Partner Study Drug Interruption Screening ID: Participant ID: Visit Date: Site Study Screening Number Site Study Couple I/P Chk dd mm yy Date study medication discontinued: 1 dd mm yy 2 Reason for interrupting or discontinuing study medication: Mark all that apply. 3 PrEP Stop: Index partner has been on ARVs for over six Yes No If yes Complete PrEP Stop months Questionnaire 4 Participant is a possible HIV seroconverter Yes No toxicity 5 Yes No 6 Serious AE, and / or AE felt related to PrEP Complete Reportable Adverse Event 7 Adverse Event (other than renal toxicity or RAE), describe: Participant refused study medication 8 (Specify reason in Comments.) a Participant has had a positive pregnancy test Yes No Complete Pregnancy Report (women only) b Participant is breastfeeding (women only) Yes No c Investigator decision, specify: Other reasons, specify: Item 8 may be completed at a time than items 1 & 2. Fax this form again when study medication is re-established, when study medication is permanently discontinued, or when participant completes study follow-up without re-establishing study medication. 9 Date study medication re-established: dd mm yy medication not re-established at end of study participation. study medication permanently discontinued Comments : Completed by: (initials/date) _________________________________________ Forms Instruction
Partner Study Drug Interruption Screening ID: Site Study Screening Number Participant ID: Site Study Couple I/P Chk Visit Date: dd mm yy 1 Date study medication discontinued: dd mm yy 2 Reason for interrupting or discontinuing study medication: Mark all that apply. 3 PrEP Stop: Index partner has been on ARVs for over six months Yes No If yes Complete PrEP Stop Questionnaire 4 Participant is a possible HIV seroconverter Yes No 5 toxicity Yes No 6 Serious AE, and / or AE felt related to PrEP Complete Reportable Adverse Event 7 Adverse Event (other than renal toxicity or RAE), describe: 8 Participant refused study medication (Specify reason in Comments.) a Participant has had a positive pregnancy test (women only) Yes No Complete Pregnancy Report b Participant is breastfeeding (women only) Yes No c Investigator decision, specify: Other reasons, specify: Item 8 may be completed at a time than items 1 & 2. Fax this form again when study medication is re-established, when study medication is permanently discontinued, or when participant completes study follow-up without re-establishing study medication. 9 Date study medication re-established: dd mm yy medication not re-established at end of study participation. study medication permanently discontinued Comments : Completed by: (initials/date) _________________________________________ Forms Instruction
CRF2_Study_Drug_Interruption.docx