NCT05219552 is a NA clinical trial of personalized lactation support in Mental Health Issue, sponsored by University of California, San Francisco.

Who is sponsoring NCT05219552?

NCT05219552 is sponsored by University of California, San Francisco.

What drugs are being tested in NCT05219552?

Interventions in NCT05219552: personalized lactation support.

What condition does NCT05219552 study?

NCT05219552 studies Mental Health Issue, Hiv, Breastfeeding, Exclusive.

Is NCT05219552 still recruiting?

NCT05219552 is currently completed. Last updated 14 August 2025.

Are results published for NCT05219552?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-08-14 · How we verify

NCT05219552

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 14 August 2025

What this trial tests

NA trial testing personalized lactation support in Mental Health Issue in 40 participants. Completed in 9 March 2023.

Timeline

23 February 2022

Primary endpoint
9 March 2023

9 March 2023

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	40
Start date	23 February 2022
Primary completion	9 March 2023
Estimated completion	9 March 2023
Sites	2 locations across Kenya

Drugs / interventions tested

personalized lactation support

Conditions studied

Mental Health Issue — all drugs for Mental Health Issue →
Hiv — all drugs for Hiv →
Breastfeeding, Exclusive — all drugs for Breastfeeding, Exclusive →

Sponsor

University of California, San Francisco

Who can join

18 and older, female only, with Mental Health Issue or Hiv. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maternal Mental Health Primary · 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.

Baseline

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	8.5	6.0 – 9.2
Control Group- Standard Care	6.5	5 – 9.8

6 weeks postpartum

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	3.0	2 – 6.2
Control Group- Standard Care	3.0	.8 – 5

6 months postpartum

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	3.0	1 – 5.2
Control Group- Standard Care	5	1 – 8

Number of Participants Who Reported Feeding Breastmilk Only Primary · 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".

2 weeks

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	19
Control Group- Standard Care	16

4 weeks

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	19
Control Group- Standard Care	19

6 weeks

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	20
Control Group- Standard Care	19

12 weeks

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	20
Control Group- Standard Care	17

Number of Participants Who Acknowledge Missing One or More HIV Infant Medications Primary · 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).

6 weeks

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	0
Control Group- Standard Care	0

6 months

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	2
Control Group- Standard Care	2

Maternal Adherence to HIV Medications Primary · 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."

Baseline

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	98.95	± 3.94
Control Group- Standard Care	98.05	± 6.95

6 weeks

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	97.7	± 10.03
Control Group- Standard Care	99.75	± 1.09

6 months

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	99.8	± 0.6
Control Group- Standard Care	99.85	± 0.48

Food Security Primary · 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.

Baseline

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	11.5	9 – 16.2
Control Group- Standard Care	12	7 – 15

6 weeks postpartum

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	1	0 – 7
Control Group- Standard Care	9.5	5.8 – 12.5

6 months postpartum

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	2	0 – 3.5
Control Group- Standard Care	9	6 – 11.5

Financial Security Primary · 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.

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	20
Intervention Group- Lactation Support and Unconditional Cash Transfers	0

Relationships Status Secondary · 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.

Baseline

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	41.3	± 11.6
Control Group- Standard Care	44.5	± 22.2

6 weeks

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	44.4	± 14.8
Control Group- Standard Care	53.3	± 11.6

6 months

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	43.1	± 15.5
Control Group- Standard Care	50.3	± 10.8

Women's Empowerment Secondary · 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.

Baseline -mainly participant decides

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	9
Control Group- Standard Care	11

Baseline- mainly husband/ partner decides

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	1
Control Group- Standard Care	2

Baseline - decides jointly

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	0
Control Group- Standard Care	7

Baseline- other

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	10
Control Group- Standard Care	0

6 weeks -mainly participant decides

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	6
Control Group- Standard Care	11

6 weeks- mainly husband/ partner decides

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	0
Control Group- Standard Care	1

6 weeks - decides jointly

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	3
Control Group- Standard Care	8

6 weeks-other

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	11
Control Group- Standard Care	0

HIV-related Stigma Secondary · 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.

Baseline

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	25.6	± 6.3
Control Group- Standard Care	30.4	± 7.1

6 weeks

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	25.9	± 3.9
Control Group- Standard Care	27.1	± 4.6

6 months

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	26.8	± 4.1
Control Group- Standard Care	28.4	± 4.7

Social Support Secondary · 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

6 weeks

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	24.5	20.2 – 31.5
Control Group- Standard Care	33.0	27.8 – 37.0

6 month

Group	Value	95% CI
Intervention Group- Lactation Support and Unconditional Cash Transfers	30.5	22.0 – 34.0
Control Group- Standard Care	31.0	27.8 – 35.5

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Infant feeding: emerging concepts to prevent HIV transmission.
Bamford A, Foster C, Lyall H. · · 2024 · cited 9× · PMID 37889586 · DOI 10.1097/qco.0000000000000986
Understanding mother-to-child transmission of HIV among mothers engaged in HIV care in Kenya: a case report.
Tuthill EL, Odhiambo BC, Maltby AE. · · 2024 · cited 7× · PMID 38395878 · DOI 10.1186/s13006-024-00622-3
Feasibility, acceptability and lessons learned from an infant feeding intervention trial among women living with HIV in western Kenya.
Maltby AE, Odhiambo BC, Nyaura M, Shikari R, et al · · 2023 · cited 6× · PMID 37798696 · DOI 10.1186/s12889-023-16794-2
"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.
Tuthill EL, Maltby AE, Odhiambo BC, Hoffmann TJ, et al · · 2023 · cited 3× · PMID 38012644 · DOI 10.1186/s13006-023-00600-1

Verify or expand the search:

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Currently open trials in the same condition.

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Other University of California, San Francisco trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05219552 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 14 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05219552.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05219552

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Mental Health Issue

Other University of California, San Francisco trials

Verify against primary sources