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

Not Applicable

Completed

• Conditions: Breastfeeding, Exclusive; Mental Health Issue; Hiv
• Interventions: Behavioral: personalized lactation support

• Registration Number: NCT05219552
• Lead Sponsor: University of California, San Francisco

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-02
• Study Start: 2022-02-23
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 20-35 weeks pregnant
• Living with HIV
• Currently prescribed antiretroviral therapy (ART)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group- lactation support and unconditional cash transfers	personalized lactation support	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.

Primary Outcome Measures

Name	Time	Method
Maternal Mental Health	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
Optimal Infant Feeding	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
Maternal Adherence to HIV medications	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum	Adherence questionnaire
Financial Stats	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum	Wealth Index from Kenya's Demographic Health Survey
Adherence to infant prophylaxis	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum	Adherence questionnaire
Food Security	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

Secondary Outcome Measures

Name	Time	Method
Relationships Status	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
Women's empowerment	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum	Select questions from the Demographic Health Survey
HIV-related stigma	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
Social Support	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

Trial Locations

Locations (2)

Kisumu County Hospital; 🇰🇪 Kisumu, Kenya

Lumumba Sub-county Hospital; 🇰🇪 Kisumu, Kenya