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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are investigating the effects of Mlambe, an economic and relationship-strengthening program designed to reduce heavy alcohol use among HIV-affected married couples in Malawi, where heavy drinking is common and negatively impacts health and relationships. This trial aims to evaluate Mlambe's effectiveness and cost-efficiency compared to enhanced usual care. The intervention addresses the interconnected issues of alcohol use, intimate partner violence, and economic insecurity, which hinder progress against HIV in sub-Saharan Africa. This is the first randomized controlled trial to combine economic support and relationship skills to reduce alcohol use in this population. The Mlambe intervention includes incentivized savings accounts, financial literacy training, and relationship skills education focused on improving couple communication and support. Participants will be divided into groups receiving Mlambe or enhanced usual care. The study will assess changes in heavy drinking behavior and relationship dynamics over time, aiming to break the cycle of poverty and alcohol misuse while strengthening couples. The intervention is behavioral and delivered through sessions that combine economic and relationship support. Participants will be followed for up to 20 months, with unhealthy alcohol use measured at 11, 15, and 20 months using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test. Researchers will monitor adherence to antiretroviral therapy, appointment attendance, viral suppression, relationship quality, and intimate partner violence. The study includes assessments of drinking days, communication, and safety concerns, ensuring comprehensive evaluation of both alcohol use and relationship outcomes.

Age: 18Years +All GendersPhase Not Applicable
1 location
G

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effectiveness of a new group postpartum and well-child care model compared to usual individual care for women and their infants in Malawi. This study focuses on how these different care approaches affect maternal and infant health outcomes during the first year after birth. The trial uses a cluster randomized controlled design with both quantitative and qualitative methods to better understand health and social needs, as well as challenges and opportunities in delivering group care in low-resource settings. The study involves 16 clinics where postpartum women and their infants receive care either in groups or individually. The group care model brings together 8-10 women and their infants born within one month of each other for one year of integrated care. Sessions, co-led by a midwife and a health surveillance assistant, last 120 minutes and include self-assessments, clinical health check-ups, and interactive health education and support activities. There are six scheduled visits aligned with Malawi's vaccination timetable at 6 weeks, 10 weeks, 14 weeks, 6 months, 9 months, and 12 months postpartum. Participants attend assessments at baseline, 6 months, and 12 months after birth, during which maternal postpartum depression scores and infant immunization completion rates are measured. Researchers also conduct interviews to explore health-related social needs and implementation factors for the group care model. Women and infants are monitored for health outcomes throughout the study, which provides important data to improve maternal and child health care delivery in similar settings.

Age: 1Week - 75YearsAll GendersPhase Not Applicable
16 locations
P

Actively Recruiting

Researchers are evaluating a couple-based intervention aimed at reducing perinatal depression (PD) and improving adherence to prevention of mother-to-child transmission (PMTCT) of HIV in Malawi. The study focuses on women living with HIV during the second or third trimester of pregnancy and their male partners. Since perinatal depression is a major factor leading to poor adherence to HIV treatment and infant care, this intervention seeks to strengthen couples' relationships, communication, and support systems to enhance PMTCT adherence and maternal mental health. The intervention uses a couples problem-solving therapy (PST) program adapted from the World Health Organization's Problem Management Plus (PM+) approach. This therapy addresses depression, food insecurity, and PMTCT adherence by helping couples improve communication and work together on problem-solving related to nutrition, mental health, and HIV care. The study is conducted in antenatal and HIV care settings in Zomba, Malawi, and involves couples where the woman screens positive for depression and has disclosed her HIV status to her partner. Participants will be assessed for participation, retention, intervention fidelity, and acceptability over an average of 5 to 11 months. Outcomes include adherence to the intervention, retention through study completion, fidelity to the therapy, and measures of acceptability at three months postpartum. The study involves monitoring couple dynamics, depressive symptoms, and PMTCT adherence to evaluate the feasibility and impact of the couple-based approach.

Age: 18Years +All GendersPhase Not Applicable
1 location
Zomba Clinical Trials | DecenTrialz