RFP 2011-N-13417 Questions Answers Round 3 July-7-2011.docx

July 7, 2011

Questions and Answers: Round 3

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

1. Section C.2 Purpose/Project Objectives, pg 5: Willingness to receive kits mailed to home is not listed as an eligibility criterion in the solicitation. Would we need to assess willingness to receive kits as part of eligibility screening? Or will men be enrolled regardless of their expressed willingness to receive a test kit at home?

ANSWER: Willingness to receive kits will be an eligibility requirement, but the location of the delivery does not need to be participant’s home. This will be reflected in the screening questionnaire that is provided y the COTR. Additional eligibility criteria may be proposed by the contractor depending on the proposed study design.

2. Is there an estimate for the price on OTC testing kits? These are not yet commercially available to our knowledge.

ANSWER: Offerors will need to estimate/determine/negotiate price for test kits. As stated in the announcement, there is currently not an FDA approved OTC test kit.

3. Is funding contingent on the licensing of an OTC testing kit?

ANSWER: No. If test kit proposed is not FDA approved for OTC use at the time of the study, the kit may be used off-label. In such case an Investigational Device Exemption (IDE) may need to be pursued.

4. Section C.2 Purpose/Project Objectives, pg 5: The language sounds like the for baseline and months 1, 3, 6, and 9, test kits could either be administered/read at home, or have a specimen mailed in (e.g., Home Access). From the goals, we infer that before month 12 the tests would be OTC – home administered/read. Please confirm.

ANSWER: All test kits must be HIV testing kits where the person can test and read result without having to mail kit to manufacturer to obtain result.

5. Section C.2 Purpose/Project Objectives, pg 5: Is the rapid self-test and experience survey instrument administered independently of the follow-up surveys, and if so should it be done once for each test used? Does the government anticipate providing incentives for that survey if it is separate?

ANSWER: Yes, they are independent of survey instruments. They should be available for each test used. The use, type and amount of incentives are a decision for the offeror; however incentives are not recommended for the test experience survey.

6. Section C.4 Technical Requirements, Task 5, pg 9: Should we choose the vendor for the 12 month test kit that is mailed in?

ANSWER: The question is not clear, please provide clarification.

7. Section C.2 Purpose/Project Objectives, pg 5 and Section C.4 Technical Requirements, Task 5, pg 9: There is little information on the condition for the 300 HIV-positive men. Is the intent that they will still receive test kits for their partners? If so, are we going to be linking their partners to care?

ANSWER: The HIV positive group of 300 should be provided kits for their use or distribution to social network affiliates. All persons who receive a reactive result from using a self-test kit in this study should be provided with information on how to access additional testing services and linkage to care services. Contractor is not required to provide linkage services for social network affiliates / partners to care and treatment services.

8. Section C.2 Purpose/Project Objectives, pg 5 and Section C.4 Technical Requirements, Task 5, pg 9: Page 5 says that the HIV negative participants should be divided into two study arms—one that gets test kits and one that doesn’t. However, page 9 says “The contractor shall offer to mail all study subjects up to five self-test kits of the participant’s choice, and a dry blood spot collection kit at the completion of the 12 month assessment.” Can we please have clarification on who receives test kits?

ANSWER: During the course of the study, test kits should be available to the 300 persons in the “positive” arm and at least 1600 persons in the “negative / unknown” “intervention” arm. The control arm would not receive kits during the course of the study. At the end of the study – after completing the 12 month assessment, all remaining subjects from all three study arms would be eligible to receive up to 5 free test kits.

9. Section C.4 Technical Requirements, Task 5, pg 9: The RFT states, “The contractor shall offer to mail all study subjects up to five self-test kits of the participant’s choice, and a dry blood spot collection kit at the completion of the 12 month assessment.” Is it correct to assume that these data are not a core data element and are not desired by CDC for all study participants?

ANSWER: No. Data from the use of these kits are desired by CDC for all study participants.

10. L.11 Technical Proposal Instructions, pg. 76: The RFP states, “A recruitment strategy that will result in the recruitment of at least 3200 HIV-negative MSM (that have not been tested in the past 12 months).” However, this is not mentioned in the eligibility criteria earlier in the RFP. Is not testing in the past 12 months an eligibility criterion?

Although the evaluation criteria included in the RFP reference recruiting MSM that have not been tested in the past 12-months, this requirement has been revised. In referring to the scope of work, this requirement was not mentioned as an eligibility requirement and should not be considered as such. Additional eligibility criteria may be included by the contractor depending on the proposed study design. A modification to section L, Page 87 Criterion 2 has been added whereby the parenthetical words “(that have not been tested in the past 12 months)” has been deleted as a part of the criterion.