There are about 751 clinical studies being (or have been) conducted in Kenya. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
In many low-income countries, unsafe abortion is recognized as a leading cause of maternal morbidity and mortality. Social stigma surrounding abortion and contraceptive use plays a critical role in the social, medical, and legal marginalization of abortion and contraceptive services. Though this stigma is pervasive and threatens women's health, it is not well understood how it can be reduced. The Stigmatizing Attitudes, Beliefs and Actions Scale (SABAS) was designed in 2013, to measure abortion stigma at individual and community level. Objective: I) to conceptualize abortion stigma among; health care providers, secondary school teachers and students, and II) to determine if a school based intervention targeting stigma specifically faced by girls when accessing abortion and contraceptive services, compared to usual standards, will decrease related stigma and increase contraceptive use among students, who are sexually active. Design, Setting, Participants: I) Focus group discussions (FGD) with service providers at YFC (n=12), secondary school teachers (n=16) and secondary school students (n=20), and II) a quasi-experimental pre- and post-intervention study, targeting 800 secondary school students (14-20 y), in Kisumu, Kenya. Two schools will be assigned; one interventions unit (n=400 students) and one control unit (n=400 students). The schools are similar according to the study site, size and academic standards. The region is chosen because of its low rate of contraceptive use, and high rate of teen pregnancy and of unsafe abortions. Standard deviation is the measure of dispersion or variability in the data. The sample size of 400 is based on a previous study and will give a power of 80% to detect differences (95% Cl) between the two groups. Intervention: An abortion- and contraceptive-use stigma reduction intervention (1-month program), capturing negative stereotypes about women that are associated with abortion and contraceptive use. Main Outcome: Abortion-stigma reduction. Secondary outcome: Contraceptive-use stigma reduction. Measured at baseline (pre-test), and post-test at 1- and 12-months, by using the validated SABA-scale. Analyses: Qualitative content analysis and repeated measures, ANOVA. Funded by: The Swedish Research Council for Health, Working Life and Welfare 2015-01194, and The Swedish Research Council 2016-05670
This project will test the feasibility of an electronic game to prevent HIV among African preadolescents, delivered via inexpensive Android smart phones. In order to collect feasibility data for a future randomized controlled trial, this study involves the pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya, where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be carried out with the Kenya Medical Research Institute (KEMRI).
An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in central and western Kenya according to national guidelines using a stepped wedge design, stratified by region.
A 4-armed cluster randomised controlled trial conducted among secondary schoolgirls in Siaya, western Kenya, where clusters are the unit of allocation and schoolgirls the unit of measurement. The overall aim of the trial is to inform evidence-based policy to develop intervention programmes which improve adolescent girls' health, school equity and life-chances. The primary objective is to determine the impact of menstrual cups or cash transfer alone, or in combination, compared against controls, on a composite of deleterious outcomes (HIV, HSV-2 infection, and school dropout) over 3 schoolyears follow-up.
The purpose of this study is to determine whether giving small financial incentives will motivate parents to test their children for HIV.
STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.
A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease
The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term heterosexual HIV-1 serodiscordant partnerships. Such couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and relinquish their childbearing desires. Based on evidence from rigorous clinical trials demonstrating the strong efficacy of individual interventions for HIV-1 prevention and formative work with HIV-1 serodiscordant couples and clinicians with expertise in HIV-1 prevention and reproductive health in the Kenyan context, this study pilots a safer conception intervention that focuses on antiretrovirals (as antiretroviral therapy [ART] taken by the HIV-1 infected partner and pre-exposure prophylaxis [PrEP] taken by the HIV-1 uninfected partner) and timed condomless sex. Additional strategies for couples include diagnosis and treatment of STIs and male circumcision. mHealth tools, including SMS and mobile applications are novel and very popular among Kenyans to ease the burden of addressing health problems. This safer conception intervention incorporates mHealth tools to improve couples' experiences tracking fertility indicators and communicating with providers about their readiness to practice safer conception. SMS surveys to collect daily information from women about their fertility signs and SMS messages are used to reinforce HIV-1 prevention, including condom use for couples during periods that do not have a high likelihood of fertility. An in-clinic mobile application is used to improve clinician-patient counseling and assessments of couple readiness to practice safer conception. To inform future engagement of mHealth tools, the investigators will prospectively evaluate clinician and patient experiences using SMS surveys and the tablet application. Couples with immediate fertility intentions will be followed longitudinally, allowing careful tracking of pregnancy and HIV-1 incidence. The study takes place in Thika, Kenya.
Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven strategies that can tackle the high burden of maternal and child mortality and morbidity currently witnessed in sub-Saharan Africa. However very few pregnant women utilize these services. This study aims to assess the impact, cost-effectiveness, and scalability of conditional cash transfers (CCTs) to promote increased and uninterrupted contact between pregnant women and the formal healthcare system in Siaya County, Kenya. The study is a cluster randomized controlled trial with the intervention being a conditional cash transfer to women each time they honour their health appointments for ANC, facility birth and PNC visits until their new-borns reach 1 year of age. Study participants are pregnant women identified during their first ANC visit (n = 7200), and their subsequent new-borns. Mothers and their children are followed up throughout their health visits and at 3 additional time points. Trial clusters are 48 public primary health facilities, (24 in the intervention arm and 24 in the control arm). The primary outcomes are: a) proportion of all eligible ANC visits made during pregnancy; b) delivery at health facility; c) proportion of all eligible PNC visits honoured; d) proportion of referrals honoured during pregnancy and postnatal period; e) proportion of child immunizations received. Secondary outcomes include; health screening and infection control, live birth, maternal and child survival 48 hours after delivery, exclusive breastfeeding, birth spacing and self-rated wellness of mother and new-born at respective time points. Primary outcomes will be measured through abstraction of health records at the health facilities attended by the women during the trial period and supplemented by data collection using an electronic based system that comprises of a card and reader system installed at recruited study facilities. Secondary data will be abstracted from the women's medical records at the health facilities and supplemented by telephone surveys administered at three time-points over the course of the study. Additional quantitative and qualitative data will be collected through questionnaires and phone interviews for process and economic evaluations. This trial will contribute to evidence on effectiveness and cost-effectiveness of conditional cash transfers in facilitating health visits and promoting maternal and child health in Kenya and other similar contexts.
Hyperglycaemia in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most common obstetric medical conditions which when undetected can cause significant adverse outcomes for the mother and the offspring. Diagnosis is typically made between 24-28 weeks of pregnancy using oral glucose tolerance test (OGTT). Therefore, some damage might have already happened prior to detection. Although universal screening is recommended by many guidelines, this is not uniformly followed across the world, partly because of doubts about cost-effectiveness. Only selective screening is followed based on presence of at least one of the high risk factors (age, BMI, previous history, etc). This strategy can miss up to 50% of GDM. In addition, no data exists in India and Kenya. In low and middle-income countries (LMICs), where majority live in rural settings, the major limitations are difficulty in conducting OGTT, which requires prompt access to laboratory facilities. Combining the clinical and easily analysable biochemical markers (composite risk score) could improve the prediction and if proven, could help to prevent the onset of GDM. Fasting glucose levels (at non-diabetes levels) in early pregnancy could predict future GDM. HbA1c in early pregnancy can be a better marker as it can be done point-of-care and does not require patients to be in a fasting state. The overall objective of the proposed project is to develop a composite risk score to predict GDM in early pregnancy using a combination of easily identifiable risk factors such as age, BMI, family history of Type 2 Diabetes along with HbA1c in Indians and Kenyans. The project will recruit pregnant women in early pregnancy from South India (n=3400) and Western Kenya (n=4000). Contribution of individual risk factors as well as the composite risk score on the risk of developing GDM will be assessed. Detailed health economic analyses will enable policy makers to make informed decision based on local data.