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

Not Applicable

Completed

Conditions: Breastfeeding, Exclusive
Mental Health Issue
Hiv

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 40

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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.
Number of Participants Who Reported Feeding Breastmilk Only	2 weeks, 4 weeks, 6 weeks, and 12 weeks postpartum	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".
Number of Participants Who Acknowledge Missing One or More HIV Infant Medications	6-weeks postpartum and 6-months postpartum	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).
Maternal Adherence to HIV Medications	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum	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."
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.
Financial Security	7 months	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.

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-"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.
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	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