Hospital-based birth defects surveillance in Kampala, Uganda | RFA GH 16 008

Frequently Asked Questions (FAQs): Hospital-based birth defects surveillance in Kampala, Uganda (RFA GH 16 008)

1) What is the title of this grant opportunity?

The opportunity is titled "Hospital-based birth defects surveillance in Kampala, Uganda".

2) What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is RFA GH 16 008.

3) Which agency is offering this funding?

The opportunity is administered by the Centers for Disease Control and Prevention (CDC).

4) What type of funding mechanism is used?

This is a discretionary cooperative agreement. That means CDC is expected to have substantial involvement in the work (for example, technical collaboration, guidance on surveillance methods, and support on study design and analysis), rather than simply providing funds with minimal ongoing engagement.

5) What is the main purpose of the project?

The project is designed to strengthen and continue a hospital-based system for tracking birth defects in Kampala, Uganda, using a systematic approach to identify and document major external structural birth defects among newborns.

6) Is this project new or does it build on earlier work?

It builds directly on an earlier CDC-supported effort identified as award #1U01GH000487.

7) Where will the surveillance activities take place?

The surveillance system is focused on Kampala, Uganda.

8) How many hospitals are included in the surveillance focus?

The core surveillance activities are focused on four major hospitals in Kampala.

9) What kinds of birth defects are being tracked?

The surveillance component is designed to systematically identify and document major external structural birth defects among newborns.

10) Why does the opportunity emphasize systematic surveillance rather than routine reporting?

The goal is to create a consistent, comparable data set over time rather than relying on irregular reporting or incomplete records. This helps establish reliable baseline rates and supports trend monitoring.

11) Does the grant include research in addition to surveillance?

Yes. In addition to ongoing surveillance, the opportunity supports a nested case-control study that runs at the same time and within the same hospital population being monitored.

12) What is a "nested case-control study" in the context of this opportunity?

In this project, the case-control study is conducted within the population covered by the hospital surveillance system. Mothers of infants with identified birth defects are included as cases, and mothers of infants without such defects are included as controls. The study then compares early pregnancy medication exposure histories between the two groups.

13) What is the main research question for the nested case-control study?

The study aims to evaluate whether maternal exposure to specific HIV-related medications during very early pregnancy is linked to an increased risk of birth defects in infants.

14) Which medications are specifically examined?

The opportunity highlights two exposure categories: cotrimoxazole (commonly used to prevent or treat opportunistic infections in people living with HIV) and antiretroviral therapies (ARTs).

15) How will medication exposure be evaluated in the study?

The study compares medication histories among mothers of babies with birth defects (cases) versus mothers of babies without birth defects (controls), in order to estimate associations between early pregnancy medication use and birth defect outcomes.

16) What practical public health outputs are expected from this project?

A central practical deliverable is the production of baseline (background) rates of major external birth defects in Kampala. These baseline rates support local public health planning, allow evaluation of changes over time, and help interpret future safety signals related to medication use in pregnancy.

17) What scientific outputs are expected from the nested case-control study?

The study is intended to generate baseline estimates of (a) how commonly cotrimoxazole and ARTs are used in early pregnancy in this setting, and (b) whether those exposure patterns appear to correlate with a higher prevalence of specific major external birth defects.

18) How do the surveillance and case-control components fit together?

The surveillance system provides the consistent identification and documentation of birth defects over time, while the nested case-control study uses the same monitored hospital population to evaluate potential associations between early pregnancy HIV-related medication exposures and birth defect outcomes.

19) What is the CFDA number for this opportunity?

The opportunity is listed under CFDA 93.067.

20) What is the activity category for this opportunity?

The opportunity falls under the health activity category.

21) Who is eligible to apply?

Eligible applicants are limited to:

• Public and state-controlled institutions of higher education
• Private institutions of higher education

This reflects an expectation that academic institutions will play a leading role in implementing surveillance operations, maintaining data quality, and conducting the epidemiologic case-control analysis.

22) What is the maximum award amount (award ceiling)?

The award ceiling is $500,000.

23) How many awards does CDC expect to make?

The opportunity indicates an expectation of a single award, meaning one lead recipient would coordinate the full scope of surveillance and research activities.

24) When was the opportunity created?

The opportunity was created on 2016-03-02.

25) What was the original application closing date?

The original application closing date was 2016-05-04.

26) Through what system is the opportunity administered?

The opportunity was administered through the CDC via ERA.

27) What is the overall value of having baseline birth defects data in Kampala?

Establishing baseline rates helps public health leaders and clinicians understand the background prevalence of major external birth defects, track changes over time, and interpret potential medication safety signals in pregnancy in a setting where HIV treatment and prophylaxis are common.