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Table 2 Study and clinic visits by intervention and standard of care arms in Step 2 of RCT in SCOPE-PP study, Cape Town, South Africa

From: Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial

If PrEP discontinued, missed visit, or poor persistence (no TFV in urine) offer new randomization (RCT 2) with chance of differentiated PrEP delivery

 

Counseling group

Community delivery group

Steps

Baseline study visit

In clinic:

PrEP refill and counseling with urine testing and feedback

At community pick up pointsa:

PrEP refill + HIV self testing for monitoring HIV status

In study site (behind clinic):

• Consent to new randomization

• Survey

• Reimbursement

3 month Service visit

In clinic:

PrEP refill and counseling with urine testing and feedback

At community pick up pointsa:

PrEP refill + HIV self testing for monitoring HIV status

Standard monitoring

• No reimbursement for time

6 month Service visit

In clinic:

PrEP refill and counseling with urine testing and feedback

In communitya:

PrEP refill + HIV self testing for monitoring HIV status

Standard monitoring

No reimbursement for time

9 month Study visit

In clinic:

PrEP refill and counseling with urine testing and feedback

In communitya:

PrEP refill + HIV self testing for monitoring HIV status

Referral to continue on PrEP at local clinic

In study site:

• Blood collection

• Survey

• Reimbursement for time

End of study and referral for ongoing PrEP care in clinic

  1. aStudy will offer community pick up in local church or hall, depending on participant preference
  2. PrEP pre-exposure prophylaxis, HIVST HIV self-testing, TFV tenofovir diphosphate