Lilongwe

Researchers are evaluating whether circulating tumor HPV DNA (ctHPVDNA) in blood plasma and transrenal HPV DNA (TrHPVDNA) in urine can serve as non-invasive biomarkers for identifying and monitoring cervical cancer. The study focuses on understanding the relationship between these HPV DNA levels and the presence of cervical cancer at diagnosis and after treatment. This research aims to improve early detection of disease recurrence and guide personalized treatment decisions since current surveillance methods rely mainly on patient history and physical exams, with limited use of cytology or imaging. Biospecimens including blood plasma and urine will be collected from women newly diagnosed with cervical cancer at the UNC Department of Gynecology Oncology and Multidisciplinary clinics. Samples will be taken before therapy and again 2 to 6 weeks after completion of definitive treatment, which may include surgery or chemoradiation. Archived or leftover tissue samples will also be reviewed to complement the analysis. Participants will provide blood and urine samples at diagnosis and post-treatment visits. Researchers will measure ctHPVDNA and TrHPVDNA levels and compare them to clinical findings to assess their usefulness as biomarkers. The study monitors these markers at baseline and after treatment to evaluate disease status and potential recurrence. Women will be asked to comply with all study procedures during their involvement, which includes biospecimen collection and clinical assessments.

Researchers are establishing a large clinical study of lymphoma patients in Malawi to address the lack of detailed data from sub-Saharan Africa. The study aims to create a long-term group of at least 800 patients suspected of having lymphoma. These patients will undergo core biopsies for accurate diagnosis and will have clinical and laboratory information collected over time to better understand lymphoma outcomes in this region. Patients with confirmed blood cancers will be treated following local standards at Kamuzu Central Hospital. They will be followed actively in the clinic for 2 years after diagnosis to monitor their health and treatment results. After 2 years, patients who are well may choose to leave clinic visits and will be contacted by phone every 6 months for up to 5 years to check their vital status. Those who remain unwell or want to continue clinic visits will be seen every 6 months until 5 years post diagnosis, with detailed treatment records maintained. Participants will undergo internationally accepted laboratory tests and procedures consistent with care normally available at the hospital. The study aims to improve consistency and quality of patient data collection over time. Researchers will track outcomes including the number of patients with suspected lymphoma over 5 years. The total participation time varies based on health status and patient preference, with some patients followed in clinic and others by phone contact.

Tuberculosis (TB) remains the leading infectious cause of death worldwide and significantly impacts people living with human immunodeficiency virus (PLHIV), especially children and adolescents. These groups face challenges like gaps in preventive care, detection, treatment adherence, and knowledge. This research aims to improve TB detection, testing, and preventive treatment strategies tailored for PLHIV to address these challenges and improve care outcomes. The study evaluates patient-centered TB preventive therapy, where participants who have been ruled out for active TB choose their preferred preventive treatment regimen. Participants are then randomized to receive one of two types of adherence support, including enhanced support through weekly text messages and clinic phone calls. These messages encourage communication with healthcare providers to address questions and improve treatment adherence. Participants will be monitored for TB screening and diagnosis over 24 to 32 months, with prevention outcomes assessed at 48 months. Researchers will also evaluate the cost-effectiveness of the TB preventive treatments over 32 months. The study involves ongoing communication between participants and trained healthcare staff to support adherence and tracks treatment success and safety throughout the study period.

Researchers are evaluating the Enhanced Friendship Bench intervention to improve perinatal depression, engagement in HIV care, and infant health outcomes among pregnant women with HIV and depression in Malawi. This study builds on a pilot trial that demonstrated the intervention's feasibility, acceptability, and preliminary effectiveness. The current randomized controlled trial aims to fully assess the intervention's impact and understand the factors influencing its effects while gathering important information for future implementation. The study compares the Enhanced Friendship Bench, which includes four prenatal and two postnatal counseling sessions focused on problem-solving therapy, enhanced with two social support sessions and monthly home visits for ART delivery and counseling during the third trimester and first three months postpartum, against enhanced usual care. The usual care consists of mental health evaluation, brief supportive counseling, education about common mental disorders, and referral support when needed. Participants will engage in counseling sessions and home visits, with ongoing monitoring of depressive symptoms and HIV care retention up to six months postpartum. Researchers will assess changes in depression and HIV care engagement as primary outcomes. The study includes mental health evaluations and tracks infant health outcomes as well, ensuring comprehensive support and observation throughout the perinatal period.

Researchers are evaluating the short-term effectiveness and implementation of Treat4All, an evidence-based intervention aimed at reducing heavy drinking and improving HIV-related outcomes. The study targets two groups: people with HIV (PWH) who report recent heavy drinking and issues with viral suppression or ART adherence, and individuals at risk of HIV who receive STI care, report recent heavy drinking, and have no recent use of PrEP. About 160 participants aged 18 years or older will be enrolled in this pilot two-arm randomized controlled trial comparing Treat4All to usual care. The Treat4All intervention consists of three weekly individual in-person sessions lasting about 30 minutes each, delivered by trained counselors over a 12-week period. The sessions provide personalized feedback on alcohol use and include content on HIV prevention and treatment such as PrEP use for those at risk and ART adherence for PWH. Usual care involves sexual risk reduction counseling with messaging on reducing alcohol use before sex and abstaining from alcohol while on ART. All participants receive counseling by trained HIV counselors and access to condoms, with PWH referred to an HIV clinic. Participants will undergo quantitative assessments through face-to-face interviews at baseline, 3 months, and 6 months, covering alcohol use, HIV testing, quality of life, depression, stigma, sexual risk behaviors, PrEP and ART use. Laboratory tests including HIV viral load, STI testing, and alcohol biomarker testing will be conducted at baseline and 6 months. HIV-negative participants at baseline will be retested for HIV at 6 months. The main outcomes measured are the proportion of heavy drinking days and engagement in HIV prevention or treatment six months after enrollment.

Researchers are evaluating a new community-based approach called the PAC-Man model to improve early infant diagnosis (EID) testing and maternal viral load testing among pregnant and breastfeeding women living with HIV in Malawi. This study uses a hybrid effectiveness-implementation stepped-wedge trial design to compare the PAC-Man model against the standard care provided by the Ministry of Health. The PAC-Man model aims to reduce mother-to-child transmission of HIV by integrating proven practices into community settings, focusing on high-risk mother-infant pairs. The PAC-Man model includes three key practices: pediatric active case finding using novel point-of-care EID technology, same-day antiretroviral therapy initiation for infants diagnosed with HIV, and maternal viral load testing with follow-up care. This model uses mobile care teams equipped with new diagnostic tools that deliver services directly in the community. The study involves gradually rolling out the PAC-Man model across 12 sites grouped into four clusters, comparing outcomes during the transition from standard care to the new model. Participants include mother-infant pairs enrolled in the national EMTCT program, with additional groups involved for interviews and focus groups. Researchers will track the proportion of infants receiving timely EID testing by age six months and assess maternal viral load testing adherence. Data collection includes surveys, interviews, and focus group discussions with health providers and policy makers. The study monitors implementation success and health outcomes over time to determine the model's impact on preventing mother-to-child HIV transmission.

This research focuses on HIV treatment in high-prevalence countries, specifically evaluating differentiated service delivery models (DSD) that aim to improve care. Many such models are being used without formal evaluation, so this project seeks to analyze existing data to understand how widely these models are offered, who is eligible, patient participation rates, health outcomes like viral suppression, resource use compared to traditional care, model variations, and their sustainability without external funding. The study involves collecting and analyzing routine medical record data from electronic systems and paper charts maintained by the Ministry of Health and partners in Malawi. It does not involve direct interaction with patients or providers. The data will cover various aspects of differentiated HIV treatment delivery models to assess coverage, uptake, patient outcomes, and distribution of different models. Participants are HIV patients aged 15 years or older receiving care during the data collection period. Researchers will analyze existing medical records to measure the time patients spend enrolled in any DSD model over 6, 12, and 24 months. The study focuses on gathering comprehensive information to support future decisions about HIV treatment delivery without additional patient visits or interventions.

Researchers are evaluating different ways to improve cervical cancer prevention in Malawi, especially among people receiving HIV care. The study focuses on identifying which strategies best increase healthcare providers' recommendations and patients' use of cervical cancer prevention methods. It also examines how acceptable, appropriate, feasible, and costly these strategies are, as well as their lasting effects. The study is a Phase 4 trial involving health workers such as clinical officers, nurses, and medical assistants. The study tests several implementation strategies including in-person training sessions, virtual training sessions, coaching through short video clips and reinforcing messages, and visual reminders to prompt providers to discuss cervical cancer prevention. These strategies are aimed at improving the delivery of prevention information by health workers to adolescent girls and young women aged 9 to 24 and their caregivers. Participants include health workers providing medical care or counseling and non-pregnant females aged 9 to 24 who receive HIV care at selected facilities. For younger participants aged 9 to 17, their parents or guardians may also participate. The study monitors discussions about cervical cancer prevention methods from months 7 to 18 and assesses the implementation strategies' sustained effects. Participants undergo regular assessments to measure these outcomes during the study period.

Researchers are evaluating the implementation of an intensity-adapted clinical practice guideline (CPG) for treating childhood acute myeloid leukemia (AML) in Malawi, a resource-limited setting where survival rates are much lower than in high-resource areas. This prospective cohort study uses the 2023 Kamuzu Central Hospital (KCH) AML therapy guideline, based on recommendations from the International Society of Paediatric Oncology (SIOP), to balance curative intent with manageable toxicity. The study aims to measure how successfully the guideline is applied and its impact on patient outcomes in a real-world setting. All children under 18 years with newly diagnosed AML at KCH will receive treatment according to the SIOP-adapted guideline, which is the standard of care in Malawi. Treatment involves multiple chemotherapy cycles including Induction 1, Induction 2, Consolidation 1, and Consolidation 2. Patients are admitted inpatient at the start of each chemotherapy cycle and discharged when stable before returning for the next cycle. Data collection during treatment includes bone marrow tests, cerebrospinal fluid analysis, blood counts, imaging, and questionnaires. Follow-up continues for up to 24 months after therapy with regular visits and telephone check-ins. Participants will be closely monitored through clinical evaluations, laboratory tests, imaging, and patient-reported quality of life measures. Researchers will assess the primary outcome of implementation success, combining how many patients complete the guideline with rates of complete remission after induction. Secondary outcomes include survival rates, adverse events, treatment adherence, and cytogenetic characteristics. This first prospective study of pediatric AML in sub-Saharan Africa will provide critical data to improve treatment strategies in resource-constrained environments.

Researchers are evaluating the effectiveness of a postpartum HIV prevention package called the LINK model among postpartum women in Lilongwe, Malawi. This study compares the LINK model to the standard care at twelve clinic sites to see if it improves persistence with Pre-exposure Prophylaxis (PrEP) use after childbirth. The study is designed as a cluster randomized trial and aims to integrate postpartum HIV testing and PrEP services with infant vaccination visits in a region with high HIV incidence. The LINK model includes four key components: linking postpartum HIV testing and PrEP services to early infant vaccinations, screening for HIV risk at infant vaccination visits, engaging male partners to support PrEP use and HIV status awareness, and providing community-facility linkage through peer mothers who support breastfeeding women on PrEP and follow up with those who disengage from care. These activities are carried out by health workers including HIV diagnostic assistants and peer mothers, integrated into existing clinic and PrEP services. Participants will be involved through medical record reviews, surveys, and in-depth interviews across both intervention and control clinics. Data collection includes demographic and HIV risk questionnaires, dried blood spot samples to measure PrEP adherence, and interviews to assess acceptability and feasibility of the LINK model. The primary outcomes measured include PrEP persistence at six months, PrEP uptake during breastfeeding, and adherence based on drug levels. The study uses a mix of prospective data and existing health records over approximately 3.5 years without longitudinal follow-up of individual participants.