Hiv Clinical Trial
Official title:
Understanding the Role of Food Insecurity and Depression in Non-adherence to Option B+ Among Perinatal Kenyan Women Living With HIV: A Syndemics Approach
Verified date | August 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 9, 2023 |
Est. primary completion date | March 9, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
Kenya | Kisumu County Hospital | Kisumu | |
Kenya | Lumumba Sub-county Hospital | Kisumu |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Kenya Medical Research Institute |
Kenya,
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal Mental Health | Patient Health Questionnaire-9: scoring ranges from 0-27 with higher scores indicating greater depressive symptoms.
Perceived Stress Scale: scoring ranges from 0-40 with higher scores indicating higher stress |
baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum | |
Primary | Optimal Infant Feeding | Lactation consultant assessment Breastfeeding self-efficacy scale: higher scores indicate greater breastfeeding self-efficacy | baseline (20-35 weeks pregnant), 2-weeks postpartum, 4-weeks postpartum, 6-weeks postpartum, 3-months postpartum and 6-months postpartum | |
Primary | Adherence to infant prophylaxis | Adherence questionnaire | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum | |
Primary | Maternal Adherence to HIV medications | Adherence questionnaire | 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 | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum | |
Primary | Financial Stats | Wealth Index from Kenya's Demographic Health Survey | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum | |
Secondary | 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 | |
Secondary | Women's empowerment | Select questions from the Demographic Health Survey | 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 | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum | |
Secondary | Social Support | Duke-University of North Carolina Functional Social Support Questionnaire: scoring ranges from 8-40 with higher values indicating greater social support | baseline (20-35 weeks pregnant), 6-weeks postpartum and 6-months postpartum |
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