Healthy Mothers: an Intervention to Support Perinatal Women Living With HIV in Kenya

Sponsor
University of California, San Francisco
Study ID
NCT05219552
Status
Completed

Conditions

  • Breastfeeding, Exclusive
  • Hiv
  • Mental Health Issue

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • personalized lactation support — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 23, 2022
Status verified
Jul 2025
Primary completion
Mar 9, 2023
Completion
Mar 9, 2023

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention group- lactation support and unconditional cash transfers
    Women in this arm will receive personal lactation support from a professional lactation specialist at 5 time points: pregnancy and at 2-weeks, 4-weeks, 6-weeks and 3-months postpartum. Women in the intervention group will also receive monthly unconditional cash transfers of 10,000 Kenyan shillings sent directly to a a mobile phone-based money transfer service accounts associated with their personal cell phone.
  • No Intervention: Control group- standard care
    The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.

Primary Outcome Measure

Maternal Mental Health [ Time Frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum ]

Related Studies