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Nationally representative surveys provide an opportunity to assess trends in recent human immunodeficiency virus (HIV) infection based on assays for recent HIV infection. We assessed HIV incidence in Kenya in 2018 and trends in recent HIV infection among adolescents and adults in Kenya using nationally representative household surveys conducted in 2007, 2012, and 2018. To assess trends, we defined a recent HIV infection testing algorithm (RITA) that classified as recently infected (<12 months) those HIV-positive participants that were recent on the HIV-1 limiting antigen (LAg)-avidity assay without evidence of antiretroviral use. We assessed factors associated with recent and long-term (≥12 months) HIV infection versus no infection using a multinomial logit model while accounting for complex survey design. Of 1,523 HIV-positive participants in 2018, 11 were classified as recent. Annual HIV incidence was 0.14% in 2018 [95% confidence interval (CI) 0.057-0.23], representing 35,900 (95% CI 16,300-55,600) new infections per year in Kenya among persons aged 15-64 years. The percentage of HIV infections that were determined to be recent was similar in 2007 and 2012 but fell significantly from 2012 to 2018 [adjusted odds ratio (aOR) = 0.31, p  < .001]. Compared to no HIV infection, being aged 25-34 versus 35-64 years (aOR = 4.2, 95% CI 1.4-13), having more lifetime sex partners (aOR = 5.2, 95% CI 1.6-17 for 2-3 partners and aOR = 8.6, 95% CI 2.8-26 for ≥4 partners vs. 0-1 partners), and never having tested for HIV (aOR = 4.1, 95% CI 1.5-11) were independently associated with recent HIV infection. Although HIV remains a public health priority in Kenya, HIV incidence estimates and trends in recent HIV infection support a significant decrease in new HIV infections from 2012 to 2018, a period of rapid expansion in HIV diagnosis, prevention, and treatment.

People who inject drugs (PWID) living with Hepatitis C (HCV) in low- and middle-income countries face substantial barriers to HCV care. We sought to gain healthcare providers' perspectives on challenges and best practices for HCV care provision among PWID in Kenya. We conducted three focus group discussions (FGD) with 23 healthcare providers working with PWID living with HCV in Nairobi and Mombasa. Transcribed interviews were analysed thematically. Overarching themes regarding HCV prevention and treatment were: (1) lack of HCV-related knowledge at the provider and patient levels; (2) stigmatisation of people living with HCV and PWID; and (3) difficulties among PWID with navigating the healthcare system. Some providers suggested systematically integrating HCV care into existing PWID-specific harm reduction programs to improve HCV care provision as well as creating national HCV guidelines to guide clinicians. This study highlights the need for national HCV treatment guidelines and increased public HCV education, as well as culturally sensitive models integrating HCV care into programs PWID are already accessing. These strategies will be useful in improving access to HCV care among PWID and has the potential to decrease HCV transmission and prevalence among this vulnerable population.

Background: People who inject drugs are at an increased risk for contracting SARS-CoV-2 and have experienced barriers to accessing harm reduction services during the COVID-19 pandemic. Understanding how to best provide these services is essential for COVID-19 mitigation. The goal of this study was to ascertain challenges and successes for caring for people who inject drugs in Kenya during the COVID-19 pandemic., Methods: We conducted focus group discussions and one-on-one key informant interviews with healthcare providers who work with people who inject drugs in Kenya. Interviews explored how COVID-19 and social distancing measures impacted service provision, as well as what strategies were used to overcome these barriers. We used thematic analysis to analyze transcribed interviews., Results: Participants included 29 service providers from 11 healthcare professions at three medication assisted treatment (MAT) and four drop-in center (DIC) sites (N=15 males and N=14 females, with an average age of 35 years). Four overarching themes emerged in our thematic analysis in which providers described both barriers to providing care and solutions to overcome them: (1) COVID-19-related misconceptions; (2) Limited COVID-19 testing and screening; (3) Structural changes related to service provision; and (4) Access to material resources such as meals, needle and syringe program kits, and personal protective equipment., Conclusions: Our findings demonstrate the COVID-19 pandemic-imposed challenges for substance use disorder treatment providers and patients, however with ingenuity many of these challenges were able to be overcome., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022. Published by Elsevier B.V.)

Despite disproportionately high rates of Hepatitis C (HCV) among people who inject drugs (PWID) in low- and middle-income countries (LMICs), understanding of HCV-related knowledge, attitudes and perceived risk behaviours among this population remains limited. We aimed to elucidate knowledge, attitudes and experiences that could minimise transmission risk and maximise HCV treatment engagement among PWID in Kenya following the integration of HCV screening and education with needle and syringe programmes in drop-in-centres (DICs). We recruited 40 PWID with chronic HCV attending DICs in Nairobi and Coastal Kenya. Semi-structured interviews revealed a general understanding of HCV and awareness of HCV risk behaviours among participants; however, many felt limited control over their transmission risk due to factors such as 'local doctors', or individuals who perform a high volume of high-risk injections. Financial barriers, distance to clinic, poor health status and HCV-related stigma were all noted as barriers to HCV treatment. In conclusion, basic knowledge of and motivation for HCV treatment among PWID accessing DICs in Kenya was high; however, structural barriers and stigma complicate access to care. Local education programmes can address knowledge gaps, and behavioural and structural interventions can maximise the impact of HCV care in LMICs.

Background and Aims: Hepatitis C virus (HCV) treatment is essential for eliminating HCV in people who inject drugs (PWID), but has limited coverage in resource-limited settings. We measured the cost-effectiveness of a pilot HCV screening and treatment intervention using directly observed therapy among PWID attending harm reduction services in Nairobi, Kenya., Design: We utilized an existing model of HIV and HCV transmission among current and former PWID in Nairobi to estimate the cost-effectiveness of screening and treatment for HCV, including prevention benefits versus no screening and treatment. The cure rate of treatment and costs for screening and treatment were estimated from intervention data, while other model parameters were derived from literature. Cost-effectiveness was evaluated over a life-time horizon from the health-care provider's perspective. One-way and probabilistic sensitivity analyses were performed., Setting: Nairobi, Kenya., Population: PWID., Measurements: Treatment costs, incremental cost-effectiveness ratio (cost per disability-adjusted life year averted)., Findings: The cost per disability-adjusted life-year averted for the intervention was $975, with 92.1% of the probabilistic sensitivity analyses simulations falling below the per capita gross domestic product for Kenya ($1509; commonly used as a suitable threshold for determining whether an intervention is cost-effective). However, the intervention was not cost-effective at the opportunity cost-based cost-effectiveness threshold of $647 per disability-adjusted life-year averted. Sensitivity analyses showed that the intervention could provide more value for money by including modelled estimates for HCV disease care costs, assuming lower drug prices ($75 instead of $728 per course) and excluding directly-observed therapy costs., Conclusions: The current strategy of screening and treatment for hepatitis C virus (HCV) among people who inject drugs in Nairobi is likely to be highly cost-effective with currently available cheaper drug prices, if directly-observed therapy is not used and HCV disease care costs are accounted for., (© 2021 Society for the Study of Addiction.)

Introduction: Targeted, tailored interventions to test high-risk individuals for HIV and hepatitis C virus (HCV) are vital to achieving HIV control and HCV microelimination in Africa. Compared with the general population, people who inject drugs (PWID) are at increased risk of HIV and HCV and are less likely to be tested or successfully treated. Assisted partner services (APS) increases HIV testing among partners of people living with HIV and improves case finding and linkage to care. We describe a study in Kenya examining whether APS can be adapted to find, test and link to HIV care the partners of HIV-positive PWID using a network of community-embedded peer educators (PEs). Our study also identifies HCV-positive partners and uses phylogenetic analysis to determine risk factors for onward transmission of both viruses., Methods: This prospective cohort study leverages a network of PEs to identify 1000 HIV-positive PWID for enrolment as index participants. Each index completes a questionnaire and provides names and contact information of all sexual and injecting partners during the previous 3 years. PEs then use a stepwise locator protocol to engage partners in the community and bring them to study sites for enrolment, questionnaire completion and rapid HIV and HCV testing. Outcomes include number and type of partners per index who are mentioned, enrolled, tested, diagnosed with HIV and HCV and linked to care., Ethics and Dissemination: Potential index participants are screened for intimate partner violence (IPV) and those at high risk are not eligible to enrol. Those at medium risk are monitored for IPV following enrolment. A community advisory board engages in feedback and discussion between the community and the research team. A safety monitoring board discusses study progress and reviews data, including IPV monitoring data. Dissemination plans include presentations at quarterly Ministry of Health meetings, local and international conferences and publications., Trial Registration Number: NCT03447210, Pre-results stage., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Despite a doubling of HIV testing coverage in Kenya over the past decade, approximately 2 in 10 people with HIV remained unaware of their infection in 2018. HIV testing is most effective in identifying people with undiagnosed HIV through frequent and strategic testing in populations at high risk. An assessment of testing frequency and predictors of first-time and repeat testing is critical for monitoring effectiveness of testing strategies., Methods: We conducted a cross-sectional analysis of adults aged ≥18 years who tested HIV-positive at 4 HIV testing and counseling clinics in Kenya from February 2015 to February 2016. We categorized individuals based on testing history, used Wilcoxon rank-sum tests to assess differences in intervals between the most recent and current HIV test, and used log-binomial regression to determine characteristics associated with first-time and repeat testing., Results: Among 1136 people testing HIV-positive, 336 (30%) had never tested before and 800 (70%) had, of whom 208 (26%) had previously tested positive. Among previously negative repeat testers, the median intertest interval was 414 days in key/priority populations (interquartile range = 179-1072) vs. 538 in the general population (interquartile range = 228-1299) (P = 0.09). Compared with previously negative repeat testers, being a first-time tester was associated with being age ≥40 years [vs. 18-24; adjusted risk ratio = 1.67, 95% confidence interval (CI): 1.23 to 2.26], men (vs. women; adjusted risk ratio = 1.45, 95% CI: 1.21 to 1.71), and testing through provider-initiated testing and counseling (vs. client initiated; 1.19, 95% CI: 1.00 to 1.40)., Conclusions: There is a need to increase HIV testing among older individuals and men, increase testing frequency in key/priority populations, and maintain provider-initiated and facility-based testing to reach first-time testers.

Introduction: Human immunodeficiency virus (HIV) assisted partner services (aPS) has been recommended as a strategy to increase HIV case finding. We evaluated factors associated with poor linkage to HIV care among newly diagnosed HIV-positive individuals (index clients) and their partners after receiving aPS in Kenya., Methods: In a cluster randomized trial conducted between 2013 and 2015, 9 facilities were randomized to immediate aPS (intervention). Linkage to care-defined as HIV clinic registration, and antiretroviral therapy (ART) initiation were self-reported. Antiretroviral therapy was only offered to those with CD4 less than 500 during this period. We estimated linkage to care and ART initiation separately for index clients and their partners using log-binomial generalized estimating equation models with exchangeable correlation structure and robust standard errors., Results: Overall, 550 index clients and 621 sex partners enrolled, of whom 46% (284 of 621) were HIV-positive. Of the 284, 264 (93%) sex partners returned at 6 weeks: 120 newly diagnosed and 144 whom had known HIV-positive status. Among the 120 newly diagnosed, only 69% (83) linked to care at 6 weeks, whereas among the 18 known HIV-positive sex partners not already in care at baseline, 61% (11) linked. Newly diagnosed HIV-positive sex partners who were younger and single were less likely to link to care (P < 0.05 for all)., Conclusion: Only two thirds of newly diagnosed, and known HIV-positive sex partners not in care linked to care after receiving aPS. The HIV aPS programs should optimize HIV care for newly diagnosed HIV-positive sex partners, especially those who are younger and single.

Estimating incidence from cross-sectional data sources is both important to the understanding of the HIV epidemic and challenging from a methodological standpoint. We develop a new incidence estimator that measures the size of the undiagnosed population and the amount of time spent undiagnosed in order to infer incidence and transmission rates. The estimator is calculated using commonly collected information on testing history and HIV status and, thus, can be deployed in many HIV surveys without additional cost. If ART biomarker status and/or viral load information is available, the estimator can be adjusted for biases in self-reported testing history. The performance of the estimator is explored in two large surveys in Kenya, where we find our point estimates to be consistent with assay-derived estimates, with much smaller standard errors., Competing Interests: Ian Fellows is employed by the commercial entity Fellows Statistics. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Use of routine HIV programme data for surveillance is often limited due to inaccuracies associated with patient misclassification which can be addressed by unique patient identification.We assessed the feasibility and acceptability of integrating an iris recognition biometric identification system into routine HIV care services at 4 sites in Kenya., Methods: Patients who had recently tested HIV-positive or were engaged in care were enrolled. Images of the iris were captured using a dual-iris camera connected to a laptop. A prototype iris biometric identification system networked across the sites, analysed the iris patterns; created a template from those patterns; and generated a 12-digit ID number based on the template. During subsequent visits, the patients' irises were re-scanned, and the pattern was matched to stored templates to retrieve the ID number., Results: Over 55 weeks 8,614 (98%) of 8,794 new patients were assigned a unique ID on their first visit. Among 6,078 return visits, the system correctly re-identified patients' IDs 5,234 times (86%). The false match rate (a new patient given the ID of another patient) was 0·5% while the generalized false reject rate (re-scans assigned a new ID) was 4·7%. Overall, 9 (0·1%) agreed to enrol but declined to have an iris scan. The most common reasons cited for declining an iris scan were concerns about privacy and confidentiality., Conclusion: Implementation of an iris recognition system in routine health information systems is feasible and highly acceptable as part of routine care in Kenya. Scale-up could improve unique patient identification and tracking, enhancing disease surveillance activities., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Cascades have been used to characterize sequential steps within a complex health system and are used in diverse disease areas and across prevention, testing, and treatment. Routine data have great potential to inform prioritization within a system, but are often inaccessible to frontline health care workers (HCWs) who may have the greatest opportunity to innovate health system improvement., Methods: The cascade analysis tool (CAT) is an Excel-based, simple simulation model with an optimization function. It identifies the step within a cascade that could most improve the system. The original CAT was developed for HIV treatment and the prevention of mother-to-child transmission of HIV., Results: CAT has been adapted 7 times: to a mobile application for prevention of mother-to-child transmission; for hypertension screening and management and for mental health outpatient services in Mozambique; for pediatric and adolescent HIV testing and treatment, HIV testing in family planning, and cervical cancer screening and treatment in Kenya; and for naloxone distribution and opioid overdose reversal in the United States. The main domains of adaptation have been technical-estimating denominators and structuring steps to be binary sequential steps-as well as logistical-identifying acceptable approaches for data abstraction and aggregation, and not overburdening HCW., Discussion: CAT allows for prompt feedback to HCWs, increases HCW autonomy, and allows managers to allocate resources and time in an equitable manner. CAT is an effective, feasible, and acceptable implementation strategy to prioritize areas most requiring improvement within complex health systems, although adaptations are being currently evaluated.

Background: Sub-Saharan Africa has a large population of people with hepatitis C virus (HCV) infection, yet little is known about HCV among people who inject drugs this region. We assessed the prevalence of HCV mono-infection and HIV-HCV co-infection, and the estimated incidence, genotypes, and risk behaviours associated with HCV among people who inject drugs in Kenya., Methods: People aged 18 years or older who were living in Nairobi, coastal Kenya, or western Kenya, had a history of injection drug use, and had used any illicit drugs in the past 12 months were recruited at needle and syringe programme sites using respondent-driven sampling. Participants were screened for the presence of an anti-HCV antibody. Those who were anti-HCV positive underwent confirmatory HCV RNA testing, and those with detectable HCV RNA were genotyped. Participants were interviewed regarding parenteral risk behaviours and exposure to services received at the needle and syringe programme sites. We examined correlates of HCV infection and HIV-HCV co-infection using bivariate and multivariate regression, and estimated HCV incidence., Findings: Of 2188 enrolled participants, 291 (13%) were anti-HCV positive: 183 (22%) of 842 participants in coastal Kenya, 105 (13%) of 817 in Nairobi, and three (1%) of 529 in western Kenya. 284 anti-HCV-positive participants underwent successful HCV RNA testing, of whom 230 (81%) were viraemic. Estimated incidence rates of anti-HCV positivity per 100 person-years were 6·31 in coastal Kenya, 3·19 in Nairobi, and 0·22 in western Kenya. HCV incidence rate was greater in coastal Kenya compared with Nairobi (incidence rate ratio 1·97 [95% CI 1·35-2·93], p=0·0001) and the western region (28·17 [7·55-236·58], p<0·0001). In the coastal region, history of incarceration, more years injecting, more injections in the past month, and receptive cooker sharing were associated with increased risk of HCV, while female sex, more years injecting, more injections in the past month, and regular use of a syringe with a detachable needle were associated with HCV risk in Nairobi. HCV prevalence among HIV-positive participants was 50% (66 of 131 participants) in coastal Kenya, 35% (42 of 121) in Nairobi, and 4% (one of 23) in western Kenya. Risk factors for HIV-HCV co-infection were similar to those observed for HCV mono-infection. The prevailing genotypes were 1a (51%), 4a (47%), and mixed (2%; three 1a/4a and one 1a/2b)., Interpretation: HCV prevalence, estimated incidence, and risk behaviours among people who inject drugs in Kenya vary with region, with the highest estimated incidence observed in coastal Kenya. These findings should be used to inform focused strategies to reduce HCV transmission, such as expansion of needle and syringe programmes, upscaling of opioid agonist therapy, and treatment as prevention in regions affected by injection drug use and HCV., Funding: National Institute on Drug Abuse., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Purpose of Review: The aim of this review is to examine the emerging results from the HIV universal test and treat (UTT) cluster-randomized trials in sub-Saharan Africa, discuss how expanding access to HIV clinical services is likely to reshape the arc of HIV epidemics, and consider implications for HIV prevention and control strategies in the coming decade., Recent Findings: The effect of universal HIV testing followed by immediate antiretroviral treatment (ART) on community-level HIV incidence remains unclear upon completion of five randomized trials. Only two of the four trials that measured HIV incidence found significant reductions in community-level incidence. Even in these trials, HIV incidence remained above levels required for epidemic control (≤1 case per 1000 person-years) despite high levels of ART coverage and viral suppression. These findings may indicate that community-delivered HIV services are not reaching the high-frequency transmitters who sustain HIV epidemics and are likely members of marginalized or hard to engage core groups., Summary: With expanded access to HIV services in sub-Saharan Africa, HIV epidemics are transitioning from hyperendemic to declining/endemic epidemic phases, characterized increasingly by the reconcentration of HIV in marginalized or hard to engage core groups. To move toward epidemic control, novel HIV service delivery models and technologies are needed to engage those who continue to drive HIV incidence in this new epidemic phase.

Background While advances have been made in HIV prevention and treatment, new HIV infections continue to occur. The introduction of pre-exposure prophylaxis (PrEP) as an additional HIV prevention option for those at high risk of HIV may change the landscape of the HIV epidemic, especially in sub-Saharan Africa, which bears the greatest HIV burden., Methods: This paper details Kenya's experience of PrEP rollout as a national public sector program. The process of a national rollout of PrEP guidance, partnerships, challenges, lessons learnt and progress related to national scale up of PrEP in Kenya, as of 2018, is described. National rollout of PrEP was strongly lead by the government, and work was executed through a multidisciplinary, multi-organisation dedicated team. This required reviewing available evidence, providing guidance to health providers, integration into existing logistic and health information systems, robust communication and community engagement. Mapping of the response showed that subnational levels had existing infrastructure but required targeted resources to catalyse PrEP provision. Rollout scenarios were developed and adopted, with prioritisation of 19 counties focusing on high incidence area and high potential PrEP users to maximise impact and minimise costs., Results: PrEP is now offered in over 900 facilities countrywide. There are currently over 14000 PrEP users 1 year after launching PrEP., Conclusions: Kenya becomes the first African country to rollout PrEP as a national program, in the public sector. This case study will provide guidance for low- and middle-income countries planning the rollout of PrEP in response to both generalised and concentrated epidemics.

Background: HIV assisted partner services (APS) are a notification and testing strategy for sex partners of HIV-infected index patients. This cluster-randomized controlled trial secondary data analysis investigated whether history of intimate partner violence (IPV) modified APS effectiveness and risk of relationship dissolution., Setting: Eighteen HIV testing and counseling sites in Kenya randomized to provide immediate APS (intervention) or APS delayed for 6 weeks (control)., Methods: History of IPV was ascertained at study enrollment and defined as reporting ever experiencing physical or sexual IPV. Those reporting IPV in the month before enrollment were excluded. We tested whether history of IPV modified intervention effectiveness and risk of relationship dissolution using population-averaged Poisson and log-binomial generalized estimating equation models. Exploratory analyses investigated associations between history of IPV and events that occurred after HIV diagnosis using log-binomial generalized estimating equation models., Results: The study enrolled 1119 index participants and 1286 partners. Among index participants, 81 (7%) had history of IPV. History of IPV did not modify APS effectiveness in testing, newly diagnosing, or linking partners to care. History of IPV did not modify the association between receiving immediate APS and relationship dissolution during the study., Conclusions: Among participants who had not experienced IPV in the last month but had experienced IPV in their lifetimes, our results suggest that APS is an effective and safe partner notification strategy in Kenya. As APS is scaled up in different contexts, these data support including those reporting past IPV and closely monitoring adverse events.

Background: Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya., Objective: The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention., Methods: The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming., Results: The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake., Conclusions: The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings., Trial Registration: ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54)., (©Jasmine Buttolph, Irene Inwani, Kawango Agot, Charles M Cleland, Peter Cherutich, James N Kiarie, Alfred Osoti, Connie L Celum, Jared M Baeten, Ruth Nduati, John Kinuthia, Timothy B Hallett, Ramzi Alsallaq, Ann E Kurth. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.03.2017.)

Assisted partner services (APS) are more effective than passive referral in identifying new cases of HIV in many settings. Understanding the barriers to the uptake of APS in sub-Saharan Africa is important before its scale up. In this qualitative study, we explored client, community, and healthcare worker barriers to APS within a cluster randomized trial of APS in Kenya. We conducted 20 in-depth interviews with clients who declined enrollment in the APS study and 9 focus group discussions with health advisors, HIV testing and counseling (HTC) counselors, and the general HTC client population. Two analysts coded the data using an open coding approach and identified major themes and subthemes. Many participants reported needing more time to process an HIV-positive result before providing partner information. Lack of trust in the HTC counselor led many to fear a breach of confidentiality, which exacerbated the fears of stigma in the community and relationship conflicts. The type of relationship affected the decision to provide partner information, and the lack of understanding of APS at the community level contributed to the discomfort in enrolling in the study. Establishing trust between the client and HTC counselor may increase uptake of APS in Kenya. A client's decision to provide partner information may depend on the type of relationship he or she is in, and alternative methods of disclosure may need to be offered to accommodate different contexts. Spreading awareness about APS in the community may make clients more comfortable providing partner information., Competing Interests: Author Disclosure Statement No competing financial interests exist.

Background: The utilization of routine health information systems (HIS) for surveillance of assisted partner services (aPS) for HIV in sub-Saharan is sub-optimal, in part due to poor data quality and limited use of information technology. Consequently, little is known about coverage, scope and quality of HIV aPS. Yet, affordable electronic data tools, software and data transmission infrastructure are now widely accessible in sub-Saharan Africa., Methods: We designed and implemented a cased-based surveillance system using the HIV testing platform in 18 health facilities in Kenya. The components of this system included an electronic HIV Testing and Counseling (HTC) intake form, data transmission on the Global Systems for Mobile Communication (GSM), and data collection using the Open Data Kit (ODK) platform. We defined rates of new HIV diagnoses, and characterized HIV-infected cases. We also determined the proportion of clients who reported testing for HIV because a) they were notified by a sexual partner b) they were notified by a health provider, or c) they were informed of exposure by another other source. Data collection times were evaluated., Results: Among 4351 clients, HIV prevalence was 14.2 %, ranging from 4.4-25.4 % across facilities. Regardless of other reasons for testing, only 107 (2.5 %) of all participants reported testing after being notified by a health provider or sexual partner. A similar proportion, 1.8 % (79 of 4351), reported partner notification as the only reason for seeking an HIV test. Among 79 clients who reported HIV partner services as the reason for testing, the majority (78.5 %), were notified by their sexual partners. The majority (52.8 %) of HIV-infected patients initiated their HIV testing, and 57.2 % tested in a Voluntary Counseling and Testing (VCT) site co-located in a health facility. Median time for data capture was 4 min (IQR: 3-15), with a longer duration for HIV-infected participants, and there was no reported data loss., Conclusion: aPS surveillance using new technologies is feasible, and could be readily expanded into HIV registries in Kenya and other sub-Saharan countries. Partner services are under-utilized in Kenya but further documentation of coverage and implementation gaps for HIV and aPS services is required.

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.

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., (© 2015 S. Karger AG, Basel.)

Objective: HIV infection in sub-Saharan Africa increasingly occurs among people who inject drugs (PWID). Kenya is one of the first to implement a national needle and syringe program. Our study undertook a baseline assessment as part of evaluating needle and syringe program in a seek, test, treat, and retain approach., Methods: Participants enrolled between May and December 2012 from 10 sites. Respondent-driven sampling was used to reach 1785 PWID for HIV-1 prevalence and viral load determination and survey data., Results: Estimated HIV prevalence, adjusted for differential network size and recruitment relationships, was 14.5% in Nairobi (95% CI: 10.8 to 18.2) and 20.5% in the Coast region (95% CI: 17.3 to 23.6). Viral load (log10 transformed) in Nairobi ranged from 1.71 to 6.12 (median: 4.41; interquartile range: 3.51-4.94) and in the Coast from 1.71 to 5.88 (median: 4.01; interquartile range: 3.44-4.72). Using log10 viral load 2.6 as a threshold for HIV viral suppression, the percentage of HIV-infected participants with viral suppression was 4.2% in Nairobi and 4.6% in the Coast. Heroin was the most commonly injected drug in both regions, used by 93% of participants in the past month, typically injecting 2-3 times/day. Receptive needle/syringe sharing at last injection was more common in Nairobi (23%) than in the Coast (4%). Estimated incidence among new injectors was 2.5/100 person-years in Nairobi and 1.6/100 person-years in the Coast., Conclusions: The HIV epidemic is well established among PWID in both Nairobi and Coast regions. Public health scale implementation of combination HIV prevention has the potential to greatly limit the epidemic in this vulnerable and bridging population.

Background: More than 4.7 million voluntary medical male circumcisions (VMMCs) had been provided by HIV prevention programs in sub-Saharan Africa through 2013. All VMMC clients are recommended to return to the clinic for postoperative follow-up, although adherence is variable. The clinical status of clients who do not return is largely unknown., Methods: VMMC clients from Nyanza Province, Kenya, aged older than or equal to 13 years, were recruited immediately after surgery from April to October 2012 from high-volume sites. Medical record reviews at 13-14 days after surgery indicated which clients had been adherent with recommended follow-up (ADFU) and which were lost-to-follow-up (LTFU). Clients in the LTFU group received clinical evaluations at home approximately 2 weeks postsurgery. Adverse events (AEs) and AE rates were compared between the ADFU and LTFU groups., Results: Of 4504 males approached in 50 VMMC sites, 1699 (37.7%) were eligible and enrolled and 1600 of 1699 (94.2%) contributed to follow-up and AE data. Medical record review indicated 897 of 1600 (56.1%) were LTFU, and 762 (84.9%) of these received home-based clinical evaluations. The rate of moderate or severe AE diagnosis was 6.8% in the LTFU group vs. 3.3% in the ADFU group (relative risk = 2.1, 95% confidence interval: 1.3 to 3.4)., Conclusions: The moderate or severe AE diagnosis rate was approximately 2 times higher in the LTFU group. National programs should consider instituting surveillance systems to detect AEs that might otherwise go unnoticed. Providers should emphasize the importance of follow-up and actively contact LTFU clients to ensure care is provided throughout the entire postoperative course for all.

Background: The rapid expansion of voluntary medical male circumcision (VMMC) has raised concerns whether health systems can deliver and sustain VMMC according to minimum quality criteria., Methods and Findings: A comparative process evaluation was used to examine data from SYMMACS, the Systematic Monitoring of the Voluntary Medical Male Circumcision Scale-Up, among health facilities providing VMMC across two years of program scale-up. Site-level assessments examined the availability of guidelines, supplies and equipment, infection control, and continuity of care services. Direct observation of VMMC surgeries were used to assess care quality. Two sample tests of proportions and t-tests were used to examine differences in the percent of facilities meeting requisite preparedness standards and the mean number of directly-observed surgical tasks performed correctly. Results showed that safe, high quality VMMC can be implemented and sustained at-scale, although substantial variability was observed over time. In some settings, facility preparedness and VMMC service quality improved as the number of VMMC facilities increased. Yet, lapses in high performance and expansion of considerably deficient services were also observed. Surgical tasks had the highest quality scores, with lower performance levels in infection control, pre-operative examinations, and post-operative patient monitoring and counseling. The range of scale-up models used across countries additionally underscored the complexity of delivering high quality VMMC., Conclusions: Greater efforts are needed to integrate VMMC scale-up and quality improvement processes in sub-Saharan African settings. Monitoring of service quality, not just adverse events reporting, will be essential in realizing the full health impact of VMMC for HIV prevention.

Background: Human resource capacity is vital to the scale-up of voluntary medical male circumcision (VMMC) services. VMMC providers are at risk of "burnout" from performing a single task repeatedly in a high volume work environment that produces long work hours and intense work effort., Methods and Findings: The Systematic Monitoring of the Voluntary Medical Male Circumcision Scale-up (SYMMACS) surveyed VMMC providers in Kenya, South Africa, Tanzania, and Zimbabwe in 2011 (n = 357) and 2012 (n = 591). Providers self-reported on their training, work experience, levels of job-fulfillment and work fatigue/burnout. Data analysis included a descriptive analysis of VMMC provider characteristics, and both bivariate and multivariate analyses of factors associated with provider work fatigue/burnout. In 2012, Kenyan providers had worked in VMMC for a median of 31 months compared to South Africa (10 months), Tanzania (15 months), and Zimbabwe (11 months). More than three-quarters (78 - 99%) of providers in all countries in 2012 reported that VMMC is a personally fulfilling job. However, 67% of Kenyan providers reported starting to experience work fatigue/burnout compared to South Africa (33%), Zimbabwe (17%), and Tanzania (15%). Despite the high level of work fatigue/burnout in Kenya, none of the measured factors (i.e., gender, age, full-time versus part-time status, length of service, number of operations performed, or cadre) were significantly associated with work fatigue/burnout in 2011. In 2012, logistic regression found increases in age (p<.05) and number of months working in VMMC (p<.01) were associated with an increased likelihood of experiencing work fatigue/burnout, while higher career total VMMCs decreased the likelihood of experiencing burnout., Conclusion: Given cross-country differences, further elucidation of cultural and other contextual factors that may influence provider burnout is required. Continuing to emphasize the contribution that providers make in the fight against HIV/AIDS is important.

Background: Countries participating in voluntary medical male circumcision (VMMC) scale-up have adopted most of six elements of surgical efficiency, depending on national policy. However, effective implementation of these elements largely depends on providers' attitudes and subsequent compliance. We explored the concordance between recommended practices and providers' perceptions toward the VMMC efficiency elements, in part to inform review of national policies., Methods and Findings: As part of Systematic Monitoring of the VMMC Scale-up (SYMMACS), we conducted a survey of VMMC providers in Kenya, South Africa, Tanzania, and Zimbabwe. SYMMACS assessed providers' attitudes and perceptions toward these elements in 2011 and 2012. A restricted analysis using 2012 data to calculate unadjusted odds ratios and 95% confidence intervals for the country effect on each attitudinal outcome was done using logistic regression. As only two countries allow more than one cadre to perform the surgical procedure, odds ratios looking at country effect were adjusted for cadre effect for these two countries. Qualitative data from open-ended responses were used to triangulate with quantitative analyses. This analysis showed concordance between each country's policies and provider attitudes toward the efficiency elements. One exception was task-shifting, which is not authorized in South Africa or Zimbabwe; providers across all countries approved this practice., Conclusions: The decision to adopt efficiency elements is often based on national policies. The concordance between the policies of each country and provider attitudes bodes well for compliance and effective implementation. However, study findings suggest that there may be need to consult providers when developing national policies.

Background: The Kenyan Ministry of Health initiated a voluntary medical male circumcision (VMMC) program in 2008. We used data from 2 nationally representative surveys to estimate trends in the number, demographic characteristics, and sexual behaviors of recently circumcised and uncircumcised HIV-uninfected men in Kenya., Methods: We compared the proportion of circumcised men between the first and second Kenya AIDS Indicator Survey (KAIS 2007 and KAIS 2012) to assess the progress of Kenya's VMMC program. We calculated the number of uncircumcised HIV-uninfected men. We conducted descriptive analyses and used multivariable methods to identify the variables independently associated with HIV-uninfected uncircumcised men aged 15-64 years in the VMMC priority region of Nyanza., Results: The proportion of men who reported being circumcised increased significantly from 85.0% in 2007 to 91.2% in 2012. The proportions of circumcised men increased in all regions, with the highest increases of 18.1 and 9.0 percentage points in the VMMC priority regions of Nyanza and Nairobi, respectively. Half (52.5%) of HIV-uninfected and uncircumcised men had never been married, and 84.6% were not using condoms at all times with their last sexual partner., Conclusions: VMMC prevalence has increased across Kenya demonstrating the success of the national program. Despite this accomplishment, the Nyanza region remains below the target to circumcise 80% of all eligible men aged 15-49 years between 2009 and 2013. As new cohorts of young men enter into adolescence, consistent focus is needed. To ensure sustainability of the VMMC program, financial resources and coordinated planning must continue.

Background: Populations with higher risks for HIV exposure contribute to the HIV epidemic in Kenya. We present data from the second Kenya AIDS Indicator Survey to estimate the size and HIV prevalence of populations with high-risk characteristics., Methods: The Kenya AIDS Indicator Survey 2012 was a national survey of Kenyans aged 18 months to 64 years which linked demographic and behavioral information with HIV results. Data were weighted to account for sampling probability. This analysis was restricted to adults aged 18 years and older., Results: Of 5088 men and 6745 women, 0.1% [95% confidence interval (CI): 0.03 to 0.14] were persons who inject drugs (PWID). Among men, 0.6% (CI: 0.3 to 0.8) had ever had sex with other men, and 3.1% (CI: 2.4 to 3.7) were males who had ever engaged in transactional sex work (MTSW). Among women, 1.9% (CI: 1.3 to 2.5) had ever had anal sex, and 4.1% (CI: 3.5 to 4.8) were women who had ever engaged in transactional sex work (FTSW). Among men, 17.6% (CI: 15.7 to 19.6) had been male clients of transactional sex workers (TSW). HIV prevalence was 0% among men who have sex with men, 6.3% (CI: 0 to 18.1) among persons who injected drugs, 7.1% (CI: 4.8 to 9.4) among male clients of TSW, 7.6% (CI: 1.8 to 13.4) among MTSW, 12.1% (CI: 7.1 to 17.1) among FTSW, and 12.1% (CI: 5.0 to 19.2) among females who ever had engaged in anal sex., Conclusions: Population-based data on high-risk populations can be used to set realistic targets for HIV prevention, care, and treatment for these groups. These data should inform priorities for high-risk populations in the upcoming Kenyan strategic plan on HIV/AIDS.

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.

Objectives: Research indicates that individuals tested for HIV have higher socio-economic status than those not tested, but less is known about how socio-economic status is associated with modes of testing. We compared individuals tested through provider-initiated testing and counselling (PITC), those tested through voluntary counselling and testing (VCT) and those never tested., Methods: Cross-sectional surveys were conducted at health facilities in Burkina Faso, Kenya, Malawi and Uganda, as part of the Multi-country African Testing and Counselling for HIV (MATCH) study. A total of 3659 clients were asked about testing status, type of facility of most recent test and socio-economic status. Two outcome measures were analysed: ever tested for HIV and mode of testing. We compared VCT at stand-alone facilities and PITC, which includes integrated facilities where testing is provided with medical care, and prevention of mother-to-child transmission (PMTCT) facilities. The determinants of ever testing and of using a particular mode of testing were analysed using modified Poisson regression and multinomial logistic analyses., Results: Higher socio-economic status was associated with the likelihood of testing at VCT rather than other facilities or not testing. There were no significant differences in socio-economic characteristics between those tested through PITC (integrated and PMTCT facilities) and those not tested., Conclusions: Provider-initiated modes of testing make testing accessible to individuals from lower socio-economic groups to a greater extent than traditional VCT. Expanding testing through PMTCT reduces socio-economic obstacles, especially for women. Continued efforts are needed to encourage testing and counselling among men and the less affluent., (© 2013 John Wiley & Sons Ltd.)

We describe the frequency of and factors associated with disclosure, knowledge of partner's HIV status, and consistent condom use among 3538 HIV-positive patients attending eighteen HIV care and treatment clinics in Kenya, Namibia, and Tanzania. Overall, 42% of patients were male, and 64% were on antiretroviral treatment. The majority (80%) had disclosed their HIV status to their partners, 64% knew their partner's HIV status, and 77% reported consistent condom use. Of those who knew their partner's status, 18% reported their partner was HIV negative. Compared to men, women were significantly less likely to report disclosing their HIV status to their sex partner(s), to knowing their partner's HIV status, and to using condoms consistently with HIV-negative partners. Other factors negatively associated with consistent condom use include nondisclosure, alcohol use, reporting a casual sex partner, and desiring a pregnancy. Health care providers should target additional risk reduction counseling and support services to patients who report these characteristics.

Disclosure of HIV status is routinely promoted as a public health measure to prevent transmission and enhance treatment adherence support. While studies show a range of positive and negative outcomes associated with disclosure, it has also been documented that disclosing is a challenging and ongoing process. This article aims to describe the role of health-care workers in Central and Nairobi provinces in Kenya in facilitating disclosure in the contexts of voluntary counselling and testing and provider-initiated testing and counselling and includes a discussion on how participants perceive and experience disclosure as a result. We draw on in-depth qualitative research carried out in 2008-2009 among people living with HIV (PLHIV) and the health workers who provide care to them. Our findings suggest that in everyday practice, there are three models of disclosure at work: (1) voluntary-consented disclosure, in alignment with international guidelines; (2) involuntary, non-consensual disclosure, which may be either intentional or accidental; and (3) obligatory disclosure, which occurs when PLHIV are forced to disclose to access services at health facilities. Health-care workers were often caught between the three models and struggled with the competing demands of promoting prevention, adherence, and confidentiality. Findings indicate that as national and global policies shift to normalize HIV testing as routine in a range of clinical settings, greater effort must be made to define suitable best practices that balance the human rights and the public health perspectives in relation to disclosure.

Unlabelled: HIV care and treatment settings provide an opportunity to reach people living with HIV/AIDS (PLHIV) with prevention messages and services. Population-based surveys in sub-Saharan Africa have identified HIV risk behaviors among PLHIV, yet data are limited regarding HIV risk behaviors of PLHIV in clinical care. This paper describes the baseline sociodemographic, HIV transmission risk behaviors, and clinical data of a study evaluating an HIV prevention intervention package for HIV care and treatment clinics in Africa. The study was a longitudinal group-randomized trial in 9 intervention clinics and 9 comparison clinics in Kenya, Namibia, and Tanzania (N = 3538). Baseline participants were mostly female, married, had less than a primary education, and were relatively recently diagnosed with HIV. Fifty-two percent of participants had a partner of negative or unknown status, 24% were not using condoms consistently, and 11% reported STI symptoms in the last 6 months. There were differences in demographic and HIV transmission risk variables by country, indicating the need to consider local context in designing studies and using caution when generalizing findings across African countries. Baseline data from this study indicate that participants were often engaging in HIV transmission risk behaviors, which supports the need for prevention with PLHIV (PwP)., Trial Registration: ClinicalTrials.gov NCT01256463.

Objective: To provide guidance for male circumcision programmes in Kenya by estimating the population of uncircumcised men and investigating the association between circumcision and infection with the human immunodeficiency virus (HIV), with particular reference to uncircumcised, HIV-uninfected men., Methods: Data on men aged 15 to 64 years were derived from the 2007 Kenya AIDS Indicator Survey, which involved interviews and blood collection to test for HIV and herpes simplex virus 2 (HSV-2). The prevalence of HIV infection and circumcision in Kenyan provinces was calculated and the demographic characteristics and sexual behaviour of circumcised and uncircumcised, HIV-infected and HIV-uninfected men were recorded., Findings: The national prevalence of HIV infection in uncircumcised men was 13.2% (95% confidence interval, CI: 10.8-15.7) compared with 3.9% (95% CI: 3.3-4.5) among circumcised men. Nyanza province had the largest estimated number of uncircumcised, HIV-uninfected men (i.e. 601 709), followed by Rift Valley, Nairobi and Western Province, respectively, and most belonged to the Luo ethnic tribe. Of these men, 77.8% did not know their HIV status and 33.2% were HSV-2-positive. In addition, 65.3% had had unprotected sex with a partner of discordant or unknown HIV status in the past 12 months and only 14.7% consistently used condoms with their most recent partner. However, only 21.8% of the uncircumcised, HIV-uninfected men aged 15 to 19 years were sexually active., Conclusion: The Kenyan male circumcision strategy should focus on the provinces with the highest number of uncircumcised, HIV-uninfected men and target young men before or shortly after sexual debut.

As the science demonstrating strong evidence for voluntary medical male circumcision (VMMC) for HIV prevention has evolved, the President's Emergency Plan for AIDS Relief (PEPFAR) has collaborated with international agencies, donors, and partner country governments supporting VMMC programming. Mathematical models forecast that quickly reaching a large number of uncircumcised men with VMMC in strategically chosen populations may dramatically reduce community-level HIV incidence and save billions of dollars in HIV care and treatment costs. Because VMMC is a 1-time procedure that confers life-long partial protection against HIV, programs for adult men are vital short-term investments with long-term benefits. VMMC also provides a unique opportunity to reach boys and men with HIV testing and counseling services and referrals for other HIV services, including treatment. After formal recommendations by WHO in 2007, priority countries have pursued expansion of VMMC. More than 1 million males have received VMMC thus far, with the most notable successes coming from Kenya's Nyanza Province. However, a myriad of necessary cultural, political, and ethical considerations have moderated the pace of overall success. Because many millions more uncircumcised men would benefit from VMMC services now, US President Barack Obama committed PEPFAR to provide 4.7 million males with VMMC by 2014. Innovative circumcision methods-such as medical devices that remove the foreskin without injected anesthesia and/or sutures-are being rigorously evaluated. Incorporation of safe innovations into surgical VMMC programs may provide the opportunity to reach more men more quickly with services and dramatically reduce HIV incidence for all.

Objectives: To assess healing with Shang Ring removal at different prespecified times; whether spontaneous detachment occurs with delayed removal; problems, complaints, and acceptability of wearing the device; satisfaction among participants; and acceptability of the procedure among providers., Methods: Fifty HIV-negative men underwent a Shang Ring circumcision in Kenya. Men were randomly assigned for device removal at 7 (15 men), 14 (15 men), or 21 days (20 men). Follow-up visits were at 7, 14, 21, 28, and 42 days after circumcision and 2 days after removal., Results: Circumcision and device removal were conducted without significant problems. Mean times for circumcision and device removal were 6.5 (SD = 2.4) and 2.5 (SD = 0.8) minutes, respectively. Complete detachment of the device occurred in 22 (66.7%) men who wore it more than 7 days. Seven men (14.0%) with partial detachments requested removal 8-14 days postcircumcision due to pain/discomfort. Healing progressed normally in all participants; cumulative probabilities of complete healing were similar across groups. No severe or serious adverse events occurred. Acceptability among participants was high. Providers reported that Shang Ring circumcision was "very easy" compared with the forceps-guided procedure., Conclusion: The Shang Ring is safe and easy to use according to label instructions (7 day removal). Detachments occurred without significant problems, although some men requested removal of partially detached rings. Removal time had little effect on healing. These data help allay concerns about men not returning for ring removal and expand the evidence base suggesting the Shang Ring could facilitate rapid male circumcision rollout in sub-Saharan Africa.

Background: We analyzed HIV testing rates, prevalence of undiagnosed HIV, and predictors of testing in the Kenya AIDS Indicator Survey (KAIS) 2007., Methods: KAIS was a nationally representative sero-survey that included demographic and behavioral indicators and testing for HIV, HSV-2, syphilis, and CD4 cell counts in the population aged 15-64 years. We used gender-specific multivariable regression models to identify factors independently associated with HIV testing in sexually active persons., Results: Of 19,840 eligible persons, 80% consented to interviews and blood specimen collection. National HIV prevalence was 7.1% (95% CI 6.5-7.7). Among ever sexually active persons, 27.4% (95% CI 25.6-29.2) of men and 44.2% (95% CI 42.5-46.0) of women reported previous HIV testing. Among HIV-infected persons, 83.6% (95% CI 76.2-91.0) were unaware of their HIV infection. Among sexually active women aged 15-49 years, 48.7% (95% CI 46.8-50.6) had their last HIV test during antenatal care (ANC). In multivariable analyses, the adjusted odds ratio (AOR) for ever HIV testing in women ≥35 versus 15-19 years was 0.2 (95% CI: 0.1-0.3; p<0.0001). Other independent associations with ever HIV testing included urban residence (AOR 1.6, 95% CI: 1.2-2.0; p = 0.0005, women only), highest wealth index versus the four lower quintiles combined (AOR 1.8, 95% CI: 1.3-2.5; p = 0.0006, men only), and an increasing testing trend with higher levels of education. Missed opportunities for testing were identified during general or pregnancy-specific contacts with health facilities; 89% of adults said they would participate in home-based HIV testing., Conclusions: The vast majority of HIV-infected persons in Kenya are unaware of their HIV status, posing a major barrier to HIV prevention, care and treatment efforts. New approaches to HIV testing provision and education, including home-based testing, may increase coverage. Targeted interventions should involve sexually active men, sexually active women without access to ANC, and rural and disadvantaged populations.

Background: Following confirmation of the effectiveness of voluntary medical male circumcision (VMMC) for HIV prevention, the World Health Organization and the Joint United Nations Programme on HIV/AIDS issued recommendations in 2007. Less than 5 y later, priority countries are at different stages of program scale-up. This paper analyzes the progress towards the scale-up of VMMC programs. It analyzes the adoption of VMMC as an additional HIV prevention strategy and explores the factors may have expedited or hindered the adoption of policies and initial program implementation in priority countries to date., Methods and Findings: VMMCs performed in priority countries between 2008 and 2010 were recorded and used to classify countries into five adopter categories according to the Diffusion of Innovations framework. The main predictors of VMMC program adoption were determined and factors influencing subsequent scale-up explored. By the end of 2010, over 550,000 VMMCs had been performed, representing approximately 3% of the target coverage level in priority countries. The "early adopter" countries developed national VMMC policies and initiated VMMC program implementation soon after the release of the WHO recommendations. However, based on modeling using the Decision Makers' Program Planning Tool (DMPPT), only Kenya appears to be on track towards achievement of the DMPPT-estimated 80% coverage goal by 2015, having already achieved 61.5% of the DMPPT target. None of the other countries appear to be on track to achieve their targets. Potential predicators of early adoption of male circumcision programs include having a VMMC focal person, establishing a national policy, having an operational strategy, and the establishment of a pilot program., Conclusions: Early adoption of VMMC policies did not necessarily result in rapid program scale-up. A key lesson is the importance of not only being ready to adopt a new intervention but also ensuring that factors critical to supporting and accelerating scale-up are incorporated into the program. The most successful program had country ownership and sustained leadership to translate research into a national policy and program. Please see later in the article for the Editors' Summary.

Since the World Health Organization and the Joint United Nations Programme on HIV/AIDS recommended implementation of medical male circumcision (MC) as part of HIV prevention in areas with low MC and high HIV prevalence rates in 2007, the government of Kenya has developed a strategy to circumcise 80% of uncircumcised men within five years. To facilitate the quick translation of research to practice, a national MC task force was formed in 2007, a medical MC policy was implemented in early 2008, and Nyanza Province, the region with the highest HIV burden and low rates of circumcision, was prioritized for services under the direction of a provincial voluntary medical male circumcision (VMMC) task force. The government's early and continuous engagement with community leaders/elders, politicians, youth, and women's groups has led to the rapid endorsement and acceptance of VMMC. In addition, several innovative approaches have helped to optimize VMMC scale-up. Since October 2008, the Kenyan VMMC program has circumcised approximately 290,000 men, mainly in Nyanza Province, an accomplishment made possible through a combination of governmental leadership, a documented implementation strategy, and the adoption of appropriate and innovative approaches. Kenya's success provides a model for others planning VMMC scale-up programs.

Voluntary medical male circumcision (VMMC) reduces female-to-male HIV transmission by approximately 60%; modeling suggests that scaling up VMMC to 80% of men 15- to 49-years-old within five years would avert over 3.3 million new HIV infections in 14 high priority countries/regions in southern and eastern Africa by 2025 and would require 20.33 million circumcisions. However, the shortage of health professionals in these countries must be addressed to reach these proposed coverage levels. To identify human resource approaches that are being used to improve VMMC volume and efficiency, we looked at previous literature and conducted a program review. We identified surgical efficiencies, non-surgical efficiencies, task shifting, task sharing, temporary redeployment of public sector staff during VMMC campaign periods, expansion of the health workforce through recruitment of unemployed, recently retired, newly graduating, or on-leave health care workers, and the use of volunteer medical staff from other countries as approaches that address human resource constraints. Case studies from Kenya, Tanzania, and Swaziland illustrate several innovative responses to human resource challenges. Although the shortage of skilled personnel remains a major challenge to the rapid scale-up of VMMC in the 14 African priority countries/regions, health programs throughout the region may be able to replicate or adapt these approaches to scale up VMMC for public health impact.

Objective: To assess safety, preliminary efficacy, and acceptability of the Shang Ring, a novel disposable device for adult male circumcision in Kenya., Methods: Forty HIV-negative men were recruited in Homa Bay, Kenya. Circumcisions were performed by a trained physician or nurse working with 1 assistant. Follow-up was conducted at 2, 7, 9, 14, 21, 28, 35, and 42 days after circumcision. Rings were removed on day 7. Pain was assessed using a visual analog scale (VAS) (0 = no pain, 10 = worst possible). Men were interviewed at enrollment and on days 7 and 42., Results: All 40 procedures were completed successfully. Mean procedure and device removal times were 4.8 (SD ± 2.0) and 3.9 (SD ± 2.6) minutes, respectively. There were 6 mild adverse events, including 3 penile skin injuries, 2 cases of edema, and 1 infection; all resolved with conservative management. In addition, there were 3 partial ring detachments between days 2-7. None required treatment or early ring removal. Erections with the ring were well tolerated, with a mean pain score of 3.5 (SD ± 2.3). By day 2, 80% of men were back to work. At 42 days, all participants were very satisfied with their circumcision and would recommend the procedure to others., Conclusions: Our results demonstrate that the Shang Ring is safe for further study in Africa. Acceptability of the Shang Ring among participants was excellent. With short procedure times, less surgical skill required, and the ease with which it can be used by nonphysicians, the Shang Ring could facilitate rapid roll-out of male circumcision in sub-Saharan Africa.

Background: In order to inform prevention programming, we analyzed HIV discordance and concordance within couples in the Kenya AIDS Indicator Survey (KAIS) 2007., Methods: KAIS was a nationally representative population-based sero-survey that examined demographic and behavioral indicators and serologic testing for HIV, HSV-2, syphilis, and CD4 cell counts in 15,853 consenting adults aged 15-64 years. We analyzed interview and blood testing data at the sexual partnership level from married or cohabitating couples. Multivariable regression models were used to identify factors independently associated with HIV discordant and concordant status., Results: Of 3256 couples identified in the survey, 2748 (84.4%) had interview and blood testing data. Overall, 3.8% of couples were concordantly infected with HIV, and in 5.8% one partner was infected, translating to 338,000 discordant couples in Kenya. In 83.6% of HIV-infected Kenyans living in married or cohabitating couples neither partner knew their HIV status. Factors independently associated with HIV-discordance included young age in women (AOR 1.5, 95% CI: 1.2-1.8; p<0.0001), increasing number of lifetime sexual partners in women (AOR 1.5, 95% CI: 1.3-1.8; p<0.0001), HSV-2 infection in either or both partners (AOR 4.1, 95% CI: 2.3-7.2; p<0.0001), and lack of male circumcision (AOR 1.6, 95% CI: 1.0-2.5; p = 0.032). Independent factors for HIV-concordance included HSV-2 infection in both partners (AOR 6.5, 95% CI: 2.3-18.7; p = 0.001) and lack of male circumcision (AOR 1.8, 95% CI: 1.0-3.3; p = 0.043)., Conclusions: Couple prevention interventions should begin early in relationships and include mutual knowledge of HIV status, reduction of outside sexual partners, and promotion of male circumcision among HIV-uninfected men. Mechanisms for effective prevention or suppression of HSV-2 infection are also needed.

Problem: In 2003, the goal of the Kenyan Ministry of Health was to avail antiretroviral treatment (ART) to 50% of the estimated 250 000 eligible individuals by the end of 2005. By July 2005, 45 000 adults and more than 2000 children were on treatment. A study was conducted to determine the barriers to identification of HIV-infected children., Approach: Existing government policies were reviewed and the ART register of the Kenya National AIDS Control Programme was used to identify facilities providing ART. This paper reports the findings around diagnosis and staging of HIV infection in children., Local Setting: At the time of the study, 58 health facilities were providing ART to children. Only one institution had achieved universal HIV testing in the antenatal clinics. Six facilities systematically followed up HIV-exposed children. HIV antibody testing was not readily available to the children. Although four research centres were capable of carrying out diagnostic HIV polymerase chain reaction (PCR), the services were restricted to research purposes. Other constraints were inadequate physical infrastructure, inadequate systems for quality control in the laboratories and shortage of staff., Lessons Learnt: The policy framework to support identification of HIV-infected children had been established, albeit with narrow focus on sick children. The assessment identified the weaknesses in the structures for systematic diagnosis of HIV through laboratory or clinical-based algorithms. The researchers concluded that health staff training and implementation of a systematic standard approach to identification of HIV-infected children is urgently required.