**Background:** Preterm birth is a major global health problem, with Malawi having a high rate of 18% compared to the global rate of 11%. Complications of prematurity account for 36% of neonatal deaths in Malawi. Kangaroo Mother Care (KMC) — near-constant skin-to-skin contact — is the standard of care for stable preterm infants in Malawi and improves survival, but mothers experience high stress, anxiety, and stigma. H-HOPE is an early behavioral intervention with both parent-focused (Parents+) and infant-focused (Massage+) components that has been shown in US studies to improve mother-infant responsivity, feeding, and development. This is the first study to test H-HOPE in an African country and the first to examine H-HOPE combined with KMC.
**Methods:** The study used a prospective cohort comparison design conducted in the KMC unit at Zomba Central Hospital, Malawi. Random assignment was not feasible because the KMC unit is an open room without privacy, which would lead to contamination. Two KMC-only cohorts were recruited (one before and one after the H-HOPE+KMC cohort) and combined after confirming no significant difference in responsivity between them (t = -0.758, p = 0.451). Inclusion criteria: infants 29–34 weeks gestational age, birth weight 950–2400 g, clinically stable with no severe neurological problems. Mothers had to be willing to participate, physically stable, and able to return to the hospital for follow-up. The final sample included 119 dyads (59 KMC only, 60 H-HOPE+KMC). H-HOPE consisted of four participatory guidance sessions for mothers plus Massage+ (30 seconds of infant-directed talk, 10 minutes of head-to-foot massage, 5 minutes of vestibular stimulation) provided by mothers twice daily for 15 minutes. Mother-infant responsivity was measured at 6 weeks corrected age using the Dyadic Mutuality Code (DMC) during a 5-minute videotaped play session. DMC scores range from 6–12, categorized as low (6–8), moderate (9–10), or high (11–12) responsivity. Inter- and intra-rater reliability were good (Cohen's Kappa 0.78 and 0.90, respectively). Internal consistency was acceptable (Cronbach's alpha = 0.73).
**Key Results:** The H-HOPE+KMC cohort had significantly higher mean DMC scores compared to the KMC only cohort (mean 9.6 vs. 7.4, t = 7.683, p < 0.001). Only 26.7% of H-HOPE+KMC dyads exhibited low responsivity compared to 83.1% in the KMC only group. More than half (56.7%) of H-HOPE+KMC dyads showed high responsivity versus 11.9% in the KMC only group. In multivariate logistic regression controlling for significant maternal and infant characteristics, H-HOPE+KMC dyads were over 11 times more likely to have moderate-to-high responsivity compared to KMC only dyads (AOR = 11.51, CI = 4.56–29.04, p < 0.001). Vaginal delivery (vs. Caesarean section) was also a significant predictor (AOR = 5.44, CI = 0.1–30.96, p = 0.02), though only 10 mothers had Caesarean deliveries. The effect size for H-HOPE+KMC was very large (1.44), substantially larger than the 0.30 effect size reported in the US trial. Maternal characteristics (age, marital status, parity, ANC initiation, number of ANC visits) were not significantly related to responsivity. Birthweight and birthweight regained by 10 days were significant in bivariate analysis but not in multivariate analysis.
**Clinical Implications:** This study demonstrates that H-HOPE can be feasibly delivered in a low-resource African setting and substantially improves mother-preterm infant responsivity when added to KMC. The very large effect size (1.44) compared to the US study (0.30) may reflect the complementary nature of KMC (constant physical contact) and H-HOPE (face-to-face interaction, cue reading, and mutual engagement), as well as the high baseline stress and isolation experienced by mothers providing KMC alone in Malawi. The high proportion of low-responsivity dyads in the KMC only group (83.1%) is clinically concerning, as low responsivity is an indicator for future mother-infant interaction problems. Incorporating H-HOPE as standard of care could dramatically reduce this proportion. However, the nursing shortage in Malawi makes delivery by nurses challenging; training patient attendants (who are already present in KMC units) to deliver H-HOPE is proposed as a cost-effective alternative. Limitations include the non-randomized design, 65% retention at 6 weeks, reliance on LMP and fundal height for gestational age estimation when ultrasound was unavailable, and the small number of Caesarean deliveries. Despite these limitations, H-HOPE offers a critical early behavioral intervention that supports WHO Sustainable Development Goal 3 to ensure optimal health and promote mother and infant well-being.