N/A
N=40
Healthy Mothers: an Intervention to Support Perinatal Women Living With HIV in Kenya
Mental Health Issue · Hiv · Breastfeeding, Exclusive
Bottom Line
View on ClinicalTrials.gov: NCT05219552 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Maternal Mental Health — 8.5; 6.5; 3.0; 3.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- personalized lactation support (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Mental Health |
8.5; 6.5; 3.0; 3.0; 3.0; 5 | — |
| PRIMARY Number of Participants Who Reported Feeding Breastmilk Only |
19; 16; 19; 19; 20; 19 | — |
| PRIMARY Number of Participants Who Acknowledge Missing One or More HIV Infant Medications |
0; 0; 2; 2 | — |
| PRIMARY Maternal Adherence to HIV Medications |
98.95; 98.05; 97.7; 99.75; 99.8; 99.85 | — |
| PRIMARY Food Security |
11.5; 12; 1; 9.5; 2; 9 | — |
| PRIMARY Financial Security |
20; 0 | — |
| SECONDARY Relationships Status |
41.3; 44.5; 44.4; 53.3; 43.1; 50.3 | — |
| SECONDARY Women's Empowerment |
9; 11; 1; 2; 0; 7 | — |
| SECONDARY HIV-related Stigma |
25.6; 30.4; 25.9; 27.1; 26.8; 28.4 | — |
| SECONDARY Social Support |
24.5; 33.0; 30.5; 31.0 | — |
Summary
The investigators will recruit 40 pregnant women living with HIV divided into 2 groups (n=20 intervention group, n=20 control group). The intervention group will receive personalized lactation support and monthly unconditional cash transfers (100USD/month) from approximately 30 weeks pregnancy to approximately 6-months postpartum. The control group will receive the current standard care.
Eligibility Criteria
Inclusion Criteria
- 20-35 weeks pregnant
- Living with HIV
- Currently prescribed antiretroviral therapy (ART)
Exclusion Criteria
- High-risk pregnancy for reasons other than HIV status (e.g., pregnancy complications, preeclampsia, gestational diabetes, preterm labor)
- Self-reported participation in another ART adherence-related intervention study
- Unable to understand consent process
- Planning on relocating out of Nyanza province within 12 months.
Data sourced from ClinicalTrials.gov (NCT05219552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.