BACKGROUND: Sub-Saharan Africa region bears the highest chronic hepatitis B virus (HBV) infection burden worldwide. National estimates of HBV burden are necessary for a viral hepatitis program planning. This study estimated the national prevalence of HBV infection in Kenya among people aged 15-64 years. METHODS: Of 27,745 participants age 15-64 years in the Kenya Population-based HIV Impact Assessment (KENPHIA) 2018 household survey, we analyzed data for all persons living with HIV (PLHIV; n = 1,521) and a random sample of HIV-negative persons (n = 1,551), totaling to 3,072 participants. We tested whole blood samples for hepatitis B surface antigen (HBsAg) using Determine™ HBsAg rapid test and used population projections to estimate national disease burden. Pearson chi square was performed and the weighted prevalence proportions presented. FINDINGS: Of the 3,072 participants,124 tested HBsAg positive, resulting in a weighted national HBV prevalence of 3.0% (95% CI: 2.2-3.9%). This translated to an HBV infection burden of 810,600 (95% CI: 582,700-1,038,600) persons age 15-64 years in Kenya. Distribution of HBV prevalence varied widely (p<0.001) by geography, ranging from 0.1% in Eastern Kenya regions to over 5% in northern and western Kenya. Prevalence of HBV infection was higher in PLHIV (4.7%; 95% CI: 3.3-6.0%) compared to HIV-negative persons (3.0%; 95% CI: 2.1-3.9%), and was highest among persons: age 45-54 years (6.4%; 95% CI: 3.3-9.5%), those who reported no formal education (10.7%; 95% CI: 5.1-16.4%), in polygamous marriages (6.8%; 95% CI: 1.7-11.8%), and in the lowest wealth quintile (5.3%; 95% CI: 2.8-7.7). When adjusted for covariates, lack of formal education (aOR = 4.2; 95% CI: 1.5-12.6) was significantly associated with HBV infection. In stratified analysis by HIV status, residing in rural areas and history of blood transfusion were independently associated with HBV infection among PLHIV, while lack of formal education and no history of blood transfusion were associated with HBV infection among HIV-negative participants (p<0.05). INTERPRETATION: HBV prevalence among persons aged 15-64 years in Kenya was 3.0%. Higher prevalence was documented among persons without formal education, in the lowest wealth quintile, and those living in Kenya's North-Eastern, Rift Valley-North and Nyanza regions. Targeted programmatic measures to strengthen interventions against HBV infections including newborn vaccination and treatment of infected adults to limit mother-to-child transmission, would be helpful in reducing burden of HBV-associated viral hepatitis.

BACKGROUND: HIV low-level viremia (LLV) (51-999 copies/mL) can progress to treatment failure and increase potential for drug resistance. We analyzed retrospective longitudinal data from people living with HIV (PLHIV) on antiretroviral therapy (ART) in Kenya to understand LLV prevalence and virologic outcomes. METHODS: We calculated rates of virologic suppression (≤50 copies/mL), LLV (51-999 copies/mL), virologic non-suppression (≥1000 copies/mL), and virologic failure (≥2 consecutive virologic non-suppression results) among PLHIV aged 15 years and older who received at least 24 weeks of ART during 2015-2021. We analyzed risk for virologic non-suppression and virologic failure using time-dependent models (each viral load (VL) <1000 copies/mL used to predict the next VL). FINDINGS: Of 793,902 patients with at least one VL, 18.5% had LLV (51-199 cp/mL 11.1%; 200-399 cp/mL 4.0%; and 400-999 cp/mL 3.4%) and 9.2% had virologic non-suppression at initial result. Among all VLs performed, 26.4% were LLV. Among patients with initial LLV, 13.3% and 2.4% progressed to virologic non-suppression and virologic failure, respectively. Compared to virologic suppression (≤50 copies/mL), LLV was associated with increased risk of virologic non-suppression (adjusted relative risk [aRR] 2.43) and virologic failure (aRR 3.86). Risk of virologic failure increased with LLV range (aRR 2.17 with 51-199 copies/mL, aRR 3.98 with 200-399 copies/mL and aRR 7.99 with 400-999 copies/mL). Compared to patients who never received dolutegravir (DTG), patients who initiated DTG had lower risk of virologic non-suppression (aRR 0.60) and virologic failure (aRR 0.51); similarly, patients who transitioned to DTG had lower risk of virologic non-suppression (aRR 0.58) and virologic failure (aRR 0.35) for the same LLV range. INTERPRETATION: Approximately a quarter of patients experienced LLV and had increased risk of virologic non-suppression and failure. Lowering the threshold to define virologic suppression from <1000 to <50 copies/mL to allow for earlier interventions along with universal uptake of DTG may improve individual and program outcomes and progress towards achieving HIV epidemic control. FUNDING: No specific funding was received for the analysis. HIV program support was provided by the President's Emergency Plan for AIDS Relief (PEPFAR) through the United States Centers for Disease Control and Prevention (CDC).

HIV-positive children and adolescents face gaps in viral load (VL) testing. To understand trends in pediatric/adolescent VL testing, 7 countries collected data from Laboratory Information Management Systems. Results showed increasing proportion of VL tests done through dried blood spot (DBS) and decreased sample rejection rates for DBS compared with plasma, supporting use of DBS VL when skilled phlebotomy is unavailable.

We analyzed data from the 2018 Kenya Population-Based HIV Impact Assessment (KENPHIA), a cross-sectional, nationally representative survey, to estimate the burden and prevalence of pediatric HIV infection, identify associated factors, and describe the clinical cascade among children aged < 15 years in Kenya. Interviewers collected information from caregivers or guardians on child's demographics, HIV testing, and treatment history. Blood specimens were collected for HIV serology and if HIV-positive, the samples were tested for viral load and antiretrovirals (ARV). For participants <18 months TNA PCR is performed. We computed weighted proportions with 95% confidence intervals (CI), accounting for the complex survey design. We used bivariable and multivariable logistic regression to assess factors associated with HIV prevalence. Separate survey weights were developed for interview responses and for biomarker testing to account for the survey design and non-response. HIV burden was estimated by multiplying HIV prevalence by the national population projection by age for 2018. Of 9072 survey participants (< 15 years), 87% (7865) had blood drawn with valid HIV test results. KENPHIA identified 57 HIV-positive children, translating to an HIV prevalence of 0.7%, (95% CI: 0.4%-1.0%) and an estimated 138,900 (95% CI: 84,000-193,800) of HIV among children in Kenya. Specifically, children who were orphaned had about 2 times higher odds of HIV-infection compared to those not orphaned, adjusted Odds Ratio (aOR) 2.2 (95% CI:1.0-4.8). Additionally, children whose caregivers had no knowledge of their HIV status also had 2 times higher odds of HIV-infection compared to whose caregivers had knowledge of their HIV status, aOR 2.4 (95% CI: 1.1-5.4)". From the unconditional analysis; population level estimates, 78.9% of HIV-positive children had known HIV status (95% CI: 67.1%-90.2%), 73.6% (95% CI: 60.9%-86.2%) were receiving ART, and 49% (95% CI: 32.1%-66.7%) were virally suppressed. However, in the clinical cascade for HIV infected children, 92% (95% CI: 84.4%-100%) were receiving ART, and of these, 67.1% (95% CI: 45.1%-89.2%) were virally suppressed. The KENPHIA survey confirms a substantial HIV burden among children in Kenya, especially among orphans.

BACKGROUND: Nationally-representative surveys provide an opportunity to assess trends in recent HIV infection based on assays for recent HIV infection. METHODS: 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. FINDINGS: 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<0.001). 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 versus 0-1 partners), and never having tested for HIV (aOR=4.1, 95% CI 1.5-11) were independently associated with recent HIV infection. INTERPRETATION: Though 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.

BACKGROUND: Since 2010, Kenya has used SLIPTA to prepare and improve quality management systems in medical laboratories to achieve ISO 15189 accreditation. However, less than 10% of enrolled laboratories had done so in the initial seven years of SLMTA implementation. OBJECTIVE: We described Kenya's experience in accelerating medical laboratories on SLMTA to attain ISO 15189 accreditation. METHODS: From March 2017 to July 2017, an aggressive top-down approach through high-level management stakeholder engagement for buy-in, needs-based expedited SLIPTA mentorship and on-site support as a rapid results initiative (RRI) was implemented in 39 laboratories whose quality improvement process had stagnated for 2-7 years. In July 2017, SLIPTA baseline and exit audit average scores on quality essential elements were compared to assess performance. RESULTS: After RRI, laboratories achieving greater than a 2-star SLMTA rating increased significantly from 15 (38%) at baseline to 33 (85%) (p < 0.001). Overall, 34/39 (87%) laboratories received ISO 15189 accreditation within two years of RRI, leading to a 330% increase in the number of accredited laboratories in Kenya. The most improved of the 12 quality system essentials were Equipment Management (mean increase 95% CI: 5.31 ± 1.89) and Facilities and Biosafety (mean increase [95% CI: 4.05 ± 1.78]) (both: p < 0.0001). Information Management and Corrective Action Management remained the most challenging to improve, despite RRI interventions. CONCLUSION: High-level advocacy and targeted mentorship through RRI dramatically improved laboratory accreditation in Kenya. Similar approaches of strengthening SLIPTA implementation could improve SLMTA outcomes in other countries with similar challenges.

BACKGROUND: TB is the leading cause of mortality among people living with HIV (PLHIV), for whom isoniazid preventive therapy (IPT) has a proven mortality benefit. Despite WHO recommendations, countries have been slow in scaling up IPT. This study describes processes, challenges, solutions, outcomes and lessons learned during IPT scale-up in Kenya.METHODS: We conducted a desk review and analyzed aggregated Ministry of Health (MOH) IPT enrollment data from 2014 to 2018 to determine trends and impact of program activities. We further analyzed IPT completion reports for patients initiated from 2015 to 2017 in 745 MOH sites in Nairobi, Central, Eastern and Western Kenya.RESULTS: IPT was scaled up 75-fold from 2014 to 2018: the number of PLHIV covered increased from 9,981 to 749,890. The highest percentage increases in the cumulative number of PLHIV on IPT were seen in the quarters following IPT pilot projects in 2014 (49%), national launch in 2015 (54%), and HIV treatment acceleration in 2016 (158%). Among 250,069 patients initiating IPT from 2015 to 2017, 97.5% completed treatment, 0.2% died, 0.8% were lost to follow-up, 1.0% were not evaluated, and 0.6% discontinued treatment.CONCLUSIONS: IPT can be scaled up rapidly and effectively among PLHIV. Deliberate MOH efforts, strong leadership, service delivery integration, continuous mentorship, stakeholder involvement, and accountability are critical to program success.

Background: HIV diagnosis is the gateway to antiretroviral therapy. However, 20-50% of HIV-infected individuals are unaware of their HIV status, derailing epidemic control. | | Objective: To increase awareness of HIV status and enrollment into HIV care & treatment (C&T) services through a national HIV testing services (HTS) rapid results initiative (RRI) campaign in Kenya. | | Design: This cross-sectional analysis presents yield of undiagnosed people living with HIV (PLHIV) and their enrollment into HIV C&T resulting from HTS RRI implemented in July-August 2013 as an example of utilizing RRIs to catalyze achievement of UNAIDS targets. | | Results: During the campaign 1,462,378 persons received HTS, of whom 220,902 (15%) were children (aged <15 years), 55,088 (7%) couples and 116,126 (8%) key populations. A total of 37,630 (2.6%) HIV+ individuals were identified. Among children who received HTS, 3,244 (1.5%) tested HIV positive, compared to 34,386 (2.8%) among adults. Of the eight regions in Kenya: Nyanza, Rift-valley and | Nairobi contributed 73.3% of all HIV+ individuals identified. HTS at health facility settings yielded the highest proportion (69%) of HIV+ and key populations had the highest prevalence (4.8%). Of those infected, 29,851 (79.3%) were enrolled into HIV C&T. Sex, age and setting of HTS were significantly associated with enrollment into HIV C&T (p<0.0001). | | Conclusion: National HTS campaigns have the potential of increasing knowledge of HIV status. Targeted provision of HTS at health facility settings, to key populations and high burden geographical regions would narrow the gap of undiagnosed PLHIV towards achieving UNIADS 90-90-90 targets for HIV epidemic control.

Background: Pre-enrollment loss to follow-up and delayed linkage to HIV care and treatment (C&T) of newly-diagnosed HIV-infected individuals are associated with increased morbidity and mortality. Objective: To describe quality improvement approach utilized by Eastern Deanery AIDS Relief Program (EDARP) to increase linkage to HIV C&T of newly-diagnosed HIV-infected individuals. Design: Cross-sectional descriptive assessement of a three-phased continuous quality improvement (CQI) project among 20,972 newly diagnosed HIV patients at 14 EDARP health facilities in Nairobi, Kenya. Phase 1 physically escorting patients to the HIV C&T clinic; Phase 2 use of linkage registers and timely tracking and tracing individuals who missed appointments; Phase 3 use of patient HIV literacy materials. Routine patient data collected during the CQI interventions implemented between October 2011 and September 2015 were analyzed. Results: Implementation of the three CQI phases significantly increased linkage to HIV C&T from 60% at baseline in 2011 to 98% in 2015 (p<0.0001). Factors associated with decreased linkage to HIV C&T through this CQI intervention were: age (adolescents aged 1019 years), [odds ratio (OR) 0.60, 95% confidence interval (CI): 0.51-7.0]; female sex [OR 0.64, (95% CI: 0.59-0.70)] and unemployement [OR 0.84, (95% CI: 0.77-0.92)]. First time tester [OR 1.9, (95% CI: 1.8-2.1)] and divorcees [OR 2.0, (95% CI: 1.7-2.3)], (p<0.001) had increased likelihood of linkage to HIV C&T. Conclusion: Successful linkage to HIV C&T services for newly-diagnosed HIV-infected individuals is achievable through adoption of feasible and low-cost multi-pronged CQI interventions.