Mombasa

Researchers are conducting a multinational, prospective observational study called the ICU-related Out-of-Pocket Expenses (ICOPE) study in African and Asian countries. This study aims to measure the financial burden on patients and families related to ICU care, focusing on out-of-pocket expenses and catastrophic health expenditure. The study includes both ventilated and non-ventilated patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. Participants are followed during their ICU stay, which averages about 7 days, and additional follow-ups occur at 30 days and 6 months after admission. The study compares costs between patients receiving invasive mechanical ventilation and those who are not ventilated. It also investigates risk factors for catastrophic health expenditure and documents how families cope with the financial demands of ICU care. Throughout the study, researchers collect data on patient expenses, including direct medical and non-medical costs, as well as indirect costs such as income loss. The main outcomes measured are the out-of-pocket cost per patient episode until ICU discharge and the relative risk of catastrophic health expenditure. The total study duration spans 18 months, allowing for comprehensive assessment of financial impact and coping strategies over time.

Researchers are studying viral suppression in people living with HIV who have high viral loads despite being on dolutegravir (DTG)-based antiretroviral therapy (ART) for at least six months. The study aims to fill gaps in data about viral suppression rates without changing the ART regimen and to monitor the emergence of drug-resistant mutations linked to DTG and their effects on viral control. The research is conducted across multiple countries including Kenya, Mozambique, Tanzania, and Lesotho. Participants will continue their DTG-based ART throughout the study, which lasts up to 12 months. Those with viral loads of 200 copies/mL or higher will receive enhanced adherence counseling during scheduled visits every three months. The counseling includes at least three sessions focused on improving medication adherence and managing other causes of viral load increase. For participants who achieve viral suppression below 200 copies/mL during follow-up, an additional viral load test will be done after three months, with longer-term outcome data collected up to 24 months. Throughout the study, participants will have viral load testing at enrollment and every three months if suppression is not reached. Researchers will track viral suppression rates at 6 and 12 months and analyze factors linked to success, development of DTG resistance mutations, and opportunistic infections. The study also collects routine clinical data such as loss to follow-up and mortality. Participants may be evaluated for eligibility in a nested clinical trial focused on managing those who develop drug resistance during the cohort study.

BACKGROUND: The majority of people living with HIV (PLWH) on first-line antiretroviral therapy (ART) in low- and middle-income countries are on dolutegravir (DTG)-containing regimens. Different countries have adopted different approaches in the management of people on DTG-based first-line ART with repeat HIV viral load (VL) of \> 1,000 copies/mL after 3 months of enhanced adherence counselling. For example, Kenya recommends a drug resistance test (DRT) to guide on switch and the optimal second-line regimen; Mozambique and Tanzania recommend switch to 2 nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitors (PIs) without drug resistance testing; South Africa does not recommend switch from DTG or DRT for those who are on first-line DTG-containing regimens within the first 2 years of treatment, after which management is guided by possible DRT and expert opinion. The World Health Organization has recognised the role of drug resistance testing (DRT) in a treatment failure algorithm for people living with HIV receiving DTG-based treatment to minimise unnecessary switches from this regimen. The switch to PI has disadvantages including higher cost, higher pill burden, less convenient administration (often should be taken with food), more potential drug-drug interactions, poorer tolerability and more long-term toxicities. GOAL: To assess the efficacy and safety of remaining on DTG compared to switching to DRV/r among people failing DTG-based ART with at least one major DTG DRM. METHODS: This is a phase 3b, multi-country, open-label, two-arm, active-controlled randomized clinical trial (RCT) over 12 months describing the efficacy and safety of switching from DTG to DRV/r among PLWH age ≥ 3 years who are failing DTG-based ART with HIV-1 RNA ≥ 200 copies/mL and ≥ 1 major DTG-associated DRM (and most recent prior HIV-1 RNA ≥ 1,000 copies/mL after at least 6 months on DTG-based ART). The primary efficacy endpoint is the proportion of participants with HIV-1 RNA \< 200 copies/mL at month 6. The study will be conducted in 9 sites in Kenya, Mozambique, Tanzania and Lesotho targeting 392 participants including 30 children aged between 3 and 14 years old. The primary efficacy analysis will assess the difference in the proportion of participants with viral suppression at month 6 using the Cochran-Mantel-Haenszel method. This RCT is nested within an observational cohort study describing HIV-1 viral suppression of people with HIV-1 RNA value of ≥ 1,000 copies/mL after at least six months on DTG-based ART.

Men who have sex with men (MSM) in Kenya face a high risk of gonorrhea, chlamydia, and syphilis infections, but many cases go undiagnosed due to limited testing options. This research investigates the impact and cost-effectiveness of two treatments: the World Health Organization (WHO) recommended periodic presumptive treatment (PPT) and doxycycline post-exposure prophylaxis (doxyPEP), compared to standard care. The study focuses on how these treatments affect infection rates and antimicrobial resistance in Neisseria gonorrhoeae, aiming to improve STI control in resource-limited settings like Kenya. The trial is an open-label, randomized clinical study with 2,900 participants assigned in a 2:2:1 ratio to receive either PPT, doxyPEP, or standard syndromic treatment. PPT involves taking 400 mg cefixime plus 1 gram azithromycin under direct observation every three months. DoxyPEP consists of 200 mg doxycycline taken within 24 to 72 hours after condomless anal or vaginal sex, as often as daily. The study spans 18 months, with treatments and follow-up carried out at three MSM-friendly clinics. Participants will attend quarterly visits during the 18-month follow-up to monitor infections using culture and molecular tests, evaluate antimicrobial resistance, and assess treatment safety and acceptability. Researchers will collect data on infections with Neisseria gonorrhoeae, Chlamydia trachomatis, and early syphilis. Results will inform health and economic models for STI control among MSM and their partners in Kenya, aiming to guide future guidelines and interventions.

Researchers are evaluating whether giving surfactant using a less invasive technique can help treat respiratory distress in preterm infants born in low- and middle-income African countries where invasive ventilators are not available. This trial focuses on infants born weighing between 750 and 2000 grams or with a gestational age of 24 to 35 weeks who have respiratory distress and are breathing on their own while receiving continuous positive airway pressure (CPAP). The study aims to see if this less invasive surfactant administration (LISA) improves survival and to monitor any medical problems that occur during treatment. In this study, preterm infants with respiratory distress will receive surfactant therapy through a thin catheter inserted into their windpipe during laryngoscopy while continuing CPAP support. This method is compared to the standard care of CPAP and caffeine citrate without surfactant. The surfactant is given shortly after birth, ideally within 24 hours, and participants are closely monitored for any complications or side effects related to the treatment. Participants will be followed throughout their hospital stay, which is on average about six months, to determine survival rates and safety outcomes. Researchers will assess the infants' response to surfactant therapy, monitor for respiratory and other medical complications, and track overall hospital survival. The study collects detailed data on the infants' health status and treatment progress to understand how well the less invasive method works in these settings.

Researchers are evaluating whether Remote Ischaemic Conditioning (RIC) can reduce death and early heart failure within 30 days in patients with ST-segment elevation myocardial infarction (STEMI) in Africa. This trial focuses on higher-risk patients treated mainly with thrombolytic therapy, across about 25 sites in seven African countries. The study includes a randomized controlled trial (RCT) and an observational arm for patients presenting later than 24 hours but less than 72 hours after symptom onset. Patients in the RCT are randomly assigned to either RIC or a sham control. RIC involves four cycles of 5-minute inflation of a cuff on the upper arm to 20 mmHg above systolic blood pressure followed by 5 minutes of deflation, repeated daily for 3 days starting before thrombolysis. The sham control uses a similar device inflated to a low pressure of 20 mmHg for the same schedule. The observational arm includes patients presenting between 24 and 72 hours after symptom onset and follows the same outcome measures. Participants undergo assessments including ECG, biomarkers, and echocardiography to confirm STEMI and monitor outcomes. The primary measure is a combined rate of all-cause death and new heart failure at 30 days after STEMI. The study also monitors safety and collects informed consent, aiming to provide a low-cost, non-invasive therapy to improve outcomes for high-risk STEMI patients in Africa.

East and Southern Africa has a high burden of HIV, with many people living with HIV (PLWH), especially adolescent girls and young women (AGYW). This research evaluates the Systems Analysis and Improvement Approach (SAIA), a strategy to integrate HIV prevention and treatment services into family planning (FP) clinics. The study focuses on improving HIV counseling, testing, linkage to care, and screening and linkage to pre-exposure prophylaxis (PrEP), aiming to help Kenya meet HIV testing and treatment goals while prioritizing AGYW. The study compares SAIA with usual care in FP clinics through a cluster-randomized trial. SAIA is a five-step continuous quality improvement cycle led by Kenyan public health workers and FP clinic staff, repeated every 4-6 weeks. It involves understanding care cascades, identifying bottlenecks, adapting workflows, monitoring performance, and repeating the process. The approach is monitored by the Mombasa Department of Health, with a focus on scaling SAIA for wider public health use. Participants include new and returning FP clients, especially AGYW, and FP clinic staff. Researchers will collect quantitative and qualitative data over 24 months using the RE-AIM framework to assess reach, effectiveness, adoption, implementation, and maintenance of SAIA. An economic evaluation will estimate costs and budget impacts for county health departments. Outcomes measured include HIV counseling effectiveness, testing, linkage to care, and PrEP screening and linkage.

Vaginal washing is a practice many women consider hygienic, but it has been linked to negative reproductive health outcomes, including an increased risk of HIV infection. The exact reasons for this increased risk are unclear, but it may be related to inflammation caused by vaginal washing. This study aims to test whether stopping vaginal washing reduces inflammation and immune cell presence in cervical tissue, lowers disruption of cervical lining, and increases protective vaginal Lactobacillus bacteria compared to no change in behavior. Participants will be part of a behavioral intervention that encourages stopping vaginal washing. They will attend weekly small group sessions designed around the transtheoretical model of behavioral change, aiming to help them quit vaginal washing. The study involves a randomized controlled trial comparing this intervention to control, with key biological measurements taken at enrollment, after 4 weeks of intervention, and again 3 months after enrollment. During the study, researchers will collect samples to measure cervicovaginal cytokines, immune cells in cervical tissue, mucin and tight junction protein expression, and Lactobacillus bacteria presence and concentrations. These assessments occur at baseline, week 4, and week 12. Participants will undergo cervical biopsies and other evaluations to understand the biological effects of stopping vaginal washing, with safety and adherence monitored throughout the study period.