Health Message Testing Review Form

Attachment 3: Health Message Testing System Expedited Review Form

Health Message Testing System Expedited Review Form

1. Title of Study: (Please append screener and questionnaire)

______________Formative Research on the Act Against Aids Campaign - Message, Concept and Materials Testing

________________________________________________________________

2. Respondent characteristics:

Number of subjects: _____385

Number of males: ___________300______________

Number of females: ___85___________________

Age range: __18-64_____________________________

Racial/ethnic composition: ___30% African American; 20% White; 40% Hispanic/Latino; 10% Other_______________

Special group status: (e.g., risk group, health care providers, etc.)

Type of group/s: __Men who have sex with men; HIV positive individuals; general population______________________________

______________________________________________

Geographic location/s: ______Recruitment and interviews will take place in U.S. cities with high HIV prevalence rates as identified through CDC’s surveillance data. Potential cities include New York, New York; Houston, Texas; Dallas, Texas; Miami, Florida; Chicago, Illinois; Los Angeles, California; San Francisco, California ; and Washington, D.C___________________________

3. Study method: (Please check one below)

Central location intercept interview: _X____

Telephone interview: _____ (CATI used: yes or no) _____

Individual in-dept interview (cognitive interview): _X____

Focus group: _X____

Online interview: _____

Other: (describe) _________________________________

4. Purpose of the overall communication effort into which this health message/s will fit:

(Please provide 2-3 sentences below.)

This message, concepts, and material testing will support four specific campaigns under the Act Against AIDS campaign umbrella. Act Against AIDS is a national communication campaign that was launched at the White House in 2009. The campaign supports the National HIV/AIDS Strategy. It consists of the umbrella Act Against AIDS campaign, which focuses on awareness about HIV, as well as more targeted behavior change campaigns. The four campaigns being tested are: 1) the umbrella Act Against AIDS campaign (a new round of advertisements); 2) an HIV testing campaign targeting Latino men who have sex with men; 3) a general HIV prevention campaign for all men who have sex with men; and 4) materials for consumers as part of the HIV Screening. Standard Care campaign. We also test our materials with different audiences outside of the campaign audiences, including HIV positive individuals, to ensure that the materials are not stigmatizing.

5. Category of time sensitivity: (Please check one below)

Health emergency: _____

Time-limited congressional/administrative mandate: _____

Press coverage correction: _____

Time-limited audience access: _____

Ineffective existing materials due to historical event/social trends: __X___

Trend tracking: _____

6. Describe nature of time sensitivity:

(Please provide 2-3 sentences below.)

The message testing is being conducted to support four specific campaigns under the Act Against AIDS campaign umbrella. The implementation for these campaigns is funded through severable contracts that do not allow for no-cost extensions. Delays will result in the potential loss of several million dollars, the implementation budget for these campaigns, and the termination of associated contract staff . Message, concept, and materials testing for the campaigns are scheduled to begin on December 12, 2011 and continue until February 28, 2012.

7. Number of burden hours requested: ___385_______

BURDEN HOURS

Category of Respondent	No. of Respondents	Participation Time	Burden
General population- intercept interviews	180	20/60	60
General population- screener	220	5/60	19
General population- consent	180	5/60	15
MSM- focus groups	200	60/60	200
MSM screener	300	5/60	25
MSM- consent	200	5/60	17
HIV positive individuals- in-depth interviews	40	60/60	40
HIV positive individuals- screener	60	5/60	5
HIV positive individuals- consent	40	5/60	4
Totals			385

10. Are you using questions from the approved question bank? If yes, please identify the number of the questions used. If using questions that are not in the question bank, please list the item numbers and provide a brief rationale for adding these questions.

Yes: __X___

1a, 1d, 2a, 4a, 5a, 5e, 7d, 8e, 9d, 10e, 12c, 13a, 14c, 16a, 17a, 18a, 19a, 19e, 20a, 20e, 21a, 22a, 23a, 24d, 25a, 26e, 27e, 28d, 29d, 31f, 32d, 32e, 33d, 33e, 36d, 37e, 39e, 43e, 47f, 52e, 58e, 59e, 60e, 61e, 62e, 68e, 69e, 70e, 71e, 73e, 75e, 80d, 91d, 97d, 104d, 108d

No: _____

*** Items Below to be completed by Office of Associate Director for Communication (OADC)***

1. Number of burden hours remaining in current year’s allocation: _______

2. OADC confirmation of time-sensitivity:

Yes: _____

No: _____

_____________________________________

Project Officer Signature

Additional Requested Information

1. Study Population and Recruitment Methods

The study population will consist of MSM, HIV positive individuals, and members of the general population. Respondents will be recruited in U.S. cities with high HIV prevalence rates as identified through CDC’s surveillance data. Potential cities include New York, New York; Houston, Texas; Dallas, Texas; Miami, Florida; Chicago, Illinois; Los Angeles, California; San Francisco, California; and Washington, D.C. The total number of participants will be 385, consisting of 300 males and 85 females. We will recruit ages 18-64, with a racial/ethnic composition of 30% African American, 20% White, $40% Hispanic/Latino, and 10% Other.

MSM will be recruited for focus groups/paper-pencil surveys, HIV+ respondents will be recruited for in-depth interviews, and general population will be recruited for intercept interviews. Recruitment procedures follow:

Focus groups/paper-pencil surveys and in-depth interviews

MSM and HIV+ respondents will be recruited in the above mentioned geographic locations through professional recruitment firms selected and reserved by RTI. The firms, under the oversight of RTI, or RTI staff will recruit study participants from a list of potential panel members from previously studies based on the current study’s eligibility criteria. As participants are recruited for the in-depth interviews and focus groups, recruitment grids will be prepared to keep track of recruitment. The recruitment grids will list the participants’ first name and some demographic information obtained from the attached screeners. The grids will not contain any identifying information. The recruitment grids will be stored in a locked file cabinet or on a password protected project share drive at RTI and at each professional recruitment firm. The professional recruitment firms will destroy their copies of the recruitment grids after data collection is completed in that city. RTI and CDC will have copies of the recruitment grids in order to describe the study sample. These copies of the recruitment grids will be kept in locked file cabinets or on a password protected project share drive at RTI and CDC for the duration of the study.

At each facility, recruitment staff will sign a Data Management Agreement acknowledging the requirement to treat all data in a secure manner and not disclose any data, unless otherwise compelled by law. At each facility and at RTI, the screeners will be kept in locked file cabinets. All identifying information (name, address, telephone number) will be recorded on the last page of the screener, which will enable the facility and/or RTI to send reminder letters/e mails and make reminder phone calls. The last page of the screener will be torn off and destroyed after the in-depth interviews/focus groups are conducted. Local professional recruitment firms will send the screeners (without the last page) to RTI. The screeners will be stored in a locked file cabinet at RTI throughout the duration of the project. Once the project ends, the screeners will be destroyed. No identifying information about participants will be kept at the professional recruitment firms after the interviews are completed and the professional recruitment firms will not send any identifying information to RTI or CDC. Again, we will not collect any personal identifying information from the intercept interview participants.

Recruitment typically begins four weeks before the in-depth interviews or focus groups are scheduled and can take about 1 month to complete. However, we will begin recruitment within a week of receiving clearance. RTI will closely communicate with each professional recruitment firm to monitor the recruitment and troubleshoot any problems. RTI will keep CDC apprised of the recruitment progress and will make any necessary adjustments during the recruitment process. Identification of recruitment facilities and recruitment will begin once IRB and OMB clearance is received. Dates will be assigned to each activity on the timeline for tracking and monitoring purposes after receiving IRB and OMB clearance.

Reminder letters/e-mails for the in-depth interviews and focus groups will be sent to potential participants prior to the data collection giving them directions to the study site. Confirmation calls will also be made 1–2 days prior to the focus group/interview to assure that all recruits are confirmed.

Once the potential participant comes to the study site and checks in for the in-depth interview or focus group he/she will be given an the applicable consent form. The individual will be given time to read the consent form on his/her own and a trained RTI staff member will be available to answer any questions. If the participant agrees to be in the study, he/she will sign the consent form. The participant will be given a copy of the consent form to keep for his/her records and we will proceed with the data collection.

Intercept interviews

Participants for the intercept interviews will be recruited by RTI staff from venues where the public tend to gather and we will obtain verbal consent rather than written consent. Once the intercept interview participant provides verbal consent, we will proceed with the 20 minute intercept interview. At the conclusion of the interview, we ask for them to initial a receipt form for their token of appreciation. The receipt form is for accounting purposes only. All participants, regardless of data collection type, will be reminded that they can refuse to answer any question and they can stop being in the study at any time, without penalty. RTI staff will FedEx or personally take these forms back to RTI after the interviews are completed in a particular city. The consent forms will be stored in a locked file cabinet at RTI for the duration of the project. Once the project ends, the forms will be destroyed. Participant responses to surveys will be maintained in the manner explained above for focus groups/paper-pencil surveys and in-depth interviews.

2. Explanation of Any Payment or Gift to Respondents

Participants will be offered a token of appreciation of up to $10 for completion of the intercept interview, or $40 for completion of the in-depth interview or focus group and paper/pencil survey. The token of appreciation is intended to recognize the time burden placed on the participants, encourage their cooperation, and convey appreciation for contributing to this important study. The time burden is reflected in the amount of the token of appreciation. The intercept interview will last 20 minutes, while the focus group and in-depth interview will last 60 minutes. Numerous empirical studies have shown that honoraria can significantly increase response rates (e.g., Abreu & Winters, 1999; Shettle & Mooney, 1999).

Because we are conducting intercept interviews, the use of a small token of appreciation is expected to enhance response rates without biasing responses or coercing respondents to participate. For each of our respondent categories, a smaller token of appreciation would not be sufficiently attractive to adults. Also, the literature suggests that the token of appreciation will result in higher data validity as adults become more engaged in the survey process (Shettle & Mooney, 1999). The amount of the token of appreciation was determined through discussions with RTI staff with expertise in conducting adult surveys about HIV. Because all selected individuals may not be eligible for the study, we want to assure sufficient project spending and only provide a token of appreciation to respondents after they are determined to be eligible.