Project Determination for IRB

Project Determination

CBO Survey on Changes in Preparedness and Resources for Support of Biomedical HIV Prevention

Project ID:	0900f3eb81a71c96
Project Contact:	Jones_Jamal (opy3)
Organization:	NCHHSTP
Status:	Pending Clearance
Intended Use:	Project Determination
Estimated Start Date:	10/02/20
Estimated Completion Date:	05/03/21
CDC/ATSDR HRPO/IRB Protocol#:
OMB Control#:

Description

Priority

Standard

Date Needed

12/23/19

Determination Start Date

12/06/19

Description

We plan to conduct a survey among clinical and non-clinical community-based organizations (CBO) funded by the CDC and unfunded clinical and non-clinical CBOs. Data collected from this survey will assess provision of Treatment as Prevention (TasP), non-occupational post-exposure prophylaxis (nPEP), and pre-exposure prophylaxis (PrEP).

Goals/Purpose

The goals of the survey are to assess CBOs awareness of, intentions to provide, and provision of TasP, nPEP, or PrEP. We will also assess changes in awareness and provision of biomedical HIV prevention interventions among these organizations by comparing responses from a newer survey to those of a previous survey (2015) conducted by DHAP’s Health Services Research for Prevention with Negatives Team (HSRPWN).

Objective

Conduct a survey among clinical and non-clinical CBOs funded by the CDC and unfunded clinical and non-clinical CBOs. Data collected from this survey will be compared to data collected in 2015 to assess differences in awareness, intentions to provide, and provision of TasP, nPEP, or PrEP. This information with help the CDC identify areas for capacity building of CBOs as well as to develop education materials on how CBOs can scale-up their biomedical prevention services.

Activities or Tasks

New Collection of Information, Data, or Biospecimens

Target Population to be Included/Represented

Healthcare Personnel: Other-Survey respondents will be representatives of the community-based organizations.

Tags/Keywords

Surveys and Questionnaires: HIV

CDC's Role

CDC is the sole institution conducting activity

Method Categories

Survey

Methods

Respondents will include organizations engaged in HIV prevention and outreach. 330 respondents (N=330; 175 funded CBOs and 155 unfunded CBOs) will be recruited to complete the survey. Selection, inclusion or sampling of participants: Two sampling strata will be created: A. Clinical and non-clinical CBOs directly funded by CDC. B. Unfunded clinical and non-clinical CBOs who applied for CDC funding. This project will employ a cross-sectional survey design. All CBOs within each of the two strata (mentioned above) will receive phone calls to elicit interest in participating in the survey and to receive the contact information of an organization’s representative to complete the survey on behalf of the organization. Each organization’s representative will be sent an email with a link to the survey website (created with Survey Monkey). The email will instruct the representative on how to complete the survey. Three email reminders will be sent to organizations for those that do not complete the survey to achieve a 50% completion rate. If responses are received from 50% of organizations in each group (A and B), the survey will be closed and responses analyzed. If this response rate is not achieved, phone calls will be made to non-responsive CBOs to elicit participation in the survey.

Collection of Info, Data, or Bio specimens

All organizations within Strata A and B will be invited to complete the survey. Phone calls will be made to each CBO to elicit interest in participating in the survey and to receive the contact information of the organization’s representative. Each representative nominated from an organization will be sent an email with a link to the survey website (created with Survey Monkey). The email will instruct the recipient on how to complete the survey. Three email reminders will be sent to organizations for those that do not complete the survey to achieve a 50% completion rate. If responses are received from 50% of invited organizations in each group (A and B), the survey will be closed and responses analyzed. If this response rate is not achieved, phone calls will be made to non-responsive CBOs to elicit participation in the survey.

Expected Use of Findings/Results and their impact

Results from the survey will be presented to CDC staff internally and to public health professionals and other scientists externally (at conferences and other scientific symposia) to inform development of educational materials for CBOs engaged in biomedical HIV prevention activities. The results will also allow CDC staff in DHAP to identify targets for capacity building so that CBOs can efficiently and effectively deliver biomedical HIV prevention tools and treatment. Findings from the survey may also be published in the form of a scientific article within a public health or HIV journal.

Will PII be captured?

Yes

Does CDC have access to the Identifiers

Yes

Is a certificate or assurance of confidentiality in place or planned?

No

Is a non-disclosure agreement in place?

No

Funding
Funding Type	Funding Title	Funding #	Original Fiscal Year	# of Years of Award

Institutions
Institution	FWA #	FWA Exp. Date	IRB Title	IRB Exp. Date	Funding #

Staff
Staff Member	SIQT Exp. Date	Citi Biomedical Exp. Date	Citi Social and Behavioral Exp. Date	Citi Good Clinical Exp. Date	Staff Role	Email	Phone #	Organization/ Institution
Dawn Smith	12/04/2021	09/29/2021			Co-Investigator	dks0@cdc.gov	404-639-5166	HSR PREVENTION WITH NEGATIVES TEAM
Karen Hoover	12/26/2021				Co-Investigator	ffw6@cdc.gov	404-639-8534	EPIDEMIOLOGY BRANCH
Susan Danner	12/31/2022				Co-Investigator	spd1@cdc.gov	404-639-3	PROGRAM OPERATIONS TEAM

DMP
Proposed Data Collection Start Date	09/01/20
Proposed Data Collection End Date	05/03/21
Proposed Public Access Level	Public
Public Access justification	All PII will be removed before the data are shared. There are no restrictions for access to the survey data and all survey data will be made available to the public.
How Access Will Be Provided for Data	Tables containing personally identifying information (PII) (i.e., name and email of the organization's representative as part of recruitment activities) will be collected electronically and stored as a password protected Excel file that is stored on a secure CDC network drive, and only the principal investigator will have access to the file. Electronic survey data will be immediately downloaded from the Survey Monkey server and stored in a CDC CSV file that is password protected and encrypted (even at rest). Any changes to the electronic database are audited by systems controls to identify who made the change, when, and what change was made. We will make survey data available to the public per the CDC’s policy on Public Health Research and Non-research Data Management and Access. Data underlying the conclusions of peer-reviewed scientific publications will be made available in a publicly accessible repository per CDC guidelines and policy.
Plans for archival and long-term preservation of the data	The project records, including data, will be archived according to CDC’s Scientific and Research Project Records Control Schedule.

Spatiality (Geographic Location)
Country	State/Province	County/Region

Determinations
Determination	Justification	Completed	Entered By & Role
HSC: Does NOT Require HRPO Review	Research that involves de-identified/unlinkable data or biospecimens, but not involving FDA investigational products	01/24/20	Dodson_Janella R. (jhd7) CIO HSC
PRA: PRA does not apply		01/30/20	Bonds_Constance (akj8) CTR OMB/PRA Coordinator