Clinical trial NCT05219552: Healthy Mothers: an Intervention to Support Perinatal Women Living With HIV in Kenya
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Hiv
Breastfeeding, Exclusive
Keywords: Prevention of Mother to Child Transmission of HIV (PMTCT)
exclusive breastfeeding
Women Living with HIV (WLWH)
financial insecurity
food insecurity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
First posted: 2022-02-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal Mental Health
timeFrame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
measure: Optimal Infant Feeding
timeFrame: baseline (20-35 weeks pregnant), 2-weeks postpartum, 4-weeks postpartum, 6-weeks postpartum, 3-months postpartum and 6-months postpartum
measure: Adherence to infant prophylaxis
timeFrame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
measure: Maternal Adherence to HIV medications
timeFrame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
measure: Food Security
timeFrame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
measure: Financial Stats
timeFrame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Secondary outcomes:
measure: Relationships Status
timeFrame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
measure: Women's empowerment
timeFrame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
measure: HIV-related stigma
timeFrame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
measure: Social Support
timeFrame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kisumu County Hospital
city: Kisumu
country: Kenya
facility: Lumumba Sub-county Hospital
Study officials:
affiliation: University of California San Fransisco
name: Emily L Tuthill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 HIV. AIDS Behav. 2021 Dec;25(12):4154-4168. doi: 10.1007/s10461-021-03283-z. Epub 2021 May 16.