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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mental Health Issue, Hiv, Breastfeeding, Exclusive

Intervention / Treatment
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* Behavioral: personalized lactation support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 20 participants recruited to the intervention group at one clinic. 20 participants simultaneously recruited to a control group at a different (but matched) clinic.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group- lactation support and unconditional cash transfers<br>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<br>* 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.<br>* Other names: unconditional cash transfers;|
| No Intervention: Control group- standard care<br>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?
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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. 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 | 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 | Adherence questionnaire | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum | 
| Maternal Adherence to HIV medications | Adherence questionnaire | 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 Stats | 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 | 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 | 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 | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food insecurity, Prevention of Mother to Child Transmission of HIV (PMTCT), exclusive breastfeeding, Women Living with HIV (WLWH), financial insecurity