The costs and financing needs of delivering Kenya's primary health care service package.

Introduction: For many Kenyans, high-quality primary health care (PHC) services remain unavailable, inaccessible, or unaffordable. To address these challenges, the Government of Kenya has committed to strengthening the country's PHC system by introducing a comprehensive package of PHC services and promoting the efficient use of existing resources through its primary care network approach. Our study estimated the costs of delivering PHC services in public sector facilities in seven sub-counties, comparing actual costs to normative costs of delivering Kenya's PHC package and determining the corresponding financial resource gap to achieving universal coverage. Methods: We collected primary data from a sample of 71 facilities, including dispensaries, health centers, and sub-county hospitals. Data on facility-level recurrent costs were collected retrospectively for 1 year (2018-2019) to estimate economic costs from the public sector perspective. Total actual costs from the sampled facilities were extrapolated using service utilization data from the Kenya Health Information System for the universe of facilities to obtain sub-county and national PHC cost estimates. Normative costs were estimated based on standard treatment protocols and the populations in need of PHC in each sub-county. Results and discussion: The average actual PHC cost per capita ranged from US$ 9.3 in Ganze sub-county to US$ 47.2 in Mukurweini while the normative cost per capita ranged from US$ 31.8 in Ganze to US$ 42.4 in Kibwezi West. With the exception of Mukurweini (where there was no financial resource gap), closing the resource gap would require significant increases in PHC expenditures and/or improvements to increase the efficiency of PHC service delivery such as improved staff distribution, increased demand for services and patient loads per clinical staff, and reduced bypass to higher level facilities. This study offers valuable evidence on sub-national cost variations and resource requirements to guide the implementation of the government's PHC reforms and resource mobilization efforts.

Computer-Based Counseling Program (CARE+ Kenya) to Promote Prevention and HIV Health for People Living With HIV/AIDS: A Randomized Controlled Trial.

In countries experiencing the dual burden of HIV disease and health care worker shortages, information and communication technology tools offer the potential to help support HIV treatment adherence and secondary HIV transmission risk reduction for people living with HIV/AIDS. We conducted a randomized controlled trial (September 1, 2011-July 12, 2012) with follow-up through April 2013. Participants were recruited from two clinics affiliated with the Academic Model Providing Access to Healthcare program in western Kenya. A total of 236 participants were enrolled, randomly assigned to intervention (n = 118) or risk-assessment only control (n = 118) and followed up for 9 months. Both arms had > 0.5 log10 reduction in viral load over time (p = .0007), a clinically relevant finding. A computer-based counseling tool is feasible and acceptable in a high-volume East African HIV setting and provides evidence-based ART adherence and risk reduction support that may extend health workforce deficits.

Tuberculosis control activities in the private and public health sectors of Kenya from 2013 to 2017: how do they compare?

BACKGROUND: Large numbers of tuberculosis (TB) patients seek care from private for-profit providers. This study aimed to assess and compare TB control activities in the private for-profit and public sectors in Kenya between 2013 and 2017. METHODS: We conducted a retrospective cross-sectional study using routinely collected data from the National Tuberculosis, Leprosy and Lung Disease Program. RESULTS: Of 421 409 patients registered and treated between 2013 and 2017, 86 894 (21%) were from the private sector. Data collection was less complete in the private sector for nutritional assessment and follow-up sputum smear examinations (p<0.001). The private sector notified less bacteriologically confirmed TB (43.1% vs 52.6%; p<0.001) and had less malnutrition (body mass index <18.5 kg/m2; 36.4% vs 43.3%; p<0.001) than the public sector. Rates of human immunodeficiency virus (HIV) testing and antiretroviral therapy initiation were >95% and >90%, respectively, in both sectors, but more patients were HIV positive in the private sector (39.6% vs 31.6%; p<0.001). For bacteriologically confirmed pulmonary TB, cure rates were lower in the private sector, especially for HIV-negative patients (p<0.001). The private sector had an overall treatment success of 86.3% as compared with the public sector at 85.7% (p<0.001). CONCLUSIONS: The private sector is performing well in Kenya although there are programmatic challenges that need to be addressed.

Efficacy and Safety of Pafuramidine versus Pentamidine Maleate for Treatment of First Stage Sleeping Sickness in a Randomized, Comparator-Controlled, International Phase 3 Clinical Trial.

BACKGROUND: Sleeping sickness (human African trypanosomiasis [HAT]) is a neglected tropical disease with limited treatment options that currently require parenteral administration. In previous studies, orally administered pafuramidine was well tolerated in healthy patients (for up to 21 days) and stage 1 HAT patients (for up to 10 days), and demonstrated efficacy comparable to pentamidine. METHODS: This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospitals in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included. The primary efficacy endpoint was the combined rate of clinical and parasitological cure at 12 months. The primary safety outcome was the frequency and severity of adverse events. The study was registered on the International Clinical Trials Registry Platform at www.clinicaltrials.gov with the number ISRCTN85534673. FINDINGS/CONCLUSIONS: The overall cure rate at 12 months was 89% in the pafuramidine group and 95% in the pentamidine group; pafuramidine was non-inferior to pentamidine as the upper bound of the 95% confidence interval did not exceed 15%. The safety profile of pafuramidine was superior to pentamidine; however, 3 patients in the pafuramidine group had glomerulonephritis or nephropathy approximately 8 weeks post-treatment. Two of these events were judged as possibly related to pafuramidine. Despite good tolerability observed in preceding studies, the development program for pafuramidine was discontinued due to delayed post-treatment toxicity.

Assessing the impact of a primary care electronic medical record system in three Kenyan rural health centers.

OBJECTIVE: Efficient, effective health care requires rapid availability of patient information. We designed, implemented, and assessed the impact of a primary care electronic medical record (EMR) in three rural Kenyan health centers. METHOD: Local clinicians identified data required for primary care and public health reporting. We designed paper encounter forms to capture these data in adult medicine, pediatric, and antenatal clinics. Encounter form data were hand-entered into a new primary care module in an existing EMR serving onsite clinics serving patients infected with the human immunodeficiency virus (HIV). Before subsequent visits, Summary Reports were printed containing selected patient data with reminders for needed HIV care. We assessed effects on patient flow and provider work with time-motion studies before implementation and two years later, and we surveyed providers' satisfaction with the EMR. RESULTS: Between September 2008 and December 2011, 72 635 primary care patients were registered and 114 480 encounter forms were completed. During 2011, 32 193 unique patients visited primary care clinics, and encounter forms were completed for all visits. Of 1031 (3.2%) who were HIV-infected, 85% received HIV care. Patient clinic time increased from 37 to 81 min/visit after EMR implementation in one health center and 56 to 106 min/visit in the other. However, outpatient visits to both health centers increased by 85%. Three-quarters of increased time was spent waiting. Despite nearly doubling visits, there was no change in clinical officers' work patterns, but the nurses' and the clerks' patient care time decreased after EMR implementation. Providers were generally satisfied with the EMR but desired additional training. CONCLUSIONS: We successfully implemented a primary care EMR in three rural Kenyan health centers. Patient waiting time was dramatically lengthened while the nurses' and the clerks' patient care time decreased. Long-term use of EMRs in such settings will require changes in culture and workflow.

Accuracy and Acceptability of Oral Fluid HIV Self-Testing in a General Adult Population in Kenya.

We evaluated performance, accuracy, and acceptability parameters of unsupervised oral fluid (OF) HIV self-testing (HIVST) in a general population in western Kenya. In a prospective validation design, we enrolled 240 adults to perform rapid OF HIVST and compared results to staff administered OF and rapid fingerstick tests. All reactive, discrepant, and a proportion of negative results were confirmed with lab ELISA. Twenty participants were video-recorded conducting self-testing. All participants completed a staff administered survey before and after HIVST to assess attitudes towards OF HIVST acceptability. HIV prevalence was 14.6 %. Thirty-six of the 239 HIVSTs were invalid (15.1 %; 95 % CI 11.1-20.1 %), with males twice as likely to have invalid results as females. HIVST sensitivity was 89.7 % (95 % CI 73-98 %) and specificity was 98 % (95 % CI 89-99 %). Although sensitivity was somewhat lower than expected, there is clear interest in, and high acceptability (94 %) of OF HIV self-testing.

Implementation and Operational Research: A Time-Motion Analysis of HIV Transmission Prevention Counseling and Antiretroviral Adherence Messages in Western Kenya.

BACKGROUND: Shortages of health workers and large number of HIV-infected persons in Africa mean that time to provide antiretroviral therapy (ART) adherence and other messages to patients is limited. METHODS: Using time-motion methodology, we documented the intensity and nature of counseling delivered to patients. The study was conducted at a rural and an urban HIV clinic in western Kenya. We recorded all activities of 190 adult patients on ART during their return clinic visits to assess type, frequency, and duration of counseling messages. RESULTS: Mean visit length for patients at the rural clinic was 44.5 (SD = 27.9) minutes and at urban clinic was 78.2 (SD = 42.1) minutes. Median time spent receiving any counseling during a visit was 4.07 minutes [interquartile range (IQR), 1.57-7.33] at rural and 3.99 (IQR, 2.87-6.25) minutes at urban, representing 11% and 8% of total mean visit time, respectively. Median time patients received ART adherence counseling was 1.29 (IQR, 0.77-2.83) minutes at rural and 1.76 (IQR, 1.23-2.83) minutes at urban (P = 0.001 for difference). Patients received a median time of 0.18 (0-0.72) minutes at rural and 0.28 (IQR, 0-0.67) minutes at urban clinic of counseling regarding contraception and pregnancy. Most patients in the study did not receive any counseling regarding alcohol/substance use, emerging risks for ongoing HIV transmission. CONCLUSIONS: Although ART adherence was discussed with most patients, time was limited. Reproductive counseling was provided to only half of the patients, and "positive prevention" messaging was minimal. There are strategic opportunities to enhance counseling and information received by clients within HIV programs in resource-limited settings.