The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms.

Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0-59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.Study registration: NCT04910750 and NCT05065320.

Pulse oximetry and clinical decision support algorithms show potential for supporting healthcare providers to identify and manage severe illness among children under-five attending primary care in resource-constrained settings, whilst promoting resource stewardship but scale-up has been hampered by evidence gaps.This study design article describes the largest scale evaluation of these interventions to date, the results of which will inform country- and global-level policy and planning .

Understanding and comparing the medical tourism cancer patient with the locally managed patient: A case control study.

INTRODUCTION: Medical tourism is characterized by people seeking treatment abroad for various medical conditions due to varied reasons, many of whom benefit from specialized care for non-communicable diseases. Conversely, there are associated negative effects such as medical complications and weakened health systems. Currently, there is paucity of scientific evidence on patient-related factors influencing seeking treatment benefits abroad. This study sought to compare patient-related factors associated with choice of cancer treatment center locally or abroad, to understand reasons for seeking treatment outside Kenya. MATERIALS AND METHODS: As a case-control study, 254 cancer patients were randomly sampled to compare responses from those who chose to receive initial treatment abroad or in Kenya. The cases were recruited from Ministry of Health while the controls from Kenyatta National Hospital and Texas Cancer Center. Data was analyzed using SPSS Software Version 21. Descriptive statistics, bivariate and multiple logistic regression analysis was carried out. Level of significance was set at 5%. RESULTS: Out of 254 respondents, 174 (69.5%) were treated for cancer in Kenya and 80 (31.5%) in India. We found that cost effectiveness was a significant factor for over 73% of all respondents. The study revealed independent predictors for seeking treatment in India were: monthly income higher than US$ 250; every additional month from when disclosure to patients was done increased likelihood by 1.16 times; physician advice (Odds Ratio(OR) 66; 95% Confidence Interval(CI) 7.9-552.9); friends and family (OR 42; 95% CI 7.07-248.6); and perception of better quality of care (OR 22.5; 95% CI 2.2-230.6). CONCLUSION: Reasons patients with cancer sought treatment in India are multifactorial. Several of these can be addressed to reverse out-ward bound medical tourism and contribute to improving the in-country cancer healthcare. It will require strengthening the health system accordingly and sensitizing the medical fraternity and general public on the same.

Incidence of depressive symptoms among sexually abused children in Kenya.

BACKGROUND: Children who experience sexual abuse undergo various negative psychosocial outcomes such as depressive symptoms. Unfortunately, not many studies have been conducted on the incidence of depressive symptoms among sexually abused children in Kenya. This study sought to ascertain the incidence of depressive symptoms among children who have experienced sexual abuse in Kenya. METHODS: This was a longitudinal study design. It was conducted at Kenyatta National Teaching and Referral Hospital and Nairobi Women's Hospitals in Kenya. One hundred and ninety-one children who had experienced sexual abuse and their parents/legal guardians were invited to participate in the study. The study administered the Becks Depression Inventory and the Child Depression Inventory to the children. RESULTS: The incidence of depressive symptoms after 1 month of sexual abuse revealed that amongst children who were below 16 years old, 14.6% had minimal-mild depressive symptoms while 85.4% had moderate-severe depressive symptoms. In comparison, children who were 16 years or older, 6.4% had minimal-mild depressive symptoms while 93.6% had moderate-severe depressive symptoms. Children below 16 years old whose parents were separated were found to have depressive symptoms (p < 0.001) as well as those who were presented early for medical care (p < 0.004), while children aged 16 years and above who were abused by strangers were more likely to have depressive symptoms (p < 0.024) and those who were not attending school (p < 0.002). CONCLUSION: Sexual abuse of children is world-wide and the Kenyan situation is comparable. Being the victim of sexual abuse as a child has major psychological and emotional sequlae which need to be addressed in Kenya. Children who experience sexual abuse have very high incidence of developing depressive symptoms. All the sexually abused children studied suffered from depressive symptoms and a large majority suffered from major depressive symptoms that should be promptly and effectively addressed to ameliorate psychological suffering among children.

The Gender Context of HIV Risk and Pregnancy Goals in Western Kenya.

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 men 18 years and older and women 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 stigmatizing. These study results are relevant to design of effective integrated delivery for reproductive and HIV services in high-burden sub-Saharan African countries.

Kenyan medical student and consultant experiences in a pilot decentralized training program at the University of Nairobi.

BACKGROUND: Over the past decade, the University of Nairobi (UoN) has increased the number of enrolled medical students threefold in response to the growing need for more doctors. This has resulted in a congested clinical training environment and limited opportunities for students to practice clinical skills at the tertiary teaching facility. To enhance the clinical experience, the UoN Medical Education Partnership Initiative Program Undertook training of medical students in non-tertiary hospitals around the country under the mentorship of consultant preceptors at these hospitals. This study focused on the evaluation of the pilot decentralized training rotation. METHODS: The decentralized training program was piloted in October 2011 with 29 fourth-year medical students at four public hospitals for a 7-week rotation. We evaluated student and consultant experiences using a series of focus group discussions. A three-person team developed the codes for the focus groups and then individually and anonymously coded the transcripts. The team's findings were triangulated to confirm major themes. RESULTS: Before the rotation, the students expressed the motivation to gain more clinical experience as they felt they lacked adequate opportunity to exercise clinical skills at the tertiary referral hospital. By the end of the rotation, the students felt they had been actively involved in patient care, had gained clinical skills and had learned to navigate socio-cultural challenges in patient care. They further expressed their wish to return to those hospitals for future practice. The consultants expressed their motivation to teach and mentor students and acknowledged that the academic interaction had positively impacted on patient care. DISCUSSION: The decentralized training enhanced students' learning by providing opportunities for clinical and community experiences and has demonstrated how practicing medical consultants can be engaged as preceptors in students learning. This training may also increase students' ability and willingness to work in rural and underserved areas.

Expanding clinical medical training opportunities at the University of Nairobi: adapting a regional medical education model from the WWAMI program at the University of Washington.

A major medical education need in Sub-Saharan Africa includes expanding clinical training opportunities to develop health professionals. Medical education expansion is a complicated process that requires significant investment of financial and human resources, but it can also provide opportunities for innovative approaches and partnerships. In 2010, the U.S. President's Emergency Plan for AIDS Relief launched the Medical Education Partnership Initiative to invest in medical education and health system strengthening in Africa. Building on a 30-year collaborative clinical and research training partnership, the University of Nairobi in Kenya developed a pilot regional medical education program modeled on the WWAMI (Washington, Wyoming, Alaska, Montana, and Idaho) medical education program at the University of Washington in the United States. The University of Nairobi adapted key elements of the WWAMI model to expand clinical training opportunities without requiring major capital construction of new buildings or campuses. The pilot program provides short-term clinical training opportunities for undergraduate students and recruits and trains clinical faculty at 14 decentralized training sites. The adaptation of a model from the Northwestern United States to address medical education needs in Kenya is a successful transfer of knowledge and practices that can be scaled up and replicated across Sub-Saharan Africa.

Incidence and correlates of HIV-1 RNA detection in the breast milk of women receiving HAART for the prevention of HIV-1 transmission.

BACKGROUND: The incidence and correlates of breast milk HIV-1 RNA detection were determined in intensively sampled women receiving highly active antiretroviral therapy (HAART) for the prevention of mother-to-child HIV-1 transmission. METHODS: Women initiated HAART at 34 weeks of pregnancy. Breast milk was collected every 2-5 days during 1 month postpartum for measurements of cell-associated HIV DNA and cell-free HIV RNA. Plasma and breast milk were also collected at 2 weeks, 1, 3 and 6 months for concurrent HIV-1 RNA and DNA measurements. Regression was used to identify cofactors for breast milk HIV-1 RNA detection. RESULTS: Of 259 breast milk specimens from 25 women receiving HAART, 34 had detectable HIV-1 RNA (13%, incidence 1.4 episodes/100 person-days 95% CI = 0.97-1.9). Fourteen of 25 (56%) women had detectable breast milk HIV-1 RNA [mean 2.5 log(10) copies/ml (range 2.0-3.9)] at least once. HIV-1 DNA was consistently detected in breast milk cells despite HAART, and increased slowly over time, at a rate of approximately 1 copy/10(6) cells per day (p = 0.02). Baseline CD4, plasma viral load, HAART duration, and frequency of breast problems were similar in women with and without detectable breast milk HIV-1 RNA. Women with detectable breast milk HIV-1 RNA were more likely to be primiparous than women without (36% vs 0%, p = 0.05). Plasma HIV-1 RNA detection (OR = 9.0, 95%CI = 1.8-44) and plasma HIV-1 RNA levels (OR = 12, 95% CI = 2.5-56) were strongly associated with concurrent detection of breast milk HIV-1 RNA. However, no association was found between breast milk HIV-1 DNA level and concurrent breast milk HIV-1 RNA detection (OR = 0.96, 95%CI = 0.54-1.7). CONCLUSIONS: The majority of women on HAART had episodic detection of breast milk HIV-1 RNA. Breast milk HIV-1 RNA detection was associated with systemic viral burden rather than breast milk HIV-1 DNA.

Highly active antiretroviral therapy versus zidovudine/nevirapine effects on early breast milk HIV type-1 Rna: a phase II randomized clinical trial.

BACKGROUND: Defining the effect of antiretroviral regimens on breast milk HIV type-1 (HIV-1) levels is useful to inform the rational design of strategies to decrease perinatal HIV-1 transmission. METHODS: Pregnant HIV-1 seropositive women (CD4+ T-cell count >250 and <500 cells/mm3) electing to breastfeed in Nairobi, Kenya were randomized to highly active antiretroviral therapy (HAART; zidovudine [ZDV], lamivudine and nevirapine [NVP]) during pregnancy and 6 months post-partum or to short-course ZDV plus single-dose NVP (ZDV/NVP). Breast milk samples were collected two to three times per week in the first month post-partum. RESULTS: Between November 2003 and April 2006, 444 breast milk samples were collected from 58 randomized women during the first month after delivery. Between 3 and 14 days post-partum, women in the HAART and ZDV/NVP arms had a similar prevalence of undetectable breast milk HIV-1 RNA. From 15 to 28 days post-partum, women in the HAART arm had significantly lower levels of breast milk HIV-1 RNA than women randomized to ZDV/NVP (1.7 log10 copies/ml [limit of detection] versus >2.10 log10 copies/ml, P<0.001). In contrast to breast milk HIV-1 RNA, suppression of plasma HIV-1 RNA during the neonatal period was consistently several log10 greater in the HAART arm compared with the ZDV/NVP arm. CONCLUSIONS: HAART resulted in lower breast milk HIV-1 RNA than ZDV/NVP; however, ZDV/NVP yielded comparable breast milk HIV-1 RNA levels in the first 2 weeks post-partum. Breast milk HIV-1 RNA remained suppressed in the ZDV/NVP arm despite increased plasma HIV-1 levels, which might reflect local drug effects or compartmentalization.

Independent effects of nevirapine prophylaxis and HIV-1 RNA suppression in breast milk on early perinatal HIV-1 transmission.

BACKGROUND: The mechanism of action of single-dose nevirapine on reducing mother-to-child transmission of HIV-1 may involve reduction of maternal HIV-1 or prophylaxis of infants. METHODS: In a study that randomized pregnant mothers to HIVNET 012 nevirapine versus short-course antenatal zidovudine, we compared breast milk HIV-1 RNA viral shedding and administration of single-dose nevirapine between mothers who transmitted HIV-1 to their infants at 6 weeks postpartum and those who did not. RESULTS: In multivariate analyses, maximum breast milk HIV-1 RNA levels (hazard ratio [HR] = 2.50, 95% confidence interval [CI]: 1.25 to 4.99; P = 0.01) and nevirapine use (HR = 0.12, 95% CI: 0.02 to 0.97; P = 0.05) were each independently associated with perinatal transmission at 6 weeks postpartum. Mothers who transmitted HIV-1 to their infants had significantly higher HIV-1 RNA levels in their breast milk between the second day and sixth week postpartum. Among mothers with maximum breast milk virus levels less than a median of 3.5 log(10) copies/mL, the administration of nevirapine further decreased HIV-1 transmission risk from 22.2% to 0.0% (P = 0.04). CONCLUSIONS: Peripartum administration of single-dose nevirapine to mother and infant decreases early perinatal HIV-1 transmission by means of breast milk HIV-1 RNA suppression and, independently, by providing the infant with exposure prophylaxis.