Search

Introduction: Reaching men aged 20-35 years, the group at greatest risk of HIV, with voluntary medical male circumcision (VMMC) remains a challenge. We assessed the impact of two VMMC demand creation approaches targeting this age group in a randomised controlled trial (RCT)., Methods: We conducted a 2×2 factorial RCT comparing arms with and without two interventions: (1) standard demand creation augmented by human-centred design (HCD)-informed approach; (2) standard demand creation plus offer of HIV self-testing (HIVST). Interpersonal communication (IPC) agents were the unit of randomisation. We observed implementation of demand creation over 6 months (1 May to 31 October 2018), with number of men circumcised assessed over 7 months. The primary outcome was the number of men circumcised per IPC agent using the as-treated population of actual number of months each IPC agent worked. We conducted a mixed-methods process evaluation within the RCT., Results: We randomised 140 IPC agents, 35 in each arm. 132/140 (94.3%) attended study training and 105/132 (79.5%) reached at least one client during the trial period and were included in final analysis. There was no evidence that the HCD-informed intervention increased VMMC uptake versus no HCD-informed intervention (incident rate ratio (IRR) 0.87, 95% CI 0.38 to 2.02; p=0.75). Nor did offering men a HIVST kit at time of VMMC mobilisation (IRR 0.65, 95% CI 0.28 to 1.50; p=0.31). Among IPC agents that reported reaching at least one man with demand creation, both the HCD-informed intervention and HIVST were deemed useful. There were some challenges with trial implementation; <50% of IPC agents converted any men to VMMC, which undermined our ability to show an effect of demand creation and may reflect acceptability and feasibility of the interventions., Conclusion: This RCT did not show evidence of an effect of HCD-informed demand intervention or HIVST on VMMC uptake. Findings will inform future design and implementation of demand creation evaluations., Trial Registration Number: PACTR201804003064160., Competing Interests: Competing interests: None declared., (©World Health Organization 2021. Licensee BMJ.)

Background: Supply and demand-side factors continue to undermine voluntary medical male circumcision (VMMC) uptake. We assessed relative economic costs of four VMMC demand creation/service-delivery modalities as part of a randomised controlled trial in Zimbabwe., Methods: Interpersonal communication agents were trained and incentivised to generate VMMC demand across five districts using four demand creation modalities (standard demand creation (SDC), demand creation plus offer of HIV self-testing (HIVST), human-centred design (HCD)-informed approach, HCD-informed demand creation approach plus offer of HIVST). Annual provider financial expenditure analysis and activity-based-costing including time-and-motion analysis across 15 purposively selected sites accounted for financial expenditures and donated inputs from other programmes and funders. Sites represented three models of VMMC service-delivery: static (fixed) model offering VMMC continuously to walk-in clients at district hospitals and serving as a district hub for integrated mobile and outreach services, (2) integrated (mobile) modelwhere staff move from the district static (fixed) site with their commodities to supplement existing services or to recently capacitated health facilities, intermittently and (3) mobile/outreach model offering VMMC through mobile clinic services in more remote sites., Results: Total programme cost was $752 585 including VMMC service-delivery costs and average cost per client reached and cost per circumcision were $58 and $174, respectively. Highest costs per client reached were in the HCD arm-$68 and lowest costs in standard demand creation ($52) and HIVST ($55) arms, respectively. Highest cost per client circumcised was observed in the arm where HIVST and HCD were combined ($226) and the lowest in the HCD alone arm ($160). Across the three VMMC service-delivery models, unit cost was lowest in static (fixed) model ($54) and highest in integrated mobile model ($63). Overall, economies of scale were evident with unit costs lower in sites with higher numbers of clients reached and circumcised., Conclusions: There was high variability in unit costs across arms and sites suggesting opportunities for cost reductions. Highest costs were observed in the HCD+HIVST arm when combined with an integrated service-delivery setting. Mobilisation programmes that intensively target higher conversion rates as exhibited in the SDC and HCD arms provide greater scope for efficiency by spreading costs., Trial Registration Number: PACTR201804003064160., Competing Interests: Competing interests: None declared., (©World Health Organization 2021. Licensee BMJ.)

PrePex™ (Circ MedTech Ltd., Tortola, British Virgin Islands) devices are being evaluated in several countries for scale-up of medical male circumcision (MMC) as an HIV prevention intervention. Health care workers' perceptions should be considered prior to scale-up. A cross-sectional open-ended questionnaire was administered to health care workers from nine MMC programs in South Africa that provided either PrePex™ and surgical circumcision (mixed sites) or surgical circumcision only (surgery-only sites). A total of 77 health care workers (37 at mixed sites and 40 at surgery-only sites) with median ages of 29 years (interquartile range 27-37) and 34 years (interquartile range 29-42), respectively, were recruited into the study. The perceived benefits of PrePex™ MMC for health care workers were: device simplicity, convenience, bloodless, and ease of use. Identified challenges included limited public knowledge of device, pain, smell of necrotic skin, and delayed healing. Health care providers perceived the PrePex™ MMC device to be simple and adaptable for existing MMC programs., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Fourteen countries in East and Southern Africa have engaged in national programs to accelerate the provision of voluntary medical male circumcision (VMMC) since 2007. Devices have the potential to accelerate VMMC programs by making the procedure easier, quicker, more efficient, and widely accessible., Methods: Pilot Implementation studies were conducted in Mozambique, South Africa, and Zambia. The primary objective of the studies was to assess the safety of PrePex device procedures when conducted by nurses and clinical officers in adults and adolescent males (13-17 years, South Africa only) with the following end points: number and grade of adverse events (AEs); pain-related AEs measured using visual analog score; device displacements/self-removals; time to complete wound healing; and procedure times for device placement and removal., Results: A total of 1401 participants (1318 adult and 83 adolescent males) were circumcised using the PrePex device across the 3 studies. Rates of moderate/severe AEs were low (1.0%; 2.0%; and 2.8%) in the studies in Mozambique, Zambia, and South Africa, respectively. Eight early self-removals of 1401 (0.6%) were observed, all required corrective surgery. High rates of moderate/severe pain-related AEs were recorded especially at device removal in South Africa (34.9%) and Mozambique (59.5%). Ninety percent of participants were healed at day 56 postplacement., Discussion: The study results from the 3 countries suggest that the implementation of the PrePex device using nonphysician health care workers is both safe and feasible, but better pain control at device removal needs to be put in place to increase the comfort of VMMC clients using the PrePex device.

Background: The PrePex medical male circumcision (MMC) device has been approved for MMC scale-up. However, the WHO has recommended that a country-specific situation analysis should be carried out before MMC device rollout., Method: A cross-sectional survey was conducted over 12 months in 3 MMC clinics, by trained nurses and researchers, to ascertain attitudes toward PrePex MMC in 3 groups: men consenting for PrePex MMC (PrePex recipients), people accompanying men, and adolescents coming for either PrePex or surgical circumcision (MMC escorts) and men refusing the PrePex device MMC (PrePex rejecters). All participants received information on surgical and the PrePex device MMC methods., Results: A total of 312 PrePex recipients, 117 MMC escorts, and 21 PrePex rejecters were recruited into the study. Ninety-nine percent of PrePex recipients thought that their expectations (safe, convenient, minimal pain) were met, and they were pleased with cosmetic outcome. Fifty-nine percent of PrePex rejecters opted for surgical circumcision because they perceived PrePex to be novel and risky. All 3 groups of participants were concerned about odor, dead skin, discomfort, healing time, and wound care. Ninety-eight percent of MMC escorts, 99% of PrePex recipient, and 81% of PrePex rejecters perceived PrePex circumcision as an acceptable option for South African MMC programmes., Conclusions: This acceptability study suggests that PrePex MMC is considered safe and convenient and could be incorporated into existing MMC programmes. Concerns about odor, pain, wound care, and healing time suggest that the need for more research to further optimize methods and that MMC clients should be counseled on available methods to enable them to choose among options based on their preferences.

Background: Several circumcision devices have been evaluated for a safe and simplified male circumcision among adults. The PrePex device was prequalified for voluntary male medical circumcision (VMMC) in May 2013 by the World Health Organization and is expected to simplify the procedure safely while reducing cost. South Africa is scaling up VMMC., Objective: To evaluate the overall unit cost of VMMC at a mixed site vs. a hypothetical PrePex-only site in South Africa., Design: We evaluated the overall unit cost of VMMC at a mixed site where PrePex VMMC procedure was added to routine forceps-guided scalpel-based VMMC in Soweto, South Africa. We abstracted costs and then modeled these costs for a hypothetical PrePex-only site, at which 9,600 PrePex circumcisions per year could be done. We examined cost drivers and modeled costs, varying the price of the PrePex device. The healthcare system perspective was used., Results: In both sites, the main contributors of cost were personnel and consumables. If 10% of all VMMC were by PrePex at the mixed site, the overall costs of the surgical method and PrePex were similar - US$59.62 and $59.53, respectively. At the hypothetical PrePex-only site, the unit cost was US$51.10 with PrePex circumcisions having markedly lower personnel and biohazardous waste management costs. In sensitivity analysis with the cost of PrePex kit reduced to US$10 and $2, the cost of VMMC was further reduced., Conclusions: Adding PrePex to an existing site did not necessarily reduce the overall costs of VMMC. However, starting a new PrePex-only site is feasible and may significantly reduce the overall cost by lowering both personnel and capital costs, thus being cost-effective in the long term. Achieving a lower cost for PrePex will be an important contributor to the scale-up of VMMC.

Background: The World Health Organisation and the Joint United Nations Programme on HIV/AIDS have recommended the scale-up of Medical Male Circumcision (MMC) in countries with high HIV and low MMC prevalence. PrePex device circumcision is proposed as an alternate method for scaling up MMC., Objective: Evaluate safety and feasibility of PrePex in South Africa., Design: A multisite prospective cohort PrePex study in adults and adolescents at three MMC clinics. Participants were followed-up 8 times, up to 56 days after PrePex placement., Results: In total, 398 PrePex circumcisions were performed (315 adults and 83 adolescents) their median ages were 26 (IQR: 22-30) and 16 years (IQR: 15-17), respectively. The median time for device placement across both groups was 6 minutes (IQR: 5-9) with the leading PrePex sizes being B (30%) and C (35%) for adults (18-45 years), and A (31%) and B (38%) for adolescents (14-17 years). Additional sizes (size 12-20) were rarely used, even in the younger age group. Pain of device application was minimal but that of removal was severe. However, described pain abated rapidly and almost no pain was reported 1 hour after removal. The Adverse Events rate were experienced by 2.7% (11/398) of all participants, three of which were serious (2 displacements and 1 self-removal requiring prompt surgery). None of the Adverse Events required hospitalization. The majority of participants returned to work within a day of device placement., Conclusion: Our study shows that PrePex is a safe MMC method, for males 14 years and above. PrePex circumcision had a similar adverse event rate to that reported for surgical MMC, but device removal caused high levels of pain, which subsided rapidly.

Background: We conducted quantitative and qualitative studies to explore barriers and motivating factors to VMMC for HIV prevention, and to assess utilization of existing VMMC communication channels., Methods and Findings: A population-based survey was conducted with 2350 respondents aged 15-49. Analysis consisted of descriptive statistics and bivariate analysis between circumcision and selected demographics. Logistic regression was used to determine predictors of male circumcision uptake compared to intention to circumcise. Focus group discussions (FGDs) were held with men purposively selected to represent a range of ethnicities. 68% and 53% of female/male respondents, respectively, had heard about VMMC for HIV prevention, mostly through the radio (71%). Among male respondents, 11.3% reported being circumcised and 49% reported willingness to undergo VMMC. Factors which men reported motivated them to undergo VMMC included HIV/STI prevention (44%), improved hygiene (26%), enhanced sexual performance (6%) and cervical cancer prevention for partner (6%). Factors that deterred men from undergoing VMMC included fear of pain (40%), not believing that they were at risk of HIV (18%), lack of partner support (6%). Additionally, there were differences in motivators and barriers by age. FGDs suggested additional barriers including fear of HIV testing, partner refusal, reluctance to abstain from sex and myths and misconceptions., Conclusions: VMMC demand-creation messages need to be specifically tailored for different ages and should emphasize non-HIV prevention benefits, such as improved hygiene and sexual appeal, and need to address men's fear of pain. Promoting VMMC among women is crucial as they appear to have considerable influence over men's decision to get circumcised.