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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH116807 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group- lactation support and unconditional cash transfers | Experimental | 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. |
|
| Control group- standard care | No Intervention | The women enrolled in the control arm will receive standard care at a clinic similar to, but distinct from, the intervention site. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| personalized lactation support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Mental Health | Patient Health Questionnaire-9: scoring ranges from 0-27 with higher scores indicating greater depressive symptoms. | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum |
| 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". | 2 weeks, 4 weeks, 6 weeks, and 12 weeks postpartum |
| 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). | 6-weeks postpartum and 6-months postpartum |
| 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." | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum |
| 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 |
| Financial Security |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Women's Empowerment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily L Tuthill, PhD | University of California San Fransisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kisumu County Hospital | Kisumu | Kenya | ||||
| Lumumba Sub-county Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33997940 | Background | 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. | |
| 33087990 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis population is the same as the assignment in Participant Flow. Baseline data for participants is reported under outcome meassures.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal Mental Health | Patient Health Questionnaire-9: scoring ranges from 0-27 with higher scores indicating greater depressive symptoms. | Posted | Median | Inter-Quartile Range | score on a scale | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum |
|
Between 8-11months depending on when a participant was recruited (recruitment was from 20-35weeks pregnant) and the time of their infants birth. Therefore, participants were assessed over a period from 8-11 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 0 Adverse Events |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Tuthill | University of California School of Nursing | 2078411983 | emily.g.tuthill@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2022 | May 29, 2024 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2021 | May 29, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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20 participants recruited to the intervention group at one clinic. 20 participants simultaneously recruited to a control group at a different (but matched) clinic.
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|
|
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.
| 7 months |
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.
| baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum |
| 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 |
| Social Support | Duke-University of North Carolina Functional Social Support Questionnaire: scoring ranges from 8-40 with higher values indicating greater social support | 6-weeks postpartum and 6-months postpartum |
| Kisumu |
| Kenya |
| 37798696 | Result | Maltby AE, Odhiambo BC, Nyaura M, Shikari R, Tuthill EL. Feasibility, acceptability and lessons learned from an infant feeding intervention trial among women living with HIV in western Kenya. BMC Public Health. 2023 Oct 5;23(1):1930. doi: 10.1186/s12889-023-16794-2. |
| 38012644 | Result | Tuthill EL, Maltby AE, Odhiambo BC, Hoffmann TJ, Nyaura M, Shikari R, Cohen CR, Weiser SD. "It has changed my life": unconditional cash transfers and personalized infant feeding support- a feasibility intervention trial among women living with HIV in western Kenya. Int Breastfeed J. 2023 Nov 27;18(1):64. doi: 10.1186/s13006-023-00600-1. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patient Health Questionnaire-9 | Patient Health Questionnaire-9: scoring ranges from 0-27 with higher scores indicating greater depressive symptoms. | Median | Inter-Quartile Range | score on a scale |
|
| OG001 | 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. |
|
|
| 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". | Posted | Count of Participants | Participants | 2 weeks, 4 weeks, 6 weeks, and 12 weeks postpartum |
|
|
|
| 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). | Posted | Count of Participants | Participants | 6-weeks postpartum and 6-months postpartum |
|
|
|
| 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." | Posted | Mean | Standard Deviation | percentage of HIV medications taken | 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. | Posted | Median | Inter-Quartile Range | units on a scale | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum |
|
|
|
| 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. | Financial security was assessed qualitatively using in depth interviews at an exit interview after intervention completion | Posted | Count of Participants | Participants | 7 months |
|
|
|
| Secondary | Relationships Status | Couples satisfaction Index: scoring ranges from 0-81 with higher scores indicating greater relationship satisfaction. | Posted | Mean | Standard Deviation | score on a scale | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum |
|
|
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| Secondary | Social Support | Duke-University of North Carolina Functional Social Support Questionnaire: scoring ranges from 8-40 with higher values indicating greater social support | Posted | Median | Inter-Quartile Range | score on a scale | 6-weeks postpartum and 6-months postpartum |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. 0 Adverse Events | 0 | 20 | 0 | 20 | 0 | 20 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| 6 weeks |
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| 12 weeks |
|
| 6 months |
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| 6 months postpartum |
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| 6 months |
|
| Baseline- mainly husband/ partner decides |
|
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| Baseline - decides jointly |
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| Baseline- other |
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| 6 weeks -mainly participant decides |
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| 6 weeks- mainly husband/ partner decides |
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| 6 weeks - decides jointly |
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| 6 weeks-other |
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| 6 months -mainly participant decides |
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| 6 months -mainly husband/ partner decides |
|
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| 6 months -decides jointly |
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| 6 months- other |
|
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| Baseline- has experienced abuse by husband/partner |
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| 6 weeks- has experienced abuse by husband/partner |
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| 6 months- has experienced abuse by husband/partner |
|
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| 6 months |
|