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CompletedNCT02925429PostNAPSUpdated Nov 13, 2020

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

An observational study in Food Insecurity, HIV and Maternal and Child Health, sponsored by Northwestern University. Completed. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Northwestern University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
246
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

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Conditions studied

  • Food Insecurity
  • HIV
  • Maternal and Child Health
  • Nutrition
  • Psychosocial Health
03

In context

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  • Women \<18 years of age
  • Women not participating in the PreNAPS study
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
246 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Approximately 1 year

Secondary outcomes

  1. 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.

    Time frame: Approximately 1 year

  2. 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.

    Time frame: Approximately 1 year

  3. 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).

    Time frame: Approximately 1 year

  4. 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.

    Time frame: Approximately 1 year

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 32604132 ↗
  • 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. PubMed 30777020 ↗
  • 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. PubMed 29356347 ↗
  • 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. PubMed 28052888 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02925429
Lead sponsor
Northwestern University
Collaborators
Cornell University, Tufts University, Weill Medical College of Cornell University, Makerere University
Responsible party
Sera Young (Associate Professor, Northwestern University) — Principal investigator
First posted
Oct 5, 2016
Start date
May 2013
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Nov 13, 2020

Study contacts

Sera L Young, MA, PhD
principal investigator · Northwestern University
Barnabas K Natamba, MPH, PhD
principal investigator · Michigan State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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