Breastfeeding, Exclusive, Hiv, Mental Health Issue
Conditions
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
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 40 |
Baseline characteristics
| Characteristic | Intervention Group- Lactation Support and Unconditional Cash Transfers | Control Group- Standard Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 27.95 years | 28.5 years | 28 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire-9 | 8.5 score on a scale | 6.5 score on a scale | 8 score on a scale |
| Region of Enrollment Kenya | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Financial Security | Exit Interview Improved Financial Security related to cash transfer intervention | 20 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Financial Security | Exit Interview No improvements to financial security related to cash transfer intervention | 0 Participants |
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Food Security | Baseline | 11.5 units on a scale |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Food Security | 6 weeks postpartum | 1 units on a scale |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Food Security | 6 months postpartum | 2 units on a scale |
| Control Group- Standard Care | Food Security | 6 months postpartum | 9 units on a scale |
| Control Group- Standard Care | Food Security | Baseline | 12 units on a scale |
| Control Group- Standard Care | Food Security | 6 weeks postpartum | 9.5 units on a scale |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Maternal Adherence to HIV Medications | 6 months | 99.8 percentage of HIV medications taken | Standard Deviation 0.6 |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Maternal Adherence to HIV Medications | Baseline | 98.95 percentage of HIV medications taken | Standard Deviation 3.94 |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Maternal Adherence to HIV Medications | 6 weeks | 97.7 percentage of HIV medications taken | Standard Deviation 10.03 |
| Control Group- Standard Care | Maternal Adherence to HIV Medications | 6 months | 99.85 percentage of HIV medications taken | Standard Deviation 0.48 |
| Control Group- Standard Care | Maternal Adherence to HIV Medications | Baseline | 98.05 percentage of HIV medications taken | Standard Deviation 6.95 |
| Control Group- Standard Care | Maternal Adherence to HIV Medications | 6 weeks | 99.75 percentage of HIV medications taken | Standard Deviation 1.09 |
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Maternal Mental Health | Baseline | 8.5 score on a scale |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Maternal Mental Health | 6 weeks postpartum | 3.0 score on a scale |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Maternal Mental Health | 6 months postpartum | 3.0 score on a scale |
| Control Group- Standard Care | Maternal Mental Health | Baseline | 6.5 score on a scale |
| Control Group- Standard Care | Maternal Mental Health | 6 weeks postpartum | 3.0 score on a scale |
| Control Group- Standard Care | Maternal Mental Health | 6 months postpartum | 5 score on a scale |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Number of Participants Who Acknowledge Missing One or More HIV Infant Medications | 6 weeks | 0 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Number of Participants Who Acknowledge Missing One or More HIV Infant Medications | 6 months | 2 Participants |
| Control Group- Standard Care | Number of Participants Who Acknowledge Missing One or More HIV Infant Medications | 6 weeks | 0 Participants |
| Control Group- Standard Care | Number of Participants Who Acknowledge Missing One or More HIV Infant Medications | 6 months | 2 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Number of Participants Who Reported Feeding Breastmilk Only | 2 weeks | 19 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Number of Participants Who Reported Feeding Breastmilk Only | 4 weeks | 19 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Number of Participants Who Reported Feeding Breastmilk Only | 6 weeks | 20 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Number of Participants Who Reported Feeding Breastmilk Only | 12 weeks | 20 Participants |
| Control Group- Standard Care | Number of Participants Who Reported Feeding Breastmilk Only | 12 weeks | 17 Participants |
| Control Group- Standard Care | Number of Participants Who Reported Feeding Breastmilk Only | 2 weeks | 16 Participants |
| Control Group- Standard Care | Number of Participants Who Reported Feeding Breastmilk Only | 6 weeks | 19 Participants |
| Control Group- Standard Care | Number of Participants Who Reported Feeding Breastmilk Only | 4 weeks | 19 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group- Lactation Support and Unconditional Cash Transfers | HIV-related Stigma | Baseline | 25.6 score on a scale | Standard Deviation 6.3 |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | HIV-related Stigma | 6 weeks | 25.9 score on a scale | Standard Deviation 3.9 |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | HIV-related Stigma | 6 months | 26.8 score on a scale | Standard Deviation 4.1 |
| Control Group- Standard Care | HIV-related Stigma | Baseline | 30.4 score on a scale | Standard Deviation 7.1 |
| Control Group- Standard Care | HIV-related Stigma | 6 weeks | 27.1 score on a scale | Standard Deviation 4.6 |
| Control Group- Standard Care | HIV-related Stigma | 6 months | 28.4 score on a scale | Standard Deviation 4.7 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Relationships Status | Baseline | 41.3 score on a scale | Standard Deviation 11.6 |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Relationships Status | 6 weeks | 44.4 score on a scale | Standard Deviation 14.8 |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Relationships Status | 6 months | 43.1 score on a scale | Standard Deviation 15.5 |
| Control Group- Standard Care | Relationships Status | Baseline | 44.5 score on a scale | Standard Deviation 22.2 |
| Control Group- Standard Care | Relationships Status | 6 weeks | 53.3 score on a scale | Standard Deviation 11.6 |
| Control Group- Standard Care | Relationships Status | 6 months | 50.3 score on a scale | Standard Deviation 10.8 |
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Social Support | 6 weeks | 24.5 score on a scale |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Social Support | 6 month | 30.5 score on a scale |
| Control Group- Standard Care | Social Support | 6 weeks | 33.0 score on a scale |
| Control Group- Standard Care | Social Support | 6 month | 31.0 score on a scale |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | 6 months -mainly participant decides | 7 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | 6 weeks - decides jointly | 3 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | Baseline - decides jointly | 0 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | 6 weeks-other | 11 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | Baseline- mainly husband/ partner decides | 1 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | 6 months -mainly husband/ partner decides | 0 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | Baseline- other | 10 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | 6 months- other | 7 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | 6 months -decides jointly | 6 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | Baseline- has experienced abuse by husband/partner | 13 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | 6 weeks -mainly participant decides | 6 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | 6 weeks- has experienced abuse by husband/partner | 10 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | Baseline -mainly participant decides | 9 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | 6 months- has experienced abuse by husband/partner | 10 Participants |
| Intervention Group- Lactation Support and Unconditional Cash Transfers | Women's Empowerment | 6 weeks- mainly husband/ partner decides | 0 Participants |
| Control Group- Standard Care | Women's Empowerment | 6 months- has experienced abuse by husband/partner | 9 Participants |
| Control Group- Standard Care | Women's Empowerment | 6 weeks-other | 0 Participants |
| Control Group- Standard Care | Women's Empowerment | 6 months -mainly husband/ partner decides | 2 Participants |
| Control Group- Standard Care | Women's Empowerment | Baseline- mainly husband/ partner decides | 2 Participants |
| Control Group- Standard Care | Women's Empowerment | Baseline - decides jointly | 7 Participants |
| Control Group- Standard Care | Women's Empowerment | Baseline- other | 0 Participants |
| Control Group- Standard Care | Women's Empowerment | 6 weeks -mainly participant decides | 11 Participants |
| Control Group- Standard Care | Women's Empowerment | 6 weeks- mainly husband/ partner decides | 1 Participants |
| Control Group- Standard Care | Women's Empowerment | 6 weeks - decides jointly | 8 Participants |
| Control Group- Standard Care | Women's Empowerment | 6 months -mainly participant decides | 14 Participants |
| Control Group- Standard Care | Women's Empowerment | 6 months -decides jointly | 4 Participants |
| Control Group- Standard Care | Women's Empowerment | 6 months- other | 0 Participants |
| Control Group- Standard Care | Women's Empowerment | Baseline- has experienced abuse by husband/partner | 14 Participants |
| Control Group- Standard Care | Women's Empowerment | 6 weeks- has experienced abuse by husband/partner | 10 Participants |
| Control Group- Standard Care | Women's Empowerment | Baseline -mainly participant decides | 11 Participants |