Table 4.
Responses for the first and second online surveys, by HPTN participants and research stakeholders.
| HPTN participants | Research stakeholders | ||||
|---|---|---|---|---|---|
| First Survey, n (%) | HPTN 069, n=14 |
HPTN 073, n=2 |
HPTN 069, n=30 |
HPTN 073, n=7 |
Total, n=53* |
| ICFs are generally too long | |||||
| Strongly agree | -- | -- | 13 (43.3) | 3 (42.9) | 16 (43.2) |
| Agree | -- | -- | 16 (53.3) | 3 (42.9) | 19 (51.4) |
| Disagree | -- | -- | 1 (3.3) | 1 (14.3) | 2 (5.4) |
| Strongly disagree | -- | -- | 0 (0) | 0 (0) | 0 (0) |
| ICF reviewed for EDICT was too long | |||||
| Strongly agree | 2 (14.3) | 0 (0) | 12 (40.0) | 2 (28.6) | 16 (30.2) |
| Agree | 8 (57.1) | 0 (0) | 17 (56.7) | 3 (42.9) | 28 (52.8) |
| Disagree | 4 (28.4) | 1 (50.0) | 1 (3.3) | 2 (28.6) | 8 (15.1) |
| Strongly disagree | 0 (0) | 1 (50.0) | 0 (0) | 0 (0) | 1 (1.9) |
| As long as the essential information is retained, ICFs should be made shorter in length | |||||
| Strongly agree | 8 (57.1) | 0 (0) | 22 (73.3) | 4 (57.1) | 34 (64.2) |
| Agree | 5 (35.7) | 2 (100.0) | 8 (26.7) | 2 (28.6) | 17 (32.1) |
| Disagree | 1 (7.1) | 0 (0) | 0 (0) | 1 (14.3) | 2 (3.8) |
| Strongly disagree | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Strategy 1: Group study procedures by frequency instead of by study visit | |||||
| Strongly agree | 8 (57.1) | 0 (0) | 18 (60.0) | 5 (71.4) | 31 (58.5) |
| Agree | 5 (35.7) | 1 (50.0) | 6 (20.0) | 1 (14.3) | 13 (24.5) |
| Disagree | 1 (7.1) | 0 (0) | 6 (20.0) | 1 (14.3) | 8 (15.1) |
| Strongly disagree | 0 (0) | 1 (50.0) | 0 (0) | 0 (0) | 1 (1.9) |
| Anticipated challenges with grouping study procedures by frequency | |||||
| Yes | -- | -- | 13 (43.3) | 5 (71.4) | 18 (48.6) |
| No | -- | -- | 17 (56.7) | 2 (28.6) | 19 (51.4) |
| Strategy 2: Provide reference information about specific study procedures in appendix† | |||||
| Strongly agree | 9 (64.3) | 1 (50.0) | 10 (34.5) | 1 (16.7) | 21 (41.2) |
| Agree | 1 (7.1) | 1 (50.0) | 12 (41.4) | 3 (50.0) | 17 (33.3) |
| Disagree | 3 (21.4) | 0 (0) | 4 (13.8) | 1 (16.7) | 8 (15.7) |
| Strongly disagree | 1 (7.1) | 0 (0) | 3 (10.3) | 1 (16.7) | 5 (9.8) |
| Anticipated challenges with providing reference information about study procedures in appendix† | |||||
| Yes | -- | -- | 14 (48.3) | 3 (50.0) | 17 (48.6) |
| No | -- | -- | 15 (51.7) | 3 (50.0) | 18 (51.4) |
| Strategy 3: List duplicative side effects once rather than listing all side effects for each drug‡ | |||||
| Strongly agree | 7 (50.0) | -- | 15 (50.0) | -- | 22 (50.0) |
| Agree | 3 (21.4) | -- | 10 (33.3) | -- | 13 (29.5) |
| Disagree | 3 (21.4) | -- | 5 (16.7) | -- | 8 (18.2) |
| Strongly disagree | 1 (7.1) | -- | 0 (0) | -- | 1 (2.3) |
| Anticipated challenges with listing duplicative side effects once | |||||
| Yes | -- | -- | 24 (82.8)§ | -- | 24 (82.8) |
| No | -- | -- | 5 (17.2) | -- | 5 (17.2) |
| HPTN participants | Research stakeholders | ||||
| Second Survey, n (%) |
HPTN 069, n=13 |
HPTN 073, n=2 |
HPTN 069, n=22 |
HPTN 073, n=6 |
Total, n=43 |
| Strategy 1 | |||||
| Challenges to grouping study procedures by frequency can be overcome | |||||
| Strongly agree | 8 (61.5) | 0 (0) | 12 (54.5) | 1 (16.7) | 21 (48.8) |
| Agree | 3 (23.1) | 2 (100) | 10 (45.5) | 3 (50.0) | 18 (41.9) |
| Disagree | 1 (7.7) | 0 (0) | 0 (0) | 2 (33.3) | 3 (7.0) |
| Strongly disagree | 1 (7.7) | 0 (0) | 0 (0) | 0 (0) | 1 (2.3) |
| Grouping study procedures by frequency should be recommended for shortening ICFs | |||||
| Strongly agree | 9 (69.2) | 0 (0) | 20 (90.9) | 3 (50.0) | 32 (74.4) |
| Agree | 3 (23.1) | 0 (0) | 2 (9.1) | 2 (33.3) | 7 (16.3) |
| Disagree | 1 (7.7) | 2 (100) | 0 (0) | 1 (16.7) | 4 (9.3) |
| Strongly disagree | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Strategy 2 | |||||
| Comfort level with placing supplemental information in appendices | |||||
| Very comfortable | 8 (61.5) | 0 (0) | 14 (63.6) | 1 (16.7) | 23 (53.5) |
| Comfortable | 5 (38.5) | 1 (50) | 7 (31.8) | 3 (50.0) | 16 (37.2) |
| Uncomfortable | 0 (0) | 1 (50) | 1 (4.5) | 2 (33.3) | 4 (9.3) |
| Very uncomfortable | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Comfort level with not requiring potential participants to read appendix before signing ICF | |||||
| Very comfortable | 6 (46.2) | 0 (0) | 7 (31.8) | 1 (16.7) | 14 (32.6) |
| Comfortable | 3 (23.1) | 0 (0) | 9 (40.9) | 2 (33.3) | 14 (32.6) |
| Uncomfortable | 4 (30.8) | 2 (100) | 3 (13.6) | 3 (50.0) | 12 (27.9) |
| Very uncomfortable | 0 (0) | 0 (0) | 3 (13.6) | 0 (0) | 3 (7.0) |
|
Study procedures examples provide information necessary for informed decision making in ICF body and provide information not needed for informed decision making in appendix | |||||
| Strongly agree | 7 (53.8) | 1 (50) | 13 (59.0) | 1 (16.7) | 22 (51.2) |
| Agree | 5 (38.5) | 1 (50) | 8 (36.4) | 4 (66.7) | 18 (41.9) |
| Disagree | 1 (7.7) | 0 (0) | 1 (4.5) | 1 (16.7) | 3 (7.0) |
| Strongly disagree | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Strategy 3 | |||||
| Challenges to listing duplicative side effects once can be overcome | |||||
| Strongly agree | 5 38.5) | 0 (0) | 2 (9.1) | 1 (16.7) | 8 (18.6) |
| Agree | 8 (61.5) | 2 (100) | 20 (90.9) | 4 (66.7) | 34 (79.1) |
| Disagree | 0 (0) | 0 (0) | 0 (0) | 1 (16.7) | 1 (2.3) |
| Strongly disagree | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Listing duplicative side effects once should be recommended for shortening ICFs | |||||
| Strongly agree | 10 (76.9) | 1 (50) | 15 (68.2) | 2 (33.3) | 28 (65.1) |
| Agree | 2 (15.2) | 0 (0) | 7 (31.8) | 3 (50.0) | 12 (27.9) |
| Disagree | 0 (0) | 1 (50) | 0 (0) | 0 (0) | 1 (2.3) |
| Strongly disagree | 1 (7.7) | 0 (0) | 0 (0) | 1 (16.7) | 2 (4.7) |
*
Unless otherwise noted by clarifying missing data or identifying when respondents were not asked the question
†
Data missing from one HPTN 069 and one HPTN 073 research stakeholder
‡
HPTN 073 study participants and research stakeholders were not asked initially about this strategy because that study provided only one drug
§
Data missing from one stakeholder