Early Infant Male Circumcision Decisions in Zambia: Demographic and Familial Influences.

Public health initiatives in Zambia encourage the uptake of early infant male circumcision (EIMC) as an HIV prevention strategy. This study assessed EIMC parental decision-making during perinatal care in Lusaka, Zambia, focusing on the influence of sociodemographic factors, family, and friends. A longitudinal pilot perinatal intervention, Like Father Like Son (LFLS), was implemented among 300 couples attending antenatal clinics in four urban community health centers. Participants were assessed postpartum regarding subsequent EIMC decisions. Partners, religion, and marital status were associated with the EIMC decision-making. Large scale EIMC promotion interventions that target both parents during perinatal care should be explored.

Factors influencing neonatal male circumcision uptake among expecting couples in Zambia: formative findings.

Male circumcision is a protective HIV prevention strategy. However, uncircumcised Zambian men are reluctant to undergo voluntary medical male circumcision (VMMC). Tailored interventions are necessary to stimulate the uptake of early infant male circumcision (EIMC) and VMMC in Zambia. This feasibility study presents the formative process of utilising the PRECEDE framework in the development of a family-centred EIMC/VMMC intervention, Like Father Like Son, and its application in an existing VMMC intervention, Spear & Shield. We found that fear of the pain associated with EIMC procedures, foreskin disposal, beliefs in children's autonomy and rights, and men's dominance in health decision-making were factors affecting EIMC uptake. Perceived benefits for infants included improved hygiene, protection from HIV infection, and faster recovery. Reinforcing factors included female partners and fathers' MC status. The availability and access to EIMC services and information, skill and experience of health workers, and engagement and belief in traditional circumcision practices were factors enabling EIMC uptake. These individual, interpersonal, and structural factors positively and negatively influencing EIMC uptake in the Zambian clinic context were integrated into the intervention for expecting parents. Feedback from community advisory boards suggested the process was effective in developing a culturally tailored and acceptable EIMC/VMMC promotion intervention.

Zambian Parents' Perspectives on Early-Infant Versus Early-Adolescent Male Circumcision.

Despite increasing interest in Early-Infant and Early-Adolescent Medical Circumcision (EIMC and EAMC, respectively) in Zambia, parental willingness to have their sons undergo the procedure has not been explored. This study describes Zambian parents' perspectives on EIMC and EAMC. A total of N = 600 men and women (n = 300 couples) were recruited. Most parents, 89% and 83%, planned to have their newborn or adolescent sons circumcised, respectively, and 70% and 57% had plans for EIMC and EAMC, respectively. Most (91% for infants and 86% for adolescents) reported they were considering the pros and cons of circumcision. Parents' age (OR 1.05), having children living in one's home (OR 3.58), and lower education (OR 0.63) were associated with sons' circumcision. The minimal risks associated with circumcision and the lifetime benefits conferred underscore its contribution to public health in high HIV prevalence areas.

RESUMEN: A pesar del creciente interés en la Circuncisión Médica Temprana de Niños y Adolescentes (EIMC y EAMC, respectivamente, por su siglas en ingles) en Zambia, no se ha explorado la voluntad de los padres, de dar consentimiento, para que sus hijos se sometan al procedimiento. Este studio, describe las perspectivas de los padres de Zambia sobre EIMC y EAMC. Se reclutaron un total de N = 600 hombres y mujeres (n = 300 parejas) que esperaban tener un hijo. La mayoría de los padres, 89% y 83%, planeaban circuncidar a sus hijos recién nacidos o adolescentes, respectivamente, y 70% y 57% tenían planes para EIMC y EAMC, respectivamente. La mayoría (91% para bebés y 86% para adolescentes) informaron que estaban considerando las ventajas y desventajas de la circuncisión. La edad de los padres (OR 1,05), tener hijos viviendo en el hogar (OR 3,58) y menor educación (OR 0,63) se asociaron con la circuncisión de los hijos. Los riesgos mínimos asociados con la circuncisión y los beneficios conferidos de por vida subrayan su contribución a la salud pública en áreas de alta prevalencia del VIH.

Female Partner Acceptance as a Predictor of Men's Readiness to Undergo Voluntary Medical Male Circumcision in Zambia: The Spear and Shield Project.

The World Health Organization has recommended the scale-up of voluntary medical male circumcision (VMMC) for HIV prevention in sub-Saharan Africa; however, men are often uninterested in undergoing VMMC. The Spear & Shield project enrolled 668 men and female partners from ten Zambian community health centers into parallel interventions promoting VMMC for HIV prevention or time-matched control conditions. A mediation model was utilized to examine the relationships between changes in women's acceptance of VMMC and men's readiness to undergo the procedure. Results demonstrated that, at 12 months post-intervention, a 5.9 % increase in the likelihood of undergoing VMMC among men in the experimental condition could be attributed to increased women's acceptance. From a public health perspective, involving women in VMMC promotion interventions such as the Spear & Shield project could significantly impact the demand for VMMC in Zambia.

Stages of Change for Voluntary Medical Male Circumcision and Sexual Risk Behavior in Uncircumcised Zambian Men: The Spear and Shield Project.

BACKGROUND: Dissemination and scale up of voluntary medical male circumcision (VMMC) programs is well supported by evidence that VMMC reduces HIV risk in populations with high HIV prevalence and low rates of circumcision, as is the case in Zambia. PURPOSE: At both individual and population levels, it is important to understand what stages of change for VMMC are associated with, especially across cultures. This study evaluated VMMC knowledge, misinformation, and stages of change for VMMC of uncircumcised men and boys (over 18 years), as well as the concurrent relationship between VMMC stages of change and sexual risk behaviors. METHOD: Uncircumcised (N = 800) adult men and boys (over 18) were screened and recruited from urban community health centers in Lusaka, Zambia, where they then completed baseline surveys assessing knowledge, attitudes, HIV risk behaviors, and stages of change for VMMC. A series of analyses explored cross-sectional relationships among these variables. RESULTS: VMMC was culturally acceptable in half of the sample; younger, unmarried, and more educated men were more ready to undergo VMMC. Stage of change for VMMC was also related to knowledge, and those at greater HIV risk reported greater readiness to undergo VMMC. CONCLUSIONS: Efforts to increase VMMC uptake should address the role of perceived HIV risk, risk behaviors, readiness, accurate knowledge, cultural acceptance, and understanding of the significant degree of HIV protection conferred as part of the VMMC decision making process. These results support incorporating comprehensive HIV risk reduction in VMMC promotion programs.

Acceptability, knowledge, beliefs, and partners as determinants of Zambian men's readiness to undergo medical male circumcision.

There is limited information about the influence of partners on medical male circumcision (MMC) uptake. This study aimed to evaluate attitudes, knowledge, and preferences about MMC among men and their partners, and their relative impact on male readiness to undergo the MMC procedure. Male participants (n = 354) and their partners (n = 273) were recruited from community health centers in Lusaka, Zambia. Men reported their readiness to undergo MMC, and both men and women were assessed regarding their attitudes and knowledge regarding MMC. Men who had discussed MMC with their partners, those who endorsed MMC for HIV risk reduction, and those viewing MMC as culturally acceptable reported increased readiness to undergo MMC. Additionally, endorsement of MMC by female partners was associated with increased men's readiness. Results support promotion of cultural acceptability of MMC, and efforts to increase MMC uptake may benefit from incorporating partners in the decision making process.

Dissemination and implementation of an evidence-based voluntary medical male circumcision program: The Spear & Shield program.

Despite compelling evidence linking voluntary medical male circumcision (VMMC) with 60-70% HIV risk reduction in sub-Saharan Africa, Zambian men have been especially reluctant to undergo VMMC. The Government of Zambia set targets for VMMC uptake and promoted community-level interventions. Spear & Shield (S&S) is an innovative, evidence-based, service program promoting VMMC uptake while ensuring both VMMC supply and demand. This study assessed the large-scale provincial rollout of the program (S&S2) utilizing the RE-AIM model for translating interventions into the community. The S&S2 study was conducted between November 2015 and December 2020, and sequentially rolled out over four Zambian provinces in 96 clinics; 24 observation clinics received VMMC training only. Local clinic healthcare workers were trained to conduct the VMMC procedure and HIV counselors were trained to lead S&S group sessions. Using the RE-AIM model, primary outcomes were: Reach, the number, proportion, and representativeness of S&S attendees; Effectiveness, the impact of S&S2 on VMMC uptake; Adoption, the number, proportion, and representativeness of clinics implementing S&S2; Implementation, fidelity to the S&S intervention manual; and Maintenance, the extent to which S&S2 became an element of standard care within community clinics. Initially, n = 109 clinics were recruited; 96 were sustained and randomized for activation (Adoption). A total of 45,630 clinic patients (n = 23,236 men and n = 22,394 women) volunteered to attend the S&S sessions (Reach). The S&S2 program ran over 2,866 clinic-months (Implementation). Although the study did not target individual-level VMMCs, ~58,301 additional VMMCs were conducted at the clinic level (Effectiveness). Fidelity to the S&S intervention by group leaders ranged from 42%-95%. Sustainability of the program was operationalized as the number of CHCs initially activated that sustained the program. Intervention delivery ended, however, when study funding ceased (Maintenance). The S&S2 program successfully utilized the RE-AIM model to achieve study goals for implementation and dissemination in four Zambian provinces. Innovative VMMC programs such as S&S2 can improve the uptake of VMMC, one of the most effective strategies in the HIV prevention arsenal.

Increasing early infant male circumcision uptake in Zambia: Like father like son.

Voluntary Medical Male Circumcision (VMMC) is an effective strategy for HIV prevention in areas with high prevalence of, and risk for, HIV. More than 361,000 male neonates are born each year in Zambia, many of whom could be eligible for Early-Infant Medical Circumcision (EIMC). Building on successful implementation strategies utilized in our Spear & Shield program, this pilot study, "Like Father, Like Son" (LFLS), evaluated the feasibility and acceptability of offering combined EIMC and VMMC services and couple-level behavioral interventions. A total of N = 702 pregnant women and their male partners (n = 351 couples) were recruited and enrolled. Couples were assessed twice pre-birth, 2 weeks post birth, and 6 months post birth. Expectant mothers were an average of 15.05 weeks pregnant (SD = 8.83). Thirty-nine pregnancies did not result in a live birth (11%), 14 couples withdrew from the study or were lost to follow-up prior to delivery (4%), and 148 babies were born female (42%), leaving 150 couples with a male infant in the analytic sample (43%). The LFLS study achieved significantly higher EIMC rates (35%) in comparison with previously observed EIMC study rates in Zambia (11%), and significantly higher than hypothetical comparison rates up to 30%. Relative to baseline rates, odds of VMMC among couples' older sons increased by 31% at post-intervention and by 90% at two-weeks following birth. Overall, this pilot study found the LFLS intervention to be feasible, acceptable, and effective in doubling the rate of EIMC in comparison with a previous longitudinal study in Zambia. Future research should consider a family-centric approach to promotion of male circumcision for infants and adolescents. LFLS may be effective in promoting father-son "bonding" by MC status; a bond that may be a bridge to increase both EIMC and VMMC uptake in newborns and couples' older sons and is a novel leverage point for promotion of this HIV prevention strategy.

Dissemination of the Spear & Shield Project using a Training of Trainers Model: A reflection on challenges and successes.

Several large-scale clinical trials have conclusively demonstrated that voluntary medical male circumcision (VMMC) could provide a 50%-70% reduction in HIV acquisition, but willingness to undergo VMMC has been lowest in Zambia compared to other countries in eastern and southern Africa. This manuscript describes training for "task-shifting" among local healthcare workers at Community Health Centers (CHCs) applying state of the art strategies (e.g., Training of Trainers, i.e., ToT, and Training of Facilitators, ToF) to provide novel clinical services. Staff at 96 CHCs from four Provinces in Zambia were sequentially trained to provide the Spear & Shield intervention. A total of 45,630 men (n = 23,236) and women (n = 22,394) volunteered to participate in the S&S intervention service program when offered in the CHCs. Group session (total = 5313 sessions; 2,736 men's and 2,582 women's sessions) were conducted over 4.5 years. Remarkably, both men and women's groups achieved 97% retention. Of these, 256 sessions recorded from 128 group leaders were assessed and scored for intervention fidelity; fidelity was 80%-90% among the majority of clinics. S&S program sustainment exceeded expectations among 85% of clinics (82/96) in all provinces across the duration of the study. Of note, attendance in the S&S program was encouraged by CHC staff, but no financial incentives were provided to those attending S&S. This study examined the effectiveness of the ToT/ToF model in dissemination of the S&S program, which proved to be feasible even in resource-limited settings. Benefits and challenges are discussed.

Understanding surgical education needs in Zambian residency programs from a Resident's perspective.

INTRODUCTION: Approximately 100 surgeons in Zambia serve a population of 16 million, a severe shortage in basic surgical care. Surgical education in Zambia and other low-middle income countries has not been well characterized. The aim of this study was to evaluate surgical training resources from a resident perspective. METHODS: 6 of 8 COSECSA-accredited major medical centers were included. We developed a Surgical Education Capacity Tool to evaluate hospital characteristics including infrastructure, education, and research. The questionnaire was completed by administrators and trainees. RESULTS: 18 of 45 trainees were surveyed. Caseloads and faculty-to-trainee ratio varied by location. No sites had surgical skills, simulation, or research labs. Most had medical libraries, lecture halls, and internet. Outpatient clinics, bedside teaching, M&M conferences, and senior supervision were widely available. Despite some exposure, research mentorship, basic science, and grant application guidance were critically limited. CONCLUSIONS: Lack of access to proper infrastructure, research, and personnel all impact surgical training and education. The Surgical Education Capacity Tool offers insights into areas of potential improvement, and is applicable to other LMICs.

Identifying factors associated with successful implementation and uptake of an evidence-based voluntary medical male circumcision program in Zambia: the Spear and Shield 2 Program.

Voluntary medical male circumcision has been shown to provide a 50%-70% reduction in the risk of HIV infection without contributing to behavioral disinhibition of safer sexual practices. This study examined the interim implementation and dissemination data of Spear and Shield 2, an HIV risk-reduction program in Zambia. The purpose of this interim review was to identify contextual challenges to implementation and implement midcourse corrections associated with sustainability of program delivery. Using a mixed-methods design, quantitative evaluations of organizational functioning, barriers to implementation, burnout, and organizational readiness, as well as qualitative data utilizing the Consolidated Framework for Implementation Research (CFIR), were examined to evaluate program implementation. Participants were 184 health care providers from 46 clinics in Zambia. Successful implementation was associated with better community and leader support, and employee readiness and motivation. Quantitative assessments were not related to implementation and provided a limited picture of implementation outcomes. Results suggest that the qualitative data underlying the CFIR constructs provided a nuanced, contextual assessment of implementation, and dissemination outcomes. The CFIR may be valuable in informing the implementation of evidence-based interventions in other parts of Zambia.

HIV Prevention among Zambian Itinerant Workers: Challenges and Solutions.

Mobility and alcohol abuse increase vulnerability to HIV among itinerants in Zambia. Itinerants face unique challenges to accessing HIV counselling, testing, and treatment. Zambian districts (Chingola, Mazabuka, Mufulira) were selected, and focus group discussions (FGDs = 12; n= 72) and key informant interviews (n = 71) were held. HIV risk and strategies to address barriers and facilitators of condom use, voluntary counselling and testing (VCT) and HIV-treatment were explored. Mobility increased sexual networks. Local bars, lodges, and truck stops were locations for sexual solicitation. Cheap lodgings were hot spots for HIV risk behavior. Difficulty accessing condoms and HIV treatment due to transience placed itinerants at elevated risk. Lack of clinics in rural areas further exacerbated itinerant risk. Initiatives to reduce these risks included implementation of border-clinics and employer-driven medical support for itinerants. Uptake of HIV prevention tools, health-education initiatives supporting itinerants, as well as health-care initiatives tailored to itinerant needs, are needed.

Increasing acceptability and uptake of voluntary male medical circumcision in Zambia: implementing and disseminating an evidence-based intervention.

Voluntary medical male circumcision (VMMC) uptake in Africa could prevent 3.4 million HIV infections across a 10 year span. In Zambia, however, ~80 per cent of uncircumcised men report no interest in undergoing VMMC. The Spear & Shield (S&S) intervention has been shown to be more effective than control or observation of only conditions at increasing the number of VMMCs. This study identified predictors of S&S implementation success or failure to create an "early warning" system to enable remedial action during implementation. Participants were n = 48 staff members from 12 community health facilities conducting the S&S program in Lusaka Province, Zambia. Quantitative assessments included demographics, provider attitudes, barriers to research uptake, staff burnout, and organizational readiness. Qualitative interviews were also conducted and quantified for analysis using the Consolidated Framework for Implementation Research (CFIR). Two-thirds (66%) of staff were women with a mean age of 37.67 years (SD = 7.51). Quantitatively, staff performance (p = .033) and decreased levels of staff burnout (p = .025) were associated with S&S implementation success. Qualitatively, constructs such as improved planning, executing, and self-reflection and evaluation were associated with S&S implementation success (p = .005). Identifying these factors facilitated remedial action across health facilities. This study illustrates the utility of the CFIR to guide program decision making in VMMC implementation in the Zambian context. Early identification of challenges to implementation may enable remedial action to enhance the likelihood of program sustainability. Effective monitoring strategies for HIV prevention interventions may thus enhance dissemination, implementation, and sustainability goals to bridge research and practice.

Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes.

OBJECTIVES: To assess the safety, effectiveness, and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia. METHODS: We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing. RESULTS: Four hundred and ninety-six men comprised the analysis population, with 255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were completely healed at the scheduled day 42 healing check visit, with similar percentages across study arms. Virtually all (99.6%) men, regardless of study arm, stated that they were very satisfied or satisfied with the appearance of their circumcised penis, and 98.6% stated that they would recommend ShangRing circumcision to family/friends. CONCLUSIONS: The moderate/severe AE rate was low and similar in the 2 study arms, suggesting that provision of one-half the number of adult device sizes is sufficient for safe service delivery. Effectiveness, time to healing, and acceptability were similar in the study arms. The simplicity of the ShangRing technique, and its relative speed, could facilitate VMMC program goals. In addition, sufficiency of fewer device sizes would simplify logistics and inventory.

Surgical Outcomes of Newly Trained ShangRing Circumcision Providers.

BACKGROUND: Devices can potentially accelerate scale-up of voluntary medical male circumcision in sub-Saharan Africa. Studies have demonstrated advantages of the ShangRing device over conventional circumcision. With the need to train providers rapidly for scale-up, concerns arise about the transferability of techniques and the expertise of new trainees. METHODS: We compared outcomes of ShangRing circumcisions conducted in Kenya by experienced providers (experience with more than 100 ShangRing circumcisions) and newly trained providers (trained in Kenya by the experienced providers before the study began). During training, trainees performed at least 7 ShangRing circumcisions and 3 removals. Newly trained providers received intermittent clinical mentoring initially during the study but otherwise conducted circumcisions on their own. RESULTS: Four hundred six and 115 ShangRing procedures were performed by the new trainees and the experienced providers, respectively. The mean duration of circumcisions was 6.2 minutes for both trained and experienced provider groups (P = 0.45), whereas the mean pain score (on an 11-point scale) was 2.5 and 3.2, respectively (P = 0.65). There was no difference in the proportion of participants healed by the day 42 visit (P = 0.13) nor in the incidence of moderate and severe adverse events observed (P = 0.16). Participants in both groups were equally satisfied with final wound cosmesis. DISCUSSION: Results demonstrate that the ShangRing circumcision technique is easy to learn and master. Newly trained providers can safely conduct ShangRing circumcisions in routine service settings. The ShangRing can facilitate rapid rollout of voluntary medical male circumcision for HIV prevention in sub-Saharan Africa.

Men's Understanding of and Experiences During the Postcircumcision Abstinence Period: Results From a Field Study of ShangRing Circumcision During Routine Clinical Services in Kenya and Zambia.

BACKGROUND: Men's understanding of counseling messages after voluntary medical male circumcision (VMMC) plays an important role in whether they follow them. Data on triggers for early resumption of sex may be useful as scale-up of VMMC for HIV prevention continues in sub-Saharan Africa. METHODS: Data on understanding of post-VMMC abstinence recommendations, resumption of sex, condom use, and triggers for resuming sex were collected from participants during a follow-up interview 35-42 days after ShangRing circumcision in Kenya and Zambia. RESULTS: Of 1149 men who had ShangRing circumcision, 1096 (95.4%) completed follow-up. Nearly all (99.2%) reported being counseled to abstain from sex post-VMMC; among those, most (92.2%) recalled the recommended abstinence period was 6 weeks. Most men (94.1%) reported that the counselor gave reasons for post-VMMC abstinence and recalled appropriate reasons. Few (13.4%) men reported resuming sex at 35-42 days' follow-up. Among those, 54.8% reported never using a condom post-VMMC. Younger participants (odds ratio 0.3, 95% confidence interval: 0.2 to 0.5, P < 0.0001) and those reporting at least some condom use at baseline (odds ratio 0.5, 95% confidence interval: 0.3 to 0.7, P = 0.0003) were less likely to report resuming sex. Among men who reported some condom use, most (71.5%) said condoms were much easier or easier to use after circumcision. Men reported various reasons for early resumption of sex, primarily strong sexual desire (76.4%). CONCLUSIONS: Most men reported awareness of and adherence to the counseling recommendations for post-VMMC abstinence. A minority reported early resumption of sex, and, among those, condom use was low. Results could be used to improve post-VMMC counseling.

Sexual Satisfaction, Performance, and Partner Response Following Voluntary Medical Male Circumcision in Zambia: The Spear and Shield Project.

BACKGROUND: Voluntary medical male circumcision (VMMC) is an important HIV prevention strategy, particularly in regions with high HIV incidence and low rates of male circumcision. However, 88% of the Zambian male population remain uncircumcised, and of these 80% of men surveyed expressed little interest in undergoing VMMC. METHODS: The Spear and Shield study (consisting of 4 weekly, 90-minute sexual risk reduction/VMMC promotion sessions) recruited and enrolled men (N = 800) who self-identified as at risk of HIV by seeking HIV testing and counseling at community health centers. Eligible men tested HIV-negative, were uncircumcised, and expressed no interest in VMMC. Participants were encouraged (but not required) to invite their female partners (N = 668) to participate in the program in a gender-concordant intervention matched to their partners'. Men completed assessments at baseline, post-intervention (about 2 months after baseline), and 6 and 12 months post-intervention; women completed assessments at baseline and post-intervention. For those men who underwent VMMC and for their partners, an additional assessment was conducted 3 months following the VMMC. The ancillary analysis in this article compared the pre- and post-VMMC responses of the 257 Zambian men who underwent circumcision during or following study participation, using growth curve analyses, as well as of the 159 female partners. RESULTS: Men were satisfied overall with the procedure (mean satisfaction score, 8.4 out of 10), and nearly all men (96%) and women (94%) stated they would recommend VMMC to others. Approximately half of the men reported an increase or no change in erections, orgasms, and time to achieve orgasms from pre-VMMC, while one-third indicated fewer erections and orgasms and decreased time to achieve orgasms post-VMMC. Nearly half (42%) of the men, and a greater proportion (63%) of the female partners, said their sexual pleasure increased while 22% of the men reported less sexual pleasure post-VMMC. Growth curve analysis of changes in sexual functioning and satisfaction over time revealed no changes in erectile functioning or intercourse satisfaction, but there were increases in orgasm functioning, overall sexual satisfaction, and sexual desire. The majority (61% to 70%) of men and women thought penile cleanliness and appearance had improved post-VMMC. Of the 69% of men who reported having sexual intercourse at least once between having the procedure and their 3-month post-VMMC assessment, the large majority (76%) waited at least 6 weeks before resuming sex. Sexual intercourse prior to the 6-week healing period was associated with adverse events and lower levels of post-VMMC sexual satisfaction. CONCLUSION: Both men and their partners can generally expect equal or improved sexual satisfaction and penile hygiene following VMMC. Future studies should consider innovative strategies to assist men in their efforts to abstain from sexual activities prior to complete healing.

The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial.

BACKGROUND: Widespread voluntary medical male circumcision in Africa could avert an estimated 3·436 million HIV infections and 300,000 deaths over the next 10 years. Most Zambian men have expressed little interest in the procedure. We tested the effect of the Spear and Shield intervention designed to increase demand for voluntary medical male circumcision among these hard-to-reach men. METHODS: This cluster randomised controlled trial was done between Feb 1, 2012, and Oct 31, 2014, in Lusaka, Zambia, where HIV prevalence is 20·8%. 13 community health centres were stratified by HIV voluntary counselling and testing rates and patient census, and randomly assigned (5:5:3) to experimental (the intervention), control, or observation-only conditions. Community health centre health-care providers at all 13 sites received training in voluntary medical male circumcision. Eligible participants were aged at least 18 years, HIV-negative, uncircumcised, and had not proactively requested or planned for voluntary medical male circumcision at the time of enrolment. Trial statisticians did not participate in randomisation. After voluntary counselling and HIV testing, participants were recruited; female partners were invited to participate. The primary outcomes at the individual level were the likelihood of voluntary medical male circumcision by 12 months post-intervention, and condom use after voluntary medical male circumcision among participants receiving the intervention. The trial is registered with ClinicalTrials.gov, number NCT01688167. FINDINGS: 800 uncircumcised HIV-negative men (400 in the experimental group, 400 in the control group) were enrolled. 161 participants in the experimental group and 96 in the control group had voluntary medical male circumcision (adjusted odds ratio 2·45, 95% CI 1·24-4·90; p=0·02). Condom use was examined in participants who had voluntary medical male circumcision and reported sexual activity within 1 month of a post-circumcision assessment (88 in the experimental group and 64 in the control group). Condom use over time increased in the experimental group (p=0·03) but not in the control group (p=0·2). One patient died in each group; no adverse events related to study participation were reported. INTERPRETATION: Comprehensive HIV prevention programmes can increase the demand for and uptake of voluntary medical male circumcision services. FUNDING: US National Institutes of Health/National Institute of Mental Health (R01MH095539).

Field study of adult male circumcision using the ShangRing in routine clinical settings in Kenya and Zambia.

BACKGROUND: Circumcision devices can facilitate adult voluntary medical male circumcision programs for HIV prevention. The World Health Organization recommends field studies to confirm the safety of devices in local settings. METHODS: We evaluated the safety of the ShangRing device in routine service delivery by measuring adverse event (AE) rates overall and by HIV status. We enrolled men aged 18-54 years and scheduled them for 2 post-circumcision follow-up visits at day 7 for device removal and days 35-42. Men were examined to document AEs and healing and to ascertain client acceptability. Provider preferences were also assessed. RESULTS: We enrolled 1163 men (557 in Kenya and 606 in Zambia); the as-treated analysis population comprised 1149 men, including 84 HIV-positive men. There were no serious AEs and 2 severe AEs: 1 severe wound dehiscence and 1 severe pain, both of which resolved with treatment. There were 18 moderate/severe AEs among 16 men (1.4% of men; 95% confidence interval: 0.8% to 2.3%). The most common AE was wound dehiscence (9 men, 0.8%). Healing was similar between HIV-infected and uninfected men, with 85.7% and 87.3% completely healed at days 35-42. Most men (94.8%) were very satisfied with post-circumcision appearance of the penis, and almost all would recommend a ShangRing procedure. Nineteen of 21 providers preferred the ShangRing over conventional surgery. CONCLUSIONS: The ShangRing has an excellent safety profile with few hemorrhagic and infectious complications. The ShangRing is well accepted by clients and preferred by providers, making it a potential boon to the scale-up of adult voluntary medical male circumcision in African countries.

Randomized controlled trial of the shang ring versus conventional surgical techniques for adult male circumcision: safety and acceptability.

OBJECTIVE: To compare clinical profiles of Shang Ring versus conventional circumcisions. DESIGN: Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites. METHODS: We enrolled HIV-negative men aged 18-54 years in Homa Bay, Kenya, and Lusaka, Zambia and followed them at 2, 7, 14, 21, 28, 42, and 60 days after Shang Ring versus conventional circumcision. We compared the duration of surgery, postoperative pain using a visual analog scale, adverse events rates, time to complete wound healing by clinical assessment, participant acceptability, and provider preferences between circumcision groups. RESULTS: We randomized 200 men to each group; 197 and 201 contributed to the Shang Ring and conventional surgery analyses, respectively. Adverse event rates were similar between groups. Pain scores at most time points were similar, however, the Shang Ring group reported higher scores for worst pain during erections (3.5 ± 1.9 vs. 2.3 ± 1.7; P < 0.001). Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision (MC), 95.7% versus 85.9% (P = 0.02) in Kenya, and 96.8% versus 71.3% (P < 0.01) in Zambia. Although median time to complete wound healing was 43 days in both groups, conventional circumcisions healed on average 5.2 days sooner (P < 0.001). Shang Ring procedures took one-third the time of conventional MC, 7 versus 20 minutes. All circumcision providers preferred the Shang Ring. CONCLUSIONS: Safety profiles of the 2 techniques were similar, all MC providers preferred the Shang Ring technique, and study participants preferred the Shang Ring's cosmetic results. The Shang Ring should be considered for adult MC as programs scale-up.