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

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

221

Medical Exam Form

407

332

332

331

221

Clinical Diagnosis & Treatment Form

407

3

332

6

221

Lab Requisition & Results

407

326

332

331

221

HIV C&T Form

407

0

332

0

221

Withdrawal Form (prior to the stated visit)

11

6

6*

6

Etiological Diagnosis and Treatment Form

147

95

167

115

90

WASH Assessment

47

0

0

0

49

Total

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Withdrawn from Study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Withdrawn from Intervention but continuing in study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Completed 12 Month Follow-Up, and withdrawn by investigators from Intervention¹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 (enrolled in a conflicting study DoxyDot[GZ1]  (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=4), relocated (n=1), died (n=1)

6

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     
    otherwise; 2 due to tracking sheet not synchronizing (10 days, 3 days).

Early for M24 Visit n=1: 15 days early,

Late for M24 Visit n=1: Late for 2 days

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

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)

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)

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)

Measure

N (%)

BL

N=407

6M

N=332

12M

N=332

13M^{1,2, 3}

N=284

14M^{1,2, 3}

N=274

15M^{1,2, 3}

N=284

18M

N=331

24M

N=221

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)

28

(12.7)

  Any Sexual abuse

  (composite of 4 questions)

23 (5.6)

6

(1.8)

11

(3.3)

NA

NA

NA

10

(3.0)

12

   (5.4)

  Raped or forced sex

4 (1.0)

0 (0.0)

0 (0.0)

NA

NA

NA

0 (0.0)

2 (0.9)

  Any Emotional or financial

  abuse (composite of 2 qs)

190 (46.6)

78

(23.6)

143

(43.1)

NA

NA

NA

103

(31.1)

97

(43.9)

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  
  less than agreed

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 
   receiving cup

236

(83.1)

264 (96.4)

281 (98.9)

   Received cup

279 (84.3)

194

(87.8)

   Still have cup

270

(96.8)

183

(94.3)

   Used cup

222

(94.1)

258

(97.7)

274

(97.5)

259

(92.8)

183

(94.3)

   Cup retention

NA

NA

NA

6 (2.7)

1 (0.5)

0 (0.0)

0 (0.0)

1 (0.6)

   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)

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)

80 (45.7)

61 (76.3)

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)

31 (17.8)

30 (17.2)

   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)

10 (5.7)

10 (5.7)

   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)

10 (5.7)

10 (5.7)

   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)

14 (8.1)

14 (8.1)

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)

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 (0.5)

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)

219 (99.1)

2 (0.9)

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)

61 (27.6)

22 (10.0)

36 (16.3)

102 (46.2)

0 (0.0)