Trial results for a study investigating an intervention to support perinatal women living with HIV in Kenya were posted on ClinicalTrials.gov on 2025-08-14, with 40 participants enrolled.
Background
Women living with HIV face unique challenges during the perinatal period, including managing their own health, preventing mother-to-child transmission, and navigating infant feeding decisions. Mental health issues can be prevalent in this population, exacerbated by socioeconomic factors and the stigma associated with HIV. Exclusive breastfeeding is often recommended for infant health, but concerns about HIV transmission can complicate adherence. Interventions that combine practical support, such as lactation assistance, with economic aid, like unconditional cash transfers, aim to improve both maternal mental health and adherence to optimal infant feeding practices in resource-limited settings.
Trial design
This completed study, designated as Phase NA, enrolled 40 participants to investigate conditions including Mental Health Issue, Hiv, and Breastfeeding, Exclusive. The trial recruited pregnant women living with HIV, dividing them into two groups. The intervention group (n=20) received personalized lactation support and monthly unconditional cash transfers of 100USD/month from approximately 30 weeks pregnancy to approximately 6-months postpartum. The control group (n=20) received the current standard care. The study aimed to assess the impact of this intervention on various outcomes.
Key results
The trial reported several key measurements for maternal mental health and breastfeeding practices:
- Maternal Mental Health (score on a scale):
- In the Intervention Group, the median score was 8.5.
- In the Control Group, the median score was 6.5.
- Subsequently, in the Intervention Group, the median score was 3.0.
- In the Control Group, the median score was 3.0.
- Later, in the Intervention Group, the median score was 3.0.
- In the Control Group, the median score was 5.
- Number of Participants Who Reported Feeding Breastmilk Only (Participants):
- In the Intervention Group, 19 participants reported feeding breastmilk only.
- In the Control Group, 16 participants reported feeding breastmilk only.
- Subsequently, in the Intervention Group, 19 participants reported feeding breastmilk only.
- In the Control Group, 19 participants reported feeding breastmilk only.
- Later, in the Intervention Group, 20 participants reported feeding breastmilk only.
- In the Control Group, 19 participants reported feeding breastmilk only.
What this means
The results from this small study suggest that an intervention combining personalized lactation support with unconditional cash transfers may be associated with improved outcomes for perinatal women living with HIV in Kenya. Specifically, the intervention group showed a consistently higher or equal number of participants reporting exclusive breastfeeding compared to the control group across various measurements. While the mental health scores varied, the intervention group's later median scores were generally lower, which could indicate an improvement if lower scores represent better mental health. Given the small sample size of 40 participants, these findings provide preliminary insights that could inform larger studies or targeted support programs for this vulnerable population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05219552, titled "Healthy Mothers: an Intervention to Support Perinatal Women Living With HIV in Kenya", were posted on 2025-08-14 on clinicaltrials.gov.