Lilongwe

Researchers are evaluating if circulating tumor HPV DNA ctHPVDNA in blood plasma and transrenal HPV DNA TrHPVDNA in urine can serve as non-invasive markers to detect and monitor cervical cancer. This study aims to understand the relationship between these DNA levels and the presence of cervical cancer at diagnosis and after treatment. The goal is to improve early detection of recurrence and guide personalized treatment decisions using these biomarkers. Participants diagnosed with cervical cancer will provide blood and urine samples before treatment and again 2 to 6 weeks after completing surgery or chemoradiation. Archived or leftover tissue samples may also be accessed. The study does not involve experimental treatments but focuses on collecting and analyzing biological samples to monitor disease status. During the study, participants will have their plasma and urine tested for ctHPVDNA and TrHPVDNA levels at baseline and post-treatment. Researchers will compare these results to evaluate changes correlated with treatment response. The main outcome is the relationship between these biomarkers and cervical cancer presence. The study will also track changes in these DNA levels following definitive therapy, with participation lasting through the post-treatment sample collection period.

Researchers are developing a large, prospective clinical cohort of lymphoma patients in Malawi to address the current lack of detailed data from sub-Saharan Africa. This observational registry study aims to better understand lymphoma and other hematologic malignancies by enrolling at least 800 patients suspected of having lymphoma. The study is led by the UNC Lineberger Comprehensive Cancer Center and focuses on collecting accurate diagnosis and clinical information over time. Patients referred to Kamuzu Central Hospital with suspected lymphoma will undergo core biopsies for precise histopathologic diagnosis. Those confirmed with hematologic malignancies will receive treatment following local standards of care. Participants will be followed actively in clinic for two years after diagnosis, with continued telephone follow-up every six months for up to five years to assess their health status. Patients who remain well may be discharged from active clinic follow-up after two years but will still be contacted to monitor their vital status. During the study, researchers will systematically collect clinical and laboratory data consistent with international standards, including quality of life assessments and viral markers related to lymphoma. The study aims to standardize and improve the consistency of lymphoma patient monitoring at Kamuzu Central Hospital. Data collected will help assess patient outcomes and better characterize lymphoma in this region over a five-year period.

Researchers are evaluating the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi. This fully powered randomized controlled trial aims to confirm the interventions effectiveness, study how it works, and gather important data to help apply the findings in real-world settings. The study follows up on a pilot trial that showed promising results for improving mental health and HIV care during and after pregnancy. Participants will receive either the Enhanced Friendship Bench intervention or enhanced usual care. The Enhanced Friendship Bench includes problem-solving therapy with four prenatal and two postnatal counseling sessions, two social support sessions, and monthly home visits for ART delivery and counseling during the third trimester and first three months postpartum. The comparison group will receive usual outpatient care enhanced with mental health evaluations, brief counseling, education about mental health, and referral support when needed. Throughout the study, participants will be monitored for changes in depressive symptoms and HIV care retention six months after giving birth. Infant growth measurements will also be taken at six months postpartum, including height-for-age, weight-for-age, and weight-for-height. Additional assessments include depression remission and HIV viral suppression up to twelve months postpartum. The study uses double-masked methods and randomizes participants to either group, with ongoing evaluations to track health outcomes and treatment engagement over time.

Researchers are evaluating the short-term effectiveness and implementation of Treat4All, an alcohol reduction intervention designed to decrease heavy drinking and improve HIV-related outcomes. The study focuses on two groups people with HIV who have a history of unsuppressed viral load or poor ART adherence and individuals at high risk for HIV who report recent heavy drinking and no recent PrEP use. About 160 participants aged 18 or older will be enrolled in this pilot randomized controlled trial comparing Treat4All to usual care. Participants in the Treat4All group will receive three weekly individual in-person sessions over three weeks, tailored to their specific issues and HIV status. These sessions include personalized feedback on alcohol use, education on alcohols impact on STI risk, goal setting, and strategies to improve HIV prevention and treatment engagement, such as ART adherence and PrEP use. The usual care group will receive sexual risk reduction counseling that includes advice on reducing alcohol use before sex and abstaining from alcohol while on ART. All participants will receive counseling and referral to HIV care as needed. Participants will complete baseline, 3-month, and 6-month assessments including face-to-face questionnaires on alcohol use, HIV testing, health status, quality of life, and other relevant measures. Laboratory tests for HIV viral load, STI screening, and alcohol biomarkers will be conducted at baseline and 6 months. HIV-negative participants will be retested for HIV at 6 months. The study includes randomization to intervention or usual care and ongoing monitoring to assess heavy drinking days and engagement in HIV prevention or treatment six months after enrollment.

Researchers are evaluating the PAC-Man model, an integrated differentiated services delivery DSD approach aimed at eliminating mother-to-child transmission of HIV in Malawi. This model combines three evidence-based practices pediatric active case finding using point-of-care early infant diagnosis technology, same-day antiretroviral therapy initiation for infants newly diagnosed with HIV, and maternal viral load testing with back-to-care services. The study uses a hybrid effectiveness-implementation stepped-wedge design involving 12 sites divided into clusters to compare the PAC-Man model with standard care. The PAC-Man model is delivered through mobile care teams equipped with new diagnostic technology that brings services directly to the community, focusing on high-risk mother-infant pairs. The implementation strategy includes task shifting of testing and treatment duties to community health workers and changing service locations to more convenient community sites. Participants are randomly assigned by clusters to either receive the PAC-Man model alongside routine care or continue with standard Ministry of Health care. Participants include mothers and infants enrolled in the national EMTCT program, healthcare workers, policymakers, and implementing partners, totaling over 2,400 individuals. The study measures outcomes such as the proportion of infants receiving early infant diagnosis testing by 6 months, maternal viral load testing adherence, infant ART initiation, viral suppression, and retention in care. Data is collected over 12 months following enrollment, and implementation outcomes like adoption rates and cost per pediatric case are also assessed.

Researchers are analyzing existing medical record data to evaluate different ways of delivering HIV treatment in Malawi. This observational study focuses on understanding the coverage, uptake, benefits, and costs of differentiated service delivery models DSD aimed at improving HIV care. The project seeks to provide information to support future decision-making and ongoing evaluation of these treatment approaches in high-prevalence settings. The study collects routine medical record data from electronic medical record systems, other electronic databases, and paper charts. It compares patients enrolled in DSD models with those not enrolled, examining how different service models are implemented and their impact on patient outcomes. There are no direct interactions with patients, providers, or caregivers during data collection. Participants are people living with HIV aged 15 years and older who received care during the data collection period. Researchers will analyze outcomes such as the number of patient-months enrolled in any DSD model over 6, 12, and 24 months. The study will assess factors like uptake of DSD, patient health outcomes, and the distribution of service delivery models, helping to inform sustainable HIV treatment strategies without ongoing external donor support.

This research aims to evaluate the implementation of pediatric acute myeloid leukemia AML treatment guidelines adapted for resource-limited settings like Malawi. The study focuses on children under 18 years diagnosed with de novo AML at Kamuzu Central Hospital, where survival rates are notably low. It assesses a clinical practice guideline CPG based on recommendations by the International Society of Paediatric Oncology SIOP, designed to balance effective treatment with manageable side effects in this setting. The study observes patients treated according to the 2023 KCH AML therapy CPG, which is the current standard of care at the hospital. The guideline involves intensity-adapted chemotherapy cycles including induction and consolidation phases, with inpatient care during chemotherapy cycles until recovery milestones. Patients then have a brief home period before the next cycle. Data collection includes routine clinical care measurements like bone marrow evaluations, blood tests, imaging, and patient questionnaires, with no extra procedures required for study participation. Participants will be followed during therapy and after treatment completion, with monthly telephone check-ins for six months and in-person visits up to two years and beyond. The study measures implementation success by combining feasibility and effectiveness, including treatment completion rates and remission outcomes. Additional outcomes include survival, adverse events, hematologic recovery, cytogenetics, and quality of life assessments. This is the first prospective pediatric AML study in sub-Saharan Africa aimed at improving care in low-resource environments.

Researchers are evaluating a postpartum prevention package called the LINK model to improve HIV prevention in postpartum women in Lilongwe, Malawi. This study aims to compare the effectiveness of the LINK model to the standard of care by examining PrEP persistence among women receiving services at randomized clinics. The study focuses on postpartum women breastfeeding and living without HIV, and will use data from medical records, surveys, and interviews to assess the intervention and its implementation. The LINK model integrates postpartum HIV testing and PrEP services with early infant vaccination visits. It includes HIV risk screening, male partner engagement to support HIV status awareness and PrEP persistence, and community-facility linkage with peer mothers who provide ongoing support to breastfeeding women using PrEP and follow-up for those who disengage from care. Twelve clinics are randomized to either the LINK model or standard care, with clinical staff and study-hired assistants delivering the intervention components alongside existing services. Participants include postpartum women breastfeeding and using PrEP, women attending infant vaccination visits, and relevant clinical and policy stakeholders. Data collection involves medical record reviews, surveys, dried blood spot tests to measure PrEP adherence, and in-depth interviews to explore acceptability and feasibility. The main outcome is the proportion of patients persisting with PrEP for six months without interruption, along with measures of PrEP uptake and adherence. The study will run for approximately 3.5 years with no longitudinal follow-up of individual participants.

Repeat and prolonged treatment interruption TI among people living with HIV is a major challenge to controlling the HIV epidemic in eastern and southern Africa, including Malawi. This research aims to evaluate an innovative long-term dynamic choice intervention called CHOICE, designed to support ART clients experiencing TI. The trial compares the CHOICE approach with standard care to see if it improves viral suppression after 12 months of follow-up. The CHOICE intervention offers person-centered counseling combined with ongoing, flexible choices about how clients receive their HIV care services. Participants can choose their ART dispensing intervals 1, 3, or 6 months, locations for ART distribution facility, home, or community, and peer mentorship options. These choices can be adjusted at any visit or by phone during the 24-month study period. The control group receives standard care, which includes 1-3 counseling sessions and routine facility-based services without these dynamic choices. Participants will be followed for 12 months to measure viral suppression, with additional monitoring up to 24 months for repeat treatment interruptions, ART coverage, and safety. The study involves regular assessments including viral load tests and will collect data on barriers and facilitators of care as well as the costs and cost-effectiveness of the intervention. This trial aims to find better ways to provide long-term, personalized support to those at risk of treatment interruption.

Researchers are evaluating a package of strategies to help people continue using pre-exposure prophylaxis PrEP for HIV prevention, focusing especially on long-acting injectable cabotegravir CAB LA. This study compares standard care with an enhanced support program across various clinics and community centers serving prioritized groups such as female sex workers, men who have sex with men, transgender individuals, and others at high risk. The goal is to see which approach better supports ongoing use of PrEP over time. Participants in the study will be part of clusters randomized to either receive the standard Ministry of Health care for PrEP continuation or an enhanced bundle of support including improved communication, peer support, and flexible clinic hours. The study uses passive enrollment from clinics and collects data on PrEP initiation, switching between oral and injectable forms, and continuation rates. Additional research includes surveys, interviews, and fidelity assessments to understand the acceptability and implementation of these strategies. Participants will be followed for at least five months after starting PrEP, with data collected through program records and additional research activities. Researchers will measure continuation of CAB LA PrEP use at five months as the main outcome, along with continuation of oral PrEP and other secondary measures. The study includes interviews to capture participant experiences and uses both quantitative and qualitative methods to analyze findings. Follow-up data will span from five to eleven months depending on enrollment timing.