Clinical trial NCT02925429: PostNAPS: FI, Nutrition, and Psychosocial Health Among Women of Mixed HIV Status and Their Infants in Gulu, Uganda
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Insecurity
HIV
Maternal and Child Health
Nutrition
Psychosocial Health
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Cornell University
name: Tufts University
name: Weill Medical College of Cornell University
name: Makerere University
First posted: 2016-10-05
Enrollment: 246
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postpartum women \>18 years of age of mixed HIV status who had attended antenatal care at Gulu Regional Referral Hospital in Gulu, Uganda and had participated in the PreNAPS longitudinal observational cohort study and their infants.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Impacts of food insecurity (IFIAS) and maternal depression (CES-D) on maternal folate levels among women of mixed-HIV status in Gulu, Uganda.
timeFrame: Approximately 1 year
measure: Impacts of food insecurity (IFIAS) and maternal depression (CES-D) on maternal B12 levels among women of mixed-HIV status in Gulu, Uganda.
timeFrame: Approximately 1 year
measure: Impacts of food insecurity (IFIAS) and maternal depression (CESD) on infant feeding among women of mixed-HIV status in Gulu, Uganda
timeFrame: Approximately 1 year
measure: Changes in food insecurity (IFIAS) within the first year of delivery among women of mixed-HIV status in Gulu, Uganda
timeFrame: Approximately 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Sera L Young, MA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Barnabas K Natamba, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lane CE, Widen EM, Collins SM, Young SL. HIV-Exposed, Uninfected Infants in Uganda Experience Poorer Growth and Body Composition Trajectories than HIV-Unexposed Infants. J Acquir Immune Defic Syndr. 2020 Oct 1;85(2):138-147. doi: 10.1097/QAI.0000000000002428.
citation: Boateng GO, Martin SL, Tuthill EL, Collins SM, Dennis CL, Natamba BK, Young SL. Adaptation and psychometric evaluation of the breastfeeding self-efficacy scale to assess exclusive breastfeeding. BMC Pregnancy Childbirth. 2019 Feb 18;19(1):73. doi: 10.1186/s12884-019-2217-7.
citation: Boateng GO, Martin SL, Collins SM, Natamba BK, Young SL. Measuring exclusive breastfeeding social support: Scale development and validation in Uganda. Matern Child Nutr. 2018 Jul;14(3):e12579. doi: 10.1111/mcn.12579. Epub 2018 Jan 22.
citation: Widen EM, Collins SM, Khan H, Biribawa C, Acidri D, Achoko W, Achola H, Ghosh S, Griffiths JK, Young SL. Food insecurity, but not HIV-infection status, is associated with adverse changes in body composition during lactation in Ugandan women of mixed HIV status. Am J Clin Nutr. 2017 Feb;105(2):361-368. doi: 10.3945/ajcn.116.142513. Epub 2017 Jan 4.