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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05219552
• Other study ID #: K23MH116807
• Status: Completed
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: March 9, 2023

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding, Exclusive
• Hiv
• Mental Health Issue

Intervention

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.

Locations

Country	Name	City	State
Kenya	Kisumu County Hospital	Kisumu
Kenya	Lumumba Sub-county Hospital	Kisumu

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Adherence to infant prophylaxis	Adherence questionnaire	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Primary	Maternal Adherence to HIV medications	Adherence questionnaire	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Primary	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
Primary	Financial Stats	Wealth Index from Kenya's Demographic Health Survey	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Secondary	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
Secondary	Women's empowerment	Select questions from the Demographic Health Survey	baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Secondary	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
Secondary	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