Mombasa

The ICU-related Out-of-Pocket Expenses ICOPE study is a multinational, prospective observational study conducted in African and Asian countries to understand the financial impact of ICU care on patients and their families. The study focuses on measuring out-of-pocket expenses and the occurrence of catastrophic health expenditure among patients who stay in the ICU for more than 24 hours, including those who receive mechanical ventilation and those who do not. The study addresses the rising cost burden related to ICU care in low- and middle-income countries LMICs and aims to identify factors contributing to financial hardship. Participants include all patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. The study compares groups of patients receiving invasive mechanical ventilation with those who do not, tracking their ICU-related expenses. The follow-up period extends from ICU admission to discharge, with additional assessments at 30 days and 6 months, spanning a total study duration of 18 months. During the study, researchers will collect detailed information about direct and indirect costs associated with ICU care, including medical and non-medical expenses. They will also examine how families cope with these costs and identify risk factors for catastrophic health expenditure. The primary outcomes include out-of-pocket cost per patient episode and the relative risk of catastrophic health expenditure by ICU discharge. Secondary outcomes include risk factors for catastrophic expenditure and the frequency of various coping strategies used by families.

Researchers are studying people living with HIV-1 infection who are on dolutegravir DTG-based antiretroviral therapy ART but have a viral load above 1,000 copiesmL after at least six months of treatment. The goal is to understand viral suppression rates and the emergence of DTG-associated drug-resistant mutations in these individuals. This multi-country prospective observational study takes place in Kenya, Mozambique, Tanzania, and Lesotho, addressing gaps in data about managing virologic failure without changing the ART regimen. Participants will continue their DTG-based ART for up to 12 months while receiving enhanced adherence counseling if their viral load remains above 200 copiesmL. Study visits and viral load testing happen at enrollment and every three months during the active follow-up period. Enhanced adherence counseling includes at least three sessions per visit to support medication adherence and address other causes of viral increase. The study also collects routine program data for up to 24 months to assess how well viral suppression lasts over time. During the study, participants undergo viral load testing, counseling, and assessments at regular intervals. Researchers will analyze viral suppression rates at 6 and 12 months and evaluate factors that predict suppression or the development of drug resistance. They will also monitor the patterns and timing of drug-resistant mutations and opportunistic infections. The study plans to enroll 6,600 participants and may invite eligible individuals to join a nested randomized clinical trial focusing on managing drug resistance.

Researchers are studying the management of drug resistance in people living with HIV who are on dolutegravir DTG-based antiretroviral therapy but experience treatment failure due to drug-resistant mutations. This phase 3b randomized clinical trial aims to compare the effectiveness and safety of continuing DTG versus switching to ritonavir-boosted darunavir DRVr in patients with HIV-1 RNA levels above 200 copiesmL and at least one major DTG-associated drug resistance mutation. The study addresses gaps in current treatment strategies across several countries. Participants will be randomly assigned to one of two groups one will continue their existing DTG-based ART regimen, and the other will switch to a DRVr-based ART regimen. The dosing will be based on weight, and the study will take place over 12 months at multiple sites in Kenya, Mozambique, Tanzania, and Lesotho. The primary measure is the proportion of participants achieving viral suppression with HIV-1 RNA below 200 copiesmL at 6 months. During the trial, participants will have regular monitoring of their viral load and drug resistance mutations, along with assessments of treatment adherence, safety, and patient satisfaction. Additional outcomes include viral suppression rates at 12 months, incidence of adverse events, and changes in CD4 counts. The study includes children aged 3 years and older and plans to enroll 392 participants. Follow-up and data collection will support understanding optimal treatment management for this population.

Men who have sex with men MSM in Kenya face a high risk of gonorrhea, chlamydia, and syphilis, but testing for these infections is often not available, resulting in many cases going undiagnosed. This research investigates the impact and cost-effectiveness of two WHO-recommended treatmentsperiodic presumptive treatment PPT given every 3 months and doxycycline post-exposure prophylaxis doxyPEP taken after condomless sexcompared to standard symptom-based treatment. The study aims to understand how these approaches affect infection rates and antibiotic resistance in Neisseria gonorrhoeae among Kenyan MSM. The trial will randomly assign 2900 participants to one of three groups in a 221 ratio the PPT group receiving cefixime and azithromycin every 3 months if eligible, the doxyPEP group receiving doxycycline to take within 24-72 hours after condomless sex, and the standard care group receiving symptom-based treatment at each visit. Participants will be followed for 18 months, with regular assessments every 3 months at clinics designed to support MSM. During the study, participants will undergo screenings for sexually transmitted infections and receive treatment as per their assigned group. Researchers will monitor infections of gonorrhea, chlamydia, and early syphilis using culture-based and molecular tests. The study will collect data on adherence, safety, and acceptability of the treatments, and use findings to model the potential health and economic benefits of wider use of these strategies in Kenya and similar settings. The total participation period is 18 months with quarterly visits to track infection outcomes and antibiotic resistance.

Researchers are evaluating the use of surfactant given by a less invasive surfactant administration LISA technique to treat respiratory distress syndrome in preterm infants in low- and middle-income African countries. This pragmatic clinical trial aims to determine whether this method improves survival compared to standard care, especially where invasive ventilators are not available. The study focuses on preterm neonates with respiratory distress who are managed with continuous positive airway pressure CPAP and caffeine citrate. The trial compares two groups one receiving standard care with CPAP and caffeine citrate, and the other receiving surfactant therapy administered through the LISA technique, which involves instilling surfactant into the lungs via a thin catheter during laryngoscopy while on CPAP. Participants are preterm infants born between 24 and 35 weeks gestation or weighing between 750 and 2000 grams with respiratory distress defined by a Silverman Anderson Score of 5 or greater. The study includes monitoring for complications and follows infants throughout hospitalization. Participants will be observed during their hospital stay, which averages about six months, to assess survival and other health outcomes such as incidence of major preterm neonatal morbidity and pneumothorax. Researchers will monitor participants from admission within 24 hours of life until discharge, evaluating hospital survival and complications related to respiratory distress and surfactant treatment. The primary outcome is all-cause in-hospital survival.

The RIC-AFRICA trial is a multi-center, sham-controlled, randomized controlled trial involving 1400 patients who have experienced ST-segment elevation myocardial infarction STEMI within 24 hours of symptom onset. The study aims to find out if Remote Ischaemic Conditioning RIC can reduce death rates and early heart failure after a heart attack in patients mainly treated with clot-busting therapy. It also includes an observational group of patients presenting between 24 and 72 hours after the heart attack to study similar outcomes without treatment intervention. Participants are randomly assigned to either the RIC group or a sham control group. Those in the RIC group will receive four cycles of blood pressure cuff inflation to 20 mmHg above their systolic blood pressure for 5 minutes, followed by 5 minutes of deflation, repeated four times, and this protocol will be repeated daily for two more days. The sham group will undergo the same cycle with low-pressure inflation to 20 mmHg. The observational group, who present later, will not receive intervention but will be followed with the same outcome measures. Throughout the study, participants will be monitored for all-cause death and new onset heart failure within 30 days after the heart attack. Assessments will include clinical evaluations, ECG, biomarkers, and echocardiography to confirm STEMI and heart function. The study will also track major adverse cardiac and cerebrovascular events at 30 days. The total participation duration varies based on the group, with interventions over three days for the randomized groups and observation for up to 72 hours for the non-randomized group.

East and Southern Africa, home to a significant portion of the global population living with HIV, faces a high HIV burden, especially among adolescent girls and young women AGYW. This research evaluates the Systems Analysis and Improvement Approach SAIA, an implementation strategy aimed at improving HIV counseling, testing, linkage to care, and pre-exposure prophylaxis PrEP services in family planning FP clinics. The study focuses on assessing SAIAs effectiveness when delivered at scale by Kenyan public health workers compared to usual procedures without specific interventions. The study involves a cluster-randomized trial where SAIA is implemented in selected FP clinics by Mombasa County public health staff. SAIA uses a five-step cycle repeated every 4-6 weeks, including understanding the care cascade, identifying bottlenecks through process mapping, implementing workflow changes, monitoring performance, and repeating improvement cycles. The intervention aims to improve HIV prevention and treatment integration within FP services, with particular attention to new FP clients and new and returning AGYW clients. Participants involvement includes receiving HIV counseling, testing, linkage to care, and PrEP screening as part of routine FP services, with data collected over 24 months. Researchers will analyze quantitative and qualitative data using the RE-AIM framework to evaluate reach, effectiveness, adoption, implementation, and maintenance of SAIA. Additionally, the study will estimate the costs and budget impact of scaling SAIA at the county level. The total study duration includes continuous monitoring and assessment of outcomes from months 1 to 24.

Researchers are investigating how vaginal washing affects cervical inflammation and may increase the risk of HIV acquisition. This study focuses on women who engage in vaginal washing and aims to understand whether stopping this practice can reduce inflammation and improve vaginal health by increasing protective Lactobacillus species and reducing immune cells and epithelial disruption in the cervix. Participants will be randomly assigned to one of two groups an intervention group that attends three weekly small-group educational sessions designed to promote vaginal washing cessation using a behavioral change model, and a control group that does not receive these sessions but completes weekly questionnaires. The study will measure biological markers at enrollment, at the end of the intervention week 4, and three months after enrollment week 12. During the study, participants will undergo evaluations including cervicovaginal fluid analysis for inflammatory cytokines, cervical biopsies to assess immune cells and epithelial proteins, and tests for vaginal Lactobacillus presence. The research team will monitor changes over time to assess the impact of stopping vaginal washing on mucosal health. Women will also complete questionnaires weekly, and the study will last for at least 12 weeks per participant.