As the HIV epidemic stabilises in Sub-Saharan Africa with effective antiretroviral therapy, cardiometabolic disorders (CMDs) remain the next major challenge for people living with HIV. Relationship dynamics and spousal support are important for the medical management of single diseases such as HIV, yet little is known about how couples manage the complexity of multiple competing health conditions and their synergistic effects on health. The Healthy Hearts study aimed to develop a conceptual model of dyadic management of HIV and CMDs, inform interventions for couples in Sub-Saharan Africa, and ultimately improve clinical practice and disease management for HIV and CMD comorbidities.

This study will enrol 250 couples who have at least one partner living with HIV and CMD (either hypertension or diabetes) for a prospective observational cohort study. Patients will be recruited from HIV and CMD clinics in Zomba and Blantyre, Malawi. Couples will attend four study visits at quarterly intervals over 12 months. Both partners are given interviewer-administered surveys and complete a clinical assessment. Regression techniques will be used to test associations between key constructs in our conceptual model, including communal coping, multimorbidity illness perceptions, relationship quality, psychosocial health, disease management (eg, adherence to lifestyle advice and medications) and disease outcomes (eg, viral suppression and CMD control). Findings will be used to identify elements to target in a couple-based intervention for CMD and HIV.

This study was approved by the University of California, San Francisco (HRPP (Human Research Protection Program); Protocol number 20–32126), and the National Health Sciences Research Committee of Malawi (Protocol number 21/04/2677). The results will be disseminated at local community meetings and conferences focused on relationships, CMDs and HIV and published in scientific journals.

Micronutrient deficiencies remain prominent drivers of adverse maternal and child health outcomes in Nepal. Gender-based inequalities and norms around women’s status and access to nutrition exacerbate poor nutritional status. Many newly married, preconception women lack adequate nutrition due to delayed engagement with the health system and limited autonomy to prioritise their own health. To address this gap, the Sumadhur trial provides multiple micronutrient supplements (MMS) alongside a household-level behavioural intervention targeting newly married women, their husbands and mothers-in-law.

This will be a village-cluster randomised controlled trial across three districts in Nepal, enrolling 700 households, each comprising a triad of newly married woman, husband and mother-in-law. Villages will be randomised to receive either Sumadhur behavioural intervention+MMS (intervention) or standard of care (control). In intervention villages, participants will join weekly group sessions for 5 months, covering maternal and reproductive health, equitable household food allocation and nutrition information, and gender norms and household relationships. Women will receive three bottles of MMS (180 tablets each) over 18 months. Quantitative data collection at baseline, 6, 12 and 18 months will include surveys, venous blood draws (not at 12 months) and anthropometry. Primary outcomes will be anaemia prevalence and micronutrient status (iron, folate, vitamin B₁₂). Secondary outcomes will include reproductive behaviours, birth outcomes and intrahousehold relationship dynamics. A nested qualitative component will employ longitudinal in-depth interviews with triads to understand the mechanisms of behavioural change. Impact will be measured through an intention-to-treat approach using mixed-effects logistic regression analyses.

The study is approved by institutional review boards in the Ethics Board of the Nepal Health Research Council and the University of California, San Francisco IRB. Results will be disseminated to participating communities, local stakeholders and international audiences through workshops, peer-reviewed publications and policy briefs.

All data will be made publicly available (deidentified) after the publication of the main impact paper.

NCT06810440.