Table 3.
Adherence and use experiences
| PK results (active arm only) | Cohort 1 37–39 weeks gestation (N = 29) |
Cohort 2 34–36 weeks gestation (N= 31) |
Total (N = 60) |
|---|---|---|---|
| Drug detectable | 17 (59%) | 16 (52%) | 33 (55%) |
| Drug not detectable | 12 (41%) | 15 (48%) | 27 (45%) |
|
| |||
| Behavioral questionnaires | Cohort 1 37– 39 weeks gestation (N = 44)a |
Cohort 2 34 – 36 weeks gestation (N = 46) |
Total (N = 90)a |
|
| |||
| Number of days inserted gel at homeb | |||
| Never | – | 1 (2%) | 1 (1%) |
| 1–4 | 4 (9%) | 6 (13%) | 10 (11%) |
| 5 or morea | 40 (91%) | 39 (85%) | 79 (88%) |
| Most important reason for not inserting study gel at homec | |||
| Not applicable, I used the gel every day | 35 (80%) | 32 (71%) | 67 (75%) |
| Inserted at clinic | 5 (11%) | 5 (11%) | 10 (11%) |
| I forgot | 3 (7%) | 3 (7%) | 6 (7%) |
| I physically could not insert it | – | 1 (2%) | 1 (1%) |
| I didn’t like the feeling of the gel | – | – | – |
| I did not have the gel with me | 1 (2%) | 1 (2%) | 2 (2%) |
| My sexual partner did not want me to use it | – | – | – |
| I was scared it could be bad for me or my baby | – | – | – |
| Otherd | – | 3 (%) | 3 (%) |
| Used less than full amount at homec | |||
| Ever | 3 (7%) | 1 (2%) | 4 (4%) |
| Never | 41 (93%) | 44 (98%) | 85 (96%) |
| Self-perceived ability to use gel as instructed at homec | |||
| Very poor | – | – | – |
| Poor | – | 1 (2%) | 1 (1%) |
| Fair | – | 2 (4%) | 2 (2%) |
| Good | 6 (14%) | 6 (13%) | 12 (13%) |
| Very good | 8 (18%) | 13 (29%) | 21 (24%) |
| Excellent | 30 (68%) | 23 (51%) | 53 (60%) |
| Inserted the gel at approximately the same time every day | |||
| Yes | 38 (86%) | 40 (87%) | 78 (87%) |
| No | 6 (14%) | 6 (13%) | 12 (13%) |
|
| |||
| Median (mean, range) | |||
|
| |||
| How easy/difficult to insert the gel at the same time every day (from: 1 difficult, to 10, easy) | 9 (8.4, 1–10) | ||
a
One evaluable participant did not complete the CASI follow-up questionnaire
b
Includes 10 participants who inserted gel at clinic during the home-dosing period
c
Among 89 participants who used gel at home
d
1 participant described timing too close to previous dose, 1 was told by PI not to dose, 1 response unclear