MTN 003 MONTHS 1 & 2 VISIT PRESENTATION ZIMBABWE TEAM JULIET MOYO RESEARCH NURSE MARTHA MASAWI COUNSELLOR
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1 MTN 003 MONTHS 1 & 2 VISIT PRESENTATION ZIMBABWE TEAM JULIET MOYO RESEARCH NURSE MARTHA MASAWI COUNSELLOR
2 CLINIC CLERK Greet participant. Create rapport Confirm PTID with Screening and Enrollment Log vs Participant s appointment card Check co enrollment N.B If participant is not co enrolled proceed If co enrolled inform clinic manager medical officer IoR, immediately withhold study product use and seek assistance from the Protocol Safety Review Team (PSRT)
3 PHARMACY Greet participant Unused product supplies returned Check PTID and study product label
4 COUNSELLOR Verify participant s binder & review previous documentation Greet participant & assure confidentiality Review elements of the IC Explain the content and sequence of procedures for the day Review/ update locator information
5 RESEARCH NURSE Welcome and greetings Explain to participant procedures to be done Urine collection Questionnaire Physical exam Blood draw Collect urine for pregnancy test and urinalysis
6 Continued RESEARCH NURSE Dipstick urinalysis for protein and glucose Month 1 (Month 2 if clinically indicated). Dipstick urinalysis for nitrites and leukocyte esterase if clinically indicated. Negative pregnancy result proceed Positive pregnancy result inform clinic manager Complete a pregnancy Report and History Form Inform participant that she must stop product use and arrange to collect product supplies
7 Continued Research Nurse Collect interval medical and menstrual history Administer monthly Product Adherence and Behavior Assessment form Document accordingly
8 COUNSELLOR Pretest HIV counselling Aim is to prepare participant for any HIV test result. Reassure confidentiality Discuss basic facts about HIV and AIDS HIV/STI risk reduction Inform participant that results will be ready in about minutes
9 RESEARCH NURSE Blood draw Month 1 1 x 5ml lavender top (ETDA) for HIV testing 1 x 5 ml red top tube for LFTs and RFTs Month 2 1 x 5 ml lavender top (ETDA) Transcribe HIV Test results N.B Verify results first before collection from lab
10 RESEARCH NURSE Perform and document physical exam and weight measurement Month 1 (Month 2 if clinically indicated) If clinically indicated, perform and document pelvic exam per follow up pelvic exam checklist Provide and explain all available findings and results
11 Continued Research nurse Contraceptive counselling and provide contraception per site SOP Provide treatment for STI for participant and partner if applicable Administer Hepatitis B vaccine if clinically indicated Complete AE log if required based on medical history, clinical examination and any results from the lab
12 Continued Research Nurse Assess eligibility to continue product use If eligible, provide product request slip, offer adherence counselling If ineligible, complete study product request slip marked Hold or Permanently Discontinued. Check if unused product has been returned to pharmacy Remind participant to bring all unused study product supplies and any medication she is currently taking
13 COUNSELLOR Post Test& Adherence Counselling Check if results are in the binder Call the participant and assure confidentiality Assess readiness to receive the HIV test results Inform participant and show her the result. If both tests are negative proceed. Discuss the meaning of result including the window period. Discuss risk reduction and partner testing issues, condom use. Offer study product adherence counselling
14 COUNSELLOR Continued Find out if she is using the study product correctly and consistently If there are any challenges on adherence, discuss how she can overcome them. Emphasise the importance of adhering to study product whilst in the study Inform participant to come back to the clinic if she has any symptoms and for more supplies Remind her to bring all unused product on next visit
15 COUNSELLOR Continued Positive Result Discuss meaning of results and implications to self, partner and family. Explore her feelings and address them accordingly. Inform participant that a WB test will be done on the same sample for confirmatory purposes. Inform her that she will stop product use and that she continues in the study.
16 COUNSELLOR Continued Discuss positive living issues Diet Risk reduction Health issues, psychological and physical Inform her that she is welcome for further counselling when needed. Offer condoms Inform clinic manager about the seroconversion
17 PHARMACY Product supply Adherence counselling based on product count Clinic manager informed if there are any challenging issues on adherence e.g. product sharing or selling before participant leaves the clinic
18 CLINIC CLERK Schedule next visit Complete registration Log Reimburse participant
19 Thank You! Bayadhanki! Zikomo! Siyabonga! Mwebale nnyo! Tatenda!
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