Background
Methods
Study setting and population
Study procedures
Diaphragm education and provision
Trial exit procedures
Post-trial visit
Study sample
Measures
Exposure measures
Covariates
Analyses
Ethical approval
Results
Study sample
Study sample | |||
---|---|---|---|
n = 801
|
%
| ||
Baseline
| |||
Randomization arm | Intervention | 381 | 47.6 |
Control | 420 | 52.4 | |
Age group | 18-24 | 261 | 32.6 |
25-34 | 379 | 47.3 | |
35+ | 161 | 20.1 | |
Education (binary) | < High school | 447 | 55.8 |
Married | Yes | 775 | 96.8 |
Cohabitating | Yes | 777 | 97.0 |
Lifetime partners (1 vs. > 1) | One lifetime partner | 628 | 78.4 |
Ever had vaginal sex using a male condom (screening) | Yes | 525 | 65.5 |
Ever had vaginal sex using a male condom (enrolment) | Yes | 728 | 91.0 |
Condom use in the past 3 months (enrolment) | Always | 215 | 26.8 |
Sometimes | 356 | 44.4 | |
Never | 230 | 28.7 | |
Male condom use at last sex (enrolment) | Yes | 569 | 71.0 |
Ever female condom use (enrolment) | Yes | 58 | 7.2 |
Female condom use at last sex (enrolment) | Yes | 27 | 3.4 |
Last sex act protected by a barrier method (enrolment) | Yes | 590 | 73.7 |
Ever used diaphragm | Yes | 1 | 0.1 |
Coital frequency per week at screening (≤3, > 3) | ≤3 | 423 | 52.8 |
Main contraceptive at screening (#) | Long term | 25 | 3.1 |
Injectable | 113 | 14.1 | |
Pill | 514 | 64.2 | |
Barrier method | 95 | 11.9 | |
Other/none | 54 | 6.7 | |
MIRA follow up and exit
| |||
Number of quarterly follow-up visits in MIRA | Mean; median (range) | 6.83; 8 (1-8) | |
Ever had a new regular partner during MIRA trial | Yes | 212 | 26.5 |
Kept/took diaphragm at exit visit (entire sample) | Yes | 579 | 72.3 |
Kept/took diaphragm in intervention arm (at exit visit) n = 381 | Yes | 369 | 96.9 |
Took diaphragm in control arm (at exit visit) n = 420 | Yes | 210 | 50.0 |
Main contraceptive at exit visit (#) | Long term | 26 | 3.3 |
Injectable | 139 | 17.4 | |
Pill | 457 | 57.1 | |
Barrier method | 108 | 13.5 | |
Other/none | 71 | 8.9 | |
Post-trial study visit
| |||
Months between last MIRA visit and post-trial visit | Mean; median (range) | 9.41; 9 (2-20) | |
Total n
|
n
| % | |
Male condom use at last sex | 801 | 497 | 62.1 |
Female condom use at last sex | 801 | 21 | 2.4 |
Diaphragm use at last sex (intervention arm) | 381 | 192 | 50.4 |
Diaphragm use at last sex (intervention arm)* | 369 | 190 | 51.5 |
Diaphragm use at last sex (control arm)* | 210 | 31 | 14.8 |
Diaphragm and male condom use at last sex (intervention arm) | 381 | 123 | 32.3 |
Diaphragm and male condom use at last sex (intervention arm)* | 369 | 122 | 33.1 |
Diaphragm and male condom use at last sex (control arm)* | 210 | 10 | 4.8 |
Protected last sex act | 801 | 597 | 74.5 |
Patterns of method(s) use at last sex
Male condoms
Diaphragm
Barrier method use (male condom, female condom and/or diaphragm) at last sex act
Multivariable analysis of individual-level changes in reported method use
Condom group
Change in condom use and use of any barrier method at last sex, among condom group participants (n = 420) | |||||||||
---|---|---|---|---|---|---|---|---|---|
Last MIRA Follow-up Visit
|
Last FU visit
|
Post-trial visit
|
AOR
|
Lower limit
|
Upper limit
|
p value
| |||
n
| % |
n
| % | ||||||
model 1 |
Condom use at last sex
| 363 | 86.43 | 283 | 67.38 | ||||
Visit type* | 0.20 | 0.12 | 0.33 | < 0.0001 | |||||
Time since trial exit | 0.95 | 0.88 | 1.03 | 0.228 | |||||
Number of MIRA visits | 1.01 | 0.84 | 1.22 | 0.8899 | |||||
model 2 |
Any barrier method
| 374 | 89.05 | 312 | 74.29 | ||||
Visit type* | 0.21 | 0.12 | 0.35 | < 0.0001 | |||||
Time since trial exit | 0.96 | 0.88 | 1.05 | 0.347 | |||||
Number of MIRA visits | 0.93 | 0.75 | 1.16 | 0.5293 |
MIRA Enrolment Visit
|
Enrolment visit
|
Post-trial visit
|
AOR
|
Lower limit
|
Upper limit
|
p value
| |||
---|---|---|---|---|---|---|---|---|---|
n
| % |
n
| % | ||||||
model 1 |
Condom use at last sex
| 310 | 73.81 | 283 | 67.38 | ||||
Visit type** | 0.66 | 0.46 | 0.93 | 0.0196 | |||||
Time since trial exit | 0.96 | 0.90 | 1.02 | 0.1824 | |||||
Number of MIRA visits | 1.07 | 0.91 | 1.25 | 0.4349 | |||||
model 2 |
Any barrier method
| 323 | 76.9 | 312 | 74.29 | ||||
Visit type** | 0.83 | 0.58 | 1.19 | 0.3178 | |||||
Time since trial exit | 0.96 | 0.90 | 1.02 | 0.2077 | |||||
Number of MIRA visits | 1.02 | 0.87 | 1.20 | 0.7732 |
Change in diaphragm, condom use and use of any barrier method at last sex, among diaphragm group participants (n = 381)
| |||||||||
---|---|---|---|---|---|---|---|---|---|
Last MIRA Follow-up Visit
|
Last FU visit
|
Post-trial visit
|
AOR
|
Lower limit
|
Upper limit
|
p value
| |||
n
| % |
n
| % | ||||||
model 1 |
Diaphragm at last sex
| 303 | 79.53 | 192 | 50.39 | ||||
Visit type* | 0.18 | 0.12 | 0.28 | < 0.0001 | |||||
Time since trial exit | 0.95 | 0.89 | 1.01 | 0.1058 | |||||
Number of MIRA visits | 1.28 | 1.09 | 1.49 | 0.0024 | |||||
model 2 |
Condom use at last sex
| 231 | 60.63 | 214 | 56.17 | ||||
Visit type* | 0.77 | 0.55 | 1.09 | 0.1425 | |||||
Time since trial exit | 1.03 | 0.96 | 1.10 | 0.4054 | |||||
Number of MIRA visits | 1.26 | 1.07 | 1.49 | 0.0062 | |||||
model 3 |
Any barrier method
| 357 | 93.7 | 285 | 74.8 | ||||
Visit type* | 0.15 | 0.08 | 0.27 | < 0.0001 | |||||
Time since trial exit | 0.93 | 0.86 | 1.00 | 0.0593 | |||||
Number of MIRA visits | 1.29 | 1.07 | 1.55 | 0.0072 |
MIRA Enrolment Visit
|
Enrolment visit
|
Post-trial visit
|
AOR
|
Lower limit
|
Upper limit
|
p value
| |||
---|---|---|---|---|---|---|---|---|---|
n
| % |
n
| % | ||||||
model 1 |
Condom use at last sex
| 259 | 67.98 | 214 | 56.17 | ||||
Visit type** | 0.55 | 0.39 | 0.76 | 0.0004 | |||||
Time since trial exit | 0.99 | 0.94 | 1.05 | 0.7865 | |||||
Number of MIRA visits | 1.18 | 1.03 | 1.36 | 0.0153 | |||||
model 2 |
Any barrier method
| 267 | 70.08 | 285 | 74.8 | ||||
Visit type** | 1.33 | 0.93 | 1.89 | 0.1134 | |||||
Time since trial exit | 0.96 | 0.90 | 1.02 | 0.1764 | |||||
Number of MIRA visits | 1.16 | 1.00 | 1.34 | 0.0553 |