CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
personalized lactation supportbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05219552
NCT05219552N/ACompleted

Understanding the Role of Food Insecurity and Depression in Non-adherence to Option B+ Among Perinatal Kenyan Women Living With HIV: A Syndemics Approach

University of California, San Francisco·interventional·Posted Feb 2, 2022·Updated Aug 14, 2025

In Brief

A clinical study evaluating personalized lactation support for Mental Health Issue and 2 related conditions. Completed, enrolled 40 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKenya

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 2, 2022
Enrollment StartFeb 23, 2022
Primary CompletionMar 9, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.4 years ago

Interventions

personalized lactation supportbehavioral

Our intervention design aims to address food insecurity and mental health by providing an unconditional cash transfer and lactation support across the perinatal period, when women are out of the workforce caring for their infant child. The study will include pregnant women living with HIV in Kisumu Kenya. The lactation support component will focus on milk insufficiency primarily as that has been a main concern of women we've worked with in this population, in addition to general breastfeeding support which will all be delivered in one-on-one sessions with a professional lactation consultant. The cash transfer will be delivered to women from their third trimester to 6 months postpartum. The amount of the cash transfer is based on preliminary data and consultation with key stakeholders to determine a reasonable and sufficient amount to basic living expenses during this period.