Table 1.
Participant baseline and final visit characteristics
Total (n=7829) |
DMPA-IM (n=2609) |
Copper IUD (n=2607) |
LNG implant (n=2613) |
|
Baseline | n (%) | n (%) | n (%) | n (%) |
Age | ||||
16–24 years old | 4967 (63) | 1673 (64) | 1627 (62) | 1667 (64) |
25–35 years old | 2862 (37) | 936 (36) | 980 (38) | 946 (36) |
Highest education level | ||||
No schooling | 49 (<1) | 16 (<1) | 12 (1) | 21 (1) |
Primary school (not complete) | 400 (5) | 118 (5) | 139 (5) | 143 (6) |
Primary school (complete) | 323 (4) | 98 (4) | 108 (4) | 117 (5) |
Secondary school (not complete) | 2866 (37) | 975 (37) | 956 (37) | 935 (36) |
Secondary school (complete) | 2949 (38) | 992 (38) | 974 (37) | 983 (38) |
Attended postsecondary school | 1242 (16) | 410 (16) | 418 (16) | 414 (16) |
Earns own income | 1697 (22) | 565 (22) | 565 (22) | 567 (22) |
Study area | ||||
Eswatini | 502 (6) | 167 (6) | 167 (6) | 168 (6) |
Kenya | 901 (12) | 299 (12) | 301 (12) | 301 (12) |
South Africa (Province) | ||||
Eastern Cape | 614 (8) | 205 (8) | 205 (8) | 204 (8) |
Gauteng | 2062 (26) | 686 (26) | 687 (26) | 689 (26) |
KwaZulu-Natal | 2125 (27) | 711 (27) | 707 (27) | 707 (27) |
North West | 407 (5) | 136 (5) | 134 (5) | 137 (5) |
Western Cape | 560 (7) | 187 (7) | 186 (7) | 187 (7) |
Zambia | 658 (8) | 218 (8) | 220 (8) | 220 (8) |
Sexual and reproductive history | ||||
Nulligravid | 1462 (19) | 509 (20) | 486 (19) | 467 (18) |
No prior contraceptive use | 586 (8) | 206 (8) | 184 (7) | 196 (8) |
Baseline STI prevalence | ||||
Chlamydia trachomatis* | 1420 (18) | 454 (17) | 486 (19) | 480 (18) |
Neisseria gonorrhoeae* | 368 (5) | 117 (5) | 124 (5) | 127 (5) |
HSV-2† | 3789 (48) | 1271 (49) | 1282 (49) | 1236 (47) |
Final visit | n (%) | n (%) | n (%) | n (%) |
Mean number months follow-up (SD) | 16 (5.0) | 15 (5.6) | 16 (4.7) | 16 (4.7) |
Randomised method non-adherence‡ | 1468 (19) | 675 (26) | 477 (18) | 316 (12) |
Method discontinuation (N)§ | 1364 | 674 | 384 | 306 |
Timing of first method discontinuation§ | ||||
Enrolment—6 months | 446 (5.7) | 164 (6.3) | 176 (6.8) | 106 (4.1) |
7–12 months | 644 (8.2) | 383 (14.7) | 130 (5.0) | 131 (5.0) |
13–18 months¶ | 274 (3.5) | 127 (4.9) | 78 (3.0) | 69 (2.6) |
*Twelve participants did not have available baseline C. trachomatis or N. gonorrhoeae results.
†An HSV-2 enzyme immunoassay index value of less than 0.90 was classified as negative, 0.90–3.50 as indeterminate and more than 3.50 as positive.
‡Includes women who did not receive randomised method at baseline visit or who discontinued randomised method during follow-up. Method discontinuation was defined as either use of a secondary hormonal method or, in the DMPA-IM group, more than 119 days between injections; in the Cu-IUD group, a spontaneous, complete expulsion without reinsertion within 28 days or IUD removal without reinsertion on the same calendar day or in the LNG implant group, implant removal without reinsertion on the same calendar day.
§A subset of randomised method non-adherence, as defined above.
¶Timing of method discontinuation could have occurred during the 18th month of follow-up but prior to study discontinuation at the scheduled 18th month visit.
DMPA-IM, intramuscular depot medroxyprogesterone acetate; HSV-2, herpes simplex virus type 2; IUD, intrauterine device; LNG, levonorgestrel.