC and EIMC, and 
tailor the LFLS intervention component to respond to these factors. The study will offer 
S&S + LFLS to pregnant couples, targeting the perinatal period to address MC for both 
father and son(s), and pilot test the biobehavioral program, assessing feasibility of 
offering S&S+LFLS in Lusaka Province CHCs, the acceptability of the pilot program, 
and the potential of S&S+LFLS to optimize both VMMC and EIMC uptake.  
 
Innovation 
This application includes a number of innovative components. Promoting the 
bonding component of the father-son relationship, this application simultaneously 
addresses both the short and long-term HIV risk reduction goals associated with 
increasing availability and acceptability of male circumcision. We are unaware of any 
evidence-based effort in sub-Saharan Africa to stimulate prospective parents to 
simultaneously consider both EIMC and VMMC. The S&S + LFLS intervention could 
stimulate both EIMC and VMMC to occur during the pre- and immediate postnatal 
period, prior to resuming sexual activities, which corresponds with both mother and 
father undergoing healing following childbirth and VMMC, respectively. (N.B.: Our 
previous research found approximately 25% of the men undergoing VMMC were unable 
to abstain from sexual activities for the 6-week healing period; this group accounted for 
the majority of adverse events and dissatisfaction with VMMC). As most Zambian men 
are uncircumcised, a combined VMMC/EIMC program could encourage prospective 
fathers choosing to undergo VMMC to circumcise their male neonates, as well as other 
sons, procedures that would render their penises identical. Among men already 
circumcised, the program provides additional support for EIMC and VMMC for other 
sons. Finally, this program includes community health center EIMC sensitization, 
training and behavioral interventions, optimizing the impact of demand generation on 
uptake.    
 
Impact  
There are several compelling reasons underscoring the potential impact of the 
combined VMMC/EIMC program. Combining availability of both circumcision services 
is cost-effective in terms of training of health care providers and equipping facilities to 
perform both procedures. The additional skills required for EIMC procedures can be 
added onto the skills of those trained in VMMC at a fraction of the cost of setting up 
EIMC training activities de novo. EIMC is safer, simpler and less expensive than adult 
VMMC with shorter healing times. It offers significant lifelong protection from HIV, 
chancroid STIs, penile cancer, HPV, and UTIs. The integration of the program within an 
evidence-based VMMC demand generation intervention would optimize sustainability 
(IIIE, 2013), establishing local capacity to provide a CHC-based VMMC/EIMC program, 
in contrast with externally supported “parachute in” programs. Finally, successful 
combined VMMC and EIMC programs would ultimately “sunset” the need for an adult 
program within a generation. 

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The National Operational Plan for VMMC In Zambia, 2016-2020 (RZMOH, 
2016, pp.62-63) calls for EIMC demand creation similar to that needed for VMMC, yet 
“scale up has been slower than anticipated.” The current application will apply demand 
generation strategies developed during formative work, utilizing CHC-tailored methods 
to optimize EIMC uptake. In addition, as noted above (RZ MOH, 2016, p.63), “the 
immediate postnatal period is too late to introduce [EIMC] to mothers/parents. Parents 
need sufficient time to discuss the issue among themselves, with their families and with 
health care workers before they are ready to authorize consent.” Consistent with the 
National Plan, this study proposes to introduce EIMC to both parents prior to delivery, 
expanding male involvement during pregnancy to maximize the impact of the 
S&S+LFLS intervention. 
 
VMMC and EIMC are high impact HIV prevention strategies: Successful 
outcomes of this study could provide a biobehavioral model to significantly increase the 
availability and acceptability of MC services within CHCs. With ~ 360,000 male 
newborns entering the population pool each year, combined EIMC/VMMC programs 
could ultimately have a major impact on the long-term health benefits conveyed by MC. 
Training existing health care staff to achieve an expanded scope of practice will leave a 
sustainable footprint by engaging both health care providers and leaders in the 
implementation and uptake of the VMMC/EIMC – S&S + LFLS Program.  
 
Preliminary studies. This research team has been working in Zambia since 1999. 
The Zambian Spear & Shield team, led by Drs. Zulu and Chitalu, has established strong 
linkages and buy-in from the Ministry of Health, and Provincial and District Health 
leadership to promote risk reduction programs throughout Zambia (Chitalu et al., 2016; 
Jones et al., 2015; Weiss et al., 2011). Our previous translation and implementation 
studies in Zambia (e.g., Vamos et al., 2014, Chitalu et al., 2016), and the US (Jones et al., 
2013, Weiss et al., 2011), have addressed the importance of engagement in achieving 
sustainable health care service programs. Drs. Weiss and Jones are co-creators of the 
Spear & Shield intervention (Weiss et al., 2015, Lancet HIV), and were co-investigators 
on Dr. Castro’s two US studies promoting infant circumcision among Hispanic couples, 
and adult VMMC among high-risk Hispanic men, a population with low MC and 
disproportionately high HIV incidence (Castro et al., 2010; 2012). Dr. Mweemba is 
experienced in VMMC research (Chanda et al., 2012). Consultant Dr. Bowa is a world- 
renowned expert on EIMC and led the original Zambian study (Bowa et al., 2013; Waters 
et al., 2012, 2013); consultant Royd Kamboyi is the National VMMC Program Officer. 
Spear & Shield 1 Project. Project aims were to increase both the availability and 
acceptability of VMMC among uncircumcised HIV- VCT participants who at study entry 
had no interest in VMMC for HIV prevention (Weiss et al., 2015; Jones, Cook et al., 
2014). This four-year, cluster RCT enrolled 800 HIV-, uncircumcised men and 668 
female partners. Experimental (S&S) group participants underwent more VMMC 
compared to Controls (40% vs. 24%; adjusted OR 2.45, 95% CI 1.24–4.90; p=0.02). 
 
VMMC rates continued to increase in the Experimental condition between 6 to 12 
months post-intervention, compared to the Control condition, which leveled off after 3-6 

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months (see Figure). Experimental group participants undergoing VMMC increased 
condom use (b = .055, 95% CI = (.01, .10), p = .027); no change was observed among 
Control participants who underwent VMMC, reinforcing the importance of “nesting” 
VMMC promotion in a comprehensive sexual risk reduction program (Rotheram-Borus 
et al., 2009; Alsallaq et al., 2013). Women’s (n = 668) increased acceptance and 
preference for VMMC was noted in the Experimental condition (b = .390, p < .001), and 
mediated the relationship between the intervention and men’s readiness to undergo 
VMMC at 12 months (indirect effect = .162, 95% CI = [.042, .318]) (Cook et al., 2015).  
Increasing the Availability and Acceptability of Medical Male Circumcision in 
Zambia: The Spear & Shield 2 Project. PI. Weiss, Co-PIs R. Zulu, N. Chitalu, K. Bowa, 
D. Jones (NIH/NIMH R01MH095539). The Spear & Shield 2 program (S&S2) is 
currently disseminating and implementing the Spear and Shield 1 intervention, increasing 
the uptake of VMMC by training CHC staff in 96 CHCs in 4 Provinces to perform 
VMMCs and training CHC VCT staff to conduct the S&S program. S&S 2 has scaled up 
in Lusaka, Central, and Southern Provinces. CHC Staff have conducted VMMCs and 
have provided the Spear & Shield intervention to ~20,000 men and women at 68 clinics 
since the intervention began almost 3 years ago. Preliminary data indicate that sites 
receiving both VMMC plus Spear & Shield training had significantly higher numbers of 
VMMCs than the sites that initially received VMMC training only (F=5.23, p=0.028). 
Over the next two years, Spear & Shield 2 will be implemented and disseminated in the 
final 28 CHCs in Copperbelt Province. In addition to training ~300 qualified health care 
providers (e.g., physicians, clinic officers, nurses) in VMMC, the program ensures space, 
surgical supplies and administrative support are available at each CHC to accommodate 
VMMC and S&S services. The existing program infrastructure provides the ideal setting 
for the integration of the EIMC program.  
Attitudes of Hispanics about male circumcision of their unborn children. PI, J 
Castro, Co-I, S Weiss & D Jones (El Centro, P60MD002266). This study was conducted 
with pregnant Hispanic women and their partners attending prenatal clinics in Miami and 
explored facilitators and challenges to promoting EIMC as an HIV prevention strategy. 
Participants (n = 148) attended gender concordant focus groups and interviews (n = 48) 
assessing EIMC attitudes. Results indicated high interest in EIMC among women, and a 
desire among men for infants to share their MC status (Castro et al., 2010). 
Barrier Acceptability among Culturally Diverse HIV+/- Women and their 
Partners (The NOW/NOW2 Projects), PI S. Weiss, CoPIs N Chitalu, D Jones 
(RO1MH63630). The NOW risk reduction intervention (n=1080 HIV+/- women 
US/Zambia) study identified influences on sexual barrier acceptability and developed and 
tested strategies to improve acceptability and maintain barrier use (e.g., Jones et al., 2001; 
2004; 2007).  
Implementing HIV Risk Reduction in Zambia (Partner/Partner 2 Projects), PI D 
Jones, Co-PIs S Weiss, N Chitalu (R24HD43613; R01HD058481). The Partner Project 
(R24HD43613, Jones, PI) (Jones et al., 2009); found a high intensity sexual behavior 
intervention increased safer sex more than a low intensity condition (n=420 couples). 
Partner 2 (260 HIV+/- couples) successfully translated the original Partner couples 
intervention to community CHCs (Jones et al., 2009; Chitalu et al., 2016; Jones, Weiss, et 
al., 2014).  

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7) Inclusion and Exclusion Criteria* 
• Men and women must be able to understand and sign the Informed Consent in 
English or local language.  
• All participants must be adults able to provide consent 
• Women participants may be pregnant  
• Individuals not yet adults (infants, children, teenagers) are not eligible to 
participate 
• Prisoners will not be eligible for recruitment  
Study population.  
Experimental sites only –participants are only recruited at experimental sites. 
Clinic leaders and health care providers will be briefed on the study and study 
eligibility by the study team.  
Potential patient candidates for couples and focus groups attending the clinic for 
HIV testing or pregnancy will be briefed on the study, and if interested, will be 
referred by clinic health care providers at the voluntary counseling and testing site 
and the antenatal clinic site (ANC) to the study staff.  
Clinic leadership will provide referrals to CAB members to attend CAB meetings.  
Participants will meet with study staff and will be verbally screened for eligibility 
based on the following criteria, by study staff at each clinic. 
CAB participants: CABs operate in each CHC clinic and are comprised of 
community zone leaders in the clinic catchment area; as zone leaders, they 
educate their community on the study objectives and sensitize their community on 
study goals, risks and benefits. Eligible CAB members will be men and women 
aged >18, representing a ward within each experimental CHC site catchment area. 
Twenty Community Advisory Board (CAB) member participants will be recruited 
from CABs at each clinic (20 CAB members x 4 clinics, n = 80), and each 
attendee will be compensated ~$US10 per visit.  
Focus Group participants. Stakeholder participants will be recruited from ANCs 
to attend gender specific focus group discussions (FGDs). A total of 8 pregnant 
couples from each of the 4 experimental CHC clinics (8 couples per clinic) will be 
recruited for this study [2 gender specific FGDs per clinic; (8 men and 8 women) 
x 4 clinics = 64 participants]. Both members of each couple must enroll to 
participate. Eligible participants will be pregnant couples (men and pregnant 
female partners) aged >18, attending the antenatal clinic of the experimental 
CHC. No personal, individually identifying information will be collected and no 
individual interviews or assessments will be conducted with FGD Members. Each 
attendee will be compensated ~$US10 per visit. 

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S&S+LFLS Participants. Pregnant couple participants (300 couples, n = 600 
participants) will be recruited over 18 months via referral from ANC/VCT and 
enrolled as couples. A total of 75 pregnant couples will be recruited from each of 
the 4 clinics participating in LFLS (75 pregnant couples per clinic x 4 clinics = 
300 couples = 600 individual men and women.) Both members of each couple 
must enroll to participate. Eligible women will be pregnant (up to 6 months 
pregnant), aged >18, any HIV status, and the partner of a male participant 
enrolling (neonates undergoing EIMC are receiving a clinical service approved by 
parents; only parents are study participants). Eligible men will be aged > 18, any 
HIV status [in accordance with Zambian and WHO/UNAIDS (2016) policy for 
MC eligibility], and the partner of the pregnant female participant enrolling. 
There is no upper age limit for participation, and each person will be compensated 
~$US10 per visit. 
8) Number of Subjects* 
A total 744 individuals will be recruited; 300 couples (600 men and 
women) and 144 CHC Community Advisory Boards members, patient 
focus group members, and EIMC experts.  
9) Study-Wide Recruitment Methods* 
Participants will be recruited by the community health center staff by referral to the study 
staff at the clinic site and by word of mouth only. Clinic sites are in Lusaka Province, and 
were reviewed and approved by the Lusaka Provincial Health Officer leadership. 
Following guidelines for site VMMC accreditation (Health Professions Council of 
Zambia, 2010), the following criteria governed selection of 8 clinic sites: 1) a community 
clinic catchment area of >30,000; 2) 2 health care providers available at site for 
VMMC/EIMC training and provision; 3) >2 voluntary counseling and testing (VCT) 
counselors and antenatal clinic (ANC) staff available for S&S+LFLS training, 4) space 
for VMMC/EIMC, 5) > 150 births per month, 6) a maternity ward. Clinic selection (n = 
8) focused on spatial separation between clinics to avoid clinic contamination. CHCs will 
be visited by the research team to introduce the study to relevant staff, and staff members 
will refer clinic patients (couples intervention and focus groups) based on study criteria 
from those attending the ANC and VCT clinics. Senior staff will refer CAB members for 
participation. EIMC experts are consultants on the project. 
 
Experimental sites only –participants are only recruited at experimental sites. 
Clinic leaders and health care providers will be briefed on the study and study 
eligibility by the study team.  
Potential patient candidates for couples and focus groups attending the clinic for 
HIV testing or pregnancy will be briefed on the study, and if interested, will be 
referred by clinic health care providers at the voluntary counseling and testing site 
and the antenatal clinic site (ANC) to the study staff.  
Clinic leadership will provide referrals to CAB members to attend CAB meetings.  

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Participants will meet with study staff and will be verbally screened for eligibility 
based on the following criteria, by study staff at each clinic. 
 
No materials will be developed for recruitment flyers, etc. as this is not needed.  
 
10) 
Study Timelines* 
 
Community Advisory Board (CAB) Members. CAB Members will meet for three 
formal group discussions in a private meeting room within their experimental clinic. 
CAB members will be asked to 1) provide input on cultural factors that influence 
attitudes, perceptions, and beliefs about EIMC within their communities and among the 
ethnic groups predominant in the Lusaka Province, and 2) provide input on the LFLS 
intervention and assessment content and information on community issues and concerns 
that could influence LFLS program uptake. CAB Members associated with each CHC 
will thereby facilitate the adaptation of the intervention strategies to the local culture and 
clinic culture, enabling LFLS to work with the community rather than imposing the 
program on the community. No personal, individually identifying information will be 
LFLS TIMELINE:  
Activity & Month 
M1-
3 
M4-
6 
M7-
9 
M10-
12 
M13-
15 
M16-
18 
M19-
21 
M22-
24 
M25-
27 
M28-
30 
M31-
33 
M34-
36 
Protocol development 
Identify 8 Lusaka CHCs  
Clinic sensitization 
Historical (1yr) data 
collection 
Monthly VMMC/EIMC 
data collect 
CAB meetings, FGDs, 
interviews  
Feedback & Prepare 
LFLS  
X 
X 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
 
 
 
 
X  
  
 
 
 
X 
  
 
 
 
X 
  
 
 
 
X 
  
 
 
 
X 
  
 
 
 
X 
X 
X 
Train 2 Providers at all 8 
sites in EIMC/VMMC 
(n=16) 
Train 2 Providers (n = 8) 
at the 4 Experimental 
sites in S&S+LFLS 
 
 
  
X 
 
X 
 
  
  
  
  
  
  
Experimental: Recruit & 
Assess 
n=300 Pregnant 
Couples 
  
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
Provide VMMC/EIMC 
Services 
Prenatal: S&S+LFLS 
Session 1  
  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Postpartum: LFLS 
Session 2 
Postpartum Follow-up 
Assess  
  
  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
6 mos post-partum: 
Assess EIMC/VMMC 
(father, sons, infant)  
  
  
 
 
  
 
  
X 
  
X 
  
X 
 
X 
X 
Data Analysis. 
Manuscripts.  
Prepare R01 application 
  
  
  
  
  
  
  
 
X 
X 
X 

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collected and no individual interviews or assessments will be conducted with CAB 
Members. 
 
Focus Group Discussion (FGD) Members. FGD members will meet in gender 
concordant groups in a private room within their experimental clinic site; members will 
provide input on cultural factors that influence attitudes, perceptions, and beliefs about 
EIMC among pregnant couples. They will provide guidance on cultural attitudes, ethnic 
preferences, beliefs and perceptions surrounding EIMC among pregnant couples in 
Lusaka. FGD members will inform the study on local issues or community concerns that 
could influence program uptake. No personal, individually identifying information will 
be collected and no individual interviews or assessments will be conducted with FGD 
members.  
 
Pregnant Couple Members attending LFLS. All S&S+LFLS study participants will be 
followed from enrollment to six months post-partum (maximum ~ time of participation 
based on enrollment at ~3-4 months pregnant = 12 months). Participants will complete 
baseline, pre-and post-partum and 6-months post-partum assessments and attend the 
Spear & Shield and 2 LFLS intervention sessions (see below).  
Enrollment will be conducted from month 7 – 24, a total of 18 months. 
11) 
Study Endpoints* 
Primary and secondary study endpoints. 
Primary endpoints.  
• EIMC uptake (infant) 
• VMMC uptake (father and other sons)  
Secondary endpoints. 
• Father’s and mother’s circumcision attitudes  
Primary or secondary safety endpoints. 
 
This is a behavioral feasibility study, not requiring safety endpoints. 
12) 
Procedures Involved* 
Design.  
Like Father Like Son(s) proposes to develop intervention materials and test the 
effectiveness of the intervention to enhance the uptake of early infant male 
circumcision (EIMC) and voluntary medical male circumcision (VMMC) in the 
community health center (CHC) setting.  
The study utilizes a longitudinal repeated measures design [2 (condition) x 4 (time 
points)]. The pilot study intervention will expand the Spear & Shield (S&S) 
intervention to include the “Like Father Like Son” component (S&S + LFLS).  

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The pilot study will randomize 8 clinics to Experimental and Observation 
conditions; clinics will be matched on catchment area size and current EIMC and 
VMMC rates.  
Experimental clinics (n = 4) will be trained to offer “S&S+LFLS”; Observation 
clinics (n = 4) will be “Observation Only” sites. Observation only sites will not 
recruit participants and will only be “observed” regarding the total number of 
VMMCs and EIMCs conducted at each individual clinic - Observation Only 
clinics will only provide clinic level aggregate data.  
The study will train both Experimental and Observation Only clinic staff to 
conduct VMMC and EIMC procedures in order to provide equivalent services at 
all clinics, controlling for the availability of circumcision at all sites. Participants 
will only be recruited from experimental sites. The study will also assess the 
feasibility and acceptability of offering S&S+LFLS at the CHC level, and if 
successful, plan for a clinical trial of the S&S+LFLS intervention. 
CAB Meetings & Focus Groups. 
CAB Meetings & FGDs. FGDs and CAB meetings’ discussion topics have been 
broken into smaller units within the context of the socio-ecological framework 
(from the individual to the context), using the PRECEDE model (Green & 
Kreuter 1999).  
CAB and FGD activities will be led by Dr. Mweemba with support from study 
staff.  
Focus group discussion stem items (see assessments attachment) explore 
intrapersonal, interpersonal and structural level factors associated with EIMC, and 
factors associated with each level. Stem items were derived from previous 
research (e.g., Albert et al., 2011; Amuri et al., 2016; Mavhu et al., 2012; Mavhu 
et al., 2016; Plank et al., 2010; Waters et al., 2012) and will be presented as open-
ended questions; time will be provided to address additional topics as they arise. 
Prior to study onset, additional stems may be proposed using an iterative, 
collaborative process involving the University of Miami/University of Zambia 
(UZ) study team, which includes psychologists, social scientists, a pediatrician, 
surgeons, an infectious disease physician, and psychometricians. Final stem items 
will be reviewed and refined by the entire team prior to initiation of FGDs and 
CABs. 
CAB meetings and FGDs will be approximately 1.5 hours in duration.  
CAB meetings (1 per clinic, 3 meetings, n = 80 persons) and FGDs (2 per clinic, 
each gender concordant, 8 FGDs, n = 64) will be audio recorded and transcribed 
by trained study staff from the UZ into English; FGDs and CABs will be 
conducted in private areas in CHCs. Field notes will be made by staff during 
FGDs, CABs and study-related CHC staff meetings; meetings will be summarized 
from field notes. The project coordinator and study staff are social scientists and 
are experienced in conducting FGDs.  

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Community Advisory Board (CAB) Members. CAB Members will meet for 
three group discussions in a private meeting room within their experimental 
clinic. CAB members will be asked to 1) provide input on cultural factors that 
influence attitudes, perceptions, and beliefs about EIMC within their communities 
and among the ethnic groups predominant in the Lusaka Province, and 2) provide 
input on the LFLS intervention and assessment content and information on 
community issues and concerns that could influence LFLS program uptake.  
CAB Members associated with each CHC will thereby facilitate the adaptation of 
the intervention strategies to the local culture and clinic culture, enabling LFLS to 
work with the community rather than imposing the program on the community.  
No personal, individually identifying information will be collected and no 
individual interviews or assessments will be conducted with CAB Members. 
Focus Group Discussion (FGD) Members. FGD members will meet in gender 
concordant groups in a private room within their experimental clinic site; 
members will provide input on cultural factors that influence attitudes, 
perceptions, and beliefs about EIMC among pregnant couples.  
They will provide guidance on cultural attitudes, ethnic preferences, beliefs and 
perceptions surrounding EIMC among pregnant couples in Lusaka. FGD 
members will inform the study on local issues or community concerns that could 
influence program uptake. No personal, individually identifying information will 
be collected and no individual interviews or assessments will be conducted with 
FGD members. 
Couples Assessments.  
Assessments at baseline will be completed using audio computer-assisted self-interview (ACASI) 
software, with support from study staff as needed. Participants will be assessed individually in a 
private office in the CHC; ACASI headphones and touchscreen computers will provide 
confidentiality and privacy. LFLS session 2 will be scheduled to coincide with the post-partum 
neonatal clinic visit in the first week following birth.  
 
Each assessment measure (see attachment) is related to the study theoretical model, outcomes 
(feasibility, acceptability, uptake) and associated factors (e.g., plans, knowledge, norms, 
attitudes/beliefs and cultural or religious values associated with EIMC/VMMC, family decision 
making, stage of readiness).  
 
After each LFLS session, a brief paper-based questionnaire will be individually administered to 
assess Stage of Change. VMMC/EIMC uptake and the role of parents, family members, peers and 
HIV serostatus in decision-making will be assessed by telephone or office visit at 6 months post-
partum. 
 
Couples intervention. 
S&S Intervention. The S&S program was developed and culturally tailored for men and 
women from qualitative data on VMMC attitudes, preferences and beliefs. This comprehensive 
risk reduction intervention consists of 4 weekly 90-minute manualized group sessions. Female 
partners of participants are invited to participate in 4 comparable sessions on women’s VMMC-
related issues (Martinez Perez et al., 2015).  

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Session One addresses HIV/STDs, safer sex, male condoms, male circumcision and sexual 
communication. Multiple strategies for protecting against HIV are discussed, emphasizing 
VMMC. The session addresses adult VMMC as a permanent method of risk reduction and 
provides a forum for discussion of the VMMC procedure, concerns, limitations and beliefs. 
Cognitive behavioral (CB) skill training heightens participants’ awareness of reactions to 
VMMC, reframing thoughts that impede VMMC uptake, condom use, and sexual 
communication. Participants receive a week’s supply of condoms after sessions 1-4. 
 
Session Two addresses female condoms and their correct usage using female anatomical 
charts. CB skills are applied to sexual negotiation and improving communication techniques in 
relationships. Potential benefits of VMMC for female partners are addressed.  
 
Session Three introduces novel products (e.g., PrEP, microbicides) and multiple protective 
strategies. The session includes sharing experiences, concerns and attitudes about female 
condoms, perceptions of partners’ reactions to VMMC, role plays for problem solving and use of 
CB skills. A peer who has undergone VMMC shares experiences, abstaining from sex during 
healing (Hewett et al., 2012), and sexual satisfaction (Kigozi et al., 2008; Zulu et al., 2015), and 
answers questions about VMMC. 
 
Session Four reviews personalized HIV risk reduction methods and includes a presentation on 
the VMMC procedure by a CHC VMMC provider, who discusses benefits and risks, post-
VMMC recovery and resumption of sexual activities. High risk sexual behavior and 
alcohol/drugs are discussed, and CB skills are used to address conflict resolution, communication 
and sexual negotiation. 
 
LFLS Intervention. The existing standard of care (RZMOH, 2016) outlines the need to ensure 
that parents and guardians need time to understand the importance of EIMC before bringing 
babies in for EIMC and should be sensitized before delivery. ANC and VCT staff are encouraged 
to sensitize ANC attendee mothers and men undergoing VMMC about EIMC, and fliers for 
family members have been developed. The LFLS program will be developed collaboratively by 
Drs. Mweemba, Jones, Weiss, Zulu, Chitalu, Bowa, Castro, and Dunleavy. The intervention will 
be culturally tailored for individual couples’ sessions using qualitative data from FGDs and 
existing research.  
 
The S&S manual will guide the first phase of the comprehensive HIV risk reduction program 
(i.e., four 90-minute weekly group sessions, audio recorded). After the S&S sessions, each 
pregnant couple will attend 2 private 90-minute LFLS sessions co-led by the male and female 
S&S facilitators, one couples session pre-delivery and one couples session immediately post-
partum. Both sessions will explore issues relevant to parental decision making related to VMMC 
and EIMC. The gap between session 1 (antenatal) and 2 (postpartum) will provide opportunity for 
parents to consult with influential others (family members and peers who are decision makers, 
e.g., in-laws, aunts, uncles, grandfathers, brothers and sisters in law, friends).  
 
Session 1 will focus 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 will be addressed during the S&S program; couples will learn 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 will be 
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 will include a testimonial from a medical practitioner with EIMC 
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influential other, if desired. EIMC brochures will be distributed and Stages of Change 
questionnaires will be administered prior to the session 
 
Topics: 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?  
 
 
Session 2 will include the opportunity for couples to bring a person culturally connected to 
making the EIMC decision to the session (e.g., paternal mother) (Mavhu et al., 2017). To enhance 
acceptability, LFLS sessions will be developed from CHC CAB members, focus group 
discussions, and health care staff. Content will be pertinent to the critical cultural, social and 
religious issues and beliefs affecting EIMC decision making, and will consider research in 
Zambia on this topic (e.g., Waters et al., 2012; 2013). The two LFLS sessions will be manualized, 
based upon the community input, and “fine-tuned” using feasibility pilot data. The preliminary 
outline, from focus discussions in Zambia, is proposed below.  
 
 
Topics: Any new questions or concerns about EIMC? How does EIMC differ from VMMC? 
What is the religious view on EIMC? What does my culture say about MC? What was the 
purpose of the foreskin? (How long is it needed?) Will EIMC affect future sexual performance, 
functioning & potency? Final questions? Stages of Change questionnaires are administered prior 
to the session. 
Location. All  research procedures will be performed at the clinic sites, in private 
offices and meeting rooms.  
Risks. 
There are no drugs or devices used in this study; all procedures discussed (EIMC, 
VMMC) are available for uptake at the clinics and are evidence based practices. 
Procedures to lessen the probability or magnitude of risks. 
Source records used to collect data. All surveys, scripts, and data collection 
forms are being developed during the formative period of this study. 
Proposed Assessments at baseline (see attachment for initially selected assessments):  
Instruments will be adapted from S&S1 and previous VMMC/EIMC studies (~45 minutes).  
1) Demographics, to include gender, age, marital status, male children MC status, education, 
income, father’s MC status, HIV status (All public health facility users are required to undergo 
HIV testing per GRZ policy) (adapted, Kabwe, 2016 and Weiss et al., 2015).  
2) Stages of Change EIMC items (Precontemplation, Contemplation, Preparation, Action, 
Maintenance) will be adapted from Redding et al. (2015). 
3) EIMC knowledge, norms, attitudes/beliefs items (adapted from Castro et al., 2010; 
Chilimampunga et al., 2017; Kabwe, 2015; Mugyawana et al., 2011; Waters et al., 2013; Young 
et al., 2016).   
4) VMMC knowledge, norms, attitudes/beliefs items will be evaluated using an adaptation of 
Kebaabetswe et al. (2003), Weiss et al. (2015)  
5) EIMC/LFLS Intervention acceptability and feasibility at the clinic level will assessed using an 
adaptation of Chilimampunga et al. (2017) and Mavhu et al. (2015). Topics include review of the 

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S&S+LFLS model, and the incorporation of EIMC services in the clinic, advantages and/or 
disadvantages of the program, and changes or recommendations for the program. Staff and CAB 
members will participate in clinic meetings to evaluate feasibility and acceptability of the 
S&S+LFLS program.  
6) EIMC decision making will be assessed using items adapted from the conceptual model 
developed by Mavhu et al. (2017).  
7) EIMC/VMMC Individual level Uptake. EIMC outcome, male infant; VMMC outcome, fathers 
and sons in the household, sex of infant & birth status (M/F; Live/Lost). VMMC/EIMC uptake 
and the role of parents, family members, peers and HIV serostatus in the decision-making process 
will be assessed by telephone or private office visit at 6 months post-partum. 
8) EIMC/VMMC Clinic level Uptake. CHCs will provide 12 months of historical VMMC/EIMC 
rate data prior to VMMC/EIMC and S&S+LFLS training. Clinics will also collect real-time 
comparative VMMC/EIMC monthly aggregate data for the duration of the study (Monthly 
EIMC/VMMC conducted following EIMC/VMMC training (M6) to M30). Historical period: 
Monthly CHC EIMC/VMMC conducted for 1 year prior to EIMC/VMMC training. 
 
Following baseline assessments, couples will complete a brief Stages of Change questionnaire 
prior to each prenatal and one-week post-partum LFLS sessions. Couples will be assessed at 6 
months post-partum to evaluate EIMC and VMMC uptake by father, sons and infant to examine 
the interactive influence of EIMC and VMMC uptake, as well as the role of both parents, family 
members, peers and HIV serostatus in the decision-making process (Montaño et al., 2018; Mavhu 
et al. 2017; Cook et al., 2015; Jones, Cook et al., 2014) (see Assessments). 
 
13) 
Data and Specimen Banking* n/a 
14) 
Data Management* 
Analytic Plan and Power Analysis  
Aim 1. Develop, pilot and conduct formative, process and outcome evaluations to assess the CHC 
level feasibility and acceptability of S&S+LFLS. 
 
Aim 2. Assess the intrapersonal, interpersonal, structural, and sociocultural factors relevant to the 
LFLS intervention, and develop program components to respond to these factors. 
Hypothesis 2. Father’s circumcision status, paternal grandparents’ circumcision attitudes, peer 
circumcision attitudes, father’s HIV status, and mother’s HIV status will be indirectly related to 
the decision to choose EIMC through the father’s circumcision attitudes. A mother’s circumcision 
attitudes will be influenced by her HIV status, and her protective attitudes toward the newborn 
which will also influence the father’s circumcision attitudes. 
 
Aim 3. Assess whether the combined S&S + LFLS pilot program will increase uptake of EIMC at 
clinic level.  
Hypothesis 3. The S&S + LFLS experimental condition clinics will have significantly higher 
numbers of EIMC in comparison with observation condition clinics. 
 
Hypothesis testing. The analyses for this feasibility pilot study will begin with examination of 
frequencies, means, skewness, and kurtosis across study variables (EIMC, VMMC, HIV status, 
attitudes) to assess normality. We will conduct 1) analysis of qualitative data, 2) a path model to 
explore undergirding sociocontextual factors of a father’s decision to elect EIMC or VMMC for 
his male children, 3) a test of comparison between conditions. 
 

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H2. Assess factors relevant to the LFLS model. To investigate the indirect effects of the five main 
predictors (paternal grandparents’ circumcision attitudes, peer attitudes surrounding circumcision, 
father’s HIV status, father’s circumcision status, and mother’s HIV status) on infant circumcision, 
a path analysis (Kline, 2011) will be conducted. To estimate the indirect effects, it will be 
specified that the paths between the five main predictors on infant circumcision will act through 
father’s circumcision attitudes. Mother’s circumcision attitudes will be regressed on mother’s 
HIV status, and a regression path between father’s and mother’s attitudes toward circumcision 
will be specified. When estimating the indirect effects, results will be adjusted for the effect of 
number of siblings circumcised.  
All potential indirect effects will be estimated by a bootstrapping approach (MacKinnon et al., 
2007). R-square of indirect effects will be used as measures of effect size (Fairchild et al., 2009). 
A sandwich estimator will be used to account for the nested data structure (e.g., individuals are 
nested by clinics). This estimator uses the Huber/White correction and adjusts for potential 
underestimated standard errors and bias in chi-square computation (Liang & Zeger 1986). 
Missing data will be handled using Full Information Maximum Likelihood estimation procedures 
(Enders & Bandalos 2001). For model fit evaluations, we will use well-established fit indices and 
cutoff values: A well-fitting model ideally will have a non-significant model χ2, a Comparative 
Fit Index / Tucker-Lewis Index greater than .95, a root mean square error of approximation less 
than .08, and a standardized root mean square residual less than .08 (Hooper et al., 2008). All 
analyses will be conducted in Mplus (V8; Muthén & Muthén, 2017). 
 
 
H3. Effect of S&S + LFLS pilot. To compare the proportion of EIMCs in the experimental group 
to the proportion found in the observation group, a one-sample z-test will be conducted. The 
population proportion will be taken to be the midpoint of the findings from Waters et al. (2013) 
on neonatal circumcision and historical numbers of circumcisions from Zambian clinics and 
hospitals. Based upon this rationale, the percentage of EIMCs in the observation group is 
anticipated to be approximately 5.0%. 
 
Exploratory analyses. To investigate change in EIMC attitudes, Stages of Change scores will be 
examined over time using an autoregressive modeling approach specifying the individual’s stage 
at 1-week postpartum as the main outcome and individual’s stage at baseline as a main predictor 
in the regression model (Hamaker et al., 2015). Variables from the previous path model will be 
included as potential covariates in attempting to explain stage movement. The estimated 
regression coefficient will reflect changes in EIMC attitudes over time. The model will use an 
ordinal logistic model to examine change over time. Odd ratios will be estimated as a measure of 
effect size (Chen et al., 2010). 
 
Power. Using a two-tailed Z test to test the difference in proportions between two conditions at an 
α level of .05, this study has over 80% power to detect a difference of 6.0% in EIMC rate 
between the two conditions. This difference in proportion translates to an effect size of an odds 
ratio (OR) = 2.4, which is considered a small (OR = 1.68) to medium (OD = 3.47) effect size, 
according to Chen et al. (2010). This 2.4 OR is based on an effect size found in previous research 
examining circumcisions (Weiss et al., 2015). With these specified parameters, 80% power is 
achieved with 140 couples (out of ~151 couples with male infants). 
 
Data Security. CAB and FGD participants will not provide any uniquely identifying information 
during participation in group discussion sessions. Pregnant couple participants in the intervention 
will be assigned a unique code upon entering the study. This number will identify all participant 
files, which will include no identifiable information. Access to the computer data files will be 
restricted by password codes. The list translating participant number to identifying information 

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will be maintained in a secure locked file in the Spear & Shield study office in Lusaka at the 
University of Zambia School of Medicine. Participants will be made explicitly aware at the time 
of the informed consent of the nature of the separate record that will be kept for them. CAB and 
focus group discussions will be audio-taped for review and summary of key discussion points; 
copies will be stored in a locked cabinet at the PI’s Lusaka offices, and deleted following 
summarization. 
Quality Assurance. The PI, Co-PIs, consultants, and study staff will train CHC staff in 
study protocols, including recruitment and intervention procedures. The US and Zambia 
will hold biweekly Skype calls to review the study progress. Semi-annual visits are made 
by members of the US team for protocol review, ongoing process monitoring and quality 
assurance; process evaluation is used to ensure fidelity to the study protocol and study 
instruments. All LFLS sessions will be recorded; 1) 10% of recordings will be randomly 
reviewed and rated for fidelity by the Project Coordinator, Ms. Banda (per existing 
random review system), and 2) feedback provided to the counselor within one week of 
the review; 3) all reviewed recordings will be entered in a spreadsheet detailing 
completed intervention components that 4) will be reviewed by the US Co-PI (Jones); 5) 
the Project Director and Dr. Jones will discuss the reviews to resolve fidelity issues 
collaboratively. ACASI assessment quality assurance will be conducted by US data 
manager biweekly. Quarterly meetings of CHC and S&S staff will be held to encourage 
team members to review study issues and discuss and resolve difficulties in a timely 
manner. Describe any procedures that will be used for quality control of collected data. 
Data collection will be conducted at the Zambia site, and reviewed for quality control at 
the US site. Both sites will have access to the final dataset for analyses, and the US site 
will lead primary study analyses. Data will be reviewed at the Zambia office, and then 
transferred biweekly to the US site for review, feedback, and return for correction. Data 
will not include unique identifiers, and data will be stored on encrypted computers at both 
sites. Data transfer will be conducted on a secure site using BOX. Written materials 
(consent) will be stored in locked cabinets in the local PI office and destroyed after 3 
years; only study staff will have access to the data. Transmission of data is conducted by 
Gibson Banda in Zambia to John Abbamonte in the US. 
Following completion of the study, electronic data will be available per data sharing in 
accordance with NIH policies, such that de-identified data will be available for analysis 
following the publication of the primary outcomes manuscripts. Access to the database 
will be available under the supervision of the collaborators within the guidelines outlined 
by the NIH for data sharing. Given the small sample size from each clinic, any clinic and 
participant identifying information will be removed prior to data sharing. Data will be 
made available as a shared resource within the guidelines of the University of Zambia 
School of Medicine, UM and NIH. 
15) 
Provisions to Monitor the Data to Ensure the Safety of Subjects* 
LFLS Monitoring Plan: As a feasibility study, there is no data monitoring board or 
committee. However, the study staff will obtain monthly feedback from senior clinic 
personnel on adverse events as well as more general problems associated with study 
participation occurring among participants. During the consent process, participants are 
encouraged to report any problems associated with participation in the study to study 
personnel (see Risks, below). 
Adverse events. As a behavioral study, adverse events are not anticipated that would be directly 
related to study involvement. However, if adverse events do occur, study procedures are in place 

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for study staff to contact the study PI, Dr. Weiss, within 24 hours of the event report. Dr. Weiss 
will ensure that the event is reported to the UM IRB and the UZ REC within 48 hours of the event 
report. Urgent issues arising will be discussed with senior clinic staff and the US/Zambia senior 
staff. 
General problems will be reported during weekly staff meetings at the Zambia site and 
reported to the US site in biweekly conference calls. All issues are documented in 
biweekly study data reports. Semi-annual visits are made by members of the US team for 
review, monitoring, and quality assurance by senior study faculty. 
Resolution. The US and Zambia teams hold biweekly Skype calls to review any study 
issues and resolve potential risks or problems arising. Quarterly meetings of CHC and 
S&S staff will be held to encourage team members to review study issues and discuss and 
resolve difficulties in a timely manner. CAB members will also provide support in 
problem solving problems arising during monthly meetings held by CHCs.  
VMMC/EIMC. The proposed study will train health care providers to 
conduct VMMC and EIMC. All 8 CHC sites will be reviewed to determine 
their needs for training health care providers to conduct VMMC (dorsal slit) and 
EIMC (Mogen Clamp) training. A minimum of 2 CHC health care providers are 
needed at each clinic to provide MC services. Each site will identify 2 health care 
providers (physicians, Clinic Officers, nurses) who are already trained or have the 
requisite background to participate in the two week VMMC and one day EIMC 
training program of the University of Zambia School of Medicine, directed by 
Dr. Zulu, Zambia Co-PI, in accordance with guidelines for provision of VMMC 
(Health Professions Council of Zambia, 2010; RZMOH, 2012).  
Training programs are conducted following the WHO MC training manual and 
recommendations by the Surgical Society of Zambia and MOH. The training in 
both dorsal slit and Mogen clamp procedures is conducted in 3 stages; Phase 1) 
theoretical training using the 10 WHO training modules, providing basic 
knowledge on VMMC/EIMC, VCT, infection prevention and M&E elements of 
VMMC/EIMC. Phase 2) classroom-based practicum in counseling, surgical skills 
and infection prevention. Phase 3) VMMC 5 days of supervised practicum, EIMC 
5 days practicum; candidates perform 10 VMMC and 10 EIMC procedures under 
close supervision, including client assessment and post-operative reviews. Upon 
practicum completion, new VMMC providers will receive supervision by Dr. 
Zulu and trainers. EIMC requires training for qualified health care providers in 
the use of the Mogen Clamp for surgeons and non-surgeons in Zambia; 10 
EIMCs must be successfully conducted and approved by the training team in 
order for the provider to receive a certificate of attendance. All EIMCs are 
documented in the EIMC register and are supervised within the CHC; after ~one-
three months, providers are certified. Due to the rigorous training requirements, 
very few adverse events have been reported. In the event of an adverse event, 
providers may be directed to re-training, depending on the outcome of the review 
of the nature of the event.  

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Adverse events. The Government of Zambia has an established system for 
collection of data related to EIMC and VMMC adverse events. 
This study is designed to make EIMC and VMMC available to those electing to 
undergo VMMC or to have their neonates circumcised. Currently, 16 clinics in 
Lusaka offer EIMC on a special day of the week when babies are circumcised, 
and they return for post-operative review after 7 days. Most babies are discharged 
at 7 days; those with adverse events (AEs, most typical have been insufficient 
skin removal, excessive skin removal, bleeding and infection) are reviewed and 
referred. Very low numbers of AEs have been reported. Staff at CHCs are 
provided with general information on EIMC management of complications and 
referral systems prior to onset of the program. EIMC surgical equipment and 
consumables are provided to all 8 CHCs to establish comparable availability of 
VMMC and EIMC services. 
16) 
Withdrawal of Subjects* 
Participants are advised during the consent process that participation in this study is 
voluntary. If they choose not to participate, they will not be denied any benefit to which 
they would be otherwise entitled and their employment will not be affected. They are free 
to withdraw from the study at any time, and if they do so, they will not suffer any 
penalty. If they decide to leave the study, they can contact the investigator or the study 
contact so that they will have no further contact. They are also advised that the 
investigators reserve the right to remove them from the study without their consent at 
such time that they feel that it is in the best interest for the participant medically or for 
administrative reasons. Finally, participants who lose their babies during or following 
pregnancy will be advised that they can drop out or attend sessions following a period of 
bereavement if they wish to continue. Information that has been collected during their 
participation in the study prior to their withdrawal will be retained by the investigator.  
17) 
Risks to Subjects* 
18) Potential Risks   
Participants should incur no appreciable physical risks. Through participation in this 
study they may undergo psychological discomfort at times, including embarrassment, 
discomfort, or distress associated with discussion of sensitive topics which may lead 
some participants to experience mild, transient anxiety. Potential risks to participants in 
this study also include negative consequences that may be suffered if confidentiality of 
information obtained in the study were breached. Participants attending groups cannot be 
assured that another group member will not divulge information shared in the group 
format; group members will be encouraged to endorse confidentiality at the onset of the 
discussion sessions. A number of steps will be taken to protect the confidentiality of 
participant data and identity. Study staff will attend training sessions by the study 
investigators and receive ongoing supervision in areas related to ethical conduct, 
confidentiality protection, and other topics of human participant protection. We will 
ensure that study staff are trained to explain the purpose of the study to potential 
respondents, obtain informed consent, and inform respondents about their rights and 
benefits in a factual and neutral way without coercion to participate. We will also ensure 
that our interviewers and group leaders inform the potential respondents about the 

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confidentiality measures put in place to protect their privacy. The assessments are 
confidential and will be conducted in a private office area inside each clinic and all 
research data obtained from participants will be labeled with a respective unique code 
and not the participant’s name. Only the unique code will appear on measures, data 
records, and computer files. A master list that includes participant identifying information 
and identifying codes will be kept in a locked file at the PI’s Lusaka site office. 
 
It is also possible that during the course of our contact with participants we may become 
aware of problems that fall outside of the scope of the proposed research but require 
intervention. As such, participants will be advised that there are certain ethical limits to 
confidentiality. Should any participant disclose that he/she is experiencing suicidal 
ideation, he/she will be immediately evaluated by a qualified physician or psychologist 
and actions may be taken to protect him or herself and others. If a participant tells the 
researcher that he or she plans to in any way physically or sexually harm an identifiable 
person including a spouse or partner, it will be required that the researchers take steps to 
intervene. If the participant tells the researcher that he or she believes an identifiable 
person is going to physically or sexually harm him or her, steps will be taken to protect 
him or her.  
 
Although EIMC is the standard of care provided in Zambian antenatal clinics, 
participants will also be advised during the informed consent and the study intervention 
of the potential risks associated with early infant circumcision. 
 
Protections Against Risk 
Intimate Partner Violence.    
Special considerations regarding the potential for intimate partner violence: Should 
participants experience extreme acute or persisting affective reactions at any point during 
the study period due to the risk or anticipation of intimate partner violence (IPV; see 
below for details), they will be referred to medical and/or human services professionals 
associated with the CHC for care. Following this evaluation, if necessary, the participant 
will be accompanied to the referral hospital for further assessment and/or hospitalization, 
or, if not in immediate danger of harming her/himself, will be referred for outpatient 
treatment. [N.B.: IPV has been a major concern in our HIV risk reduction studies in 
Zambia over the past 20 years. We are pleased to report that either a reduction or lack of 
increase in IPV has been observed post-intervention, despite the sensitivities of issues 
such as disclosure of status or use of sexual barriers among couples. We believe post-
intervention improvement in couple communication and coping skills as well as anger 
management/assertiveness training have contributed to these reductions in IPV, even in 
venues with high rates of IPV].  
 
Our previous Zambian studies utilized a gender-concordant group strategy and the 
proposed LFLS component utilizes a couples-based session format focused on joint 
decision making for EIMC. Our previous and ongoing couples-based studies in South 
Africa were sensitized to the potential for IPV when using a couples-based approach to 
reduce stigma (e.g., Peltzer et al., 2018) and promote healthy pregnancy practices (Jones 
et al., 2018). Our experiences with couple negotiation have contributed to our attention to 

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prodromal signs of IPV. However, although decision making discussions regarding adult 
and infant circumcision have not been typically associated with IPV, we will train 
counselors and staff to be aware of participant IPV and topics under discussion associated 
with its potential, and will apply elements from the existing standard of care for 
counselors to utilize a couples’ voluntary HIV testing and counseling (CVCT) model 
based on the CVCT Intervention and Training Curriculum developed by CDC and the 
Rwanda Zambia HIV Research Group (CDC, 2011; Wu et al., 2018). 
 
Procedures related to Intimate Partner Violence (IPV). In the event of a report of IPV, the 
CHC protocol for responding to reported IPV is 1) interview with offending partner 
(usually the husband), 2) medical examination of victim spouse and possible inpatient 
admission or 3) referral to the alternative community shelter for mother and children, 
provision of 4) medical treatment and counseling support. Based on the results of the 
medical examination, 5) a police report is also submitted by CHC staff and 6) police will 
then interview the domestic partner (husband). In the case of reported abuse of children, 
children are 1) assessed and as appropriate, 2) placed in the protective care. Following a 
report of IPV, all subsequent sessions and assessments will be conducted independently; 
no partners will attend sessions or assessments at coinciding times. In the event that both 
partners request to reunite, they will begin assessments at coinciding or overlapping 
times, if they prefer.    
 
19) 
Potential Benefits to Subjects* 
Risks to study participants related to attendance in the study are low, and the potential 
benefits to participants include discussion of information and experiences during 
assessments that may be helpful; participants may benefit from non-specific effects of 
discussing work experiences under the guidance of trained assessors.  
20) 
Vulnerable Populations*  pregnant women being enrolled. 
21) 
Multi-Site Research* 
This study is being conducted in Zambia and the US. The PI is located in Miami. 
• 
Prior to study start, both sites will finalize the protocol, and both sites will have the 
most current version of the protocol, and consent document (there are no HIPAA 
authorizations required as there is no uniquely identifiable data being collected). 
• 
Prior to study start, the required approval from the Zambia Research Ethics 
Committee will have been obtained. 
• 
All modifications will be communicated to both sites, and approved (including 
approval by the site’s IRB of record) before the modification is implemented. 
• 
Both sites will safeguard data as required by local information security policies. 
• 
All local site investigators will conduct the study appropriately. 
• 
All non-compliance with the study protocol or applicable requirements will 
reported in accordance with local policy. 
 
The following management structure is already in place and will be maintained at both 
the Miami and Zambia sites. Two project management teams (Miami: Weiss, Jones, 
Castro, Lee; Zambia: Zulu, Bowa, Chitalu, Mweemba) will ensure appropriate 
coordination, consistency and quality control in implementing the research protocol 

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across the two sites. The investigators will be responsible for the administration of the 
study at their respective sites, including Institutional Review / Ethical Review and 
approval, implementation of protocol and procedures, and oversight of issues related to 
human subject protections.  
 
Fiscal and management coordination: Dr. Weiss is responsible for scientific direction and 
Drs. Weiss and Zulu will oversee fiscal management at their respective sites. Dr. Weiss 
will be responsible for the overall fiscal management as the University of Miami is the 
primary grantee. 
 
Roles of Investigators and Process for Decision Making: 
Dr. Weiss (PI) will provide guidance for overall study policy development, achievement 
of scientific aims, data analysis, publication and quality assurance for the study. Dr. 
Weiss will oversee the implementation of the aims of the study and maintain 
communication across both sites. Policy guidelines for the project and quality assurance 
include standards for staff training, assessment, treatment, quality control and 
maintenance procedures, as well as data review and analysis. Assessment and 
Intervention Manuals and Manual of Operations will be created in Miami and adapted to 
the Zambian context through consensus by both teams. “Like Father, Like Son” 
intervention manuals and assessments will be collaboratively developed by US and 
Zambia investigators with input from stakeholders. Publications and authorship will be 
collaboratively developed and shared between both sites. 
 
Decisions on procedural issues and scientific management will be reached using a Project 
Executive Committee, chaired by Dr. Weiss, comprised of Drs. Weiss, Zulu, Bowa, 
Chitalu, Mweemba, and Jones. During semi-annual meetings, Dr. Bowa and Mr. 
Kamboyi will provide additional consultation on the project, providing guidance on the 
current standards on EIMC/VMMC and information on regional EIMC/VMMC uptake 
and acceptability. Dr. Jones will oversee quality assurance and training and chair the 
Publications Committee; Dr. Lee will oversee statistical issues and data review. The 
committee will meet twice a year in person during site visits, and twice per month on 
conference calls. 
 
Dr. Zulu (co-PI) will chair the Project Steering Committee, comprised of Dr. Chitalu, Dr. 
Mweemba, Ms. Banda, and Mr. Mwanza, and oversee the scientific/operational arms of 
the study, and be responsible for site-specific program management, e.g., administration 
and site issues that may impinge on study conduct and/or outcome and operating 
procedures. Dr. Zulu will also organize and oversee the training of qualified healthcare 
providers from the 8 CHCs to perform VMMC and EIMC at the University Teaching 
Hospital. Decisions on procedures for recruitment, intake, assessment, treatment, 
maintenance and follow-up will be reached by the Project Steering Committee. The 
Committee will meet weekly, and minutes will be provided to the Miami site as a record 
of study progress. 
 
Dr. Chitalu (co-Investigator) will oversee all administrative issues related to the project, 
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staff recruitment. Regular email communication and twice monthly conference calls over 
the course of the project will maintain a regular system of reporting on issues that may 
affect the conduct of the study.  
 
Procedure for conflict resolution: The process for conflict resolution will, as in our 
previous collaborations, be designed to arrive at mutually agreeable solutions. In that rare 
instance when agreement cannot be resolved by discussion and simple vote, the 
chairperson of the respective committee will make the final decision, i.e., Dr. Weiss will 
make the final decision in the Project Executive Committee, Dr. Zulu will make the final 
decision in the Project Steering Committee. 
 
Communication: Information sharing and project management will be facilitated by 
scheduled bi-monthly calls, and supplemented by email. The PI and Co-investigator 
(Jones) will travel to Zambia at the onset of the study to finalize all guidelines and 
protocols and train staff; Dr. Bowa and Mr. Kamboyi will travel to the main office for 
semi-annual meetings. Drs. Weiss and Jones will travel to the Zambia site twice yearly 
for the duration of the study (see Budget Justification), and hold monthly meeting with 
Miami investigators, consultant, statistician and staff. 
 
Study Team and CHC staff roles: Zambia 
Dr. Robert Zulu, Zambia senior co-Investigator 
Dr. Kasonde Bowa, Zambia co-investigator 
Dr. Ndashi Chitalu, Zambia co-investigator 
Dr. Oliver Mweemba, Zambia co-investigator 
Dr. Kasonde Bowa, Zambia consultant 
Mr. Royd Kamboyi, Zambia consultant 
Agatha Banda, Certified Project Manager, 
Chileshe Mwanza, Administrator 
Richard Msimuko, senior trainer and assessor 
Mirriam Mwaba-Chisongo, senior trainer and assessor 
Sharon Kalebaila, trainer and assessor 
Rogers Mofya, trainer and assessor 
Wazala Zulu, Driver 
Gibson Banda, Data Management coordinator 
TBA 8 Clinic sister/clinic officers (8 clinics, 1 per clinic) 
TBA 16 EIMC Providers (8 clinics, 2 per clinic) 
TBA 8 S&S LFLS Providers (4 clinics, 2 per clinic) 
 
22) 
Community-Based Participatory Research* 
CAB Meetings & Focus Groups (see above, PROCEDURES). 
Content of CAB Meetings & FGDs. To address Aims 1&2, FGDs and CAB 
meetings’ discussion topics have been broken into smaller units within the context 
of the socio-ecological framework (from the individual to the context), using the 
PRECEDE model (Green & Kreuter 1999). Activities will be led by Dr. 
Mweemba. Focus group discussion stem items explore intrapersonal, 

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interpersonal and structural level factors associated with EIMC, and factors 
associated with each level. Stem items were derived from previous research (e.g., 
Albert et al., 2011; Amuri et al., 2016; Mavhu et al., 2012; Mavhu et al., 2016; 
Plank et al., 2010; Waters et al., 2012) and will be presented as open-ended 
questions; time will be provided to address additional topics as they arise. FGDs 
will be approximately 1.5 hours in duration. Prior to study onset, additional stems 
may be proposed using an iterative, collaborative process involving the University 
of Miami/University of Zambia (UZ) study team, which includes psychologists, 
social scientists, a pediatrician, surgeons, an infectious disease physician, and 
psychometricians. Final stems will be reviewed and refined by the entire team 
prior to initiation of FGDs and CABs. CAB meetings (1 per clinic, 3 meetings, n 
= 80 persons) and FGDs (2 per clinic, each gender concordant, 8 FGDs, n = 64) 
will be audio recorded and transcribed by trained study staff from the UZ into 
English; FGDs and CABs will be conducted in private areas in CHCs. Field notes 
will be made by staff during FGDs, CABs and study-related CHC staff meetings; 
meetings will be summarized from field notes. The project coordinator and study 
staff are social scientists and are experienced in conducting FGDs.  
Community Advisory Board (CAB) Members. CAB Members will meet for three 
formal group discussions in a private meeting room within their experimental clinic. 
CAB members will be asked to 1) provide input on cultural factors that influence 
attitudes, perceptions, and beliefs about EIMC within their communities and among the 
ethnic groups predominant in the Lusaka Province, and 2) provide input on the LFLS 
intervention and assessment content and information on community issues and concerns 
that could influence LFLS program uptake. CAB Members associated with each CHC 
will thereby facilitate the adaptation of the intervention strategies to the local culture and 
clinic culture, enabling LFLS to work with the community rather than imposing the 
program on the community. No personal, individually identifying information will be 
collected and no individual interviews or assessments will be conducted with CAB 
Members. 
Focus Group Discussion (FGD) Members. FGD members will meet in gender 
concordant groups in a private room within their experimental clinic site; 
members will provide input on cultural factors that influence attitudes, 
perceptions, and beliefs about EIMC among pregnant couples. They will provide 
guidance on cultural attitudes, ethnic preferences, beliefs and perceptions 
surrounding EIMC among pregnant couples in Lusaka. FGD members will inform 
the study on local issues or community concerns that could influence program 
uptake. No personal, individually identifying information will be collected and no 
individual interviews or assessments will be conducted with FGD members. 
 
 
23) 
Sharing of Results with Subjects* 
No relevant information will be collected to share with participants. 

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24) 
Setting 
Describe the sites or locations where your research team will conduct the 
research. 
Proposed clinic sites (N=8) are to be drawn from n = 14 potential clinics in 
Lusaka Province, and were reviewed and approved by the Lusaka Provincial 
Health Officer leadership. Following guidelines for site VMMC accreditation 
(Health Professions Council of Zambia, 2010), the following criteria govern 
selection of 8 clinic sites: 1) a community clinic catchment area of >30,000; 2) 2 
health care providers available at site for VMMC/EIMC training and provision; 
3) >2 VCT counselors and antenatal clinic (ANC) staff available for S&S+LFLS 
training, 4) space for VMMC/EIMC, 5) > 150 births per month, 6) a maternity 
ward. Clinic selection (n = 8) will focus on spatial separation between clinics to 
avoid clinic contamination. Randomization. Clinics will be matched by 
catchment area size and historical EIMC/VMMC rates and randomized by a non-
study member; statistician will be blinded to clinic assignment. Following site 
selection and randomization, CHCs will be visited by the research team to 
introduce the study to relevant staff. Sites will be reviewed for adequate space. 
Approval from the Research Ethics Committee and the Institutional Review 
Board will be obtained prior to any study activities.  
Lusaka Province Community Health Clinics (CHCs). All CHCs identified in 
Lusaka Province for potential participation offer Voluntary Counseling and 
Testing (VCT) (Republic of Zambia Ministry of Health, 2013). All sites include 
qualified staff to provide leadership and to implement the Project, willingness to 
conduct sessions, adequate space to meet patients, and willingness to work with 
the Project to expand the delivery of VCT/ANC services to offer VMMC/EIMC 
services. CHC clinic doctors confirmed available staff, time, space and facilities, 
and required staff expertise and willingness for full participation in enrolling and 
assessing participants. Clinic sites acknowledged qualified VCT staff at all sites 
(i.e., having the minimum qualifications and experience to receive training), and 
a catchment area of at least 30,000 individuals. Finally, each site will establish 
special recruitment and follow-up efforts if necessary. Out of the available CHCs, 
all clinic sites have easy access by paved roads frequently traveled by local 
minibuses and taxis and with signs advertising the VCT program.  
Lusaka Province & MC Attitudes & Culture. Lusaka Province has a 
population of 3,186,000. The provincial capital is Lusaka city, which is also the 
capital of Zambia. Lusaka Province is a link to all provinces, and people with 
different cultural backgrounds from other provinces and countries move to 
Lusaka looking for employment and other business ventures. The rate of 
traditional MC in Lusaka is estimated to be approximately 10.2% (Makawa, 
2012), with an estimated HIV prevalence of 20.8%. Barriers to MC in Lusaka 
include fear of pain associated with the procedure along with the healing process. 
Fears related to the healing process have been perpetuated by reports of men who 

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indicate that the healing process did not go well for them. Others also report a 
fear that one could die from the procedure (Mwale & Jairos, 2009).  
Zambia has many native languages which are spoken across Zambia in 
combination with English, which is the official language of the country. All 
languages are often used along with English in schools and government 
publications. In the 2010 census, 34% of Zambians reported speaking Bemba as 
their primary language, whereas 15% spoke Nyanja, 11% Tonga and 6% Lozi 
(Central Statistical Office, 2012). English is only natively spoken by 2% of the 
population but is commonly spoken as a secondary language by Zambians. 
Bemba and Nyanja and English are spoken in Lusaka. 
Lusaka District (Urban). Lusaka is the largest city in Zambia, and is considered 
one of the fastest-developing cities in the Southern part of Africa. English is the 
official language of the city, but Nyanja and Bemba are also commonly spoken. 
Some of the sociocultural barriers to implementing HIV-risk reduction programs 
in Lusaka have been reported to be poverty and refugee status. In addition, the 
organizational structure in health care settings and HIV-related stigma have been 
identified as barriers to seeking care. Cultural characteristics, such as traditional 
gender roles combined with religious beliefs, are also factors that may inhibit 
men from considering undergoing VMMC (Auvinen, Kylma, Valimaki, Bweupe, 
& Suominen, 2013). Younger men in Lusaka assert they would be willing to 
consider circumcision if the services were more accessible and if more 
information was provided regarding the procedure (Chanda, Likwa-Ndonyo, 
Nzala, & Mweemba, 2012). 
Kafue District. Kafue is in southern Lusaka Province located to the north of the 
Kafue River. According to the 2010 census, Kafue has a population of 
approximately 219,000 people. In some areas of Kafue, such as Nyimba and 
Namalyo, HIV prevalence is estimated to be 23.7% or higher (Lungu & Husken, 
2010). Under a regional program, the WorldFish Center in Zambia conducted 
research in the Kafue Flats to investigate the accessibility of health care services, 
as well as to identify factors that may potentially explain the increased risk of 
HIV/AIDS among fishing communities (Lungu & Husken, 2010). Those working 
in the fishing industry are among the most vulnerable to HIV infection, and 
female fish traders often visit fishing communities in search of fish. Transactional 
sex (“fish-for-sex”) is a common occurrence in the Kafue Flats, increased by the 
high demand for fish. Both male and female traders are at a higher risk of 
contracting HIV and STIs (Lungu & Husken, 2010). 
Potential CHC study sites: Lusaka Province (8 to be selected) 
• Bauleni (Lusaka District, large) 
• Mtendere (Lusaka District, large) 
• Chilanga (Lusaka District, large) 
• Chongwe (Chongwe District, large) 

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• Karakantapa (Chongwe District, medium) 
• Kriskatumba (Chilanga District, medium) 
• Chainda (Chongwe District, small) 
• Mwembeshi (Chilanga District, small) 
• CHC study sites: Lusaka Province (alternates) 
• Chalimbana (Chongwe District, small) 
• 
Makeni Konga (Chilanga District, medium)Resources Available 
Qualifications (e.g., training, experience, oversight) of US PI and team 
including experience and knowledge of local study sites, culture and society.  
• Stephen M Weiss, PhD, MPH, PI, USA is Professor, Department of 
Psychiatry and Behavioral Sciences, University of Miami School of 
Medicine. Dr. Weiss is a clinical health psychologist with additional 
expertise in cultural anthropology (doctoral minor) and public health 
(MPH). He has extensive international experience in HIV research with a 
focus on sub-Saharan Africa, including being PI of the Spear & Shield 
studies, R01MH095539, “Increasing Availability and Acceptability of 
Circumcision in Zambia” and coPI of “Implementing Comprehensive 
PMTCT & HIV Prevention for South African Couples” 
(R01HD078187/R01HD078187-S1). He was PI of the US/Zambia 
multisite study “Reducing Risk for Multicultural HIV+/- Women & 
Partners” (R01MH63630), and Co-PI of “Implementing HIV Risk 
Reduction in Zambia” (R01HD058481). In the US, Dr. Weiss was Co-PI 
on US studies addressing infant and adult male circumcision, 
“Acceptability of Neonatal Circumcision among Hispanics” 
(P30AI073961; PI, J Castro), “Attitudes towards Circumcision among 
Hispanics: Avenues for HIV Prevention (P60MD002266; PI, J Castro), 
and “HIV Prevention Strategies Preferences” (P30AI073961; PI, J 
Castro). As the PI for the proposed study, Dr. Weiss will provide overall 
leadership and scientific guidance, including oversight of intervention 
training at the Zambian site.  
• Deborah Jones, PhD, MEd, Co-Investigator USA, is Professor, 
Department of Psychiatry & Behavioral Sciences, University of Miami 
Miller School of Medicine. Dr. Jones is a clinical health psychologist with 
additional training in education (M.Ed.). She has extensive experience in 
conducting HIV/AIDS research and in developing psychosocial 
interventions for men and women living with HIV/AIDS in sub-Saharan 
Africa and the US. She is co-investigator and the co-creator of the 
intervention and assessments utilized in the Spear & Shield study, 
R01MH095539, “Increasing Availability and Acceptability of 
Circumcision in Zambia” and was Co-PI and Project Director on the 
US/Zambia study, “Reducing Risk for Multicultural HIV+/- Women & 
Partners” (R01MH63630) and was PI of “Implementing HIV Risk 
Reduction in Zambia” (R01HD058481). Dr. Jones was Co-PI on US 
studies addressing infant and adult male circumcision, e.g., “HIV 

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Prevention Strategies Preferences” (P30AI073961; PI, J Castro), 
“Acceptability of Neonatal Circumcision among Hispanics” 
(P30AI073961; PI, J Castro) and “Attitudes towards Circumcision among 
Hispanics: Avenues for HIV Prevention (P60MD002266; PI, JCastro), 
conducting qualitative data analysis for these studies. Dr. Jones has a long 
history in pregnancy-based interventions in the US/Southern Africa and is 
PI of the perinatal intervention “Implementing Comprehensive PMTCT & 
HIV Prevention for South African Couples” 
(R01HD078187/R01HD078187-S1) and was PI on “Pathways to Health 
Conception Practices” (U01 AI103397; PI Fischl; P30AI073961; PI 
Pahwa).  
• Jose Castro, MD, MPH, Co-Investigator USA, is Associate Professor, 
Department of Infectious Diseases, University of Miami School of 
Medicine. Dr. Castro was PI of 3 studies addressing attitudes on infant 
and adult male circumcision among men, women and physicians, 
“Acceptability of Neonatal Circumcision among Hispanics” 
(P30AI073961; PI, J Castro), “Attitudes towards Circumcision among 
Hispanics: Avenues for HIV Prevention (P60MD002266; PI, JCastro), 
and “HIV Prevention Strategies Preferences” (P30AI073961; PI, J 
Castro). He is co-investigator on the Spear & Shield grant and will serve 
as the US medical consultant for the proposed EIMC study and provide 
guidance on the development of the study protocol 
• Robert Zulu, MD, Surgeon, Co-Principal Investigator, ZAMBIA, is 
Honorary Lecturer, Department of Medicine, University of Zambia 
School of Medicine (UZSOM), Chainama College of Health Sciences, 
and Cavendish University. He is Director of Clinical services and 
Consultant Surgeon for the University Teaching Hospital (UTH) under 
the Ministry of Health. He is in-country co-PI of the previous (S&S1) and 
current Spear and Shield Projects (S&S2), and co-PI of 2 studies on MC 
devices (Shang Ring studies on male circumcision). He currently oversees 
all VMMC training for the study. Together with collaborative input from 
Drs. Bowa, Weiss, Jones, Chitalu and Castro, Dr. Zulu will be responsible 
for the implementation of the biomedical component of the revised 
application, specifically the recruitment and training of health care 
personnel from the selected district sites in Lusaka for EIMC training. He 
will oversee and provide the EIMC Clinical Circumcision Training to 
community health center (CHC) staff through mobilization of the 
Zambian Association of Surgeons training group, in collaboration with 
the EIMC consultant, Dr. Bowa. Dr. Zulu will supervise the 
implementation and execution of the biomedical component of the 
application, periodic review of EIMC trainees for quality assurance 
during the course of the study. He will be responsible, together with Dr. 
Chitalu and the Project Coordinator, for oversight of study activities at the 
8 clinical sites. 
• Ndashi W Chitalu, M.D., MPH, Co-Investigator ZAMBIA, is a 
Pediatrician and Senior Lecturer, Department of Medicine at the 

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University of Zambia School of Medicine, and Head of Emergency Care 
at the Paediatrics Unit of the University Teaching Hospital. Dr. Chitalu 
has extensive experience in the oversight and implementation of 
HIV/STD research in Zambia and is the Co-PI of the previous (S&S1) 
and current Spear and Shield Projects (S&S2). He was in-country co-
investigator of “Implementing HIV Risk Reduction in Zambia” 
(R01HD058481), and of “Reducing Risk for Multicultural HIV+/- 
Women & Partners” (R01MH63630). Dr. Chitalu was a Fogarty Scholar 
at the University of Miami School of Medicine, and has served as an 
invited consultant for the Malawi Ministry of Health. He is the former 
National Director of the YMCA in Zambia and is trained in qualitative 
research methods. He will provide guidance on the pediatric component 
of the study, and will be administratively responsible to Dr. Zulu and the 
PI, Dr. Weiss. He will collaborate on the development and 
implementation of the intervention, behavioral research, and training.  
• Oliver Mweemba, PhD, Co-Investigator ZAMBIA, is a 
Lecturer/Researcher in the Department of Health Promotion and 
Education, School of Public Health at the University of Zambia. Dr. 
Mweemba was a Fogarty Scholar in the African Bioethics Training 
Program (FABTP) at the Berman Institute of Bioethics, School of Public 
Health, Johns Hopkins University (JHU). His research addresses 
masculinity, gender, sexuality and health; ethical, legal, and social 
implications of advances in biomedical research and health systems; the 
link between public policy, health inequalities, and human rights; and life 
courses and health needs of vulnerable and marginalized groups and 
communities. He was co-PI on a Medical Research Council (MRC) MDP 
301 multi-centre clinical trial assessing the effectiveness of candidate 
microbicides, PRO 2000, and was a site PI on an MRC multi-centre Top-
up study, determining the feasibility of conducting a microbicide trial of 
the daily vaginal gel, and to inform the way adherence should be assessed. 
He has been co-Investigator on two NIH projects; 1) A dyad approach to 
combination HIV prevention in pregnancy for Zambia and Malawi, in 
which he was a Zambian site principal investigator for the formative 
phase, and 2) An assessment of capacity to prevent and manage major 
non-communicable diseases (NCDs) in primary care centres in Zambia 
using a health system approach. He is currently co-PI on a multi-centre 
collaborative research project with University of Oxford and Child 
Frontiers, funded by the Canadian International Development Research 
Centre, on Early Marriages and Parenthood, focusing on experiences of 
children who marry and become parents, the predictors of and motivations 
for child marriage and parenthood, and the wider implications for sexual 
and reproductive health, gender inequality and intergenerational poverty. 
He is also co-PI on an H3 Africa multi-centre and collaborative study 
with University of Oxford, London School of Hygiene and Tropical 
Medicine, and University of Cape Town, funded by Welcome Trust, 
aimed at developing a robust and supportive ethical and governance 

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framework for genomic research in Africa. Dr. Mweemba has taken an 
active role in the development of the formative elements of the study, the 
issues surrounding couples, families, and gender roles as they relate to 
early infant male circumcision. In collaboration with Drs., Weiss and 
Zulu, he will oversee the formative elements of the study, and in 
collaboration with Drs. Jones, Chitalu and Weiss, will provide training 
and oversight on the behavioral intervention and evaluation of the study 
outcomes.  
• Kasonde Bowa, MD, MPH, Investigator, ZAMBIA, is Professor of 
Urology at the Copperbelt School of Medicine in Ndola, Copperbelt 
Province, and head of Urology at the Ndola Central Hospital. He is a 
Fellow of the Royal College of Surgeons in Glasgow, a Fellow of the 
American College of Surgeons, and a Fellow of the College of East and 
Central Africa in Urology. He was the founding Dean of the Copperbelt 
University School of Medicine. Dr. Bowa has been a leader in VMMC for 
HIV prevention and research for over a decade and was a collaborator on 
the WHO guidance documents on VMMC and EIMC training and on MC 
devices, is on the WHO committee of MC experts, and is a consultant on 
MC for numerous studies. He is a respected physician and local expert in 
cultural matters in the Copperbelt; he will assist in the planning of the 
training of healthcare personnel in adult and infant male circumcision 
according to current standards for the Like Father Like Son study, as well 
as advising the team on culturally relevant matters related to uptake and 
acceptability of VMMC/EIMC.  
• Royd Kamboyi, MPH, Consultant, ZAMBIA, is the national VMMC 
Program Officer, Ministry of Health, Zambia with collaborative oversight 
of over 200 staff implementing VMMC nationally. Mr. Kamboyi was 
previously VMMC Provincial Coordinator, Society for Family Health 
Zambia, at Petauke District Hospital. He is a public health specialist and 
social scientist with experience in the Zambian health sector under the 
Ministry of Health and Non-Governmental Organizations, including the 
Centers for Disease Control and Prevention. Mr. Kamboyi is experienced 
in HIV/AIDs programming and implementation of interventions in the 
health sector, and has expertise in health systems strengthening in 
VMMC, PMTCT, HTC, ART services including general nursing care 
services. Mr. Kamboyi is a certified National Trainer in VMMC, ART 
and PMTCT.   
• Recruitment. Our previous studies have recruited over 5,000 Zambian 
men and women within the agreed recruitment periods over the last 20 
years. The study staff have access to ~50,000 eligible men per clinic. Our 
most recent Spear & Shield study recruited 800 eligible men in under two 
years. 
Spear & Shield Project Offices. The UTH Pediatrics Wing at the 
Ridgeway Campus is the home to the NOW/Partner/WASH/Spear & 
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Medicine through the SOM. The projects are housed in a dedicated 2000 
sq. ft fully renovated building with computer systems offering wireless 
and fibre optic cable networks. Computers (24) are housed in 14 offices 
and include laptops (12) for ACASI data collection as well as desktops for 
on-site work. On site equipment includes desks, cabinets, computer 
projectors, air conditioners (6), freezers (2), photocopiers, 
television/VCR/Disk players (5), tape recorders (4), telephones and Skype 
capability. 
 
Medical and/or psychological resources are available at both the 
community clinics and University Teaching Hospital to provide support 
for consequences of the human research, as outlined in the RISKS section. 
 
All study staff have been working with the project for the last 4 years, and 
a system has been established of providing training on the study protocol, 
research procedures, and their duties and functions. Following training, all 
study staff review and sign off on the study SOPs. 
25) 
Prior Approvals 
Prior to study onset, the University of Zambia Biomedical Research Ethics 
Committee will need to provide an approval. 
26) 
Recruitment Methods 
Recruitment and Retention. Experimental Clinics Only 
Community Advisory Board (CAB) Members.  
Referral. CAB members will be approached for participation in study 
meetings by the study staff member, Sister in Charge or Clinic Officer at 
the experimental clinic sites (n = 4 clinics; n = 80 participants).  
Overview. CAB members will be briefed on the nature of the study by the 
Sister in Charge or Clinic Officer. 
Focus Group Discussion (FGD) Members.  
Referral. FGD members will be approached for participation by a study 
staff member during antenatal clinic (ANC) days or at the VCT at the 
experimental clinic sites (n = 4 clinics, 64 participants). Women attending 
ANC are asked to bring their partners to ANC visits, and clinics will have 
both women and men in attendance. FGD participants will be couples 
(men and pregnant female partners). Couples participating in the FGDs 
will deliver following completion of the formative activities, and therefore 
will not be eligible to enroll in the LFLS program.  
Pregnant Couple Members attending LFLS.  
Referral. Pregnant couples, both members aged 18 or older, will be 
recruited over an eighteen month period from each of the 4 experimental 
clinics (75 pregnant couples per clinic x 4 clinics = 300 couples = 600 

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individual men and women.) Recruitment will be from both the VCT and 
the ANC; both men and women in pregnant couples will be eligible to 
participate with their partners. Women attending ANC are asked to bring 
their partners to ANC visits, and clinics will have both women and men in 
attendance. Those who participated in FGDs will not be eligible to enroll 
in the LFLS program. 
No recruitment materials will be created. 
Compensation. Participants are compensation $10 each for each study 
visit. Study visits are 1-2 hours per visit. 
27) 
Local Number of Subjects 
N=744 participants will be enrolled.  
It is anticipated that N = 744 will be enrolled and will be needed to 
complete the research. 
28) 
Confidentiality 
Data Confidentiality. CAB and FGD participants will not provide any uniquely 
identifying information during participation in group discussion sessions. Pregnant 
couple participants in the intervention will be assigned a unique code upon entering the 
study. This number will identify all participant files, which will include no identifiable 
information. Access to the computer data files will be restricted by password codes. The 
list translating participant number to identifying information will be maintained in a 
secure locked file in the Spear & Shield study office in Lusaka at the University of 
Zambia School of Medicine. Participants will be made explicitly aware at the time of the 
informed consent of the nature of the separate record that will be kept for them. CAB and 
focus group discussions will be audio-taped for review and summary of key discussion 
points; copies will be stored in a locked cabinet at the PI’s Lusaka offices, and deleted 
following summarization. 
 
No specimens will be collected. 
 
29) 
Provisions to Protect the Privacy Interests of Subjects 
Prior to obtaining consent, study staff will review the environment in which the study 
will take place, and steps that will be taken to protect subjects’ privacy interests. As the 
study uses group interventions, study participants will interact with other pregnant men 
and women. This is outlined in the consent. 
 
Prior to beginning assessments, study staff traditionally, in Zambian culture, exchange 
general discussion to foster a positive environment. Participants are made to feel at ease 
during the entire research experience, and are welcome to ask questions and discuss the 
elements of the study at any time. When participants appear ill at ease, they are invited to 
return on another visit. Participants wishing to process difficult issues are invited to share 

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with the assessors, who are trained counselors, and can also be referred to support staff in 
the clinic. 
 
The research team is only able to access study data; there is no potential for the study 
staff to access private health data at the clinic. 
 
30) 
Compensation for Research-Related Injury 
The research involves only Minimal Risk. The following is language relevant to 
compensation for research-related injury contained in the consent. 
“Although risks are unlikely, if injury should occur, treatment will in most cases be 
available.  If you have insurance, your insurance company may or may not pay for these 
costs. If you do not have insurance, or if your insurance company refuses to pay, you will 
be expected to pay. Funds to compensate for pain, expenses, lost wages and other 
damages caused by injury are not routinely available.” 
   
31) 
Economic Burden to Subjects 
N/A 
32) 
Consent Process 
Study Procedures – Informed Consent:  
The informed consent will be reviewed in detail and read aloud to the 
prospective participant (CAB member, FGD member, or pregnant couple 
member) individually in their preferred language in a private room in the 
study offices at the CHC. The consent will then be reviewed section by 
section to ensure comprehension. Study candidates will be asked to recount 
the essential content of the informed consent back to the staff member using a 
consent comprehension test and agreeing to the terms of the consent before 
signing the form. Any items of confusion will be clarified by the study 
recruiter. Each study candidate will be asked to sign or provide their mark on 
the form after reading or having the contents read and explained, and if 
agreeing to its terms, and the signature of a witness will be obtained. [N.B. 
Neonates are not participants in LFLS, and are only potential recipients of a 
health care service provided by the clinics.] Our current consent process in 
Zambia is ~30 minutes in duration. 
The following questions will be used to evaluate comprehension of Informed 
Consent. 
• Purpose: Can you tell me in your own words what this project is all about? 
• Procedure: Can you tell me how many visits you are expected to complete? 
• Can you tell me how long a focus group will be? 
• Risks: Can you tell me if there are any risks in participating in the study? 
• Compensation: Can you tell me if there is any compensation? 

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• Confidentiality: Can you tell me how your records will be kept safe? 
• Withdrawal: Can you tell me if you can drop out of the study? 
• Summary: Do you have any questions or concerns about the study? 
• Can you tell me how to get questions answered by the Zambia Research 
Ethics Committee? 
Non-English Speaking Subjects 
• Participants enrolled will be both English-speaking and non-English speaking. 
Local languages in the Lusaka area are Bemba and Nyanja, and all study 
materials will be translated into local language(s) in addition to English. 
• Participants are in area are fluent in both Bemba and Nyanja, and all 
interventionists, group leaders, assessors and recruiters speak local language 
and English, enabling all participants to be enrolled, understand the materials. 
To ensure that the oral and written information provided to participants will be 
in their preferred language, and consent materials and assessment materials 
will be translated and back translated to local language.  
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
• N/A 
Subjects who are not yet adults (infants, children, teenagers) 
• N/A 
Cognitively Impaired Adults 
• Adults are eligible to enroll if they are able to understand the elements of the 
consent in the consent process.  
Adults Unable to Consent 
• Adults unable to provide consent will not be enrolled.  
33) 
Process to Document Consent in Writing 
• Consent will be documented in writing by signed or thumb print document on 
consent. Research presents no more than minimal risk of harm to subjects. 
• Consent – following ZAMBIAN standard format – is attached.  

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34) 
Drugs or Devices 
• N/A 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X