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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05219552
Enrollment
40
Registered
2022-02-02
Start date
2022-02-23
Completion date
2023-03-09
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Exclusive, Hiv, Mental Health Issue

Keywords

Prevention of Mother to Child Transmission of HIV (PMTCT), exclusive breastfeeding, Women Living with HIV (WLWH), financial insecurity, food insecurity

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.

Interventions

BEHAVIORALpersonalized 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.

Sponsors

Kenya Medical Research Institute
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Financial Security7 monthsThese 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.
Number of Participants Who Reported Feeding Breastmilk Only2 weeks, 4 weeks, 6 weeks, and 12 weeks postpartumBreast 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 Medications6-weeks postpartum and 6-months postpartumQuestionnaire 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 Medicationsbaseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartumQuestionnaire 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 Securitybaseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartumHousehold Food Insecurity Access scale: scoring ranges from 0-27 with higher scores indicating greater food insecurity.
Maternal Mental Healthbaseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartumPatient Health Questionnaire-9: scoring ranges from 0-27 with higher scores indicating greater depressive symptoms.

Secondary

MeasureTime frameDescription
Women's Empowermentbaseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartumSelect 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 Stigmabaseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum12-item HIV stigma scale: scoring ranges from 12-48 higher scores reflect a higher level of perceived HIV-related stigma.
Social Support6-weeks postpartum and 6-months postpartumDuke-University of North Carolina Functional Social Support Questionnaire: scoring ranges from 8-40 with higher values indicating greater social support
Relationships Statusbaseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartumCouples satisfaction Index: scoring ranges from 0-81 with higher scores indicating greater relationship satisfaction.

Countries

Kenya

Participant flow

Participants by arm

ArmCount
Intervention Group- Lactation Support and Unconditional Cash Transfers
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. 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.
20
Control Group- Standard Care
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
20
Total40

Baseline characteristics

CharacteristicIntervention Group- Lactation Support and Unconditional Cash TransfersControl Group- Standard CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants20 Participants40 Participants
Age, Continuous27.95 years28.5 years28 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants20 Participants40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Patient Health Questionnaire-98.5 score on a scale6.5 score on a scale8 score on a scale
Region of Enrollment
Kenya
20 participants20 participants40 participants
Sex: Female, Male
Female
20 Participants20 Participants40 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 20
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

Financial Security

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.

Time frame: 7 months

Population: Financial security was assessed qualitatively using in depth interviews at an exit interview after intervention completion

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention Group- Lactation Support and Unconditional Cash TransfersFinancial SecurityExit Interview Improved Financial Security related to cash transfer intervention20 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersFinancial SecurityExit Interview No improvements to financial security related to cash transfer intervention0 Participants
Primary

Food Security

Household Food Insecurity Access scale: scoring ranges from 0-27 with higher scores indicating greater food insecurity.

Time frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

ArmMeasureGroupValue (MEDIAN)
Intervention Group- Lactation Support and Unconditional Cash TransfersFood SecurityBaseline11.5 units on a scale
Intervention Group- Lactation Support and Unconditional Cash TransfersFood Security6 weeks postpartum1 units on a scale
Intervention Group- Lactation Support and Unconditional Cash TransfersFood Security6 months postpartum2 units on a scale
Control Group- Standard CareFood Security6 months postpartum9 units on a scale
Control Group- Standard CareFood SecurityBaseline12 units on a scale
Control Group- Standard CareFood Security6 weeks postpartum9.5 units on a scale
Primary

Maternal Adherence to HIV Medications

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.

Time frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

ArmMeasureGroupValue (MEAN)Dispersion
Intervention Group- Lactation Support and Unconditional Cash TransfersMaternal Adherence to HIV Medications6 months99.8 percentage of HIV medications takenStandard Deviation 0.6
Intervention Group- Lactation Support and Unconditional Cash TransfersMaternal Adherence to HIV MedicationsBaseline98.95 percentage of HIV medications takenStandard Deviation 3.94
Intervention Group- Lactation Support and Unconditional Cash TransfersMaternal Adherence to HIV Medications6 weeks97.7 percentage of HIV medications takenStandard Deviation 10.03
Control Group- Standard CareMaternal Adherence to HIV Medications6 months99.85 percentage of HIV medications takenStandard Deviation 0.48
Control Group- Standard CareMaternal Adherence to HIV MedicationsBaseline98.05 percentage of HIV medications takenStandard Deviation 6.95
Control Group- Standard CareMaternal Adherence to HIV Medications6 weeks99.75 percentage of HIV medications takenStandard Deviation 1.09
Primary

Maternal Mental Health

Patient Health Questionnaire-9: scoring ranges from 0-27 with higher scores indicating greater depressive symptoms.

Time frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

ArmMeasureGroupValue (MEDIAN)
Intervention Group- Lactation Support and Unconditional Cash TransfersMaternal Mental HealthBaseline8.5 score on a scale
Intervention Group- Lactation Support and Unconditional Cash TransfersMaternal Mental Health6 weeks postpartum3.0 score on a scale
Intervention Group- Lactation Support and Unconditional Cash TransfersMaternal Mental Health6 months postpartum3.0 score on a scale
Control Group- Standard CareMaternal Mental HealthBaseline6.5 score on a scale
Control Group- Standard CareMaternal Mental Health6 weeks postpartum3.0 score on a scale
Control Group- Standard CareMaternal Mental Health6 months postpartum5 score on a scale
Primary

Number of Participants Who Acknowledge Missing One or More HIV Infant Medications

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).

Time frame: 6-weeks postpartum and 6-months postpartum

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention Group- Lactation Support and Unconditional Cash TransfersNumber of Participants Who Acknowledge Missing One or More HIV Infant Medications6 weeks0 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersNumber of Participants Who Acknowledge Missing One or More HIV Infant Medications6 months2 Participants
Control Group- Standard CareNumber of Participants Who Acknowledge Missing One or More HIV Infant Medications6 weeks0 Participants
Control Group- Standard CareNumber of Participants Who Acknowledge Missing One or More HIV Infant Medications6 months2 Participants
Primary

Number of Participants Who Reported Feeding Breastmilk Only

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.

Time frame: 2 weeks, 4 weeks, 6 weeks, and 12 weeks postpartum

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention Group- Lactation Support and Unconditional Cash TransfersNumber of Participants Who Reported Feeding Breastmilk Only2 weeks19 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersNumber of Participants Who Reported Feeding Breastmilk Only4 weeks19 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersNumber of Participants Who Reported Feeding Breastmilk Only6 weeks20 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersNumber of Participants Who Reported Feeding Breastmilk Only12 weeks20 Participants
Control Group- Standard CareNumber of Participants Who Reported Feeding Breastmilk Only12 weeks17 Participants
Control Group- Standard CareNumber of Participants Who Reported Feeding Breastmilk Only2 weeks16 Participants
Control Group- Standard CareNumber of Participants Who Reported Feeding Breastmilk Only6 weeks19 Participants
Control Group- Standard CareNumber of Participants Who Reported Feeding Breastmilk Only4 weeks19 Participants
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.

Time frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

ArmMeasureGroupValue (MEAN)Dispersion
Intervention Group- Lactation Support and Unconditional Cash TransfersHIV-related StigmaBaseline25.6 score on a scaleStandard Deviation 6.3
Intervention Group- Lactation Support and Unconditional Cash TransfersHIV-related Stigma6 weeks25.9 score on a scaleStandard Deviation 3.9
Intervention Group- Lactation Support and Unconditional Cash TransfersHIV-related Stigma6 months26.8 score on a scaleStandard Deviation 4.1
Control Group- Standard CareHIV-related StigmaBaseline30.4 score on a scaleStandard Deviation 7.1
Control Group- Standard CareHIV-related Stigma6 weeks27.1 score on a scaleStandard Deviation 4.6
Control Group- Standard CareHIV-related Stigma6 months28.4 score on a scaleStandard Deviation 4.7
Secondary

Relationships Status

Couples satisfaction Index: scoring ranges from 0-81 with higher scores indicating greater relationship satisfaction.

Time frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

ArmMeasureGroupValue (MEAN)Dispersion
Intervention Group- Lactation Support and Unconditional Cash TransfersRelationships StatusBaseline41.3 score on a scaleStandard Deviation 11.6
Intervention Group- Lactation Support and Unconditional Cash TransfersRelationships Status6 weeks44.4 score on a scaleStandard Deviation 14.8
Intervention Group- Lactation Support and Unconditional Cash TransfersRelationships Status6 months43.1 score on a scaleStandard Deviation 15.5
Control Group- Standard CareRelationships StatusBaseline44.5 score on a scaleStandard Deviation 22.2
Control Group- Standard CareRelationships Status6 weeks53.3 score on a scaleStandard Deviation 11.6
Control Group- Standard CareRelationships Status6 months50.3 score on a scaleStandard Deviation 10.8
Secondary

Social Support

Duke-University of North Carolina Functional Social Support Questionnaire: scoring ranges from 8-40 with higher values indicating greater social support

Time frame: 6-weeks postpartum and 6-months postpartum

ArmMeasureGroupValue (MEDIAN)
Intervention Group- Lactation Support and Unconditional Cash TransfersSocial Support6 weeks24.5 score on a scale
Intervention Group- Lactation Support and Unconditional Cash TransfersSocial Support6 month30.5 score on a scale
Control Group- Standard CareSocial Support6 weeks33.0 score on a scale
Control Group- Standard CareSocial Support6 month31.0 score on a scale
Secondary

Women's Empowerment

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.

Time frame: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum

Population: Some participants chose the option not applicable for the decision making question since they were not earning any money. Also, data are missing from several participants on the questions about experience of abuse- see # of participants analyzed.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's Empowerment6 months -mainly participant decides7 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's Empowerment6 weeks - decides jointly3 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's EmpowermentBaseline - decides jointly0 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's Empowerment6 weeks-other11 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's EmpowermentBaseline- mainly husband/ partner decides1 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's Empowerment6 months -mainly husband/ partner decides0 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's EmpowermentBaseline- other10 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's Empowerment6 months- other7 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's Empowerment6 months -decides jointly6 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's EmpowermentBaseline- has experienced abuse by husband/partner13 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's Empowerment6 weeks -mainly participant decides6 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's Empowerment6 weeks- has experienced abuse by husband/partner10 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's EmpowermentBaseline -mainly participant decides9 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's Empowerment6 months- has experienced abuse by husband/partner10 Participants
Intervention Group- Lactation Support and Unconditional Cash TransfersWomen's Empowerment6 weeks- mainly husband/ partner decides0 Participants
Control Group- Standard CareWomen's Empowerment6 months- has experienced abuse by husband/partner9 Participants
Control Group- Standard CareWomen's Empowerment6 weeks-other0 Participants
Control Group- Standard CareWomen's Empowerment6 months -mainly husband/ partner decides2 Participants
Control Group- Standard CareWomen's EmpowermentBaseline- mainly husband/ partner decides2 Participants
Control Group- Standard CareWomen's EmpowermentBaseline - decides jointly7 Participants
Control Group- Standard CareWomen's EmpowermentBaseline- other0 Participants
Control Group- Standard CareWomen's Empowerment6 weeks -mainly participant decides11 Participants
Control Group- Standard CareWomen's Empowerment6 weeks- mainly husband/ partner decides1 Participants
Control Group- Standard CareWomen's Empowerment6 weeks - decides jointly8 Participants
Control Group- Standard CareWomen's Empowerment6 months -mainly participant decides14 Participants
Control Group- Standard CareWomen's Empowerment6 months -decides jointly4 Participants
Control Group- Standard CareWomen's Empowerment6 months- other0 Participants
Control Group- Standard CareWomen's EmpowermentBaseline- has experienced abuse by husband/partner14 Participants
Control Group- Standard CareWomen's Empowerment6 weeks- has experienced abuse by husband/partner10 Participants
Control Group- Standard CareWomen's EmpowermentBaseline -mainly participant decides11 Participants

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026