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Table 1 Study procedures

From: Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial

Study visit month

S

0

3

6

9

12

Study coordination

 Obtain informed consent

X

     

 Screen for inclusion/exclusion

X

X

    

 Randomization

 

X

    

 Collect updated contact information

X

X

X

X

X

X

 Reimbursement

X

X

X

X

X

X

Questionnaires

 Demographic information

X

X

    

 Behavioral questionnaire

 

X

 

X

 

X

 HIV risk perception

 

X

X

X

X

X

 Social Harms and Intimate partner violence (IPV)

 

X

X

X

X

X

 Sexual behavior and exposure history

 

X

X

X

X

X

 PrEP adherence

 

X

X

X

X

X

 dPEP adherence (timeline follow-back calendar)

  

X a

X a

X a

X a

 Fertility intention

 

X

X

X

X

X

 Quality of Life

 

X

X

X

X

X

Clinical study care

 Medication review

X

X

X

X

X

X

 General symptom assessment

 

X

X

X

X

X

 WHO pregnancy checklist

X

X

X

X

X

X

 STI symptom assessment

X

X

X

X

X

X

 Supply condoms

X

X

X

X

X

X

 Contraception counseling and provision/referral

X

X

X

X

X

X

 Risk reduction counseling

X

X

X

X

X

X

 dPEP pill count and refill

  

Xa

X a

X a

X a

Sample collection

 HIV testing (rapid test)

X

 

X

X

X

X

 Urine pregnancy testing (rapid test)

X b

X

X b

X b

X b

X b

 Syphilis testing (serum rapid plasma reagin (RPR))

 

X

X

X

X

X

 Creatinine (serum)

 

Xb

Xb

Xb

Xb

Xb

 CT/NG testing and resistance (endocervical swabs) c

 

X

X

X

X

X

 Hair PrEP and doxycycline drug levels

 

X

X

X

X

X

 Trichomonas screening (vaginal swab)

 

X

X

X

X

X

  1. S screening visit
  2. aintervention arm only
  3. bif clinically indicated
  4. cParticipants diagnosed with an STI will return 2 weeks following treatment for test of cure