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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are evaluating an intervention called Mlambe designed to reduce heavy alcohol use among married or cohabitating couples affected by HIV in Malawi. The study addresses how alcohol use, intimate partner violence, and economic insecurity affect health outcomes and HIV treatment adherence. This trial is the first to combine economic support and relationship skills to help couples break the cycle of poverty and reduce harmful drinking. Participants are randomly assigned to either standard HIV care with brief alcohol advice or the Mlambe intervention. Mlambe includes incentivized savings accounts, financial literacy training, and relationship skills education aimed at improving couple communication and support. The trial will compare the effectiveness and cost-effectiveness of Mlambe versus usual care over several months. During the study, researchers will assess alcohol use through questionnaires and biomarker tests at 11, 15, and 20 months. They will also monitor HIV viral suppression, medication adherence, appointment attendance, and relationship dynamics. Participants will be followed up over nearly two years to measure changes in drinking behavior, HIV outcomes, and couple support.

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

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effectiveness of an integrated group postpartum and well-child care model compared to usual individual care for postpartum women and their infants. This cluster randomized controlled trial involves 16 clinics in Zomba District, Malawi, aiming to improve maternal and child health outcomes during the first year after birth. The study also explores health and social needs arising after birth and identifies challenges and supports for group care implementation in low-resource settings. Participants in the group care model meet in groups of 8-10 women and their infants born within one month of each other, attending six sessions over one year aligned with the Malawian vaccine schedule. Each 120-minute session includes self-assessments, clinician health checks, and interactive health promotion activities, co-facilitated by a midwife and a health surveillance assistant. The comparison group receives usual individual postpartum and well-child care based on standard clinic visits. Women and their infants are followed at baseline, 6 months, and 12 months postpartum. Researchers collect data on postpartum depression, infant immunization completion, breastfeeding, nutrition, maternal and infant health markers, child development, and mortality. Surveys, clinical assessments, and interviews are used to measure health outcomes and social experiences. The trial lasts through 2030, providing insights to enhance maternal and infant healthcare delivery in similar low-resource contexts.

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

Actively Recruiting

Researchers are evaluating a new approach to help women living with HIV who are experiencing depression during pregnancy and after childbirth in Malawi. The study focuses on improving adherence to prevention of mother-to-child transmission PMTCT of HIV, which involves taking antiretroviral therapy, infant prophylaxis, and exclusive breastfeeding. Depression during this period often leads to poor adherence and ongoing HIV presence in mothers. This trial aims to develop and test a couple-based intervention that strengthens partner support, communication, and problem-solving skills to address depression and improve PMTCT adherence. The study compares two groups one receiving standard care, including regular HIV and perinatal care with referrals for depression services, and the other receiving a couples-based intervention adapted from the World Health Organizations Problem Management Plus PM program. This intervention consists of five sessions covering stress management, problem-solving, behavioral activation, and skills to enhance social support and couple communication. Special emphasis is placed on addressing food insecurity, a major issue for participants, by helping couples brainstorm solutions related to nutrition and access to food. Participants will engage in the intervention over about five months, with follow-up continuing for roughly eleven months to assess participation, retention, intervention quality, and acceptability. Researchers will measure changes in depression symptoms, viral suppression, adherence to antiretroviral therapy and infant prophylaxis, infant HIV testing, and breastfeeding practices at three and six months postpartum. The study takes place within antenatal and HIV care settings, offering a comprehensive evaluation of this novel couple-based support approach.

Age: 18Years +All GendersPhase Not Applicable
1 location