Justification for Non-Substantive Change

Assessment to Estimate the Effect of Community-Wide Vector Control Initiatives on Zika Virus Transmission in Puerto Rico, 2016

0920-1137

Exp Date: 03/31/2017

Circumstances of Change Request:

In Puerto Rico, we know that household-based cluster investigations have limitations because only people that are home at the time of the contact attempt have the opportunity to participate in the study. Additionally, many people offered participation refuse to participate because they are required to provide a blood sample. Also, parents may be reluctant to allow children to participate because they have to give a blood sample. Given this issue, it would be helpful to collect demographics of refusing households in order to understand differences from participating households.

For homes that are offered enrollment and refuse to participate we will gather categorical demographic information on sex and age of the household inhabitants. This will allow us to compare demographic makeup of the participants to those that refuse. Based on a refusal rate of 32% during the Chikungunya cluster investigation, we expect roughly 100 homes will refuse participation.

New Form:

We are requesting to add a short form to capture the basic demographic information for households that refuse, in order to try to understand if refusing households differ substantially from participating households. how many people live in their home in 3 different age categories for both males and females: minors <21 years old, adults 21-64 years old, and seniors 65+. This information will help us understand if the demographics of the people that participate are similar or not to the demographics of people that refuse to participate. We will not be able to gather any information on homes that are unoccupied at the time of encounter.

New burden is highlighted below – an increase in 3 hours.

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
General public	Household questionnaire	200	1	18/60	60
	Individual questionnaire	500	2	30/60	500
	Individual specimen collection of blood, urine, and saliva	500	1	10/60	83.3
	Refusal demographic form	100	1	2/60	3.3
Total					646.9

Annualized Burden Costs

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
General public	Household questionnaire	60	$22.71	$1,362.60
	Individual questionnaire	500	$22.71	$11,355.00
	Refusal demographic form	3.3	$22.71	$74.94
Total				$12,792.54

Additional revisions requested:

CDC held a field training recently practicing the questionnaire. Based on feedback we made minor modifications to the questions. We changed “gender” to “sex” and added in fields “refused to answer” or “do not know.” There is no change of burden associated with