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

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

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 Overview

• Status: Completed
• Conditions: Hiv; Mental Health Issue; Breastfeeding, Exclusive
• Intervention / Treatment: Behavioral: personalized lactation support

Detailed Description

In Phase One of this study, the investigators identified perceived or actual milk insufficiency, as primary barrier to exclusive breastfeeding not addressed through the current education and support being provided at the clinic. Furthermore, the investigators identified financial insecurity as a deeply-rooted threat to the health and well-being of perinatal women living with HIV and their infants across time. Based on findings from the longitudinal qualitative study, key informant interviews, focus groups with the target population and a review of the literature, the investigators developed an intervention which will be pilot tested to determine the potential impact of providing individualized support from a local lactation specialist along with monthly unconditional cash transfers (UCTs) to women living with HIV from 20-35 weeks pregnancy to 6-months postpartum.

The pilot test will be carried out among 40 pregnant women divided into 2 groups (n=20 intervention group, n=20 control group). The intervention group will receive personalized lactation support and monthly UCTs from approximately 30 weeks pregnancy to approximately 6-months postpartum. Personalized lactation support will be provided by a local, experienced lactation consultant. The support will be aimed at providing person centered care to assess for and address barriers to optimal, safe infant feeding with a focus on exclusive breastfeeding for the first 6-months postpartum. The cash transfer will be 10,000 Kenyan shillings per month. This amount is slightly less than the median amount participants in the preliminary study reported needing to meet their basic needs (13,500 Kenyan shillings) and is in line with other cash transfers completed in the area. This amount is equivalent to approximately 3.33 USD per day, or about 40% more than the World Bank's most recent poverty line estimate of 1.90 USD per person per day. This amount is lower than the estimated median monthly income for those informally employed in sectors such as retail trade or food service in Kenya (estimated at 15,000 and 30,000 Kenyan shillings monthly in rural and urban areas respectively). The investigators expect this amount will allow participants to meet many basic needs during late pregnancy and throughout the period of exclusive breastfeeding when women are largely unable to maintain gainful employment.

The control group will receive the current standard care.

The investigators will recruit women during their 20th-35th week of pregnancy and follow participants until 6-months postpartum. Survey and clinical data will be collected at baseline (20-35 weeks pregnancy), 2-weeks, 4-weeks, 6-weeks, 3-months and 6-months. Qualitative interviews will be conducted at the end of the intervention period with all 20 participants in the intervention group to evaluate the acceptability of the pilot intervention as well as to better understand how UCTs were used and the perceived impact on financial security, food security, mental health, relationships with primary partners and the ability to adhere to the prevention of mother to child transmission of HIV strategies.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kisumu County Hospital
  • Kisumu, Kenya
    • Lumumba sub-County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: personalized lactation support; 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.; Other Names: unconditional cash transfers
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Mental Health	Patient Health Questionnaire-9: scoring ranges from 0-27 with higher scores indicating greater depressive symptoms.	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Number of Participants Who Reported Feeding Breastmilk Only	Breast feeding behavior questionnaires where participants were asked, "What are you currently feeding your baby". The count of participants is the number of participants who selected, "breastmilk only".	2 weeks, 4 weeks, 6 weeks, and 12 weeks postpartum
Number of Participants Who Acknowledge Missing One or More HIV Infant Medications	Questionnaire on adherence to infant HIV prophylaxis- participant count is the number of participants who acknowledged missing one more more dose of their infant's HIV medications (collected at 6 weeks and 6 months).	6-weeks postpartum and 6-months postpartum
Maternal Adherence to HIV Medications	Questionnaire on Maternal Adherence to HIV medications- the reported data comes from a visual analog scale where participants were instructed, "Please point or mark at the point showing how much of your ARVs you have taken in the past 30 days."	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Food Security	Household Food Insecurity Access scale: scoring ranges from 0-27 with higher scores indicating greater food insecurity.	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Financial Security	These data were collected qualitatively using in depth exit interviews with intervention only participants to better understand how the cash transfer was used, what changes resulted in their lives related to increased financial security due to the cash transfer.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationships Status	Couples satisfaction Index: scoring ranges from 0-81 with higher scores indicating greater relationship satisfaction.	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Women's Empowerment	Select questions from the Demographic Health Survey-"Who usually decides how the money you earn will be used: mainly you, mainly your husband/partner, or you and your husband/partner jointly?" and a series of questions asking if the participants current partner has been verbally, physically and/or sexually abusive over the preceding 12 months.	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
HIV-related Stigma	12-item HIV stigma scale: scoring ranges from 12-48 higher scores reflect a higher level of perceived HIV-related stigma.	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Social Support	Duke-University of North Carolina Functional Social Support Questionnaire: scoring ranges from 8-40 with higher values indicating greater social support	6-weeks postpartum and 6-months postpartum

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Mental Health (NIMH); Kenya Medical Research Institute
• Investigators: Principal Investigator: Emily L Tuthill, PhD, University of California San Fransisco

Publications and helpful links

General Publications

• Haushofer J, Shapiro J. THE SHORT-TERM IMPACT OF UNCONDITIONAL CASH TRANSFERS TO THE POOR: EXPERIMENTAL EVIDENCE FROM KENYA. Q J Econ. 2016 Nov;131(4):1973-2042. doi: 10.1093/qje/qjw025. Epub 2016 Jul 19.
• Tuthill EL, Maltby AE, Odhiambo BC, Akama E, Pellowski JA, Cohen CR, Weiser SD, Conroy AA. "I Found Out I was Pregnant, and I Started Feeling Stressed": A Longitudinal Qualitative Perspective of Mental Health Experiences Among Perinatal Women Living with HIV. AIDS Behav. 2021 Dec;25(12):4154-4168. doi: 10.1007/s10461-021-03283-z. Epub 2021 May 16.
• Maltby AE, Odhiambo BC, Nyaura M, Shikari R, Tuthill EL. Feasibility, acceptability and lessons learned from an infant feeding intervention trial among women living with HIV in western Kenya. BMC Public Health. 2023 Oct 5;23(1):1930. doi: 10.1186/s12889-023-16794-2.
• Tuthill EL, Maltby AE, Odhiambo BC, Hoffmann TJ, Nyaura M, Shikari R, Cohen CR, Weiser SD. "It has changed my life": unconditional cash transfers and personalized infant feeding support- a feasibility intervention trial among women living with HIV in western Kenya. Int Breastfeed J. 2023 Nov 27;18(1):64. doi: 10.1186/s13006-023-00600-1.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: food insecurity; exclusive breastfeeding; Prevention of Mother to Child Transmission of HIV (PMTCT); Women Living with HIV (WLWH); financial insecurity
• Other Study ID Numbers: K23MH116807 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IDP sharing planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No