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Background: Continuous proficiency testing (PT) is a key component of external quality assurance component in Xpert MTB/RIF assay for tuberculosis. In Kenya, this exercise is poorly covered and frequently interrupted due to the limited supply of PT materials, which mainly come as donations from CDC-Atlanta, USA, but are insufficient for all the Xpert MTB/RIF sites, posing a risk of obtaining unreliable results that can negatively impact patients’ management and TB control programs.Objective: This study aimed to develop in-country dried tube specimens (DTS) for Xpert MTB/RIF proficiency testing in Kenya and pilot them in all Xpert MTB/RIF- TB testing sites in Nairobi County. Methods: A laboratory-based experimental design was adopted. DTS panels were developed following standard bacteriological procedures, and their accuracy and precision were assessed. We evaluated the performance of the developed DTS in all the 20 Xpert MTB/RIF- TB testing sites in Nairobi County from November to December 2019.Results: Validation of developed DTS showed 100% concordance with the pretesting results. Ninety per cent (18/20) of piloted sites had satisfactory scores, 80% (16/20) excellent, 10% (2/20) unsatisfactory results. Ninety-six per cent of the laboratories results were concordant with the expected, whereas 4% (4/100) were discordant. Two Sites (2/20, 10%) recorded an error (code 5007). Conclusion: Developed DTS panels showed a high-performance level as an Xpert/MTB/RIF quality assurance checker. There is a need to upscale production to satisfy quality assessment needs in all Xpert MTB/RIF testing sites in the Country by establishing a fully independent and sustainable local DTS production pipeline.

IntroductionWomen who use contraceptive methods sometimes stop early, use methods intermittently, or switched contraceptive methods. All these events (discontinuations and switching) contribute to the occurrence of unwanted and close pregnancies. This study aimed to explore contraceptive discontinuation and switching during the Yam-Daabo project to measure the effect of interventions on the continuation of contraceptive methods use.MethodsWe conducted a secondary analysis of the Yam-Daabo trial data. We choose the discontinuation and switching of a modern contraceptive method as outcome measures. We performed a survival analysis using the Stata software package to estimate the effect of the interventions on contraceptive discontinuation. We also studied the main reasons for discontinuation and switching.ResultsIn total, 637 out of the 1120 women used at least one contraceptive method (of any type), with 267 women in the control and 370 in the intervention group. One hundred seventy-nine women of the control group used modern methods compared to 279 women of the intervention group with 24 and 32 who discontinued, respectively. We observed no statistically significant association between interventions and modern methods discontinuation and switching. However, modern methods' discontinuation was higher in pills and injectables users than implants and IUDs users. The pooled data comparison showed that, in reference to the women who had not switched while using a modern method, the likelihood of switching to a less or equal effectiveness method among the women of the control group was 3.8(95% CI: 1.8-8.0) times the likelihood of switching to a less or equal effectiveness method among the women of the intervention group. And this excess was statistically significant (p ConclusionThe results of this study show no statistically significant association between interventions and modern methods discontinuation. Discontinuation is more related to the methods themselves than to any other factor. It is also essential to set up specific actions targeting women's partners and influential people in the community to counter inhibiting beliefs.Trial registrationPan African Clinical Trials Registry (PACTR201609001784334, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1784 ).

BACKGROUND:In rural Burkina Faso, a package of six low-technology, post-partum contraceptive interventions (ie, refresher training for providers, a counselling tool, supportive supervision, daily availability of contraceptive services, client appointment cards, and invitation letters to attend appointments for partners), aimed at strengthening existing primary health-care services and enhancing demand for them, doubled the use of modern contraceptives at 12 months post partum (ie, 55% uptake in intervention recipients vs 29% in routine-care users). This study assessed the effect of a similar package but in urban settings of Kinshasa province, Democratic Republic of the Congo, in an effort to reduce the unmet need for post-partum family planning. METHODS:Yam Daabo was a multi-intervention, single-blinded, cluster-randomised controlled trial done in six primary health-care centres (clusters) in Kinshasa. Centres were randomly allocated to receive the six-component intervention or standard antenatal and postnatal care in matched pairs (1:1) on the basis of number of monthly births, the ratio of health workers per population in the health zone, and the urban and suburban settings. Only data analysts could be masked to cluster allocation. Health-care facilities were eligible if they provided a continuum of antenatal, delivery, and postnatal care, were well stocked with contraceptives, and were situated close to the main study centre. All pregnant women presenting to the six centres were eligible if they were in their third pregnancy trimester and had no counterindications to deliver in the facility. The main outcome was prevalence of use of modern contraceptives at 12 months after delivery. Analysis was by modified intention-to-treat using generalised linear mixed models or Fisher's exact test for small groups. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334). FINDINGS:From July 1, 2016, to Feb 2, 2017, eight of 52 clinics assessed for eligibility met the criteria and were randomised. Of 690 women approached, 576 (83%) women were enrolled: 286 in the four intervention clusters and 290 in the four control clusters. Of them, 519 (90%) completed the 12-month study exit interview (252 in the intervention group and 267 in the control group) and were included in the intention-to-treat analysis. At 12 months, 115 (46%) of 252 women in the intervention group and 94 (35%) of 267 in the control group were using modern contraceptives (adjusted prevalence ratio [PR] 1·58, 95% CI 0·74-3·38), with significant differences in the use of contraceptive implants (22% vs 6%; adjusted PR 4·36, 95% CI 1·96-9·70), but without difference in the use of short-acting contraceptives (23% vs 28%; 0·92, 0·29-2·98) and non-modern or inappropriate methods (7% vs 18%; 0·45, 0·13-1·54). There were no serious adverse events or maternal deaths related to the study. INTERPRETATION:The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth. However, interferences from external family planning initiatives in the control group might have diminished differences between the services received. Such an intervention could be potentially relevant in similar contexts in DR Congo and other countries. FUNDING:Government of France; UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

Background: Clinical guidelines when implemented correctly have shown to improve disease outcomes. This study describes utilization of Kenya National guidelines in managing ante partum haemorrhage (APH) in 3rd trimester.Objective: To describe adherence to clinical guideline in management of antepartum haemorrhage at Garissa Provincial General Hospital Design: Crossectional mixed methods studySetting: Garissa Provincial General HospitalSubjects: Medical records of patients managed for APH between 2002 and 2012 and Key Informant Interviews (KIIs) of Health workers.Results: 36.1% of the cases assessed were managed with strict adherence to guidelines. 90% of health care workers had high levels of awareness of the existence of guidelines and sited utilization challenges attributed to resource inadequacies.Conclusion: Clinicians are skilled on APH guidelines, but adherence levels are still low. Therefore, continuous appraisal of clinical practices, availing equipment, facilities and supplies to reinforce adherence is recommended.

Objective: To evaluate the impact of highly active antiretroviral therapy (HAART) on CMV transmission and breast milk level in the context of maternal HIV. Design: Specimens from a randomized trial conducted in Nairobi, Kenya between 2003–2005 were used to compare CMV transmission and breast milk levels between mother-infant pairs randomized to HAART versus short-course antenatal zidovudine plus single-dose nevirapine (ZDV/sdNVP) for prevention of mother-to-child HIV transmission (PMTCT). Methods: Fifty-one antiretroviral-naïve women ≤32 weeks gestation, and CD4 between 200–500 cells/mm3 were randomized at 34 weeks to begin either antenatal ZDV/sdNVP, or HAART through 6 months postpartum. Mean breast milk CMV levels and transmission were compared between arms. Results: Age, sociodemographics, CD4%, and HIV plasma RNA viral load were similar between arms at baseline. CMV viral loads were measured from 243 infant plasma and 185 breast milk specimens during the first year postpartum. The probability of infant CMV infection at 12 months was 19% lower in the HAART arm compared to ZDV/sdNVP (75% vs. 94%, p = .04). All women had CMV detected in breast milk, with 72%, 98%, and 97% testing positive during the first, second, and third weeks postpartum, respectively. There was a trend for early higher mean breast milk CMV level in the HAART arm at 1 week (p = .08), and there was significantly slower decline in breast milk CMV levels (area under the curve, p = .01). Conclusions: HAART started during the third trimester may decrease infant CMV infections, by mechanisms independent of breast milk CMV levels. Clinical trials registration: NCT00167674.

Giant condylomata accuminata also known as Buschke Lowenstein Tumor (BLT) is a benign extensive cauliflower like lesion that is commonly found in the genital area. Its etiology is human pappiloma virus. It occurs more in men than women with a ratio of 2.7:1. Immunosuppresssion with HIV is the main risk factor but it has also been associated with pregnancy, diabetes, chronic steroid use and organ transplants. It is debilitating with extensive psychosocial maladjustments and has 50% potential for malignant transformation. The study was undertaken at Kenyatta National Hospital Gynecological ward. A 37 year old Para 2+0, HIV-infected woman on Highly Active Antiretroviral Therapy (HAART) for the past eight years, presented with a seven year history of progressive vulval growths and a five year history of per vaginal discharge and pruritus. The growths were insidious in onset and progressive but with no associated pain. The discharge was yellow, watery, copious and not foul smelling. There was no history of dyspareunia or post coital bleeding. She had been treated with various creams and antibiotics with no improvement. The physical examination revealed extensive cauliflower vulvo-vaginal and perianal warts with confluence in the mons pubis and labia majora bilaterally. The lesions appeared flat and brownish- black, and of variable diameter ranging from 0.5cm to 3cm. The lesions were not friable and did not bleed upon touch. Due to the extensive nature of the lesions, a decision to undertake simple vulvectomy was made. The patient was consented for the surgery, wide excision was done with successful primary closure of wound site. Histopathology results confirmed giant condylomata acuminata, with no malignant changes noted and free margins. The wound healed by primary intention within one week of surgery. At one year follow up, the patient was still on HAART, no recurrence of the vulval lesions and a Pap smear cytology report was normal. She was advised on condom use, adherence to HAART and on the importance of sustained follow up. We concluded that HIV-infected women on HAART are at risk for BLT, a severe disease associated with malignant transformation, vulvo-perineal examination should be scheduled into routine follow up for early diagnosis and treatment.

Background: Hepatitis B Virus (HBV) and HIV spread in the same manner, but HBV is more infectious than HIV-1. Active HBV requires modification of HIV-1 therapy and is associated with increased risk for sexual transmission of HBV.Objective: To determine the prevalence and knowledge of HBV among HIV-1 discordant couples.Design: A cross-sectional study.Setting: Couple Counselling Centres in Nairobi and Thika clinics in Kenya.Subjects: HIV discordant couples attending Couples Counselling Centres in Nairobi and Thika clinics in Kenya.Results: One hundred and sixty one couples with a mean age of 33 years (Standard Deviation 8.4) were enrolled into the study. HBV prevalence was higher among HIV positive women than among HIV negative women (10.2% vs. 5.9%, OR=0.5, 95% CI 0.2-1.0; p=0.05). However, among men, prevalence of HBV was higher among the HIV negative than the HIV positive participants (8.4 vs. 6.2%, OR=3.0, CI 1.3-6.5; p=0.04). There was no association between HBV and HIV (p=0.4) or gender (p=0.5). HIV positive participants were more likely to have adequate knowledge compared to HIV negative participants (13% vs. 3.7%, OR=2.7, 95% CI 1.95-7.9; p=0.05)Conclusions: Female index participants had the highest HBV prevalence. Knowledge on HBV was lacking, particularly among the HIV negative; a target group for health education regarding risk factors and prevention of HBV infection.

Background: Intentional childbearing may place heterosexual couples at risk of HIV infection in resource-limited settings with high HIV prevalence areas where society places great value on having children.Objective: To explore cognitive, cultural, and spatial mapping of sexual and reproductive health domains and services in western Kenya among men and women.Design: Community-based formative qualitative study design.Setting: Five administrative/geographical divisions of Nyando District, western Kenya.Subjects: Adult male 18 years and older and female who were of reproductive-potential ages (15 to 49 years for females)(n=90).Results:Men and women have disparate goals for number of children and engage in gendered patterns of protective method use (contraceptives used by women often in secret, condoms by men but rarely).Conclusion: HIV infection was still seen as stigmatising. These study results are relevant to design of effective integrated delivery for reproductive and HIV services in high-burden sub-Saharan African countries.

Introduction: strategies to transfer international health research training programs to sub-Saharan African institutions focus on developing cadresof local investigators who will lead such programs. Using a critical leadership theory framework, we conducted a qualitative study of one program to understand how collaborative training and research can support early career investigators in Kenya toward the program transfer goal.Methods: We used purposive sampling methods and a semi-structured protocol to conduct in-depth interviews with US (N=5) and Kenyan (N=5)independent investigators. Transcripts were coded using a two-step process, and then compared with each other to identify major themes.Results: A limited local research environment, funding needs and research career mentorship were identified as major influences on early career researchers. Institutional demands on Kenyan faculty to teach rather than complete research restricted investigators' ability to develop research careers. This was coupled with lack of local funding to support research. Sustainable collaborations between Kenyan, US and other international investigators were perceived to mitigate these challenges and support early career investigators who would help build a robust local research environment for training. Conclusion: mutually beneficial collaborations between Kenyan and US investigators developed during training mitigate these challenges and build a supportive research environment for training. In these collaborations, early career investigators learn how to navigate the complex international research environment to build local HIV research capacity.Shared and mutually beneficial resources within international research collaborations are required to support early career investigators and plans to transfer health research training to African institutions.

Background: Mother-to-child transmission (MTCT) of Human Immunodeficiency Virus (HIV) contributes to over 90% of the paediatric HIV infections. The national PMTCT guidelines make recommendations for specific interventions to reduce perinatal transmission. Data on adherence to the guidelines by caregivers and quality of PMTCT care is however limited.objective: To evaluate the extent to which PMTCT care offered to HIV positive women admitted for delivery at Kenyatta National Hospital (KNH) and Pumwani Maternity Hospital (PMH) adheres to National Guidelines in order to reduce vertical transmission of HIV during labour and delivery.Design: A cross-sectional study.Setting: Kenyatta National Hospital and Pumwani Maternity Hospitalfrom January to April 2009.Subjects: All consenting HIV positive women admitted to the labour wards at the two facilities and planned for delivery.Results: A total of 370 women were enrolled, 266 at Pumwani Maternity Hospital and 104 at Kenyatta National Hospital. Among the enrolled women 357 (96.4%) had been counselled on vertical transmission and 205(55.4%) had HIV disease staging by CD4 cell count. There were no significant differences between the two study sites in the proportion of women counselled on MTCT (p=0.398) and receiving HIV disease staging by CD4 testing (p=0.28). Three hundred and forty nine (94.3%) women were offered varied ARV regimens for PMTCT. 101(27.3%) received HAART, 94(26.9%) were given single dose nevirapine and 130(37%) received AZT+NVP combination prophylaxis. Twenty one women received no ARV prophylaxis. Overall, 268 women (72.5%) had spontaneous vertex delivery. An episiotomy rate of 7% was observed and no vacuum delivery was recorded. A Caesarean section rate of 27.5% was recorded with PMTCT as aan indication in almost half of the cases. Women delivered at KNH were more likely to receive HAART (p