RFP 2011-N-13417 QUESTIONS ANSWERS ROUND 4.docx

July 14, 2011

Questions and Answers: Round 4

RFP 2001-N-13417, Evaluation of Rapid HIV Self-Testing among MSM in High Prevalence Cities

Sites, Retention, Respondent Population

Q1. Could you please confirm your expected retention rate? On page 5 you indicate 80% retention. But later on you indicate that you expect 17,500 completed interviews at the end with six data collection periods. In the very back you ask for at least 70%.

ANSWER: The minimum acceptable rate would be 70%, with the expectation that the contractor obtain 80% at each point and this value was used to calculate an estimated number of surveys: 17500 = 3500 baseline+ (3500 persons x 5 assessments x 0.8 follow-up rate). The goal is for 100% of surveys (21,000) to be completed.

Q2. Do 20% Black and 15% Hispanic rates apply to each site or is that the total distribution across sites?

ANSWER: Across all sites.

Q3. Do you expect an equal distribution across all sites of the 3200 HIV Negative or unknown status MSMs and 300 HIV Positive MSMs?

ANSWER: No. If more than one site is used, there may be differential recruitment by sites.

Q4. Are there demographic specs/requirements for participants in the focus group? Do the 20% Black and 15% Hispanic rates apply to focus groups as well?

ANSWER: No.

Task 2

Q5. One Page 6 Objective #1, the RFP implies the contractor will assist with drafting the OMB package (if it is needed). However, Task 2 doesn’t explicitly call for drafting the submission package. Please confirm if the contractor should assume time and effort for drafting the OMB package.

ANSWER: Yes. If an OMB package is required, time and effort should be included. The assistance provided by the contractor to the COTR in drafting the OMB package will include but not limited to the prompt notification of descriptions concerning protocol, recruitment and retention methods, quality control methods, security, and other elements and details that are required for the OMB package.

Task 4.2

Q6. Could you clarify if the C&A process is required only of the organization hosting the secure web application?

ANSWER: All organizations involved in the collection, management, transferring, and receipt of personal identifiable information will be required to complete the C&A process.

Task 5.3

Q7. Will the dry blood spot cards be anonymous-with no respondent identifiers?

ANSWER: The dried blot spots would be labeled with a study identifier, but not the participant’s name.

Task 6.2

Q8. Will CDC directly fund the CBO/Health Dept for the additional clients routed to them from this study?

ANSWER: CDC will not directly fund CBOs or Health Departments for additional clients.

Task 7.2

Q9. Will the contractor be responsible for testing the data collection instruments provided by COTR?

ANSWER: The COTR will provide a final hardcopy version of the instruments with skip patterns included. The contractor should plan to test the instruments to ensure there are no errors in the system that they develop, such as data entry, skip patterns, etc. (See 4.3. The contractor shall identify and address relevant technical considerations for web-based survey implementation. Such considerations shall include look-and-feel issues, layout, number of questions per page, and accessibility.)

Q10. Task 7.2 notes COTR will provide data collection instruments for the screener, baseline, follow-up, and self-test use experience questionnaire. Task 7.3 notes follow-up in months 1, 3, 6, 9, and 12 (a total of 5 follow-up surveys). Task 7.5 notes a total of 6 assessments. Please clarify the number of surveys to be administered.

ANSWER: There will be a screening instrument, 6 assessments (baseline and 5 follow-up assessments), and a self-test use experience questionnaire.

Q11. Will the follow-up surveys (administered at months 1, 3, 6, 9, and 12) all use the same survey instrument?

ANSWER: The instruments will have common sections, comparable in length, but may not be identical.

Q12. Will each of the survey instruments (screener, baseline, follow-up, self-test use) include no more than 2 to 3 open ended questions?

ANSWER: This has not been determined at this time.

Task 9

Q 13. Task 9 calls for the delivery of the final dataset and no analysis. Could you please confirm that the contractor is not responsible for any data analysis?

ANSWER: The contractor will be responsible for analyzing data for progress reports as described in the scope of work. Data analyses for scientific dissemination (e.g., papers, presentations) are not required.

ANSWER: The contractor shall recruit participants via the internet, and potentially other methods.

ANSWER: There is not a limit on individual study participant incentives. However, per required IRB review the incentives offered for participation should not be coercive.

ANSWER: No. See previous response to similar question.

ANSWER: Not at this time. If an OMB approval is required, the protocol and IRB approvals will need to be prepared and obtained by the contractor before seeking OMB approval.

ANSWER: CDC will not provide materials for this activity.

ANSWER: CDC will not provide rapid HIV test kits.

ANSWER: Analyses that meets the requirements of the progress reports. See previous response to similar question.

ANSWER: YES, the Original is included as a part of the 6 copies

ANSWER: Both. Read the instructions for each section

Q. Does the government have a preferred vendor for saliva and DBS self-test kits?

ANSWER: No.

q. Does the draft information systems security plan called for on page 16 count against the 25 page limit?

ANSWER: No. (Technical Proposal text must be single spaced, single sided, standard 8 ½ x 11 inch pages of normal type size (either Times Roman or Arial, 12 point), with 1 inch margins, and the entire proposal should not exceed a total of 25 pages, excluding title page, executive summary, table of contents, Information Security, references, appendices and resumes of key personnel.)

ANSWER: The goal should be 100% of assessments to be completed. The contractor is expected to achieve at least an 80% retention rate at each assessment point, with a minimum acceptable rate of 70%.

Q. Is the contractor expected to meet the race/ethnicity distribution requirement of 20% black and 15% Latino in both the HIV negative and the HIV unknown groups (minimum 3200) and the HIV+ group (300)?

ANSWER: Yes, both conditions should meet the race ethnicity recruitment rates.