PostNAPS: FI, Nutrition, and Psychosocial Health Among Women of Mixed HIV Status and Their Infants in Gulu, Uganda

HIV Clinical Trial

— PostNAPS  

Official title:

The PostNAPS Study: Food Insecurity As A Major Determinant of Poor Nutritional and Psychosocial Health Outcomes Among HIV-Infected and -Uninfected Lactating Women and Their Infants in Gulu, Northern Uganda.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925429
• Other study ID #: 1302003634
• Status: Completed
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: November 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

PostNAPs was a continuation of the PreNAPs study. 246 women were enrolled in the postnatal period with the primary scientific objective of determining whether food insecurity was an independent risk factor for poor maternal nutritional or psychosocial outcomes or for sub-optimal infant feeding practices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Postpartum women >18 years of age

• Attended antenatal care at Gulu Regional Referral Hospital

• Participated in the PreNAPS study

• Infants that were born to women participating in the PreNAPS study

Exclusion Criteria:

• Women <18 years of age

• Women not participating in the PreNAPS study

Related Conditions & MeSH terms

• Food Insecurity
• HIV
• Maternal and Child Health
• Nutrition
• Psychosocial Health

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Northwestern University	Cornell University, Makerere University, Tufts University, Weill Medical College of Cornell University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impacts of food insecurity (IFIAS) on maternal and infant health indicators (i.e. changes in body composition, hemoglobin, morbidity, etc.) among lactating women of mixed-HIV status and their infants in Gulu, Uganda	Explore the underlying mechanisms and impacts of food insecurity (using the Individual Food Insecurity Access Scale (IFIAS)) on body composition changes (weight in kg, bioelectrical impedance analysis (among women), skin folds, MUAC), morbidity (malaria, diagnoses or symptoms of fever, typhoid, diarrhea, etc.), micronutrient status (hemoglobin), and other health indicators among women of mixed-HIV status and their infants in Gulu, Uganda.	Approximately 1 year
Secondary	Impacts of food insecurity (IFIAS) and maternal depression (CES-D) on maternal folate levels among women of mixed-HIV status in Gulu, Uganda.	Describe the relationship between food insecurity (IFIAS) and maternal depression (CES-D) on maternal folate levels and assess if these relationships are modified by maternal HIV status.	Approximately 1 year
Secondary	Impacts of food insecurity (IFIAS) and maternal depression (CES-D) on maternal B12 levels among women of mixed-HIV status in Gulu, Uganda.	Describe the relationship between food insecurity (IFIAS) and maternal depression (CES-D) on maternal B12 levels and assess if this relationship is modified by HIV status.	Approximately 1 year
Secondary	Impacts of food insecurity (IFIAS) and maternal depression (CESD) on infant feeding among women of mixed-HIV status in Gulu, Uganda	Explore the impacts of food insecurity (IFIAS) and maternal depression (CESD) on infant feeding (breastfeeding, introduction of complimentary foods, infant dietary diversity).	Approximately 1 year
Secondary	Changes in food insecurity (IFIAS) within the first year of delivery among women of mixed-HIV status in Gulu, Uganda	Measure changes in the prevalence and severity of food insecurity from delivery to approximately 1 year postpartum among women of mixed-HIV status in Gulu, Uganda.	Approximately 1 year