The Kanyakla study: Randomized controlled trial of a microclinic social network intervention for promoting engagement and retention in HIV care in rural western Kenya.

BACKGROUND: Existing social relationships are a potential source of "social capital" that can enhance support for sustained retention in HIV care. A previous pilot study of a social network-based 'microclinic' intervention, including group health education and facilitated HIV status disclosure, reduced disengagement from HIV care. We conducted a pragmatic randomized trial to evaluate microclinic effectiveness. METHODS: In nine rural health facilities in western Kenya, we randomized HIV-positive adults with a recent missed clinic visit to either participation in a microclinic or usual care (NCT02474992). We collected visit data at all clinics where participants accessed care and evaluated intervention effect on disengagement from care (≥90-day absence from care after a missed visit) and the proportion of time patients were adherent to clinic visits ('time-in-care'). We also evaluated changes in social support, HIV status disclosure, and HIV-associated stigma. RESULTS: Of 350 eligible patients, 304 (87%) enrolled, with 154 randomized to intervention and 150 to control. Over one year of follow-up, disengagement from care was similar in intervention and control (18% vs 17%, hazard ratio 1.03, 95% CI 0.61-1.75), as was time-in-care (risk difference -2.8%, 95% CI -10.0% to +4.5%). The intervention improved social support for attending clinic appointments (+0.4 units on 5-point scale, 95% CI 0.08-0.63), HIV status disclosure to close social supports (+0.3 persons, 95% CI 0.2-0.5), and reduced stigma (-0.3 units on 5-point scale, 95% CI -0.40 to -0.17). CONCLUSIONS: The data from our pragmatic randomized trial in rural western Kenya are compatible with the null hypothesis of no difference in HIV care engagement between those who participated in a microclinic intervention and those who did not, despite improvements in proposed intervention mechanisms of action. However, some benefit or harm cannot be ruled out because the confidence intervals were wide. Results differ from a prior quasi-experimental pilot study, highlighting important implementation considerations when evaluating complex social interventions for HIV care. TRIAL REGISTRATION: Clinical trial number: NCT02474992.

The MOMENTUM study: Putting the 'Three Delays' to work to evaluate access to emergency obstetric and neonatal care in a remote island community in Western Kenya.

Despite worldwide improvements in maternal and infant mortality, mothers and babies in remote, low-resource communities remain disproportionately vulnerable to adverse health outcomes. In these settings, delays in accessing emergency care are a major driver of poor outcomes. The 'Three Delays' model is now widely utilised to conceptualise these delays. However, in out-of-hospital contexts, operational and methodological constraints present major obstacles in practically quantifying the 'Three Delays'. Here, we describe a novel protocol for the MOMENTUM study (Monitoring of Maternal Emergency Navigation and Triage on Mfangano), a 12-month cohort design to assess delays during obstetric and neonatal emergencies within the remote villages of Mfangano Island Division, Lake Victoria, Kenya. This study also evaluates the preliminary impact of a community-based intervention called the 'Mfangano Health Navigation' programme. Utilising participatory case audits and contextually specific chronological reference strategies, this study combines quantitative tools with deeper-digging qualitative inquiry. This pragmatic design was developed to empower local research staff and study participants themselves as assets in unravelling the complex socio-economic, cultural, and logistical dynamics that contribute to delays, while providing real-time feedback for locally driven intervention. We present our methods as an adaptive framework for researchers grappling with similar challenges across fragmented, rural health landscapes.