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MONTH 24 STUDY RESULTS
Screening and Enrollment Flow Analysis Flow Reporting Tables Table 1. Expected and Actual Enrollment by month during the enrollment period Month,...
Screening and Enrollment Flow
Analysis Flow
Reporting Tables
Table 1. Expected and Actual Enrollment by month during the enrollment period
Month, Dates | Expected Enrollment, N (%) | Actual, N (%) |
Month 1, Feb 9 - 28 | 67 | 41 |
Month 2, March 1 – 27 | 67 | 51 |
Month 3, April 3 - 28 | 67 | 18 |
Month 4, May 10-31 | 67 | 51 |
Month 5, June 1-30 | 67 | 50 |
Month 6, July 1-31 | 67 | 52 |
Month 7, Aug 1-30 | - | 84 |
Month 8, Sept 1-30 | - | 60 |
Total | 402 | 407 |
Table 2. Completed Study Forms
Database Forms | Number Completed | ||||
Baseline | 6 Months | 12Months | 18Months | 24Months | |
Screening & Eligibility | 473 | X | X | X | X |
Locator Form1 | 407 | X | X | X | X |
Behavioral Survey | 407 | 332 | 332 | 331 | 343 |
Medical Exam Form | 407 | 332 | 332 | 331 | 343 |
Clinical Diagnosis & Treatment Form | 407 | 3 | 332 | 6 | 343 |
Lab Requisition & Results | 407 | 326 | 332 | 331 | 343 |
HIV C&T Form | 407 | 0 | 332 | 0 | 343 |
Withdrawal Form (prior to the stated visit) | 11 | 6 | 6* | 11 | |
Etiological Diagnosis and Treatment Form | 147 | 95 | 167 | 115 | 164 |
WASH Assessment | 47 | 0 | 0 | 0 | 49 |
Total | |||||
1 Contact information is confirmed and updated as needed at each study visit. *1 withdrew post 12M and prior to intervention.
Table 3. Expected and Actual Study Visits by Time Point
Database Forms | Expected | Actual |
Initial Screen | 503 | 473 |
Baseline Enrollment | 402 | 407 |
6 Month Follow-Up (August 2023) | 41 | 52 |
6 Month Follow –Up (September) | 51 | 41 |
6 Month Follow – Up (October) | 18 | 32 |
6 Month Follow - Up (November) | 51 | 25 |
6 Month Follow – Up (December) | 50 | 14 |
6 Month Follow – Up (January 2024) | 52 | 66 |
6 Month Follow – Up (February 2024) | 84 | 40 |
6 Month Follow – Up (March 2024) | 60 | 54 |
6 Month Follow – Up (April 2024) | 14 | 8 |
12 Month Follow Up (January 2024) | 13 | |
12 Month Follow UP (February 2024) | 52 | 51 |
12 Month Follow Up (March 2024) | 41 | 27 |
12 Month Follow Up (April 2024) | 32 | 36 |
12 Month Follow Up (May 2024) | 25 | 26 |
12 Month Follow Up (June 2024) | 14 | 21 |
12 Month Follow Up (July 2024) | 66 | 37 |
12 Month Follow Up (August 2024) | 40 | 56 |
12 Month Follow Up (September 2024) | 54 | 57 |
12 Month Follow Up (October 2024) | 8 | 4 |
12 Month Follow Up (November 2024) | 1 | |
Intervention | 306 | |
18 Month Follow Up (July) | 14 | 11 |
18 Month Follow Up (August) | 51 | 43 |
18 Month Follow up (September) | 27 | 44 |
18 Month Follow Up (October) | 36 | 9 |
18 Month Follow Up (November) | 26 | 40 |
18 Month Follow Up (December) | 21 | 13 |
18 Month Follow Up (January 2025) | 41 | 38 |
18 Month Follow Up (February 2025) | 67 | 55 |
18 Month Follow Up (March 2025) | 64 | 66 |
18 Month Follow Up (April 2025) | 16 | 12 |
18 Month Follow Up (May 2025) | 2 | 0 |
18 Month Follow Up (June 2025) | 1 | 0 |
24 Month Follow-Up | 322* | |
24 Month Follow Up (January 2025) | 12 | 24 |
24 Month Follow Up (February 2025) | 41 | 46 |
24 Month Follow Up (March 2025) | 3 | 45 |
24 Month Follow Up (April 2025) | 3 | 8 |
24 Month Follow Up (May 2025) | 5 | 44 |
24 Month Follow Up (June 2025) | 129 | 81 |
24 Month Follow Up (July 2025) | 85 | 76 |
24 Month Follow Up (August 2025) | 31 | 19 |
24 Month Follow Up (September 2025) | 26 | |
24 Month Follow Up (October 2025) | ||
24 Month Follow Up (November 2025) |
*Estimate 80% Completion at End line in sample size calculation
Table 4. Number of early withdrawals from the trial
Total Early Withdrawal | Withdrawn from Study N (%) | Withdrawn from Intervention but continuing in study |
Screen failure: After consent, ineligible (gave incorrect birthdate (n=1), disclosed amenorrhea (n=4), declined pelvic exam (n=2), died (n=1)) | 8 | |
After Baseline, before 6 months (no longer interested (n=2), relocated (n=8), incarcerated (n=1)) | 11 | |
After 6 Month Follow-Up, before 12 months (no longer interested (n=4), relocated (n=2)) | 6 | |
After 12 Month Follow-Up, before Intervention (co-enrolled in another study (n=1)) | 1 | |
Completed 12 Month Follow-Up, and withdrawn by investigators from Intervention1 | 22 | |
After Completion of Intervention and before 18 Month Follow-Up (co-enrolled in another study (n=1), inserted an IUD (n=2), no longer interested (n=1), relocated (n=1) | 5 | |
After 18 Month Follow-Up and before 24 Month Follow-Up -no longer interested (n=8), relocated (n=1), died (n=1), Had an Hysterectomy (n=1) | 11 |
1 Reasons withdrawn from intervention: Taking part in PrEP cervical ring study (n=2); currently pregnant (n=14); recently delivered (6)
Table 5. Number and Type of protocol deviations
Protocol Deviations | N |
Issues with enrollment: | 0 |
Outside of Age Range | 0 |
Other exclusion/inclusion criterion error | 0 |
Intervention Delayed > 4 weeks1 | 6 reported to IRB |
Other: | |
Extra specimens/tests taken | 0 |
Wrong appointment date2 Late for 12M visit due to traveling, n=3: 27 days late, 14 days late, 20 days late Late for 18M visit due to traveling, n=4: 4d late, 10d late, 2d late, 9d late Early for 12M visit, n=4: 5d early b/c traveling to TZ and would miss visit Early for M24 [GZ1] [GZ2] Visit n=1: 15 days early n=1, Late for M24 Visit n=2: Late for 2 days, n=1: Late for 12 days, n=1 | 13 reported to IRB |
Serious adverse event not reported within 48 hours | 0 |
ID assigned to two clients but corrected | 0 |
Appropriate form(s) not completed | 0 |
Appropriate specimens/tests not taken | 2 not reported |
Sample results delayed | 0 |
Impersonator took visit | 0 |
Wrong treatment given for BV | 85 – reported all to IRBs, NIH, and DSMB |
Total | 106 |
1 One participant received intervention 16 days late, 1 received 26 days late (could not get time off from work); one was 7 days late due to traveling for a funeral; one was 26 days late due to waiting for 6-moth post-partum period to complete; 1 was 2 days late due to a funeral; 1 was 1 day late due to phone got lost.
2 Six participants were prior to their 12 month visit date opening: 1 was to travel to Tanzania and would have missed her visit otherwise; 5 were seen early due to synchronization issue with tracker.
5 participants were seen late (2 M12, 3 M18); 4 due to travel, 1 due to lost phone. 1 Participant was seen early for M24, was travelling to West Pokot, 1 Participant was seen late due to being away from Kisumu.
The minor deviations are being batched for report to IRB.
Table 6. Baseline Characteristics
Baseline Characteristics | N (%) |
Age in years (median, IQR) | 27.3 (23.7-31.1) |
Ethnic Group: | |
Luo | 365 (89.7) |
Other | 42 (10.3) |
Education Level: | |
< Secondary school | 241 (59.2) |
Secondary school or more | 166 (40.8) |
Employment | |
Sex work only | 238 (58.5) |
Sex work + other | 169 (41.5) |
Has non-paying male partner (husband, boyfriend, etc.) | 283 (69.5) |
Table 7. Baseline Vaginal Microbiome, STI and HIV, and Signs and Symptoms of Infection
Baseline Physical Characteristics | N (%) |
Laboratory Results | |
Herpes Simplex Virus Type 2 seropositive (invalid, n=3; missing n=1) | 253 (62.8) |
Composite STI | 90 (22.1) |
Trichomonas vaginalis (missing, n=2) | 30 (7.4) |
Neisseria gonorrhoeae (missing, n=1) | 22 (5.4) |
Chlamydia trachomatis (missing, n=1) | 53 (13.0) |
Bacterial vaginosis (missing, n=2) | 171 (42.0) |
HIV (missing, n=1) | 100 (24.6) |
Community State Type (CST) (missing, n=1) CST-I (L. crispatus dominated) CST-II (L. gasseri dominated) CST-III (L. iners dominated) CST-IV (G. vaginalis dominated; mixed) CST-V (L. jensenii dominated) | 31 (7.6) 1 (0.2) 118 (29.1) 255 (62.8) 1 (0.2) |
Physical Exam Results | |
Vaginal or cervical discharge | 55 (13.5) |
Genital ulcers or vesicles | 3 (0.9) |
Cervical motion tenderness or friability | 3 (0.9) |
Adnexal tenderness or mass | 3 (0.9) |
Cervical abnormalities: laceration, excoriation, edema, erosion, abrasion, ecchymosis, tear, fissure | 1 (0.3) |
Table 8. Baseline Confounders
Baseline Confounders | N (%) |
HSV-2 Serostatus | 253 (62.8) |
HIV Status | 100 (24.6) |
Employment Sex work only Sex work plus other work (less economically dependent) | 238 (58.5) 169 (41.5) |
Baseline method of menstrual management Disposable pads Reusable Pads Cloth Cotton Wool/Balls Tissues Tampons | 378 (92.9) 21 (5.2) 32 (7.9) 139 (34.2) 56 (13.8) 9 (2.2) |
Sex work during menses Stays same Reduces Increases | 173 (42.5) 232 (57.0) 2 (0.5) |
Table 9. Adverse events
Measure | N (%) | |||||||
BL N=407 | 6M N=332 | 12M N=332 | 13M1,2, 3 N=284 | 14M1,2, 3 N=274 | 15M1,2, 3 N=284 | 18M N=331 | 24M N=343 | |
Abuse and Violence | ||||||||
Any Physical abuse (composite of 6 questions) | 59 (14.5) | 20 (6.1) | 44 (13.6) | NA | NA | NA | 36 (10.9) | 33 (9.6) |
Any Sexual abuse (composite of 4 questions) | 23 (5.6) | 6 (1.8) | 11 (3.3) | NA | NA | NA | 10 (3.0) | 14 (4.1) |
Raped or forced sex | 4 (1.0) | 0 (0.0) | 0 (0.0) | NA | NA | NA | 0 (0.0) | 2 (0.6) |
Any Emotional or financial abuse (composite of 2 qs) | 190 (46.6) | 78 (23.6) | 143 (43.1) | NA | NA | NA | 103 (31.1) | 111 (32.4) |
Cervicovaginal injuries4 | ||||||||
Vaginal laceration | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
Cervical laceration | 1 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
Menstrual toxic shock syndrome | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
Client was angry you were having your menses | 52 (12.8) | 24 (7.2) | 29 (8.7) | 1 (0.3) | 0 (0.0) | |||
Client reaction to menses | ||||||||
Refused to pay, paid | 25 (6.1) | 10 (3.0) | 10 (3.0) | 0 (0.0) | 0 (0.0) | |||
Verbal assault | 23 (5.6) | 10 (3.0) | 10 (3.0) | 1 (0.3) | 0 (0.0) | |||
Physical assault | 2 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
Cup related | ||||||||
Had menses since | 236 (83.1) | 264 (96.4) | 281 (98.9) | |||||
Received cup | 279 (84.3) | 285 (83.1) | ||||||
Still have cup | 270 (96.8) | 264 (92.6) | ||||||
Used cup | 222 (94.1) | 258 (97.7) | 274 (97.5) | 259 (92.8) | 272 (95.4) | |||
Cup retention | NA | NA | NA | 6 (2.7) | 1 (0.5) | 0 (0.0) | 0 (0.0) | 1 (0.4) |
Pain during / after cup use | NA | NA | NA | 16 (7.2) | 3 (1.5) | 2 (0.9) | 1 (0.4) | 0 (0.0) |
Partner violence due to cup use (refused to pay, paid less than agreed, verbal assault, physical assault) | NA | NA | NA | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
1Full IPV and abuse scales are not implemented at the 13-, 14-, and 15- month phone calls post intervention.
2Participants reporting pain with menstrual cup use are asked to return for retraining and examination if needed.
3Denominators for cup-related concerns are restricted to those who report having used their cup in that time period.
4Genital examination with bimanual and speculum exam is planned at baseline, 12-, and 24- month visits, and is conducted at 6- and 18- month visits for participants reporting vaginal symptoms, or requesting examination.
Table 10. Outcomes (every 6 months)
Outcome | N (%) |
Primary: BV cumulative prevalence* Control period Baseline prevalence 6 months prevalence Proportion with prior BV 12 months prevalence Proportion with prior BV (BL or 6M) Intervention period 18 months prevalence Proportion with prior BV (BL, 6M, or 12M) 24 months prevalence Proportion with prior BV (BL, 6M, 12M, 18M) | 171 (42.0) 144 (42.9) 71 (49.7) 145 (43.7) 108 (74.5) 135 (40.8) 115 (85.2) 153 (44.5) 122 (80.3) |
Secondary: STI Composite cumulative incidence* Control period Baseline prevalence Prevalence at 12 months Incidence at 12 months Intervention period Prevalence at 24 months Incidence at 24 months | 90 (22.1) 78 (23.4) 71 (21.3) 68 (19.9) 61 (17.9) |
Trichomonas vaginalis Control period Baseline prevalence Prevalence at 12 months Incidence at 12 months Intervention period Prevalence at 24 months Incidence at 24 months | 30 (7.4) 25 (7.5) 25 (7.5) 24 (7.0) 19 (5.6) |
Neisseria gonorrhoeae Control period Baseline prevalence Prevalence at 12 months Incidence at 12 months Intervention period Prevalence at 24 months Incidence at 24 months | 22 (5.4) 17 (5.1) 15 (4.5) 17 (5.0) 14 (4.1) |
Chlamydia trachomatis Control period Baseline prevalence Prevalence at 12 months Incidence at 12 months Intervention period Prevalence at 24 months Incidence at 24 months | 53 (12.8) 45 (13.6) 40 (12.0) 37 (10.9) 35 (10.3) |
Secondary: CST-I (vs. non-optimal vaginal microbiome) Control period Baseline 6 Months 12 Months Intervention period 18 Months 24 Months | 31 (7.6) 16 (4.8) |
Mean Relative abundance (SD) L. crispatus Control period Baseline 6 Months 12 Months Intervention period 18 Months 24 Months | 7.2 (23.7) 4.8 (18.7) |
*Infections following previously treated infections are included; for infections in which prior treatment is not documented, they are not included as incident infection.
Table 11. Other Outcomes (monthly)
Unsafe menstrual management practices | N (%) | |||||
BL | 6M | 12M | 18M | 24M |
| |
The last time you had sex: did you insert objects inside vagina for sex during menses (e.g., Kusunda, cotton wool, tissue, sponge, mattress stuffing, foam) [q65_b1] | 23 (5.6) | 14 (4.3) | 17 (5.1) | 2 (0.6) | 1 (0.3) |
|
In the past 6 months: Used drying or tightening agents inside vagina for sex during menses (e.g., vinegar, soap, ice, etc.) Never Sometimes Often Always Declined | 261 (64.0) 51 (12.5) 12 (2.9) 71 (18.6) 8 (2.0) | 275 (82.6) 25 (7.5) 18 (5.4) 15 (4.5) 0 (0.0) | 292 (88.0) 17 (5.1) 8 (2.4) 15 (4.5) 0 (0.0) | 322 (97.3) 4 (1.2) 3 (0.9) 2 (0.6) 0 (0.0) | 339 (98.8) 4 (1.2) 0 (0.0) 0 (0.0) 0 (0.0) |
|
How often do you use a cloth, tissue, paper, or cotton to wipe inside your vagina? [q82] Never Sometimes Often Always Declined | 29 (7.1) 10 (2.5) 55 (13.5) 313 (76.9) 0 (0.0) | 131 (39.5) 21 (6.3) 42 (12.7) 138 (41.6) 0 (0.0) | 28 (8.4) 21 (6.3) 57 (17.2) 226 (68.1) 0 (0.0) | 162 (48.9) 13 (3.9) 41 (12.4) 115 (34.7) 0 (0.0) | 163 (47.5) 31 (9.0) 38 (11.1) 111 (32.4) 0 (0.0) |
|
Table 12. Post-Trial Cup Distribution
N (%) | |
Did not receive cup at M12 and completed M24 visit Contacted Not Eligible to receive cup (pregnant, recently delivered, IUD) Eligible to receive cup Scheduled to come for post-trial cup intervention Attended Did not attend Received cup previously but it was lost or stolen/taken and is being replaced Scheduled to come for post-trial cup distribution Attended Did not attend | 82 0 82 82 60 22 22 22 18 4 |
For participants receiving cup for first time after the M24 visit 1-Month phone survey Completed Not completed | |
For those without prior cup | |
Used cup | |
Cup retention | |
Pain during / after cup use | |
Partner violence due to cup use (refused to pay, paid less than agreed, verbal |
