ARCHIVED - Formative Evaluation of the Canadian HIV Vaccine Initiative

Appendix F: External Stakeholders Interview Guide

CHVI Office, Other PHAC Staff, and CHVI Committee Members – Interview Guide

The Office of HIV Vaccines has retained the services of the management consulting firm Goss Gilroy Inc. (GGI) to conduct a formative Evaluation of the Canadian HIV Vaccine Initiative (CHVI). The purpose of the evaluation is to assess the progress of the CHVI in the first two years of implementation. The evaluation will look at progress made to date by the initiative and determine if changes are required to the design, delivery and direction of the initiative or program areas.

The evaluation involves comprehensive interviews as well as a document and file reviews. In the evaluation, interviews are being conducted with key stakeholders.

Your participation in this interview is voluntary, and your responses will be treated confidentially by GGI. Results will be reported at an aggregate level only. The interview will take approximately 20-30 minutes to complete, depending on your level of involvement with the CHVI.

Introduction

1. Please describe your involvement with the CHVI and how it connects with your responsibilities in your organization.

Probe: Involvement in different CHVI components/ Existence of collaborative arrangements.

NOTE: Participants may not know the exact name of the component they are/were involved with. Check for information about the involvement/ area of expertise of each respondent.

Ask of All Respondents

Role of CHVI, Ongoing Relevancy and Promising Practices

1. What programs and services are currently required in the HIV vaccine environment? (Issue 14)

1. Is CHVI consistent with these needs? (Issue 16)
2. What changes do you recommend to ensure that CHVI becomes more/ remains consistent with these needs?

2. Is CHVI linking well with key stakeholders involved in the HIV vaccine field? (Issue 22)

1. Is yes, which ones and how?
2. If not, what changes do you recommend for CHVI to better link with key stakeholders?

3. (Ask only if respondent is familiar with HIV prevention field (e.g. microbicides) Is CHVI linking well with key stakeholders in other areas of the HIV prevention technology field? (Issue 23)

1. If not, what changes do you recommend for CHVI to better linking with key stakeholders?

4. (Ask only of participants in organizations that have collaborative arrangements) To what extent are collaborative arrangements between your organization and CHVI effective? (Issue 8)

1. Can you suggest improvements in these collaborative arrangements?

CHVI Discovery and Social Research

Description of component (share with interviewees as needed): (1) the discovery of HIV vaccines and related issues (e.g., mucosal and innate immunity); and (2) social and behavioural issues around HIV vaccines (e.g., accessibility to, and acceptability of, vaccines and cultural and other sensitivities to HIV vaccine use).

A key objective in this program area is to promote greater collaboration between researchers in Canada and in LMICs who are working in HIV vaccine discovery and social research. To maximize the potential for important scientific discoveries, a multi-pronged approach is being used to support creativity by both individual investigators and collaborative teams.

Implementation Progress

5. How does this component contribute to the global effort toward an HIV vaccine?

6. (ask only of participants who are very involved) What progress has been made in the CHVI Discovery and Social Research program area? (Issue 10)

1. Barriers or challenges to progress towards the implementation of this component?
2. If there have been delays, what are the reasons for these delays? What should have or could have been done differently to avoid these delays?
3. What have been the successes?

7. Are there any areas of duplication between the activities of Discovery and Social Research program area and activities in other organizations? (e.g. as other government departments or agencies or other)? (Issue 9)

1. If so, do you have any suggestions for addressing this/ these areas of duplication?

CHVI Pilot Scale Manufacturing Capacity for Clinical Trial Lots

Description of component (share with interviewees as needed): CHVI is to contribute funds to a not-for-profit corporation (NPC) to build and govern a pilot scale facility in Canada to manufacture promising HIV vaccine candidates for clinical trials to be conducted mostly in, and for the benefit of, LMICs. The pilot scale manufacturing facility will produce clinical trial lots for HIV vaccine candidates discovered by researchers around the world.

Implementation Progress

8. How does this component contribute to the global effort toward an HIV vaccine?

9. What progress has been made in the CHVI Pilot Scale Manufacturing Capacity for Clinical Trial Lots? (Issue 10 and 21)

1. Barriers or challenges to progress towards the implementation of this component?
2. If there have been delays, what are the reasons for these delays? What should have or could have been done differently to avoid these delays?
3. What have been the successes in the RFP/RFA/LOI process for the Pilot Scale Manufacturing facility? (Issue 18)
4. What were some of the challenges?

10. Are there areas of duplication between the CHVI Pilot Scale Manufacturing Capacity for Clinical Trial Lots and other organizations? (e.g. as other government departments or agencies or other)? (Issue 9)

1. If so, do you have any suggestions for addressing this/ these areas of duplication?

CHVI Clinical Trials Capacity Building and Networks

(Description of component (share with interviewees as needed): The Clinical Trial Capacity Building and Networks program area aims to strengthen the capacity of researchers and research institutions to conduct high-quality clinical trials and to build site capacity to undertake clinical trials of HIV vaccines and other preventive technologies in LMICs.

Implementation Progress

11. How does this component contribute to the global effort toward an HIV vaccine?

12. What progress has been made in the Clinical Trials Capacity Building and Networks component? (Issue 10)

1. Barriers or challenges to progress towards the implementation of this component?
2. If there have been delays, what are the reasons for these delays? What should have or could have been done differently to avoid these delays?
3. What have been the successes in the RFP/RFA/LOI process for the clinical trials capacity building and networks? (Issue 18)
4. What were some of the challenges?

13. Are there areas of duplication between the CHVI Clinical Trials Capacity Building and Networks activities and that of other organizations? (e.g. as other government departments or agencies or other)? (Issue 9)

1. If so, do you have any suggestions for addressing this/ these areas of duplication?

CHVI Policy, Regulatory, Community and Social Dimensions

Description of component (share with interviewees as needed): Aims to strengthen vaccine policy approaches that promote global access to HIV vaccines; enhance the regulatory pathway and processes for HIV vaccines in LMICs; collaborate with partners in Canada and LMICs to advance legal, ethical and human rights dimensions of HIV vaccines; and strengthen existing mechanisms to support community involvement in vaccine research and development, clinical trials and activities related to public awareness, education and participation.

Implementation Progress

14. How does this component contribute to the global effort for an HIV vaccine?

15. What progress has been made in the CHVI Policy, Regulatory, Community and Social Dimensions component? (10)

1. Barriers or challenges to progress towards the implementation of this component?
2. If there have been delays, what are the reasons for these delays? What should have or could have been done differently to avoid these delays?
3. What have been the successes?
4. Did CHVI reach the right community organizations?
5. What have been the successes in the RFP process for the CHVI Policy, Regulatory, Community and Social Dimensions component? (Issue 18)
6. What were some of the challenges?

16. Are there areas of duplication between the Policy, Regulatory, Community and Social Dimensions activities and that of other organizations? (e.g. as other government departments or agencies or other)? (Issue 9)

1. If so, do you have any suggestions for addressing this/ these areas of duplication?

Ask of All Respondents

17. Can you suggest other ways to improve the effectiveness or efficiency of the CHVI program delivery? (Issue 24)