Trial Outcomes & Findings for Healthy Mothers: an Intervention to Support Perinatal Women Living With HIV in Kenya (NCT NCT05219552)
NCT ID: NCT05219552
Last Updated: 2025-08-14
Results Overview
Patient Health Questionnaire-9: scoring ranges from 0-27 with higher scores indicating greater depressive symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum
Results posted on
2025-08-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthy Mothers: an Intervention to Support Perinatal Women Living With HIV in Kenya
Baseline characteristics by cohort
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
Control Group- Standard Care
n=20 Participants
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.95 years
n=5 Participants
|
28.5 years
n=7 Participants
|
28 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Patient Health Questionnaire-9
|
8.5 score on a scale
n=5 Participants
|
6.5 score on a scale
n=7 Participants
|
8 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (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.
Outcome measures
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
Control Group- Standard Care
n=20 Participants
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
|
|---|---|---|
|
Maternal Mental Health
Baseline
|
8.5 score on a scale
Interval 6.0 to 9.2
|
6.5 score on a scale
Interval 5.0 to 9.8
|
|
Maternal Mental Health
6 weeks postpartum
|
3.0 score on a scale
Interval 2.0 to 6.2
|
3.0 score on a scale
Interval 0.8 to 5.0
|
|
Maternal Mental Health
6 months postpartum
|
3.0 score on a scale
Interval 1.0 to 5.2
|
5 score on a scale
Interval 1.0 to 8.0
|
PRIMARY outcome
Timeframe: 2 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".
Outcome measures
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
Control Group- Standard Care
n=20 Participants
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
|
|---|---|---|
|
Number of Participants Who Reported Feeding Breastmilk Only
2 weeks
|
19 Participants
|
16 Participants
|
|
Number of Participants Who Reported Feeding Breastmilk Only
4 weeks
|
19 Participants
|
19 Participants
|
|
Number of Participants Who Reported Feeding Breastmilk Only
6 weeks
|
20 Participants
|
19 Participants
|
|
Number of Participants Who Reported Feeding Breastmilk Only
12 weeks
|
20 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 6-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).
Outcome measures
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
Control Group- Standard Care
n=20 Participants
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
|
|---|---|---|
|
Number of Participants Who Acknowledge Missing One or More HIV Infant Medications
6 weeks
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Acknowledge Missing One or More HIV Infant Medications
6 months
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: baseline (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."
Outcome measures
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
Control Group- Standard Care
n=20 Participants
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
|
|---|---|---|
|
Maternal Adherence to HIV Medications
Baseline
|
98.95 percentage of HIV medications taken
Standard Deviation 3.94
|
98.05 percentage of HIV medications taken
Standard Deviation 6.95
|
|
Maternal Adherence to HIV Medications
6 weeks
|
97.7 percentage of HIV medications taken
Standard Deviation 10.03
|
99.75 percentage of HIV medications taken
Standard Deviation 1.09
|
|
Maternal Adherence to HIV Medications
6 months
|
99.8 percentage of HIV medications taken
Standard Deviation 0.6
|
99.85 percentage of HIV medications taken
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: baseline (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.
Outcome measures
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
Control Group- Standard Care
n=20 Participants
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
|
|---|---|---|
|
Food Security
Baseline
|
11.5 units on a scale
Interval 9.0 to 16.2
|
12 units on a scale
Interval 7.0 to 15.0
|
|
Food Security
6 weeks postpartum
|
1 units on a scale
Interval 0.0 to 7.0
|
9.5 units on a scale
Interval 5.8 to 12.5
|
|
Food Security
6 months postpartum
|
2 units on a scale
Interval 0.0 to 3.5
|
9 units on a scale
Interval 6.0 to 11.5
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: Financial security was assessed qualitatively using in depth interviews at an exit interview after intervention completion
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.
Outcome measures
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
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.
|
|---|---|---|
|
Financial Security
Exit Interview Improved Financial Security related to cash transfer intervention
|
20 Participants
|
—
|
|
Financial Security
Exit Interview No improvements to financial security related to cash transfer intervention
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: baseline (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.
Outcome measures
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
Control Group- Standard Care
n=20 Participants
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
|
|---|---|---|
|
Relationships Status
Baseline
|
41.3 score on a scale
Standard Deviation 11.6
|
44.5 score on a scale
Standard Deviation 22.2
|
|
Relationships Status
6 weeks
|
44.4 score on a scale
Standard Deviation 14.8
|
53.3 score on a scale
Standard Deviation 11.6
|
|
Relationships Status
6 months
|
43.1 score on a scale
Standard Deviation 15.5
|
50.3 score on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartumPopulation: 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.
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.
Outcome measures
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
Control Group- Standard Care
n=20 Participants
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
|
|---|---|---|
|
Women's Empowerment
Baseline -mainly participant decides
|
9 Participants
|
11 Participants
|
|
Women's Empowerment
Baseline- mainly husband/ partner decides
|
1 Participants
|
2 Participants
|
|
Women's Empowerment
Baseline - decides jointly
|
0 Participants
|
7 Participants
|
|
Women's Empowerment
Baseline- other
|
10 Participants
|
0 Participants
|
|
Women's Empowerment
6 weeks -mainly participant decides
|
6 Participants
|
11 Participants
|
|
Women's Empowerment
6 weeks- mainly husband/ partner decides
|
0 Participants
|
1 Participants
|
|
Women's Empowerment
6 weeks - decides jointly
|
3 Participants
|
8 Participants
|
|
Women's Empowerment
6 weeks-other
|
11 Participants
|
0 Participants
|
|
Women's Empowerment
6 months -mainly participant decides
|
7 Participants
|
14 Participants
|
|
Women's Empowerment
6 months -mainly husband/ partner decides
|
0 Participants
|
2 Participants
|
|
Women's Empowerment
6 months -decides jointly
|
6 Participants
|
4 Participants
|
|
Women's Empowerment
6 months- other
|
7 Participants
|
0 Participants
|
|
Women's Empowerment
Baseline- has experienced abuse by husband/partner
|
13 Participants
|
14 Participants
|
|
Women's Empowerment
6 weeks- has experienced abuse by husband/partner
|
10 Participants
|
10 Participants
|
|
Women's Empowerment
6 months- has experienced abuse by husband/partner
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: baseline (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.
Outcome measures
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
Control Group- Standard Care
n=20 Participants
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
|
|---|---|---|
|
HIV-related Stigma
Baseline
|
25.6 score on a scale
Standard Deviation 6.3
|
30.4 score on a scale
Standard Deviation 7.1
|
|
HIV-related Stigma
6 weeks
|
25.9 score on a scale
Standard Deviation 3.9
|
27.1 score on a scale
Standard Deviation 4.6
|
|
HIV-related Stigma
6 months
|
26.8 score on a scale
Standard Deviation 4.1
|
28.4 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 6-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
Outcome measures
| Measure |
Intervention Group- Lactation Support and Unconditional Cash Transfers
n=20 Participants
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.
|
Control Group- Standard Care
n=20 Participants
The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site.
|
|---|---|---|
|
Social Support
6 weeks
|
24.5 score on a scale
Interval 20.2 to 31.5
|
33.0 score on a scale
Interval 27.8 to 37.0
|
|
Social Support
6 month
|
30.5 score on a scale
Interval 22.0 to 34.0
|
31.0 score on a scale
Interval 27.8 to 35.5
|
Adverse Events
Intervention Group- Lactation Support and Unconditional Cash Transfers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group- Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Emily Tuthill
University of California School of Nursing
Phone: 2078411983
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place