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

NCT05219552 | Completed Results

• 1 other identifier: K23MH116807
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mental Health Issue; Hiv; Breastfeeding, Exclusive

Keywords

Prevention of Mother to Child Transmission of HIV (PMTCT); exclusive breastfeeding; Women Living with HIV (WLWH); financial insecurity; food insecurity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Relationships Status

  baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

• Women's Empowerment

  baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

• HIV-related Stigma

  baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

• Social Support

  6-weeks postpartum and 6-months postpartum

Study Arms (2)

Intervention group- lactation support and unconditional cash transfers

EXPERIMENTAL

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

Control group- standard care

NO INTERVENTION

The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.

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.

Also known as: unconditional cash transfers

Intervention group- lactation support and unconditional cash transfers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• weeks pregnant
• Living with HIV
• Currently prescribed antiretroviral therapy (ART)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Kenya Medical Research Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Kisumu County Hospital

Kisumu, Kenya

Location

Lumumba Sub-county Hospital

Kisumu, Kenya

Location

Related Publications (4)

• 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.

  PMID: 33997940 BACKGROUND

• 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.

  PMID: 33087990 BACKGROUND

• 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.

  PMID: 37798696 RESULT

• 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.

  PMID: 38012644 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Breast Feeding

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Feeding Behavior; Behavior

Results Point of Contact

• Title: Dr. Emily Tuthill
• Organization: University of California School of Nursing

emily.g.tuthill@gmail.com

2078411983

Study Officials

• Emily L Tuthill, PhD

  University of California San Fransisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 20 participants recruited to the intervention group at one clinic. 20 participants simultaneously recruited to a control group at a different (but matched) clinic.

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 2, 2022
• Study Start: February 23, 2022
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2)