Effect of an opt-out point-of-care HIV-1 nucleic acid testing intervention to detect acute and prevalent HIV infection in symptomatic adult outpatients and reduce HIV transmission in Kenya: a randomized controlled trial.

BACKGROUND: In sub-Saharan Africa, adult outpatients with symptoms of acute infectious illness are not routinely tested for prevalent or acute HIV infection (AHI) when seeking healthcare. METHODS: Adult symptomatic outpatients aged 18-39 years were evaluated by a consensus AHI risk score. Patients with a risk score ≥ 2 and no previous HIV diagnosis were enrolled in a stepped-wedge trial of opt-out delivery of point-of-care (POC) HIV-1 nucleic acid testing (NAAT), compared with standard provider-initiated HIV testing using rapid tests in the observation period. The primary outcome was the number of new diagnoses in each study period. Generalized estimating equations with a log-binomial link and robust variance estimates were used to account for clustering by health facility. The trial is registered with ClinicalTrials.gov NCT03508908. RESULTS: Between 2017 and 2020, 13 (0.9%) out of 1374 participants in the observation period and 37 (2.5%) out of 1500 participants in the intervention period were diagnosed with HIV infection. Of the 37 newly diagnosed cases in the intervention period, two (5.4%) had AHI. Participants in the opt-out intervention had a two-fold greater odds of being diagnosed with HIV (odds ratio = 2.2, 95% confidence interval: 1.39-3.51) after adjustment for factors imbalanced across study periods. CONCLUSIONS: Among symptomatic adults aged 18-39 years targeted by our POC NAAT intervention, we identified one chronic HIV infection for every 40 patients and one AHI patient for every 750 patients tested. Although AHI yield was low in this population, routinely offered opt-out testing could diagnose twice as many patients as an approach relying on provider discretion.

Lay health worker experiences administering a multi-level combination intervention to improve PMTCT retention.

BACKGROUND: The recent scale-up of prevention of mother-to-child transmission of HIV (PMTCT) services has rapidly accelerated antiretroviral therapy (ART) uptake among pregnant and postpartum women in sub-Saharan Africa. The Mother and Infant Retention for Health (MIR4Health) study evaluates the impact of a combination intervention administered by trained lay health workers to decrease attrition among HIV-positive women initiating PMTCT services and their infants through 6 months postpartum. METHODS: This was a qualitative study nested within the MIR4Health trial. MIR4Health was conducted at 10 health facilities in Nyanza, Kenya from September 2013 to September 2015. The trial intervention addressed behavioral, social, and structural barriers to PMTCT retention and included: appointment reminders via text and phone calls, follow-up and tracking for missed clinic visits, PMTCT health education at home visits and during clinic visits, and retention and adherence support and counseling. All interventions were administered by lay health workers. We describe results of a nested small qualitative inquiry which conducted two focus groups to assess the experiences and perceptions of lay health workers administering the interventions. Discussions were recorded and simultaneously transcribed and translated into English. Data were analyzed using framework analysis approach. RESULTS: Study findings show lay health workers played a critical role supporting mothers in PMTCT services across a range of behavioral, social, and structural domains, including improved communication and contact, health education, peer support, and patient advocacy and assistance. Findings also identified barriers to the uptake and implementation of the interventions, such as concerns about privacy and stigma, and the limitations of the healthcare system including healthcare worker attitudes. Overall, study findings indicate that lay health workers found the interventions to be feasible, acceptable, and well received by clients. CONCLUSIONS: Lay health workers played a fundamental role in supporting mothers engaged in PMTCT services and provided valuable feedback on the implementation of PMTCT interventions. Future interventions must include strategies to ensure client privacy, decrease stigma within communities, and address the practical limitations of health systems. This study adds important insight to the growing body of research on lay health worker experiences in HIV and PMTCT care. TRIAL REGISTRATION: Clinicaltrials.gov NCT01962220 .

Effects of exposure to an intensive HIV-prevention programme on behavioural changes among female sex workers in Nairobi, Kenya.

While Kenya has had a long-standing national HIV-prevention programme, evidence on the level of exposure to its interventions and related effects on behavioural changes among female sex workers (FSWs) is limited. Using cross-sectional behavioural data collected in 2013 from 1 357 FSWs aged 18 years and above in Nairobi, Kenya, this study explores the relationship between FSW programme exposure levels and behavioural outcomes including condom use, sexually transmitted infection (STI)-treatment, and empowerment measures like disclosure of self-identity and violence reporting. We categorised programme exposure levels as none, moderate and intensive. Multivariate logistic regression was used for analysis. Overall, 35% of the FSWs were not exposed to any HIV prevention programme, whereas about 24% had moderate and 41% had intensive exposure. FSWs having intensive programme exposure had a higher likelihood of using condoms consistently with occasional clients (AOR: 1.57; 95% CI: 1.08-2.31) and seeking treatment for STIs (AOR: 3.37; 95% CI: 1.63-7.02) compared to FSWs with no or moderate exposure. Intensive programme exposure was also associated with higher self-disclosure of sex-work identity (AOR: 1.63; 95% CI: 1.19-2.24), reporting of violence to police (AOR: 2.45; 95% CI: 1.03-5.84), and negotiation of condom use at last sex when the client was under the influence of alcohol (AOR: 1.63; 95% CI: 0.94-2.82). Although HIV prevention programmes in Kenya have been underway for over a decade, programme efforts were largely focused on saturating the coverage (intervention breadth). Strategies should now focus on ensuring improved quality of contacts through intensified programme exposure (intervention depth) to enhance gains in behavioural change among FSWs and preventing the burden of HIV infection among them.

Notes from the Field: Tetanus Cases After Voluntary Medical Male Circumcision for HIV Prevention--Eastern and Southern Africa, 2012-2015.

Voluntary medical male circumcision (VMMC) decreases the risk for female-to-male HIV transmission by approximately 60%, and the President's Emergency Plan for AIDS Relief (PEPFAR) is supporting the scale-up of VMMC for adolescent and adult males in countries with high prevalence of human immunodeficiency virus (HIV) and low coverage of male circumcision. As of September 2015, PEPFAR has supported approximately 8.9 million VMMCs.

Evaluation of Kenya's readiness to transition from sentinel surveillance to routine HIV testing for antenatal clinic-based HIV surveillance.

BACKGROUND: Sentinel surveillance for HIV among women attending antenatal clinics using unlinked anonymous testing is a cornerstone of HIV surveillance in sub-Saharan Africa. Increased use of routine antenatal HIV testing allows consideration of using these programmatic data rather than sentinel surveillance data for HIV surveillance. METHODS: To gauge Kenya's readiness to discontinue sentinel surveillance, we evaluated whether recommended World Health Organization standards were fulfilled by conducting data and administrative reviews of antenatal clinics that offered both routine testing and sentinel surveillance in 2010. RESULTS: The proportion of tests that were HIV-positive among women aged 15-49 years was 6.2% (95% confidence interval [CI] 4.6-7.7%] in sentinel surveillance and 6.5% (95% CI 5.1-8.0%) in routine testing. The agreement of HIV test results between sentinel surveillance and routine testing was 98.0%, but 24.1% of specimens that tested positive in sentinel surveillance were recorded as negative in routine testing. Data completeness was moderate, with HIV test results recorded for 87.8% of women who received routine testing. CONCLUSIONS: Additional preparation is required before routine antenatal HIV testing data can supplant sentinel surveillance in Kenya. As the quality of program data has markedly improved since 2010 a repeat evaluation of the use of routine antenatal HIV testing data in lieu of ANC sentinel surveillance is recommended.

Medication Adherence Clubs: a potential solution to managing large numbers of stable patients with multiple chronic diseases in informal settlements.

OBJECTIVES: To assess the care of hypertension, diabetes mellitus and/or HIV patients enrolled into Medication Adherence Clubs (MACs). METHODS: Retrospective descriptive study was carried out using routinely collected programme data from a primary healthcare clinic at informal settlement in Nairobi, Kenya. All patients enrolled into MACs were selected for the study. MACs are nurse-facilitated mixed groups of 25-35 stable hypertension, diabetes mellitus and/or HIV patients who met quarterly to confirm their clinical stability, have brief health discussions and receive medication. Clinical officer reviewed MACs yearly, when a patient developed complications or no longer met stable criteria. RESULTS: A total of 1432 patients were enrolled into 47 clubs with 109 sessions conducted between August 2013 and August 2014. There were 1020 (71%) HIV and 412 (29%) non-communicable disease patients. Among those with NCD, 352 (85%) had hypertension and 60 (15%) had DM, while 12 had HIV concurrent with hypertension. A total of 2208 consultations were offloaded from regular clinic. During MAC attendance, blood pressure, weight and laboratory testing were completed correctly in 98-99% of consultations. Only 43 (2%) consultations required referral for clinical officer review before their routine yearly appointment. Loss to follow-up from the MACs was 3.5%. CONCLUSIONS: This study demonstrates the feasibility and early efficacy of MACs for mixed chronic disease in a resource-limited setting. It supports burden reduction and flexibility of regular clinical review for stable patients. Further assessment regarding long-term outcomes of this model should be completed to increase confidence for deployment in similar contexts.

Enhancing Maternal and Child Health using a Combined Mother & Child Health Booklet in Kenya.

Under Kenyan guidelines, HIV-exposed infants should be tested for HIV DNA at 6 weeks or at first clinical contact thereafter, as infants come for immunization. Following the introduction of early infant diagnoses programmes, however, many infants were not being tested and linked to care and treatment. We developed the Mother & Child Health Booklet to help relate mothers' obstetrical history to infants' healthcare providers to facilitate follow-up and timely management. The booklet contains information on the mother's pregnancy, delivery and postpartum course and her child's growth and development, immunization, nutrition and other data need to monitor the child to 5 years of age. It replaced three separate record clinical cards. In a 1 year pilot evaluation of the booklet in Nyanza province in 2007-08, the number of HIV DNA tests on infants increased by 34% from 9966 to 13 379. The booklet was subsequently distributed nationwide in 2009. Overall, the numbers of infants tested for HIV DNA rose from 27 000 in 2007 to 60 000 in 2012, which represents approximately 60% of the estimated HIV-exposed infants in Kenya. We believe that the booklet is an important strategy for identifying and treating infected infants and, thus, in progress toward Millennium Development Goal 4.

Exploring the use of mobile phone technology for the enhancement of the prevention of mother-to-child transmission of HIV program in Nyanza, Kenya: a qualitative study.

BACKGROUND: Community-based mobile phone programs can complement gaps in clinical services for prevention of mother-to-child transmission (PMTCT) of HIV in areas with poor infrastructure and personnel shortages. However, community and health worker perceptions on optimal mobile phone communication for PMTCT are underexplored. This study examined what specific content and forms of mobile communication are acceptable to support PMTCT. METHODS: Qualitative methods using focus groups and in-depth interviews were conducted in two district hospitals in Nyanza Province, Kenya. A total of 45 participants were purposefully selected, including HIV-positive women enrolled in PMTCT, their male partners, community health workers, and nurses. Semi-structured discussion guides were used to elicit participants' current mobile phone uses for PMTCT and their perceived benefits and challenges. We also examined participants' views on platform design and gender-tailored short message service (SMS) messages designed to improve PMTCT communication and male involvement. RESULTS: Most participants had access to a mobile phone and prior experience receiving and sending SMS, although phone sharing was common among couples. Mobile phones were used for several health-related purposes, primarily as voice calls rather than texts. The perceived benefits of mobile phones for PMTCT included linking with health workers, protecting confidentiality, and receiving information and reminders. Men and women considered the gender-tailored SMS as a catalyst for improving PMTCT male involvement and couples' communication. However, informative messaging relayed safely to the intended recipient was critical. In addition, health workers emphasized the continual need for in-person counseling coupled with, rather than replaced by, mobile phone reinforcement. For all participants, integrated and neutral text messaging provided antenatally and postnatally was most preferred, although not all topics or text formats were equally acceptable. CONCLUSIONS: Given the ubiquity of mobile phones in Kenya and current health-related uses of mobile phones, a PMTCT mobile communications platform holds considerable potential. This pre-intervention assessment of community and health worker preferences yielded valuable information on the complexities of design and implementation. An effective PMTCT mobile platform engaging men and women will need to address contexts of non-disclosure, phone sharing, and linkages with existing community and facility-based services.

Modeling the impact of different PrEP targeting strategies combined with a clinic-based HIV-1 nucleic acid testing intervention in Kenya.

BACKGROUND: Up to 69% of adults who acquire HIV in Kenya seek care for acute retroviral symptoms, providing an important opportunity for early diagnosis and HIV care engagement. The Tambua Mapema Plus (TMP) trial tested a combined HIV-1 nucleic acid testing, linkage, treatment, and partner notification intervention for adults with symptoms of acute HIV infection presenting to health facilities in coastal Kenya. We estimated the potential impact on the Kenyan HIV epidemic of providing PrEP to individuals testing negative in TMP, if scaled up. METHODS: We developed an agent-based simulation of HIV-1 transmission using TMP data and current Kenyan statistics. PrEP interventions were layered onto a model of TMP as standard of care, to estimate additional potential population-level impact of enrolling HIV-negative individuals identified through TMP on PrEP over 10 years. Four scenarios were modeled: PrEP for uninfected individuals in disclosed serodiscordant couples; PrEP for individuals with concurrent partnerships; PrEP for all uninfected individuals identified through TMP; and PrEP integrated into the enhanced partner services component of TMP. FINDINGS: Providing PrEP to both individuals with concurrent partnerships and uninfected partners identified through enhanced partner services reduced new HIV infections and was efficient based on numbers needed to treat (NNT). The mean percent of infections averted was 2.79 (95%SI:-10.83, 15.24) and 4.62 (95%SI:-9.5, 16.82) when PrEP uptake was 50% and 100%, respectively, and median NNT was 22.54 (95%SI:not defined, 6.45) and 27.55 (95%SI:not defined, 11.0), respectively. Providing PrEP for all uninfected individuals identified through TMP averted up to 12.68% (95%SI:0.17, 25.19) of new infections but was not efficient based on the NNT: 200.24 (95%SI:523.81, 123.23). CONCLUSIONS: Providing PrEP to individuals testing negative for HIV-1 nucleic acid after presenting to a health facility with symptoms compatible with acute HIV adds value to the TMP intervention, provided PrEP is targeted effectively and efficiently. FUNDING: National Institutes of Health, Sub-Saharan African Network for TB/HIV Research Excellence.

Modeling the Impact of HIV-1 Nucleic Acid Testing Among Symptomatic Adult Outpatients in Kenya.

BACKGROUND: Up to 69% of adults who acquire HIV in Kenya seek care before seroconversion, providing an important opportunity for early diagnosis and treatment. The Tambua Mapema Plus (TMP) trial tested a combined HIV-1 nucleic acid testing, linkage, treatment, and partner notification intervention for adults aged 18-39 years with symptoms of acute HIV infection presenting to health facilities in coastal Kenya. We estimated the potential impact of TMP on the Kenyan HIV epidemic. METHODS: We developed an agent-based network model of HIV-1 transmission using TMP data and Kenyan statistics to estimate potential population-level impact of targeted facility-based testing over 10 years. Three scenarios were modeled: standard care [current use of provider-initiated testing and counseling (PITC)], standard HIV rapid testing scaled to higher coverage obtained in TMP (scaled-up PITC), and the TMP intervention. RESULTS: Standard care resulted in 90.7% of persons living with HIV (PLWH) knowing their status, with 67.5% of those diagnosed on treatment. Scaled-up PITC resulted in 94.4% of PLWH knowing their status and 70.4% of those diagnosed on treatment. The TMP intervention achieved 97.5% of PLWH knowing their status and 80.6% of those diagnosed on treatment. The percentage of infections averted was 1.0% (95% simulation intervals: -19.2% to 19.9%) for scaled-up PITC and 9.4% (95% simulation intervals: -8.1% to 24.5%) for TMP. CONCLUSION: Our study suggests that leveraging new technologies to identify acute HIV infection among symptomatic outpatients is superior to scaled-up PITC in this population, resulting in >95% knowledge of HIV status, and would reduce new HIV infections in Kenya.

Testing strategies to detect acute and prevalent HIV infection in adult outpatients seeking healthcare for symptoms compatible with acute HIV infection in Kenya: a cost-effectiveness analysis.

BACKGROUND: Detection of acute and prevalent HIV infection using point-of-care nucleic acid amplification testing (POC-NAAT) among outpatients with symptoms compatible with acute HIV is critical to HIV prevention, but it is not clear if it is cost-effective compared with existing HIV testing strategies. METHODS: We developed and parametrised a decision tree to compare the cost-effectiveness of (1) provider-initiated testing and counselling (PITC) using rapid tests, the standard of care; (2) scaled-up provider-initiated testing and counselling (SU-PITC) in which all patients were tested with rapid tests unless they opted out; and (3) opt-out testing and counselling using POC-NAAT, which detects both acute and prevalent infection. The model-based analysis used data from the Tambua Mapema Plus randomised controlled trial of a POC-NAAT intervention in Kenya, supplemented with results from a stochastic, agent-based network model of HIV-1 transmission and data from published literature. The analysis was conducted from the perspective of the Kenyan government using a primary outcome of cost per disability-adjusted life-year (DALY) averted over a 10-year time horizon. RESULTS: After analysing the decision-analytical model, the average per patient cost of POC-NAAT was $214.9 compared with $173.6 for SU-PITC and $47.3 for PITC. The mean DALYs accumulated per patient for POC-NAAT were 0.160 compared with 0.176 for SU-PITC and 0.214 for PITC. In the incremental analysis, SU-PITC was eliminated due to extended dominance, and the incremental cost-effectiveness ratio (ICER) comparing POC-NAAT to PITC was $3098 per DALY averted. The ICER was sensitive to disability weights for HIV/AIDS and the costs of antiretroviral therapy. CONCLUSION: POC-NAAT offered to adult outpatients in Kenya who present for care with symptoms compatible with AHI is cost-effective and should be considered for inclusion as the standard of HIV testing in this population. TRIAL REGISTRATION NUMBER: Tambua Mapema ("Discover Early") Plus study (NCT03508908) conducted in Kenya (2017-2020) i.e., Post-results.

A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a Randomized Controlled Trial.

BACKGROUND: Detection and management of acute HIV infection (AHI) is a clinical and public health priority, and HIV infections diagnosed among young adults aged 18 to 39 years are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including linkage to treatment as prevention, access to risk reduction counseling and treatment, and notification of partners in need of HIV testing. OBJECTIVE: The Tambua Mapema Plus study aims to (1) test 1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted HIV partner notification services to all patients with HIV, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life year averted using data on study outcomes. METHODS: A modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care, employs HIV partner notification services to identify linked acute and prevalent infections, and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes, including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis uptake in uninfected individuals in discordant partnerships. RESULTS: Enrollment started in December 2017. As of April 2020, 1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period. Analysis is ongoing and will include adjusted comparisons of the odds of the following outcomes in the observation and intervention periods: being tested for HIV infection, newly diagnosed with prevalent or acute HIV infection, linked to care, and starting ART by week 6 following HIV diagnosis. Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes. CONCLUSIONS: The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16198.

Effectiveness of a Lay Counselor-Led Combination Intervention for Retention of Mothers and Infants in HIV Care: A Randomized Trial in Kenya.

BACKGROUND: Retention of mothers and infants across the prevention of mother-to-child HIV transmission (PMTCT) continuum remains challenging. We assessed the effectiveness of a lay worker administered combination intervention compared with the standard of care (SOC) on mother-infant attrition. METHODS: HIV-positive pregnant women starting antenatal care at 10 facilities in western Kenya were randomized using simple randomization to receive individualized health education, retention/adherence support, appointment reminders, and missed visit tracking vs. routine care per guidelines. The primary endpoint was attrition of mother-infant pairs at 6 months postpartum. Attrition was defined as the proportion of mother-infant pairs not retained in the clinic at 6 months postpartum because of mother or infant death or lost to follow-up. Intent-to-treat analysis was used to assess the difference in attrition. This trial is registered with ClinicalTrials.gov; NCT01962220. RESULTS: From September 2013 to June 2014, 361 HIV-positive pregnant women were screened, and 340 were randomized to the intervention (n = 170) or SOC (n = 170). Median age at enrollment was 26 years (interquartile range 22-30); median gestational age was 24 weeks (interquartile range 17-28). Overall attrition of mother-infant pairs was 23.5% at 6 months postpartum. Attrition was significantly lower in the intervention arm compared with SOC (18.8% vs. 28.2%, relative risk (RR) = 0.67, 95% confidence interval: 0.45 to 0.99, P = 0.04). Overall, the proportion of mothers who were retained and virally suppressed (<1000 copies/mL) at 6 months postpartum was 54.4%, with no difference between study arms. CONCLUSIONS: Provision of a combination intervention by lay counselors can decrease attrition along the PMTCT cascade in low-resource settings.

HIV-Related Deaths in Nairobi, Kenya: Results From a HIV Mortuary Surveillance Study, 2015.

BACKGROUND: Death is an important but often unmeasured endpoint in public health HIV surveillance. We sought to describe HIV among deaths using a novel mortuary-based approach in Nairobi, Kenya. METHODS: Cadavers aged 15 years and older at death at Kenyatta National Hospital (KNH) and City Mortuaries were screened consecutively from January 29 to March 3, 2015. Cause of death was abstracted from medical files and death notification forms. Cardiac blood was drawn and tested for HIV infection using the national HIV testing algorithm followed by viral load testing of HIV-positive samples. RESULTS: Of 807 eligible cadavers, 610 (75.6%) had an HIV test result available. Cadavers from KNH had significantly higher HIV positivity at 23.2% (95% CI: 19.3 to 27.7) compared with City Mortuary at 12.6% (95% CI: 8.8 to 17.8), P < 0.001. HIV prevalence was significantly higher among women than men at both City (33.3% vs. 9.2%, P = 0.008) and KNH Mortuary (28.8% vs. 19.0%, P = 0.025). Half (53.3%) of HIV-infected cadavers had no diagnosis before death, and an additional 22.2% were only diagnosed during hospitalization leading to death. Although not statistically significant, 61.9% of males had no previous diagnosis compared with 45.8% of females (P = 0.144). Half (52.3%) of 44 cadavers at KNH with HIV diagnosis before death were on treatment, and 1 in 5 (22.7%) with a previous diagnosis had achieved viral suppression. CONCLUSIONS: HIV prevalence was high among deaths in Nairobi, especially among women, and previous diagnosis among cadavers was low. Establishing routine mortuary surveillance can contribute to monitoring HIV-associated deaths among cadavers sent to mortuaries.

Progress toward elimination of perinatal HIV transmission in Kenya: Analysis of early infant diagnosis data.

Interrupting vertical transmission of HIV from mothers to infants provides opportunity to transform the HIV/AIDS epidemic by eliminating new infections among children. We estimate mother-to-child transmission rates of infants born to known HIV-positive mothers offered prevention of mother-to-child transmission interventions and provide an indication of Kenya's progress toward elimination of perinatal transmission. We obtained from the Kenya National Early Infant Diagnosis (EID) database, all 131,451 DNA polymerase chain reaction test results of HIV-exposed infants aged 0-18 months who had dried blood spot samples taken between January 2008 and October 2013. The majority of samples were from infants aged 0-6 months (81.0%). Infants aged 6-12 months comprised 15.5%, while those aged 12-18 months were 3.5%. Overall, 11,439 (8.7%) were HIV-positive. Positivity rates were higher among older age groups: 6.8, 14.6, and 27.5% in age groups 0-6 months, 6-12 months, and 12-18 months old, respectively. In Kenya, scale-up and decentralization to primary health centers of EID services has been remarkable. Both increasing HIV-positivity trends in age groups 12-18 months and differences between provinces require further interrogation. Although significant, declining HIV-positivity trends in age groups 0-6 months and 6-12 months old observed between 2008 and 2013 is insufficient to achieve the elimination agenda.

Scale-up of Kenya's national HIV viral load program: Findings and lessons learned.

OBJECTIVES: Kenya is one of the first African countries to scale up a national HIV viral load monitoring program. We sought to assess program scale up using the national database and identify areas for systems strengthening. METHODS: Data from January 2012 to March 2016 were extracted from Kenya's national viral load database. Characteristics of 1,108,356 tests were assessed over time, including reason for testing, turnaround times, test results, treatment regimens, and socio-demographic information. RESULTS: The number of facilities offering viral load testing increased to ~2,000 with >40,000 tests being conducted per month by 2016. By March 2016, most (84.2%) tests were conducted for routine monitoring purposes and the turnaround time from facility-level sample collection to result dispatch from the lab was 21(24) [median (IQR)] days. Although the proportions of repeat viral load tests increased over time, the volumes were lower than expected. Elevated viral load was much more common in pediatric and adolescent patients (0-<3 years: 43.1%, 3-<10 years: 34.5%, 10-<20 years: 36.6%) than in adults (30-<60 years: 13.3%; p<0.001). CONCLUSIONS: Coverage of viral load testing dramatically increased in Kenya to >50% of patients on antiretroviral therapy (ART) by early 2016 and represents a relatively efficient laboratory system. However, strengthening of patient tracking mechanisms and viral load result utilization may be necessary to further improve the system. Additional focus is needed on paediatric/adolescent patients to improve viral suppression in these groups. Kenya's national viral load database has demonstrated its usefulness in assessing laboratory programs, tracking trends in patient characteristics, monitoring scale-up of new policies and programs, and identifying problem areas for further investigation.

Changes in HIV prevention programme outcomes among key populations in Kenya: Data from periodic surveys.

The Kenya National AIDS and STI Control Programme (NASCOP) conducted annual polling booth surveys (PBS) in 2014 and 2015 to measure outcomes from the national HIV prevention programme for key populations (KPs), comprising behavioural, biomedical and structural interventions. KPs included female sex workers (FSWs), men who have sex with men (MSM) and people who inject drugs (PWID). We compared survey results from the first and second rounds. Comparing the second to the first round, significantly more FSWs (93% vs. 88%, p<0.001) and MSM (77% vs. 58%, p<0.001) reported condom use at last sex with a paying client, and at last anal sex among MSM (80% vs. 77%, p<0.05) and PWID (48% vs. 27%, p<0.01). However, condom use with regular partners remained low, at less than 53% for FSWs and 69% for MSM. Among PWID, there was a significant increase in use of new needles and syringes at last injection (93% vs. 88%, p<0.001), and a significant decrease in reported non-availability of clean needles (23% vs. 36%, p<0.001). The number of overdoses in the past six months reduced significantly but remained high (40% vs. 51%, p<0.001). FSWs and MSM reported significantly higher HIV testing, and in all KP groups, over 93% reported ever having been tested for HIV. Among the respondents self-reporting to have tested HIV positive (24% of FSW, 22% of MSM and 19% of PWID), 80% of FSWs, 70% of MSM, and 73% of PWID reported currently taking antiretroviral therapy (ART). While the experience of forced intercourse by partners declined among FSWs (18% vs. 22%, p<0.01) and MSM (13% vs. 17%, p<0.01), more FSWs reported violence by law enforcement personnel (49% vs. 44%, p<0.001). These findings provide valuable information on the programme's progress, and a signpost for the integrated behavioural, biomedical and structural interventions to achieve their HIV prevention targets.

Pre-exposure prophylaxis rollout in a national public sector program: the Kenyan case study.

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.

Mother-to-child transmission of HIV in Kenya: A cross-sectional analysis of the national database over nine years.

OBJECTIVE: To describe factors associated with mother-to-child HIV transmission (MTCT) in Kenya and identify opportunities to increase testing/care coverage. DESIGN: Cross-sectional analysis of national early infant diagnosis (EID) database. METHODS: 365,841 Kenyan infants were tested for HIV from January 2007-July 2015 and results, demographics, and treatment information were entered into a national database. HIV risk factors were assessed using multivariable logistic regression. RESULTS: 11.1% of infants tested HIV positive in 2007-2010 and 6.9% in 2014-2015. Greater odds of infection were observed in females (OR: 1.08; 95% CI:1.05-1.11), older children (18-24 months vs. 6 weeks-2 months: 4.26; 95% CI:3.87-4.69), infants whose mothers received no PMTCT intervention (vs. HAART OR: 1.92; 95% CI:1.79-2.06), infants receiving no prophylaxis (vs. nevirapine for 6 weeks OR: 2.76; 95% CI:2.51-3.05), and infants mixed breastfed (vs. exclusive breastfeeding OR: 1.39; 95% CI:1.30-1.49). In 2014-2015, 9.1% of infants had mothers who were not on treatment during pregnancy, 9.8% were not on prophylaxis, and 7.0% were mixed breastfed. Infants exposed to all three risky practices had a seven-fold higher odds of HIV infection compared to those exposed to recommended practices. The highest yield of HIV-positive infants were found through targeted testing of symptomatic infants in pediatric/outpatient departments (>15%); still, most infected infants were identified through PMTCT programs. CONCLUSION: Despite impressive gains in Kenya's PMTCT program, some HIV-infected infants present late and are not benefitting from PMTCT best practices. Efforts to identify these early and enforce evidence-based practice for PMTCT should be scaled up. Infant testing should be expanded in pediatric/outpatient departments, given high yields in these portals.

HIV-associated mortality in the era of antiretroviral therapy scale-up - Nairobi, Kenya, 2015.

BACKGROUND: Declines in HIV prevalence and increases in antiretroviral treatment coverage have been documented in Kenya, but population-level mortality associated with HIV has not been directly measured. In urban areas where a majority of deaths pass through mortuaries, mortuary-based studies have the potential to contribute to our understanding of excess mortality among HIV-infected persons. We used results from a cross-sectional mortuary-based HIV surveillance study to estimate the association between HIV and mortality for Nairobi, the capital city of Kenya. METHODS AND FINDINGS: HIV seropositivity in cadavers measured at the two largest mortuaries in Nairobi was used to estimate HIV prevalence in adult deaths. Model-based estimates of the HIV-infected and uninfected population for Nairobi were used to calculate a standardized mortality ratio and population-attributable fraction for mortality among the infected versus uninfected population. Monte Carlo simulation was used to assess sensitivity to epidemiological assumptions. When standardized to the age and sex distribution of expected deaths, the estimated HIV positivity among adult deaths aged 15 years and above in Nairobi was 20.9% (95% CI 17.7-24.6%). The standardized mortality ratio of deaths among HIV-infected versus uninfected adults was 4.35 (95% CI 3.67-5.15), while the risk difference was 0.016 (95% CI 0.013-0.019). The HIV population attributable mortality fraction was 0.161 (95% CI 0.131-0.190). Sensitivity analyses demonstrated robustness of results. CONCLUSIONS: Although 73.6% of adult PLHIV receive antiretrovirals in Nairobi, their risk of death is four-fold greater than in the uninfected, while 16.1% of all adult deaths in the city can be attributed to HIV infection. In order to further reduce HIV-associated mortality, high-burden countries may need to reach very high levels of diagnosis, treatment coverage, retention in care, and viral suppression.