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

August 16, 2023 updated by: University of California, San Francisco

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Patient Health Questionnaire-9: scoring ranges from 0-27 with higher scores indicating greater depressive symptoms.

Perceived Stress Scale: scoring ranges from 0-40 with higher scores indicating higher stress
baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Optimal Infant Feeding
Time Frame: baseline (20-35 weeks pregnant), 2-weeks postpartum, 4-weeks postpartum, 6-weeks postpartum, 3-months postpartum and 6-months postpartum
Lactation consultant assessment Breastfeeding self-efficacy scale: higher scores indicate greater breastfeeding self-efficacy
baseline (20-35 weeks pregnant), 2-weeks postpartum, 4-weeks postpartum, 6-weeks postpartum, 3-months postpartum and 6-months postpartum
Adherence to infant prophylaxis
Time Frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Adherence questionnaire
baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Maternal Adherence to HIV medications
Time Frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Adherence questionnaire
baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Food Security
Time Frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
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 Stats
Time Frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Wealth Index from Kenya's Demographic Health Survey
baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationships Status
Time Frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
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
Time Frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Select questions from the Demographic Health Survey
baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
HIV-related stigma
Time Frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
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
Time Frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Duke-University of North Carolina Functional Social Support Questionnaire: scoring ranges from 8-40 with higher values indicating greater social support
baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Kenya Medical Research Institute

Investigators

  • Principal Investigator: Emily L Tuthill, PhD, University of California San Fransisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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