Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative.

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.

Formative assessment to identify perceived benefits and barriers of HIV oral self-testing among female sex workers, service providers, outreach workers, and peer educators to inform scale-up in Kenya.

In Kenya, HIV prevalence estimates among female sex workers (FSWs) are almost five times higher than among women in the general population. However, only 68% of infected FSWs are aware of their HIV-positive status. We aimed to identify perceived benefits, opportunities, and barriers of HIV self-testing (HIVST) in improving testing coverage among FSWs. Twenty focus group discussions were conducted with 77 service providers, 42 peer educators (PEs) and outreach workers, and 37 FSWs attending drop-in centers (DiCEs) in four regions of Kenya. An additional 8 FSWs with HIV-negative or unknown status-completed in-depth interviews. Data were analyzed thematically. Acceptability of HIVST was high, with cited benefits including confidentiality, convenience, and ease of use. Barriers included absence of counseling, potential for inaccurate results, fear of partner reaction, possible misuse, and fear that HIVST could lead to further stigmatization. PEs and DiCEs were the preferred models for distributing HIVST kits. FSWs wanted kits made available free or at a nominal cost (100 Kenya Shillings or ∼USD 1). Linkage to confirmatory testing, the efficiency of distributing HIVST kits using peers and DiCEs, and the types and content of effective HIVST messaging require further research.

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 with Scale-Up of HIV Viral Load Monitoring - Seven Sub-Saharan African Countries, January 2015-June 2016.

The World Health Organization (WHO) recommends viral load testing as the preferred method for monitoring the clinical response of patients with human immunodeficiency virus (HIV) infection to antiretroviral therapy (ART) (1). Viral load monitoring of patients on ART helps ensure early diagnosis and confirmation of ART failure and enables clinicians to take an appropriate course of action for patient management. When viral suppression is achieved and maintained, HIV transmission is substantially decreased, as is HIV-associated morbidity and mortality (2). CDC and other U.S. government agencies and international partners are supporting multiple countries in sub-Saharan Africa to provide viral load testing of persons with HIV who are on ART. This report examines current capacity for viral load testing based on equipment provided by manufacturers and progress with viral load monitoring of patients on ART in seven sub-Saharan countries (Côte d'Ivoire, Kenya, Malawi, Namibia, South Africa, Tanzania, and Uganda) during January 2015-June 2016. By June 2016, based on the target numbers for viral load testing set by each country, adequate equipment capacity existed in all but one country. During 2015, two countries tested >85% of patients on ART (Namibia [91%] and South Africa [87%]); four countries tested <25% of patients on ART. In 2015, viral suppression was >80% among those patients who received a viral load test in all countries except Côte d'Ivoire. Sustained country commitment and a coordinated global effort is needed to reach the goal for viral load monitoring of all persons with HIV on ART.

Scale-up of HIV Viral Load Monitoring--Seven Sub-Saharan African Countries.

To achieve global targets for universal treatment set forth by the Joint United Nations Programme on human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) (UNAIDS), viral load monitoring for HIV-infected persons receiving antiretroviral therapy (ART) must become the standard of care in low- and middle-income countries (LMIC) (1). CDC and other U.S. government agencies, as part of the President's Emergency Plan for AIDS Relief, are supporting multiple countries in sub-Saharan Africa to change from the use of CD4 cell counts for monitoring of clinical response to ART to the use of viral load monitoring, which is the standard of care in developed countries. Viral load monitoring is the preferred method for immunologic monitoring because it enables earlier and more accurate detection of treatment failure before immunologic decline. This report highlights the initial successes and challenges of viral load monitoring in seven countries that have chosen to scale up viral load testing as a national monitoring strategy for patients on ART in response to World Health Organization (WHO) recommendations. Countries initiating viral load scale-up in 2014 observed increases in coverage after scale-up, and countries initiating in 2015 are anticipating similar trends. However, in six of the seven countries, viral load testing coverage in 2015 remained below target levels. Inefficient specimen transport, need for training, delays in procurement and distribution, and limited financial resources to support scale-up hindered progress. Country commitment and effective partnerships are essential to address the financial, operational, technical, and policy challenges of the rising demand for viral load monitoring.

Dried tube specimens: a simple and cost-effective method for preparation of HIV proficiency testing panels and quality control materials for use in resource-limited settings.

HIV testing has rapidly expanded worldwide, but proficiency testing (PT) programs to monitor and improve the quality of testing are often lacking in resource-limited settings (RLS). Traditional PT programs and quality control reagents use serum or plasma specimens requiring stringent conditions for storage and transportation. A novel, simple and easy to use approach, based on dried tube specimens (DTS), was developed that can help monitor the quality of HIV antibody testing in RLS. DTS were prepared by drying 20 microl of specimen overnight at room temperature. The addition of a green dye (0.1%) made the DTS pellets visible without affecting the test results. Before testing, the DTS were rehydrated with 200 microl of PBS-Tween buffer. A panel of 303 DTS samples (135 HIV positive and 168 HIV negative) was evaluated with two rapid tests. Sensitivity and specificity with the Determine HIV-1/2 test were 99.3% and 99.4%, respectively, and with OraQuick were 98.5% and 100%, respectively. Stability studies showed that HIV-specific antibodies in the DTS specimens were stable at 4 degrees C and 25 degrees C for 4 weeks, with only marginal decline at 37 degrees C and 45 degrees C over 4 weeks. The DTS-based PT program was piloted successfully in 24 testing sites in Kenya. Results demonstrate that the DTS is a simple to use, practical method to prepare and distribute PT panels and quality control specimens to monitor HIV testing practices in RLS.