Prospective comparison of two models of integrating early infant male circumcision with maternal child health services in Kenya: The Mtoto Msafi Mbili Study.

As countries scale up adult voluntary medical male circumcision (VMMC) for HIV prevention, they are looking ahead to long term sustainable strategies, including introduction of early infant male circumcision (EIMC). To address the lack of evidence regarding introduction of EIMC services in sub-Saharan African settings, we conducted a simultaneous, prospective comparison of two models of EIMC service delivery in Homa Bay County, Kenya. In one division a standard delivery package (SDP) was introduced and included health facility-based provision of EIMC services with community engagement for client referral versus in a different division a standard package plus (SDPplus) that included community-delivered EIMC services. Babies 1-60 days old were eligible for EIMC. A representative sample of mothers and fathers of baby boys at 16 health facilities was surveyed. We examined differences between mothers and fathers in the SDP and SDPplus divisions and identified factors associated with EIMC uptake. We report adjusted prevalence ratios (aPR). Of 1660 mothers interviewed, 1501 (89%) gave approval to contact the father, and 1259 fathers (84%) were interviewed. The proportion of babies circumcised was slightly greater in the SDPplus division than the SDP division (27.3% vs 23.7%), but the difference was not significant (p = 0.08). In adjusted analyses, however, the prevalence of babies being circumcised was greater in the SDPplus division (aPR = 1.23, 95% CI:1.04-1.45) and the factors associated with a baby being circumcised were the mother having received information about EIMC (during pregnancy, aPR = 4.81, 95% CI: 2.21-3.42), having discussed circumcision with the father if married or cohabiting (aPR = 5.39, 95% CI: 3.31-8.80) or being single (aPR = 5.67, 95% CI: 3.31-9.69), perceiving herself to be living with HIV (aPR = 1.39, 95% CI: 1.15-1.67), or having a post-secondary education (aPR = 1.33, 95% CI: 1.04-1.69), and the father being Muslim (aPR = 1.85, 95% CI: 1.29-2.65) or circumcised (aPR = 1.34, 95% CI: 1.13-1.59). The median age of 2117 babies circumcised was 8 days (IQR: 1-36), and the median weight was 3.6 kg (IQR: 3.2-4.4). There were 6 moderate adverse events (AEs) (0.28%); 5 severe AEs (0.24%), all involving an injury to the glans penis, requiring hospitalization and corrective surgery; and one death probably related to the procedure. There were no AEs among the 365 procedures performed outside health facilities. Information and education campaigns must reach members of the general population, especially men and fathers, who are influential to the EIMC decision. Serious AEs using the Mogen clamp are rare, but do occur and require efficient, reliable emergency back-up. Our results can assist countries considering scale-up of EIMC services for HIV prevention as their adult VMMC programs mature.

Rapid reduction of maternal mortality in Uganda and Zambia through the saving mothers, giving life initiative: results of year 1 evaluation.

BACKGROUND: Achieving maternal mortality reduction as a development goal remains a major challenge in most low-resource countries. Saving Mothers, Giving Life (SMGL) is a multi-partner initiative designed to reduce maternal mortality rapidly in high mortality settings through community and facility evidence-based interventions and district-wide health systems strengthening that could reduce delays to appropriate obstetric care. METHODS: An evaluation employing multiple studies and data collection methods was used to compare baseline maternal outcomes to those during Year 1 in SMGL pilot districts in Uganda and Zambia. Studies include health facility assessments, pregnancy outcome monitoring, enhanced maternal mortality detection in facilities, and population-based investigation of community maternal deaths. Population-based evaluation used standard approaches and comparable indicators to measure outcome and impact, and to allow comparison of the SMGL implementation in unique country contexts. RESULTS: The evaluation found a 30% reduction in the population-based maternal mortality ratio (MMR) in Uganda during Year 1, from 452 to 316 per 100,000 live births. The MMR in health facilities declined by 35% in each country (from 534 to 345 in Uganda and from 310 to 202 in Zambia). The institutional delivery rate increased by 62% in Uganda and 35% in Zambia. The number of facilities providing emergency obstetric and newborn care (EmONC) rose from 10 to 25 in Uganda and from 7 to 11 in Zambia. Partial EmONC care became available in many more low and mid-level facilities. Cesarean section rates for all births increased by 23% in Uganda and 15% in Zambia. The proportion of women with childbirth complications delivered in EmONC facilities rose by 25% in Uganda and 23% in Zambia. Facility case fatality rates fell from 2.6 to 2.0% in Uganda and 3.1 to 2.0% in Zambia. CONCLUSIONS: Maternal mortality ratios fell significantly in one year in Uganda and Zambia following the introduction of the SMGL model. This model employed a comprehensive district system strengthening approach. The lessons learned from SMGL can inform policymakers and program managers in other low and middle income settings where similar approaches could be utilized to rapidly reduce preventable maternal deaths.

Factors Associated With Delayed Healing in a Study of the PrePex Device for Adult Male Circumcision in Kenya.

OBJECTIVES: To explore factors associated with healing requiring more than 6 weeks after placement of the PrePex device for adult medical male circumcision. METHODS: We enrolled 427 men ages 18-49 years in an observational study of PrePex at 1 urban and 2 peripheral clinics in western Kenya. Participants were scheduled for device removal at day 7 and a follow-up visit at day 42 (allowable range, 40-44) at which the provider recorded wound status, with complete healing defined as a dry wound without any scab, later confirmed by site investigator review of digital penile photographs. We performed univariate and multivariate logistic regression to explore associations between selected demographic, surgical, and follow-up factors and delayed healing (not healed by day 42 visit). RESULTS: Of the 427 men, 341 completing a day 42 visit with physical examination and recorded healing status were included. Fifty-four percent of included men were healed by day 42 visit. Factors associated with delayed healing in univariate analysis and remaining significant in the multivariate analysis were as follows: age 25 years or older [odds ratio (OR): 1.8; 95% confidence interval (CI): 1.4 to 2.4], an adverse event by day 44 (OR: 1.4; 95% CI: 1.03 to 2.0), and severe pain during device removal (protective association: OR: 0.7; 95% CI: 0.5 to 0.99). CONCLUSIONS: Older age (25+ years), occurrence of an adverse event, and lesser self-reported pain at device removal were associated with delayed wound healing. If confirmed by larger surveillance studies, these results should be incorporated into the counseling given to male circumcision clients.

Unexpected Complications Following Adult Medical Male Circumcision Using the PrePex Device.

INTRODUCTION: In this study, we describe and depict unexpected sequelae of adult medical male circumcision (MMC) using the PrePex device. MATERIALS AND METHODS: The PrePex system is an elastic compression device for adult MMC. The device is well studied, has been pre-qualified by the World Health Organization (WHO), and its use is being scaled-up in African countries targeted by WHO. We conducted a PrePex implementation study in routine service delivery among 427 men in the age range of 18-49 in western Kenya. We captured penile photographs to create a record of adverse events (AEs) and to monitor healing. Several unexpected AEs ensued, including some that have not been reported in other PrePex studies. We describe and depict those unexpected complications and resulting treatments to alert circumcision providers in the relevant areas. RESULTS: We observed 5 device displacements (1.2%); 3 cases of early sloughing of foreskin tissue (0.7%) among men with long foreskins; 2 cases of a long foreskin obstructing urine flow, as it became dry and necrotic (0.5%); and 2 cases of insufficient foreskin removal caused by invagination for which surgical completion was necessary (0.5%). All of the participants healed completely by day 42 post-circumcision or shortly thereafter. CONCLUSION: The potential for these complications should be incorporated into PrePex training programs. Integration of devices into MMC programs in medically underserved areas requires the availability of prompt surgical intervention for some sequelae, particularly displacement events.

Identifying and addressing barriers to uptake of voluntary medical male circumcision in Nyanza, Kenya among men 18-35: a qualitative study.

BACKGROUND: Uptake of VMMC among adult men has been lower than desired in Nyanza, Kenya. Previous research has identified several barriers to uptake but qualitative exploration of barriers is limited and evidence-informed interventions have not been fully developed. This study was conducted in 2012 to 1) increase understanding of barriers to VMMC and 2) to inform VMMC rollout through the identification of evidence-informed interventions among adult men at high risk of HIV in Nyanza Province, Kenya. METHODS: Focus groups (n = 8) and interviews were conducted with circumcised (n = 8) and uncircumcised men (n = 14) from the two districts in Nyanza, Kenya. Additional interviews were conducted with female partners (n = 20), health providers (n = 12), community leaders (n = 12) and employers (n = 12). Interview and focus group guides included questions about individual, interpersonal and societal barriers to VMMC uptake and ways to overcome them. Inductive thematic coding and analysis were conducted through a standard iterative process. RESULTS: Two primary concerns with VMMC emerged 1) financial issues including missing work, losing income during the procedure and healing and family survival during the recovery period and 2) fear of pain during and after the procedure. Key interventions to address financial concerns included: a food or cash transfer, education on saving and employer-based benefits. Interventions to address concerns about pain included refining the content of demand creation and counseling messages about pain and improving the ways these messages are delivered. CONCLUSIONS: Men need accurate and detailed information on what to expect during and after VMMC regarding both pain and time away from work. This information should be incorporated into demand creation activities for men considering circumcision. Media content should frankly and correctly address these concerns. Study findings support scale up and/or further improvement of these ongoing educational programs and specifically targeting the demand creation period.

Surgical efficiencies and quality in the performance of voluntary medical male circumcision (VMMC) procedures in Kenya, South Africa, Tanzania, and Zimbabwe.

INTRODUCTION: This analysis explores the association between elements of surgical efficiency in voluntary medical male circumcision (VMMC), quality of surgical technique, and the amount of time required to conduct VMMC procedures in actual field settings. Efficiency outcomes are defined in terms of the primary provider's time with the client (PPTC) and total elapsed operating time (TEOT). METHODS: Two serial cross-sectional surveys of VMMC sites were conducted in Kenya, Republic of South Africa, Tanzania and Zimbabwe in 2011 and 2012. Trained clinicians observed quality of surgical technique and timed 9 steps in the VMMC procedure. Four elements of efficiency (task-shifting, task-sharing [of suturing], rotation among multiple surgical beds, and use of electrocautery) and quality of surgical technique were assessed as explanatory variables. Mann Whitney and Kruskal Wallis tests were used in the bivariate analysis and linear regression models for the multivariate analyses to test the relationship between these five explanatory variables and two outcomes: PPTC and TEOT. The VMMC procedure TEOT and PPTC averaged 23-25 minutes and 6-15 minutes, respectively, across the four countries and two years. The data showed time savings from task-sharing in suturing and use of electrocautery in South Africa and Zimbabwe (where task-shifting is not authorized). After adjusting for confounders, results demonstrated that having a secondary provider complete suturing and use of electrocautery reduced PPTC. Factors related to TEOT varied by country and year, but task-sharing of suturing and/or electrocautery were significant in two countries. Quality of surgical technique was not significantly related to PPTC or TEOT, except for South Africa in 2012 where higher quality was associated with lower TEOT. CONCLUSIONS: SYMMACS data confirm the efficiency benefits of task-sharing of suturing and use of electrocautery for decreasing TEOT. Reduced TEOT and PPTC in high volume setting did not result in decreased quality of surgical care.

Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya.

OBJECTIVE: To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya. METHODS: We enrolled 427 men ages 18-49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs) and time to complete healing, and interviewed men about acceptability and pain. RESULTS: Placement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%-8.5%), all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%). Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30-0.58), and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family. CONCLUSIONS: The PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates. TRIAL REGISTRATION: ClinicalTrials.gov NCT01711411.

The PrePex device is unlikely to achieve cost-savings compared to the forceps-guided method in male circumcision programs in sub-Saharan Africa.

BACKGROUND: Male circumcision (MC) reduces the risk of heterosexual HIV acquisition in men by approximately 60%. MC programs for HIV prevention are currently being scaled-up in fourteen countries in sub-Saharan Africa. The current standard surgical technique for MC in many sub-Saharan African countries is the forceps-guided male circumcision (FGMC) method. The PrePex male circumcision (PMC) method could replace FGMC and potentially reduce MC programming costs. We compared the potential costs of introducing the PrePex device into MC programming to the cost of the forceps-guided method. METHODS: Data were obtained from the Nyanza Reproductive Health Society (NRHS), an MC service delivery organization in Kenya, and from the Kenya Ministry of Health. Analyses are based on 48,265 MC procedures performed in four Districts in western Kenya from 2009 through 2011. Data were entered into the WHO/UNAIDS Decision Makers Program Planning Tool. The tool assesses direct and indirect costs of MC programming. Various sensitivity analyses were performed. Costs were discounted at an annual rate of 6% and are presented in United States Dollars. RESULTS: Not including the costs of the PrePex device or referral costs for men with phimosis/tight foreskin, the costs of one MC surgery were $44.54-$49.02 and $54.52-$55.29 for PMC and FGMC, respectively. CONCLUSION: The PrePex device is unlikely to result in significant cost-savings in comparison to the forceps-guided method. MC programmers should target other aspects of the male circumcision minimum package for improved cost efficiency.

Safety of over twelve hundred infant male circumcisions using the Mogen clamp in Kenya.

BACKGROUND: Several sub-Saharan African countries plan to scale-up infant male circumcision (IMC) for cost-efficient HIV prevention. Little data exist about the safety of IMC in East and southern Africa. We calculated adverse event (AE) rate and risks for AEs associated with introduction of IMC services at five government health facilities in western Kenya. METHODS: AE data were analyzed for IMC procedures performed between September, 2009 and November, 2011. Healthy infants aged ≤ 2 months and weighing ≥ 2.5 kg were eligible for IMC. Following parental consent, trained clinicians provided IMC services free of charge under local anesthesia using the Mogen clamp. Odds ratios and 95% confidence intervals were used to explore AE risk factors. FINDINGS: A total of 1,239 IMC procedures were performed. Median age of infants was 4 days (IQR=1, 16). The overall AE rate among infants reviewed post-operatively was 2.7% (18/678; 95%CI: 1.4, 3.9). There was one severe AE involving excision of a small piece of the lateral aspect of the glans penis. Other AEs were mild or moderate and were treated conservatively. Babies one month of age or older were more likely to have an AE (OR 3.20; 95%CI: 1.23, 8.36). AE rate did not differ by nurse versus clinical officer or number of previous procedures performed. CONCLUSION: IMC services provided in Kenyan Government hospitals in the context of routine IMC programming have AE rates comparable to those in developed countries. The optimal time for IMC is within the first month of life.

Implementing voluntary medical male circumcision for HIV prevention in Nyanza Province, Kenya: lessons learned during the first year.

BACKGROUND: In 2007, the World Health Organization endorsed male circumcision as an effective HIV prevention strategy. In 2008, the Government of Kenya (GoK) launched the national voluntary medical male circumcision (VMMC) program in Nyanza Province, the geographic home to the Luo, the largest non-circumcising ethnic group in Kenya. Currently, several other African countries are in the early stages of implementing this intervention. METHODS AND RESULTS: This paper uses data from a health facility needs assessment (n = 81 facilities) and a study to evaluate the implementation of VMMC services in 16 GoK facilities (n = 2,675 VMMC clients) to describe Kenya's experience in implementing the national program. The needs assessment revealed that no health facility was prepared to offer the minimum package of services as outlined by the national guidelines, and partner organizations were called upon to fill this gap. The findings concerning human resource shortages facilitated the GoK's decision to endorse trained nurses to provide VMMCs, enabling more facilities to offer the service. Findings from the evaluation study resulted in replacing voluntary counseling and testing (VCT) with provider-initiated testing and counseling (PITC) and subsequently doubling the proportion of VMMC clients tested for HIV. CONCLUSIONS: This paper outlines how certain challenges, like human resource shortages and low HIV test rates, were addressed through national policy changes, while other challenges, like large fluctuations in demand, were addressed locally. Currently, the program requires significant support from partner organizations, but a strategic plan is under development to continue to build capacity in GoK staff and facilities. Coordination between all parties was essential and was facilitated through the formation of national, provincial, and district VMMC task forces. The lessons learned from Kenya's VMMC implementation experience are likely generalizable to other African countries.

The effect of community-based support services on clinical efficacy and health-related quality of life in HIV/AIDS patients in resource-limited settings in sub-Saharan Africa.

Antiretroviral therapy (ART) for HIV/AIDS in developing countries has been rapidly scaled up through directed public and private resources. Data on the efficacy of ART in developing countries are limited, as are operational research studies to determine the effect of selected nonmedical supportive care services on health outcomes in patients receiving ART. We report here on an investigation of the delivery of medical care combined with community-based supportive services for patients with HIV/AIDS in four resource-limited settings in sub-Saharan Africa, carried out between 2005 and 2007. The clinical and health-related quality of life (HRQOL) efficacy of ART combined with community support services was studied in a cohort of 377 HIV-infected patients followed for 18 months, in community-based clinics through patient interviews, clinical evaluations, and questionnaires. Patients exposed to community-based supportive services experienced a more rapid and greater overall increase in CD4 cell counts than unexposed patients. They also had higher levels of adherence, attributed primarily to exposure to home-based care services. In addition, patients receiving home-based care and/or food support services showed greater improvements in selected health-related QOL indicators. This report discusses the feasibility of effective ART in a large number of patients in resource-limited settings and the added value of concomitant community-based supportive care services.