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