A cluster randomized controlled trial to assess the impact of the 'Caring for Providers to Improve Patient Experience' intervention on person-centered maternity care in Kenya and Ghana: Study Protocol.

Background: Poor person-centered maternal care (PCMC) contributes to high maternal mortality and morbidity, directly and indirectly, through lack of, delayed, inadequate, unnecessary, or harmful care. While evidence on poor PCMC prevalence, as well as inequities, expanded in the last decade, there is still a significant gap in evidence-based interventions to address PCMC. We describe the protocol for a trial to test the effectiveness of the "Caring for Providers to Improve Patient Experience" (CPIPE) intervention, which includes five strategies for provider behavior change, targeting provider stress and bias as intermediate factors to improve PCMC and to address inequities. Methods: The trial will assess the effect of CPIPE on PCMC, as well as on intermediate and distal outcomes, using a two-arm cluster randomized controlled trial in 40 health facilities in Migori and Homa Bay Counties in Kenya and Upper East and Northeast Regions in Ghana. Twenty facilities in each country will be randomized to 10 intervention and 10 control sites. The primary intervention targets are all healthcare workers who provide maternal health services. The intervention impact will also be assessed first among providers, and then among women who give birth in health facilities. The primary outcome is PCMC measured with the PCMC scale, via multiple cross-sectional surveys of mothers who gave birth in the preceding 12 weeks in study facilities at baseline (prior to the intervention), midline (6 months after intervention start), and endline (12 months post-baseline) (N = 2000 across both countries at each time point). Additionally, 400 providers in the study facilities across both countries will be followed longitudinally at baseline, midline, and endline, to assess intermediate outcomes. The trial incorporates a mixed-methods design; survey data alongside in-depth interviews (IDIs) with healthcare facility leaders, providers, and mothers to qualitatively explore factors influencing the outcomes. Finally, we will collect process and cost data to assess intervention fidelity and cost-effectiveness. Discussion: This trial will be the first to rigorously assess an intervention to improve PCMC that addresses both provider stress and bias and will advance the evidence base for interventions to improve PCMC and contribute to equity in maternal and neonatal health.

Diabetes mellitus and associated risk factors among HIV infected patients on HAART.

BACKGROUND: Understanding the impact of disease associations is becoming a priority in Kenya and other countries bearing the load of infectious diseases. With the increased incidences of non-communicable diseases and the endemicity of infectious diseases in Sub-Saharan Africa, their co-existence poses significant challenges to patients, health workers and an overwhelmed health sector. Classical risk factors for diabetes such as physical inactivity and unhealthy diet may not solely explain the current trends, suggesting the role of novel risk factors including infections/inflammation. HIV and its treatment have been identified as potential contributors especially to patients with family history of confirmed diabetes cases. Co-infections frequently observed during HIV infection also significantly influence both the epidemiological and pathophysiological of the link between HIV and diabetes. Understanding the correlates of HIV and diabetes is crucial to inform management and prevention strategies of the twin infections. We therefore aimed to determine the prevalence of diabetes mellitus and risk factors in a population of HIV infected patients on HAART. This study determined the association of diabetes/impaired glucose regulation in the context of HIV-1. A cross-sectional study was conducted at a comprehensive care clinic in Nairobi (Kenya). Participants were screened for diabetes and impaired glucose regulation using random blood glucose and glycated haemoglobin (HbA1c) This paper describes the prevalence of diabetes mellitus in Human Immunodeficiency Virus positive individuals and the associated risk factors. We have demonstrated that family history is a risk factor for diabetes. While age and BMI are known risk factors, they were not associated with diabetes in this study.

Mixed methods evaluation of the Caring for Providers to Improve Patient Experience intervention.

OBJECTIVE: To assess the impact of the Caring for Providers to Improve Patient Experience (CPIPE) intervention, which sought to improve person-centered maternal care (PCMC) by addressing two key drivers: provider stress and bias. METHODS: CPIPE was successfully piloted over 6 months in two health facilities in Migori County, Kenya, in 2022. The evaluation employed a mixed-methods pretest-posttest nonequivalent control group design. Data are from surveys with 80 providers (40 intervention, 40 control) at baseline and endline and in-depth interviews with 20 intervention providers. We conducted bivariate, multivariate, and difference-in-difference analysis of quantitative data and thematic analysis of qualitative data. RESULTS: In the intervention group, average knowledge scores increased from 7.8 (SD = 2.4) at baseline to 9.5 (standard deviation [SD] = 1.8) at endline for stress (P = 0.001) and from 8.9 (SD = 1.9) to 10.7 (SD = 1.7) for bias (P = 0.001). In addition, perceived stress scores decreased from 20.9 (SD = 3.9) to 18.6 (SD = 5.3) (P = 0.019) and burnout from 3.6 (SD = 1.0) to 3.0 (SD = 1.0) (P = 0.001), with no significant change in the control group. Qualitative data indicated that CPIPE had an impact at multiple levels. At the individual level, it improved provider knowledge, skills, self-efficacy, attitudes, behaviors, and experiences. At the interpersonal level, it improved provider-provider and patient-provider relationships, leading to a supportive work environment and improved PCMC. At the institutional level, it created a system of accountability for providing PCMC and nondiscriminatory care, and collective action and advocacy to address sources of stress. CONCLUSION: CPIPE impacted multiple outcomes in the theory of change, leading to improvements in both provider and patient experience, including for the most vulnerable patients. These findings will contribute to global efforts to prevent burnout and promote PCMC and equity.

Mothers' Willingness to Use Workplace Lactation Supports: Evidence from Formally Employed Mothers in Central Kenya.

Background: Formally employed mothers are vulnerable to early cessation of exclusive breastfeeding. Kenyan national policy requires employer-provided maternity benefits and workplace lactation supports. Objective: The objective of this study was to evaluate willingness to use nationally mandated workplace lactation supports among formally employed women in Kenya. Methods: We conducted a cross-sectional survey among 304 mothers of children ages ≤12 mo in Naivasha, Kenya, who were currently formally employed and employed before delivery of the most recent child to assess availability of and willingness to use current and potential future workplace lactation supports. Results: The most available reported workplace lactation supports were schedule flexibility to arrive late or leave early (87.8%) or visit a child to nurse during lunch (24.7%), followed by company-funded community-based daycare (7.6%). Few (<4.0%) reported the availability of lactation rooms, on-site daycares, transportation to breastfeed during lunch, refrigerators for expressed milk, or manual or electric breastmilk pumps. If made available, >80% of mothers reported moderate or strong willingness to use flexible schedules to arrive late or leave early, break during lunch, and transportation to visit a child to nurse. A moderate proportion reported strong willingness to use on-site daycares (63.8%), company-funded community-based daycare (56.9%), on-site lactation rooms (60.5%), refrigeration for expressed milk (49.3%), manual (40.5%), and electric pumps (27.6%). Mothers expressed fear of missing production targets and reported more willingness to use on-site compared with off-site daycare to save transportation time but noted concerns about chemical exposures and early arrival times with young infants. Hesitations regarding the use of on-site lactation rooms included concerns about privacy, milk identification and storage, and use and sharing of pumps. Conclusions: Flexible schedules were the workplace lactation supports in highest demand among formally employed mothers. Maternal willingness to use lactation rooms, refrigeration, and pumping equipment was moderate to low, suggesting sensitization may help to increase demand as the implementation of Kenyan policies moves forward.

Perinatal care and breastfeeding education during the COVID-19 pandemic: Perspectives from Kenyan mothers and healthcare workers.

The impact of the COVID-19 pandemic on breastfeeding (BF) practices in low- and middle-income countries (LMICs) is not well understood. Modifications in BF guidelines and delivery platforms for breastfeeding education during the COVID-19 pandemic are hypothesised to have affected BF practices. We aimed to understand the experiences with perinatal care, BF education and practice among Kenyan mothers who delivered infants during the COVID-19 pandemic. We conducted in-depth key informant interviews with 45 mothers who delivered infants between March 2020 and December 2021, and 26 health care workers (HCW) from four health facilities in Naivasha, Kenya. While mothers noted that HCWs provided quality care and BF counselling, individual BF counselling was cited to be less frequent than before the pandemic due to altered conditions in health facilities and COVID-19 safety protocols. Mothers stated that some HCW messages emphasised the immunologic importance of BF. However, knowledge among mothers about the safety of BF in the context of COVID-19 was limited, with few participants reporting specific counselling or educational materials on topics such as COVID-19 transmission through human milk and the safety of nursing during a COVID-19 infection. Mothers described COVID-19-related income loss and lack of support from family and friends as the major challenge to practising exclusive breastfeeding (EBF) as they wished or planned. COVID-19 restrictions limited or prevented mothers' access to familial support at facilities and at home, causing them stress and fatigue. In some cases, mothers reported job loss, time spent seeking new means of employment and food insecurity as causes for milk insufficiency, which contributed to mixed feeding before 6 months. The COVID-19 pandemic created changes to the perinatal experience for mothers. While messages about the importance of practising EBF were provided, altered HCW education delivery methods, reduced social support and food insecurity limit EBF practices for mothers in this context.

Sources of stress and coping mechanisms: Experiences of maternal health care providers in Western Kenya.

The dynamic and complex nature of care provision predisposes healthcare workers to stress, including physical, emotional, or psychological fatigue due to individual, interpersonal, or organizational factors. We conducted a convergent mixed-methods study with maternity providers to understand their sources of stress and coping mechanisms they adopt. Data were collected in Migori County in western Kenya utilizing quantitative surveys with n = 101 maternity providers and in-depth interviews with a subset of n = 31 providers. We conducted descriptive analyses for the quantitative data. For qualitative data, we conducted thematic analysis, where codes were deductively developed from interview guides, iteratively refined based on emergent data, and applied by a team of five researchers using Dedoose software. Code queries were then analysed to identify themes and organized using the socioecological (SE) framework to present findings at the individual, interpersonal, and organizational levels. Providers reported stress due to high workloads (61%); lack of supplies (37%), poor salary (32%), attitudes of colleagues and superiors (25%), attitudes of patients (21%), and adverse outcomes (16%). Themes from the qualitative analysis mirrored the quantitative analysis with more detailed information on the factors contributing to each and how these sources of stress affect providers and patient outcomes. Coping mechanisms adopted by providers are captured under three themes: addressing stress by oneself, reaching out to others, and seeking help from a higher power. Findings underscore the need to address organizational, interpersonal, and individual level stressors. Strategies are needed to support staff retention, provide adequate resources and incentives for providers, and ultimately improve patient outcomes. Interventions should support and leverage the positive coping mechanisms identified.

Caring for providers to improve patient experience (CPIPE): intervention development process.

A growing body of research has documented disrespectful, abusive, and neglectful treatment of women in facilities during childbirth, as well as the drivers of such mistreatment. Yet, little research exists on effective interventions to improve Person-Centred Maternal Care (PCMC)-care that is respectful and responsive to individual women's preferences, needs, and values. We sought to extend knowledge on interventions to improve PCMC, with a focus on two factors - provider stress and implicit bias - that are driving poor PCMC and contributing to disparities in PCMC. In this paper we describe the process towards the development of the intervention. The intervention design was an iterative process informed by existing literature, behaviour change theory, formative research, and continuous feedback in consultation with key stakeholders. The intervention strategies were informed by the Social Cognitive Theory, Trauma Informed System framework, and the Ecological Perspective. This process resulted in the 'Caring for Providers to Improve Patient Experience (CPIPE)' intervention, which has 5 components: provider training, peer support, mentorship, embedded champions, and leadership engagement. The training includes didactic and interactive content on PCMC, stress, burnout, dealing with difficult situations, and bias, with some content integrated into emergency obstetric and neonatal care (EmONC) simulations to enable providers apply concepts in the context of managing an emergency. The other components create an enabling environment for ongoing individual behavior and facility culture change. The pilot study is being implemented in Migori County, Kenya. The CPIPE intervention is an innovative theory and evidence-based intervention that addresses key drivers of poor PCMC and centers the unique needs of vulnerable women as well as that of providers. This intervention will advance the evidence base for interventions to improve PCMC and has great potential to improve equity in PCMC and maternal and neonatal health.

Provider perceptions of lack of supportive care during childbirth: A mixed methods study in Kenya.

Supportive care is a key component of person-centered maternity care (PCMC), and includes aspects such as timely and attentive care, pain control, and the health facility environment. Yet, few researchers have explored the degree of supportive care delivered or providers' perceptions on supportive care practices during childbirth. The researchers' aim is to evaluate the extent of supportive care provided to women during childbirth and to identify the drivers behind the lack of supportive care from the perspective of maternity providers in a rural county in Western Kenya. Data are from a mixed-methods study in Migori County in Western Kenya with 49 maternity providers (32 clinical and 17 non-clinical). Providers were asked structured questions on various aspects of supportive care followed by open ended questions on why certain practices were performed or not. We conducted descriptive analysis of the quantitative data and thematic analysis of the qualitative data. We analyzed data and found inconsistent and suboptimal practices with regards to supportive care. Some providers reported long patient wait times in their facilities as well as the inability to provide the best care due to staff shortages in their facilities. Others also reported low interest and inquiry about women's experience of pain during childbirth, which was driven by perceptions of pain during childbirth as normal, facility culture and norms, and lack of pain medicine. For the facility environment, providers reported relatively clean facilities. They, however, noted inconsistent water and electricity as well as inadequate safety. We conclude that many drivers of the lack of supportive care are caused by structural health systems issues, therefore a health system strengthening approach can be useful for improving the supportive care dimension of PCMC, and thus quality of care overall.

Community Perceptions of Person-Centered Maternity Care in Migori County, Kenya.

Background: Community perceptions of quality of maternal healthcare services-including Person-centered maternity care (PCMC)-influences the health-seeking behavior of women. Yet few studies have examined this quantitatively. This study aims to examine community perceptions of PCMC and its associated factors. Materials and Methods: We used data from a survey on community perceptions of PCMC in Migori County, Kenya conducted in August 2016. Community members were relatives or friends of women aged 15 to 49 years who gave birth in the 9 wk preceding the survey (N = 198). PCMC was measured using a 30-item scale with three sub-scales for dignity and respect, communication and autonomy, and supportive care. PCMC scores were standardized to range from 0 to 100, with higher scores indicative of higher PCMC. Descriptive, bivariate, and multivariate analyses were performed in STATA (version 14). Results: The average total PCMC score was 62 (SD = 15.7), with scores of 74, 63, and 53 for dignity and respect, supportive care, and communication and autonomy, respectively. Controlling for other factors, respondents who were employed and literate had higher PCMC perception scores than those who were less literate and unemployed. Respondents who rated their health as very good had higher PCMC perception scores than those who rated their health as poor. Female respondents who previously gave birth at a health facility had lower perceptions of dignity and respect than those with no prior facility birth. Conclusion: The findings imply that community perceptions of PCMC, particularly related to communication and autonomy, are poor. Given the effects of these perceptions on use of maternal health services, there is a need to improve PCMC.

Exclusive breastfeeding among working mothers in Kenya: Perspectives from women, families and employers.

Exclusive breastfeeding (EBF) for the first 6 months of life improves survival, growth and development. In Kenya, recent legislation and policies advocate for maternity leave and workplace support for breastfeeding and breast milk expression. We conducted a qualitative study to describe factors influencing EBF for 6 months among mothers employed in commercial agriculture and tourism. We interviewed employed mothers (n = 42), alternate caregivers and employed mothers' husbands (n = 20), healthcare providers (n = 21), daycare directors (n = 22) and commercial flower farm and hotel managers (n = 16) in Naivasha, Kenya. Despite recognizing the recommended duration for EBF, employed mothers describe the early cessation of EBF in preparation for their return to work. Managers reported supporting mothers through flexible work hours and duties. Yet, few workplaces have lactation spaces, and most considered adjusting schedules more feasible than breastfeeding during work. Managers and healthcare providers believed milk expression could prolong EBF but thought mothers lack experience with pumping. The most frequently suggested interventions for improving EBF duration were to expand schedule flexibility (100% of groups), provide on-site daycare (80% of groups) and workplace lactation rooms (60% of groups), improve milk expression education and increase maternity leave length (60% of groups). Returning to work corresponds with numerous challenges including lack of proximate or on-site childcare and low support for and experience with milk expression. These factors currently make EBF for 6 months unattainable for most mothers in these industries. Interventions and supports to improve breastfeeding upon return to work are recommended to strengthen employed mothers' opportunity for EBF.

Psychological and physiological stress and burnout among maternity providers in a rural county in Kenya: individual and situational predictors.

BACKGROUND: Stress and burnout among healthcare workers has been recognized as a global crisis needing urgent attention. Yet few studies have examined stress and burnout among healthcare providers in sub-Saharan Africa, and even fewer among maternity providers who work under very stressful conditions. To address these gaps, we examined self-reported stress and burnout levels as well as stress-related physiologic measures of these providers, along with their potential predictors. METHODS: Participants included 101 maternity providers (62 nurses/midwives, 16 clinical officers/doctors, and 23 support staff) in western Kenya. Respondents completed Cohen's Perceived Stress Scale, the Shirom-Melamed Burnout scale, and other sociodemographic, health, and work-related items. We also collected data on heart rate variability (HRV) and hair cortisol levels to assess stress-related physiologic responses to acute and chronic stress respectively. Multilevel linear regression models were computed to examine individual and work-related factors associated with stress, burnout, HRV, and cortisol level. RESULTS: 85% of providers reported moderate stress and 11.5% high stress. 65% experienced low burnout and 19.6% high burnout. Average HRV (measured as the root mean square of differences in intervals between successive heart beats: RMSSD) was 60.5 (SD = 33.0) and mean cortisol was mean cortisol was 44.2 pg/mg (SD = 60.88). Greater satisfaction with life accomplishments was associated with reduced stress (ß = - 2.83; CI = -5.47; - 0.18), while motivation to work excessively (over commitment) was associated with both increased stress (ß = 0.61 CI: 0.19, 1.03) and burnout (ß = 2.05, CI = 0.91, 3.19). Female providers had higher burnout scores compared to male providers. Support staff had higher HRV than other providers and providers under 30 years of age had higher HRV than those 30 and above. Although no association between cortisol and any predictor was statistically significant, the direction of associations was consistent with those found for stress and burnout. CONCLUSIONS: Most providers experienced moderate to high levels of stress and burnout. Individuals who were more driven to work excessively were particularly at risk for higher stress and burnout. Higher HRV of support staff and providers under age 30 suggest their more adaptive autonomic nervous system response to stress. Given its impact on provider wellbeing and quality of care, interventions to help providers manage stress are critical.

Quality of antenatal care and associated factors in a rural county in Kenya: an assessment of service provision and experience dimensions.

BACKGROUND: This study aimed to assess the quality of antenatal care (ANC) women received in Migori county, Kenya-including both service provision and experience dimensions-and to examine factors associated with each dimension. METHODS: We used survey data collected in 2016 in Migori county from 1031 women aged 15-49 who attended ANC at least once in their most recent pregnancy. ANC quality service provision was measured by nine questions on receipt of recommended ANC services, and experience of care by 18 questions on information, communication, dignity, and facility environment. We summed the responses to the individual items to generate ANC service provision and experience of care scores. We used both linear and logistic regression to examine predictors. RESULTS: The average service provision score was 10.9 (SD = 2.4) out of a total of 16. Most women received some recommended services once, but not at the frequency recommended by the Kenyan Ministry of Health. About 90% had their blood pressure measured, and 78% had a urine test, but only 58 and 14% reported blood pressure monitoring and urine test, respectively, at every visit. Only 16% received an ultrasound at any time during ANC. The average experience score is 27.3 (SD = 8.2) out of a total score of 42, with key gaps demonstrated in communication. About half of women were not educated on pregnancy complications. Also, about one-third did not often understand the purposes of tests and medicines received and did not feel able to ask questions to the health care provider. In multivariate analysis, women who were literate, employed, and who received all their ANC in a health center had higher experiences scores than women who were illiterate (coefficient = 1.52, CI:0.26,2.79), unemployed (coefficient = 2.73, CI:1.46,4.00), and received some ANC from a hospital (coefficient = 1.99, CI: 0.84, 3.14) respectively. The wealthiest women had two times higher odds of receiving an ultrasound than the poorest women (OR = 2.00, CI:1.20,3.33). CONCLUSION: Quality of ANC is suboptimal in both service provision and experience domains, with disparities by demographic and socioeconomic factors and facility type. More efforts are needed to improve quality of ANC and to eliminate the disparities.

Antiretroviral resistance among HIV-1 patients on first-line therapy attending a comprehensive care clinic in Kenyatta National Hospital, Kenya: a retrospective analysis.

INTRODUCTION: Antiretroviral therapy plays a major role in reducing the impact of Human Immunodeficiency Virus/Acquired Immune Disease Syndrome, especially in resource-limited settings. However, without proper infrastructure, it has resulted in emergence of drug resistance mutations in infected populations. To determine drug resistance mutations among patients attending a comprehensive care facility in Nairobi, 65 blood samples were successfully sequenced. METHODS: Whole blood samples were also tested for CD4+T-cell count and plasma HIV-1 RNA Viral load. Drug-resistance testing targeting the HIV-1 RT gene was determined. Patients were on first line ART that consisted of two NRTIs, and one NNRTI. RESULTS: Females were younger (mean 42) than males (mean 45) and lower median CD4+ counts (139 cells/µl) than males (152 cells/µl). The prevalence of drug resistance mutations (any major mutation) in this population was 23.1% (15/65). Major NRTI mutations were detected in 11 patient samples, which included M184V (n = 6), M41L (n=3), D67N (n=2), K219Q (n=3) and T215F (n=2). Major NNRTI mutations were detected in 14 patient samples. They included K103N (n = 10), G190A (n = 1), Y181C (n = 1) and Y188L (n = 1). CONCLUSION: Presence of major mutations in this study calls for proper laboratory infrastructure to monitor treatment as well as regular appraisals of available regimens.

Hepatitis C virus genotypes in Kenya.

Hepatitis C virus is a great public-health concern worldwide. Phylogenetic analysis of the HCV genome has identified six different genotypes that have generally been divided into several subtypes. There is very little information on HCV seroprevalence and genotypes in Kenya. To determine the genotypes of HCV circulating in Kenya, blood donor samples were serologically tested and confirmed by polymerase chain reaction (PCR). Positive samples were cloned and sequenced, and phylogenetic analysis conducted to determine the HCV genotypes. One hundred Murex-seropositive samples were re-tested using a passive hemagglutination test, and 16 of these were identified as seropositive. Further testing of all of the samples by PCR identified only 10 of the 16 samples as positive. Thus, only 10 % (10/100) of the samples were viremic. Six were from females (60 %), and four were from males (40 %). The mean age of the positive donors was considerably low, at 25 +/- 9 years. Genotypic testing indicated the presence of genotype 1a (10 %) and genotype 2b (90 %). This study reports on HCV genotypes in a blood donor population in Kenya where little had been done to provide information on HCV genotypes.

Implementation and Operational Research: Correlates of Adherence and Treatment Failure Among Kenyan Patients on Long-term Highly Active Antiretroviral Therapy.

BACKGROUND: Universal access to highly active antiretroviral therapy (HAART) is still elusive in most developing nations. We asked whether peer support influenced adherence and treatment outcome and if a single viral load (VL) could define treatment failure in a resource-limited setting. METHODS: A multicenter longitudinal and cross-sectional survey of VL, CD4 T cells, and adherence in 546 patients receiving HAART for up to 228 months. VL and CD4 counts were determined using m2000 Abbott RealTime HIV-1 assay and FACS counters, respectively. Adherence was assessed based on pill count and on self-report. RESULTS: Of the patients, 55.8%, 22.2%, and 22% had good, fair, and poor adherence, respectively. Adherence, peer support, and regimen, but not HIV disclosure, age, or gender, independently correlated with VL and durability of treatment in a multivariate analysis (P < 0.001). Treatment failure was 35.9% using sequential VL but ranged between 27% and 35% using alternate single VL cross-sectional definitions. More patients failed stavudine (41.2%) than zidovudine (37.4%) or tenofovir (28.8%, P = 0.043) treatment arms. Peer support correlated positively with adherence (χ(2), P < 0.001), with nonadherence being highest in the stavudine arm. VL before the time of regimen switch was comparable between patients switching and not switching treatment. Moreover, 36% of those switching still failed the second-line regimen. CONCLUSION: Weak adherence support and inaccessible VL testing threaten to compromise the success of HAART scale-up in Kenya. To hasten antiretroviral therapy monitoring and decision making, we suggest strengthening patient-focused adherence programs, optimizing and aligning regimen to WHO standards, and a single point-of-care VL testing when multiple tests are unavailable.

HIV-1 drug resistance-associated mutations among HIV-1 infected drug-naïve antenatal clinic attendees in rural Kenya.

BACKGROUND: Access to antiretroviral therapy (ART) has increased dramatically in Sub-Saharan Africa. In Kenya, 560,000 people had access to ART by the end of 2011. This scaling up of ART has raised challenges to the Kenyan health system due to emergence of drug resistant viruses among those on treatment and possible onward transmission. To counter this, and come up with an effective treatment strategy, it has become vital to determine baseline mutations associated with drug resistance among the circulating strains of HIV-1 in Kenya. METHODS: The prevalence of mutations associated with drug resistance in HIV-1 protease (PR) and reverse transcriptase (RT) regions from 188 HIV-1 infected treatment-naïve pregnant women was investigated in Kapsabet, Nandi Hills and Kitale district hospitals of Kenya. Blood samples were collected between April 2005 and June 2006. The HIV-1 pol gene was amplified using primers for HIV-1 PR and RT and sequenced using the BigDye chemistry. The mutations were analyzed based on the IAS algorithm as well as the Stanford University HIV Drug Resistance Database. RESULTS: Based on the PR and RT sequences, HIV-1 subtypes A1 (n=117, 62.2%), A2 (n=2, 1.1%), D (n=27, 14.4%), C (n=13, 6.9%), G (n=3, 1.6%), and possible recombinants (n=26, 13.8%) were detected. Mutations associated with nucleoside reverse transcriptase inhibitors (NRTI) and non-nucleoside RTI (NNRTI)-resistance were detected in 1.6% (3 of 188) and 1.1% (2 of 188), respectively. Mutations associated with PI resistance were detected in 0.5% (1 of 188) of the study population. CONCLUSION: The prevalence of drug resistance among drug-naïve pregnant women in rural North Rift, Kenya in 2006 was 3.2%. Major drug resistance mutations associated with PIs, NRTIs and NNRTIs do exist among treatment-naïve pregnant women in North Rift, Kenya. There is a need for consistent follow-up of drug-naïve individuals in this region to determine the impact of mutations on treatment outcomes.

Switch from 200 to 350 CD4 baseline count: what it means to HIV care and treatment programs in Kenya.

INTRODUCTION: With the increasing population of infected individuals in Africa and constrained resources for care and treatment, antiretroviral management continues to be an important public health challenge. Since the announcement of World Health Organization recommendation and guidelines for initiation of antiretroviral Treatment at CD4 count below 350, many developing countries are adopting this strategy in their country specific guidelines to care and treatment of HIV and AIDS. Despite the benefits to these recommendations, what does this switch from 200 to 350 CD4 count mean in antiretroviral treatment demand? METHODS: A Multi-centre study involving 1376 patients in health care settings in Kenya. CD4 count was carried out by flow cytometry among the HIV infected individuals in Kenya and results analyzed in view of the In-country and the new CD4 recommendation for initiation of antiretroviral treatment. RESULTS: Across sites, 32% of the individual required antiretroviral at <200 CD4 Baseline, 40% at <250 baseline count and 58% based on the new criteria of <350 CD4 Count. There were more female (68%) than Male (32%).Different from <200 and <250 CD4 baseline criteria, over 50% of all age groups required antiretroviral at 350 CD4 baseline. Age groups between 41-62 led in demand for ART. CONCLUSION: With the new guidelines, demand for ARVs has more than doubled with variations noted within regions and age groups. As A result, HIV Care and Treatment Programs should prepare for this expansion for the benefits to be realized.

Predicted HIV-1 coreceptor usage among Kenya patients shows a high tendency for subtype d to be cxcr4 tropic.

BACKGROUND: CCR5 antagonists have clinically been approved for prevention or treatment of HIV/AIDS. Countries in Sub-Saharan Africa with the highest burden of HIV/AIDS are due to adopt these regimens. However, HIV-1 can also use CXCR4 as a co-receptor. There is hence an urgent need to map out cellular tropism of a country's circulating HIV strains to guide the impending use of CCR5 antagonists. OBJECTIVES: To determine HIV-1 coreceptor usage among patients attending a comprehensive care centre in Nairobi, Kenya. METHODS: Blood samples were obtained from HIV infected patients attending the comprehensive care centre, Kenyatta National Hospital in years 2008 and 2009. The samples were separated into plasma and peripheral blood mononuclear cells (PBMCs). Proviral DNA was extracted from PBMCs and Polymerase Chain reaction (PCR) done to amplify the HIV env fragment spanning the C2-V3 region. The resultant fragment was directly sequenced on an automated sequencer (ABI, 3100). Co-receptor prediction of the env sequences was done using Geno2pheno [co-receptor], and phylogenetic relationships determined using CLUSTALW and Neighbor Joining method. RESULTS: A total of 67 samples (46 treatment experienced and 21 treatment naive) were successfully amplified and sequenced. Forty nine (73%) sequences showed a prediction for R5 tropism while 18(27%) were X4 tropic. Phylogenetic analysis showed that 46(69%) were subtype A, 11(16%) subtype C, and 10(15%) subtype D. No statistical significant associations were observed between cell tropism and CD4+ status, patient gender, age, or treatment option. There was a tendency for more X4 tropic strains being in the treatment experienced group than the naive group: Of 46 treatment experiencing participants, 14(30%) harboured X4, compared with 4(19%) of 21 of the treatment-naïve participants, the association is however not statistically significant (p = 0.31). However, a strong association was observed between subtype D and CXCR4 co- receptor usage (p = 0.015) with 6(60%) of the 10 subtype D being X4 tropic and 4(40%) R5 tropic. CONCLUSION: HIV-1 R5 tropic strains were the most prevalent in the study population and HIV infected patients in Kenya may benefit from CCR5 antagonists. However, there is need for caution where subtype D infection is suspected or where antiretroviral salvage therapy is indicated.

HIV type 1 gag genetic diversity among antenatal clinic attendees in North Rift Valley, Kenya.

HIV genetic recombination and high mutation rate increase diversity allowing it to escape from host immune response or antiretroviral drugs. This diversity has enabled specific viral subtypes to be predominant in specific regions. To determine HIV-1 subtypes among seropositive antenatal clinic attendees in Kenya's North Rift Valley, a cross-sectional study was carried out on 116 HIV-1-positive blood samples. Proviral DNA was extracted from peripheral blood mononuclear cells by DNAzol lysis and ethanol precipitation. Polymerase chain reactions using specific primers for HIV-1 gag and population sequencing on resulting amplicons were carried out. Phylogenetic analysis revealed that 81 (70%) were subtype A1, 13 (11%) subtype D, 8 (7%) subtype C, 3 (3%) subtype A2, 1 (1%) subtype G, and 10 showed possible recombinants: 5 (4%) subtype A1D, 4 (3%) subtype A1C, and 1 (1%) subtype A2C. These data support the need to establish circulating subtypes for better evaluation of effective HIV diagnostic and treatment options in Kenya.

Genetic characterization of HIV type 1 among patients with suspected immune reconstitution inflammatory syndrome after initiation of antiretroviral therapy in Kenya.

Antiretroviral therapy (ART) has improved the survival of HIV patients but is also associated with unique manifestations of disease in some subjects during the initial months of therapy. Immune reconstitution inflammatory syndrome (IRIS) is a disorder among individuals starting ART, with no evidence-based treatment and management guidelines. We characterized HIV-1 and determined drug resistance among 14 Kenyan patients with suspected IRIS after ART initiation in 2005. Polymerase chain reaction, sequencing, and phylogenetic analysis of viral pol and env showed the following HIV-1 subtypes: A1/A1/A1 (pol-RT/gp41/C2V3), 5; A1/C/A1, 1; A1/D/A1, 2; D/A1/A1, 1; D/C/A1, 1; D/D/A1, 2; D/D/D, 1; and D/A1/A2, 1. Three patients had viruses with major drug resistance-associated mutations. These included nucleoside reverse transcriptase inhibitor (RTI) mutations: M41L, K65R, D67N, K70R, M184V, and K219Q, and nonnucleoside RTI mutations: K101P, L100I, K103N, and Y181C. Twelve patients harbored viruses that are predicted to use chemokine coreceptor 5 (CCR5) whereas two had variant viruses predicted to use the CXCR4 coreceptor. Drug resistance may not be the only cause of ART adverse events. HIV-1 characterization would be important before and during HIV therapy to avoid treatment failure.