Sitakhela Likusasa Impact Evaluation Evaluating the Effectiveness of Incentives to improve HIV Prevention Outcomes for Young Females in Eswatini Standard Operating Procedure - # 2 Biomedical testing (Raffle, Baseline, Midline and Endline HIV and STI counseling, testing, treatment and referral for the Sitakhela Likusasa Impact Evaluation) Document 2 in a series of 20 Standard Operating Procedures Version date 10 May 2019 Status Final © International Bank for Reconstruction and Development / The World Bank 1818 H Street NW, Washington DC 20433 Internet: www.worldbank.org; Telephone: 202 473 1000 This work is a product of the staff of The World Bank with external contributions. The findings, interpretations, and conclusions expressed in this work do not necessarily reflect the views of the Executive Directors of The World Bank or other partner institutions or the governments they represent. The World Bank does not guarantee the accuracy of the data included in this work. 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Page ii Standard Operating Procedure - # 2 Biomedical testing (Raffle, Baseline, Midline and Endline HIV and STI counseling, testing, treatment and referral for the Sitakhela Likusasa Impact Evaluation) NERCHA – National Emergency Research Council on HIV and AIDS authors: Khanyakwezwe Mabuza and Tengetile Dlamini World Bank authors: Marelize Görgens, Damien de Walque, Andrew Longosz and Sosthenes Ketende IHM Southern Africa authors: Vimbai Tsododo, Mthokozisi Dlamini, Tendai Chipepera and Nontobeko Fakudze Independent authors: Futhi Dennis MINISTRY OF EDUCATION AND MINISTRY OF HEALTH TRAINING National Reference Laboratory, and Swaziland National AIDS Programme (SNAP) KINGDOM OF ESWATINI KINGDOM OF ESWATINI Main study implementation partner SGBV counselling and follow up For baseline survey For baseline survey Page iii Table of Contents 1 Introduction.......................................................................................................................................... 5 2 Overview of HIV and STI counseling, testing, selective confirmatory testing, treatment and referral.................................................................................................................................................. 5 2.1 Eswatini HIV Testing Guidelines ................................................................................................. 5 2.2 HIV and STI testing process at endline ......................................................................................... 6 2.2.1 Step 5: Conduct pre-test counselling.................................................................................... 7 2.2.2 Step 6. Undertake STI and HIV testing............................................................................... 11 2.2.3 Step 7. Undertake Post-test counseling .............................................................................. 28 2.3 STI process for raffle rounds ...................................................................................................... 30 2.3.1 Step 1. Conduct pre- STI counselling ................................................................................. 32 2.3.2 Step 2. Provide container and explain vaginal swab and self collection of urine sample..... 33 2.3.3 Step 3. Execute vaginal swab and self collection of urine sample ....................................... 33 2.3.4 Step 4. Explain vaginal swab collection and execute .......................................................... 33 2.3.5 Step 5. Administer OSOM Trichomonas Rapid Test ........................................................... 34 2.3.6 Step 7: Administer Syphilis Rapid Test............................................................................... 37 2.3.7 Step 8. Conduct STI post-test counselling .......................................................................... 40 2.3.8 Step 9: Record information in Survey Solutions form ......................................................... 40 List of Youth Friendly ART Centres ......................................................................................................... 41 List of teen clubs for ARV support for adolescents .................................................................................. 41 Page 4 1 Introduction The goal of this standard operating procedure (SOP) is to: a) provide guidance on baseline HIV and STI counseling, rapid testing, confirmatory testing, treatment, and referrals b) provide guidance on midline and endline HIV and STI counseling, rapid testing, confirmatory testing, treatment, and referrals c) Provide guidance on STI counselling, rapid testing, confirmatory testing, treatment, and referrals for Raffle Rounds. d) Ensure that all participants who test positive to HIV are linked to HIV prevention, care, and support services. 2 Overview of HIV and STI counseling, testing, selective confirmatory testing, treatment and referral 2.1 Eswatini HIV Testing Guidelines HIV, syphilis and trichomonas vaginalis testing will all be done at baseline, midline and endline. In addition, syphilis and trichomonas vaginalis testing will be done at each raffle round where 400 randomly selected AGYW will be invited to identified health facilities or mobile sites. This SOP provides step-by-step guidance as to how counselling, testing, treatment and referrals for HIV, syphilis and trichomonas vaginalis should be conducted. HIV testing algorithm: In the Sitakhela Likusasa impact evaluation, the evaluation team at baseline, midline and endline will conduct the Alere Determine HIV 1/2 Rapid Test, and the Uni-Gold rapid test for confirmation, as per national Eswatini HIV testing guidelines illustrated below: Figure 1: Eswatini HIV Testing Guidelines Page 5 Participants who test positive (are reactive) to these tests will be referred to care and treatment, and will be linked to the PLHIV teen clubs for HIV positive adolescents and young women. For quality assurance purposes, whole blood will be drawn from every 10th participant so as to perform HIV confirmatory testing in line with Eswatini’s national HIV testing protocol. Syphilis testing algorithm: In the Sitakhela Likusasa impact evaluation, the evaluation team at baseline, during the raffle, at midline and at end line will conduct the Syphilis Test. Individuals who test positive (are reactive) will be declared positive, will not receive additional confirmatory testing, and will be given treatment (as per national Eswatini STI syndromic guidelines). Trichomonas vaginalis testing algorithm: In the Sitakhela Likusasa impact evaluation, the evalustion team will only conduct testing using the OSOM® Trichomonas Rapid Test. Individuals who test positive (are reactive) will be declared positive, will receive additional confirmatory testing, and will be given treatment (as per national Eswatini STI syndromic guidelines). For quality assurance purposes, every 10th participant will be tested with a confirmatory test, using the TV Xpert Assay, on the GenExpert platform, using urine samples. The NRL will be responsible for carrying out the quality assurance test. 2.2 HIV and STI testing process at endline The diagram below illustrates the process overview for endline data collection. The steps articulated in this section are the biomedical steps, step 5, 6 and 7 in the flow chart below. Page 6 Figure 2: Endline Process Overview 2.2.1 Step 5: Conduct pre-test counselling The flowchart below illustrates step 5 of the endline process Page 7 Figure 3: HIV & STI Counselling 2.2.1.1 Step 5.1 Conduct HIV and Pre STI test counselling Ensure that the “5 Cs” are respected throughout the process of counseling and testing: 1. Informed consent  PIHTS: An opt-out approach is used where HTS is offered by a HCW and consent is assumed unless the client explicitly declines the HIV test.  CIHTS: Clients request HTS and verbal consent is obtained to conduct the HIV test. 2. Confidentiality  Testing results and any discussions between the HTS provider and the client should not be disclosed to anyone without the expressed consent of the person being tested.  Shared confidentiality among HCWs to promote linkages and further client management should be explained to the client. 3. Counseling  Accompany testing with appropriate, brief and high-quality pre-test information and post-test counselling.  Messages should be tailored to the client’s needs and focused on encouraging notification/disclosure of HIV status to sexual partners and family members or trusted others, where beneficial.  Post-test counselling should also include messages designed to facilitate linkages to prevention and treatment services following HIV testing. 4. Correct test results  Perform testing according to the relevant national testing algorithm including confirmation of all reactive self-test results.  Adhere to national quality assurance standards to ensure correct and accurate results are given to the client. 5. Connection/linkage to prevention, care and treatment Page 8  Increased efforts to refer and link all clients to appropriate HIV prevention, treatment, and other support services, according to their result. Personnel: HIV Testing Services (HTS) Counselor (this counselor can also do counseling for STIs) Location: Isolated participant counselling rooms or in a quite secluded and private space (in a more informal setting) When: Before the commencement of the HIV, syphilis and the trichomonas vaginalis test Pre-test information Pre-test information giving and/or counselling shall be offered to all participants in the impact evaluation. This should be done in the form of individual information giving sessions. Pre-test information should include:  Informed Consent  Obtain informed verbal consent according to guiding Principles of Counseling.  The benefits of STI testing (highlighting the positive benefits).  The meaning of an STI-positive and an STI-negative diagnosis:  The services available case of either a positive/negative syphilis test or a positive/negative trichomonas vaginalis test.  A brief description of HIV and STI prevention options and encouragement of partner testing.  The fact that the test result and any information shared by the client is confidential.  Assurance or recommendation regarding disclosure of STI test results  An offer to answer any question the participant /client may have HIV and STI pre-test counseling session with HTS counsellor Sit down and talk with the participant and discuss the health topics that related to HIV and STI testing. The health talk should always include key messages about HIV and STI testing and counseling.  Confirm participant ID and identity  Open Survey solutions form (STI testing form) with correct PID number  Explain to the participant the procedures of syphilis and trichomonas vaginalis testing  Explain the clinical and prevention benefits of STI testing  Explain to the participant what will happen during their visit  Further reassure the participant that records are kept under lock and key  Perform individualized risk assessment and risk reduction  Demonstrate condom use (both female and male condoms)  Give the client information on available health services and give a directory for these services  Encourage couple testing  The meaning of STI test results Page 9  The fact that the client has the right to refuse to be tested and that declining testing will not affect the client’s access to STI- related services or general medical care as well as their participation in the impact evaluation.  Potential risks of testing to the client in settings where there are legal implications for those who test positive and/or for those whose sexual or other behavior is stigmatized.  An opportunity to ask the provider questions.  Clinical and prevention benefits of STI testing.  Benefits of taking treatment if found to be reactive to either syphilis of trichomonas vaginals.  Encourage voluntary notification of partners and disclosure of status.  Gender-based violence assessments for adolescent girls and young women  Reflect on each session, immediately afterwards NB. Explain to participant why they are not going to be tested for HIV. 2.2.1.2 Step 5.2 Conduct Pre HIV and STI test counselling Pre-test information Pre-test information giving and/or counselling shall be offered to all participants in the impact evaluation. This should be done in the form of individual information giving sessions. Pre-test information should include:  Informed Consent  Obtain informed verbal consent according to guiding Principles of HTS.  The benefits of HIV testing (highlighting the positive benefits).  The meaning of an HIV-positive and an HIV-negative diagnosis:  The potential for incorrect results if a person already on ART is tested.  The services available in the case of an HIV-positive/negative diagnosis, including where ART is provided as well as the services available in case of either a positive/negative syphilis test or a positive/negative trichomonas vaginalis test.  A brief description of HIV and STI prevention options and encouragement of partner testing.  The fact that the test result and any information shared by the client is confidential.  Assurance or recommendation regarding disclosure of the HIV and STI test results  An offer to answer any question the participant /client may have HIV and STI pre-test counseling session with HTS counsellor: Sit down and talk with the participant and discuss the health topics that related to HIV and STI testing. The health talk should always include key messages about HIV and STI testing and counseling.  Confirm participant ID and identity  Open Survey solutions form (HIV and STI testing form) with correct PID number  Explain to the participant the procedures of HIV, syphilis and trichomonas vaginalis testing  Explain the HTC process  Explain the clinical and prevention benefits of HIV testing  Explain to the participant what will happen during their visit Page 10  Further reassure the participant that records are kept under lock and key  Perform individualized risk assessment and risk reduction  Demonstrate condom use (both female and male condoms)  Give the client information on available health services and give a directory for these services  Encourage couple testing  The meaning of HIV &STI test results  The fact that the client has the right to refuse to be tested and that declining testing will not affect the client’s access to HIV-related services or general medical care as well as their participation in the evaluation  Potential risks of testing to the client in settings where there are legal implications for those who test positive and/or for those whose sexual or other behavior is stigmatized.  An opportunity to ask the provider questions.  Clinical and prevention benefits of HIV testing.  Benefits of ART and the Test and Start approach (starting treatment within 2 weeks of diagnosis).  Encourage voluntary notification of partners and disclosure of status.  Gender-based violence assessments for adolescent girls and young women  Reflect on each session, immediately afterwards NB. If participant reports to have sero-converted post midline, explain the need to test for HIV during endline data collection despite self-reporting that they are now HIV positive and still obtain verbal consent. 2.2.2 Step 6. Undertake STI and HIV testing During endline data collection, HIV testing is done under the following scenarios: a. Participant was reactive at midline but cofirmatory blood sample was not taken to the NRL. Both determine and unigold tests are done and a blood sample is collected for confirmatory purposes and sent to the NRL. b. Participant was not tested at midline. If reactive a blood specimen to be collected and to be sent to NRL for confirmatory testing. c. Participant sero-converted after midline. Both determine and unigold tests are done and a blood sample for confirmatory testing is collected and sent to NRL. d. Participant was negative at midline. If reactive a blood specimen to be collected and to be sent to NRL for confirmatory testing. Please note that HIV testing is not to be conducted for participants who were positive at midline and a blood sample for confirmatory testing was sent to NRL and confirmation of HIV positive was received from NRL. The flowchart below illustrates step 6 of the endline process Page 11 Page 12 Page 13 2.2.2.1 Step 6.1. Provide container and explain vaginal swab and self collection of urine sample 1. In this case the participant has qualified for quality assurance and a urine sample is to be collected. 2. Show the participant the laminated sheet that illustrates the vaginal swab procedure 3. Answer any questions the participant has about the procedure Follow the steps below for collecting urine sample for the trichomonas vaginalis quality 1. Show the participant the private location where she can collect her own urine sample 2. Advise the participant to wash her hands before sample collection 3. Advise her to urinate into the given container, collect a sample of first catch urine (about half the container) and tightly screw back the top of the container. 4. Advise her to wash her hands thoroughly after collection and to return the closed urine sample to you. 2.2.2.2 Step 6.2. Execute vaginal swab and self collection of urine sample 1. Label the container with the PID number, site name, date and time of collection 2. Provide her with the provided culture swab and urine specimen jar 3. Allow the participant to conduct the vaginal swab and collect urine sample in privacy with no one watching 4. Store the urine sample in the provided cooler box at 2-8 degrees Celsius when being stored for 4 days and 15-30 degrees Celsius when being stored for 4 hours before the samples reach the laboratory. 2.2.2.3 Step 6.3. Explain vaginal swab collection and execute 1. Show the participant the laminated sheet that illustrates the vaginal swab procedure 2. Answer any questions the participant has about the procedure Follow the steps below for collecting vaginal swab specimen for the trichomonas test 1. Show the participant the private location where she can collect her own vaginal swab sample 2. Advise the participant to wash her hands before sample collection 3. Advise her to insert the supplied culture swab into the vaginal cavity (about 2,5cm of the culture swab) and rotate clockwise or anti-clockwise 5-8 times 4. Advise her that care must be taken to not contaminate the collected specimen by carefully returning it into the sterile opened packet 5. Advise her to wash her hands thoroughly after collection and to return the culture swab to the nurse 2.2.2.4 Step 6.4: Administer OSOM Trichomonas Rapid Test Materials Needed:  OSOM Trichomonas Rapid Test Page 14  Timer/Stop Watch - Very Important  25 Test Sticks  25 Sterile Swabs  Sample Buffer dropper top  Trichomonas Positive Control Kit  Marker or Pen  Positive control swab  Gloves  Biohazard disposal container  Laminated sheet with image that explains the self-swabbing process Follow steps below  Process the swab as soon as possible after collecting the specimen. Specimens may be held at room temperature for no longer than 24 hours. Swabs may also be stored at 4° C or -20° C for up to 36 hours  Specimens collected with cotton tips or wooden shafts are not acceptable for testing  Specimens collected from any site other than the vaginal cavity are not acceptable for testing. 1. Add sample buffer to test tube by filling the dropper to the line indicated on the barrel and expel entire contents into the tube 2. Add the swab to the test tube and mix vigorously 10 times and allow the swab to soak for 1 minute 3. Squeeze the side of the tube to express as much liquid from the swab as possible a. Squeeze out as much liquid as possible from the swab by pinching the side of the flexible test tube as the swab is removed. b. At least 1/4” of Sample Buffer solution must remain in the tube for adequate capillary migration to occur. c. Discard the swab in a suitable biohazardous waste container. 4. Place absorbent end of test stick into the solution and allow the solution to incubate/ rest for 10 minutes a. Unused sticks removed from the canister should be discarded after 1 hour 5. Read the test results 6. Rerun test, if inconclusive 7. Record outcomes on HIV and STI Testing Survey Solutions Form. Page 15 Follow these steps for collecting urine sample for the trichomonas vaginalis confirmatory testing: 1. Label the container with the PID number, site name, date and time of collection 2. Show the participant the private location where she can collect her own urine sample 3. Advise the participant to wash her hands before sample collection 4. Provide her with the container 5. Advise her to urinate into the given container, collect a sample of first catch urine (about half the container) and tightly screw back the top of the container. 6. Advise her to wash her hands thoroughly after collection and to return the closed urine sample to you. 7. Store the urine sample in the provided cooler box at 2-8 degrees Celsius when being stored for 4 days and 15-30 degrees Celsius when being stored for 4 hours before the samples reach the laboratory. Page 16 2.2.2.5 Step 6.6: Obtain whole blood samples for HIV testing and/or quality assurance testing as well as syphilis testing Personnel: Nurse Location: Isolated participant counselling rooms or in a quite secluded and private space (in a more informal setting) When: Immediately after HIV screening Tools: Panel for dry blood spot collection, lancet, alcohol swabs, sharps container, pipettes, blood collection tubes, bandages, gloves, biohazard bags, tourniquet, timer and gauze Actions during this step: Depending on whether the person has been selected for confirmatory HIV testing, either collect whole blood using venture puncture, or prick the participant’s finger for dry blood spot collection. 2.2.2.6 Step 6.5 Draw whole blood 1. Select a suitable site for venipuncture 2. Prepare the equipment, the participant and puncture site 3. Perform the venipuncture 4. Collect the sample in the blood sample container 5. Recognize complications associated with the phlebotomy procedure 6. Assess the need for sample recollection and / or rejection 7. Label the collection tubes at the drawing area with participant ID, venue, date and time of collection 8. Gently shake the blood sample within 30 minutes after collection and before putting it in the cooler box so as to prevent hemolysis 9. Promptly store the sample for collection at the end of the day. 2.2.2.7 Step 6.6: Obtain dry blood spots for HIV and syphilis testing Personnel: Nurse Location: Isolated participant counselling rooms or in a quite secluded and private space (in a more informal setting) When: Immediately after HIV screening Tools: Panel for dry blood spot collection, lancet, alcohol swabs, sharps container, pipettes, blood collection tubes, bandages, gloves, biohazard bags, tourniquet, timer and gauze Page 17 Actions during this step: Depending on whether the person has been selected for confirmatory HIV testing, either collect whole blood using venture puncture, or prick the participant’s finger for dry blood spot collection. Follow these detailed steps for dry blood spot collection: 1. Wash and sanitize nurse’s hands 2. Put on disposable gloves 3. Position hand palm-side up (use less dominant hand) 4. Choose either the ring or middle finger which is least calloused 5. Warm the finger by wrapping with a warm cloth during cold weather or by rubbing the finger with you hand to help the blood flow 6. Clean the fingertip with alcohol 7. Start in the middle and work outward to prevent contamination of the area 8. Allow the area to dry after the alcohol swab 9. Hold the finger and firmly place a new sterile lancet off-center on the fingertip 10. Firmly press the lancet to puncture the fingertip (Do not puncture the center or the tip of the finger) 11. Wipe away the first drop of blood with a sterile gauze pad (This drop contains tissue fluid, so it must not be used for testing) 12. Collect the specimen using a pipette (The blood may flow best if the finger is held lower than the elbow) 13. Gently massage to promote blood flow 14. Apply a gauze pad to the puncture site and have the participant hold the gauze until the bleeding stops 15. Apply a sterile adhesive bandage over the puncture site 16. Discard all used materials in to biohazard bags including disposable gloves 17. Put on a new set of gloves for the next participant Page 18 2.2.2.1 Step 6.7: Store whole blood for later quality assurance or confirmatory testing in laboratory Put the collected and labelled blood sample in the cooler box provided for this purpose at the study site. If the collection at the end of the day does not happen, then the samples have to be stored overnight at the field site so as to preserve the samples. The samples should NOT be stored in the cooler box, but rather in the fridge in the local laboratory at the field site, as per arrangements made with the particular field site. From the field site, the samples will be transported no later than 24 hours after collection, to the NRL for confirmatory testing. The NRL will perform confirmatory testing using their procedures. Page 19 2.2.2.2 Step 6.8: Administer Syphilis Rapid Test Kit Storage:  Kit component are stable until expiration date when handled and stored as directed.  Do not use kit component beyond expiration date. Materials Needed:  Alere Determine Syphilis Rapid test  Chase buffer  Timer/Stop Watch - Very Important  Micropipette and Tips with volume of 10 µL  Disposable plastic pipettes  Test cassette  Marker or Pen  Blood sample  Gloves  Biohazard disposal container Testing procedure: 1. Use the blood sample obtained by finger prick 2. Apply 20µl of sample (EDTA capillary tube) in the “S” hole. 3. Add 3-4 drops of assay diluent in the “S” hole 4. Wait 5-20 minutes 5. Interpret the results if the test is positive (reactive) 6. Record outcomes on HIV and STI Testing CAPI Form. Page 20 2.2.2.3 Step 6.9: Administer Alere Determine HIV 1/2 Rapid Test Kit Storage:  The Alere Determine HIV1/2 Test kits must be stored at 2-30°C until the expiration date.  Kit component are stable until expiration date when handled and stored as directed. Do not use kit component beyond expiration date. Materials Needed:  Alere Determine HIV 1/2 Rapid Test Kit and Strip  Chase buffer  Timer/Stop Watch- Very Important  Pipette 50µL or 100µL/ graduated pipette  Pipette tips (yellow)  Marker or Pen  Blood sample (dry blood or whole blood)  Gloves  Biohazard disposal container Testing procedures: HIV Determine HIV 1/2 rapid test 1. Use the blood sample obtained by finger prick 2. Apply 50µl of sample (EDTA capillary tube) to the sample pad (marked by the arrow symbol). 3. Wait until the blood is absorbed into the sample pad, then apply one drop of Chase Buffer to the sample pad. 4. Wait a minimum of 15 times (up to 60 minutes) and read result. 5. Read the test result between 20 and 30 minutes after the addition of the Chase Buffer. 6. Rerun test if inconclusive and use Uni-Gold HIV if more than 1 inconclusive test 7. If the test result is positive (reactive), then test using the Unigold HIV Rapid Test 8. Record outcomes on HIV and STI Testing survey solution form. Page 21 2.2.2.4 Step 6.10: Administer Uni-Gold HIV Rapid Test Page 22 Kit Storage:  The Uni-Gold HIV Rapid Test must be stored at 2-30°C until the expiration date.  Kit component are stable until expiration date when handled and stored as directed. Do not use kit component beyond expiration date. Materials Needed:  Uni-Gold HIV Test Kit  Chase buffer  Timer/Stop Watch- Very Important  Pipette 50µL or 100µL/ graduated pipette  Pipette tips (yellow)  Marker or Pen  Blood sample (dry blood or whole blood)  Gloves  Biohazard disposal container Testing procedures: 1. Only use the Uni-Gold Rapid Test if Determine HIV-1/HIV-2 test is positive (reactive) 2. Use the blood sample obtained by finger prick 3. Apply 50µl of sample (EDTA capillary tube) to the sample pad (marked by the arrow symbol) 4. Wait until the blood is absorbed into the sample pad, then apply one drop of Chase Buffer to the sample pad. 5. Wait a minimum of 15 minutes (up to 60 minutes) and read result. 6. The following results might be obtained:  Negative - A line in the control region only indicates a negative test  Positive - A line of any intensity forming in the test region, plus a line forming in the control region, indicates a positive result  Inconclusive - No line appears in the control region. The test should be repeated with a fresh device, irrespective of a line developing in the test region. 7. Record outcomes on HIV and STI Testing survey solutions form. 8. If the Uni Gold HIV rapid test is positive collect a blood specimen for confirmatory testing and send to NRL. Page 23 Page 24 2.2.2.5 Step 6.11 Collect blood sample for NRL 1. Explain procedure to participant 2. Select a suitable site for venipuncture 3. Prepare the equipment, the participant and puncture site 4. Perform the venipuncture 5. Collect the sample in the blood sample container 6. Recognize complications associated with the phlebotomy procedure 7. Assess the need for sample recollection and / or rejection 8. Label the collection tubes at the drawing area with participant ID, venue, date and time of collection 9. Gently shake the blood sample within 30 minutes after collection and before putting it in the cooler box so as to prevent hemolysis 10. Promptly store the sample for collection at the end of the day. 2.2.2.1 Step 6.12: Disclose results to participant Personnel: HTC Counselor Location: Isolated participant counselling rooms When: Immediately after HIV and STI testing Tools: Referral forms 1. Disclose the participant’s HIV and STI statuses  Give simple and clear test results of HIV and STI testing  Give time for the results to sink in  Make sure the participant understands the results  Give the participant an opportunity to ask questions  Review of risk reduction plan including condom and lubricant use skills building  Development of a coping strategy for the participant  Assessment of referral, if need for other services  Discussion of disclosure of test results  Discussion of partner referral for HIV and STI testing where appropriate Page 25 2.2.2.2 Administer syphilis treatment (Nurse Only)  Syphilis treatment should be done by a nurse only  Consult the participant for allergies  If no allergies: 1. Benzathine Penicillin 2.4 MU IM once.  Provide a packet of Erythromycin 500 mg orally to take home  Ask the participant to take one pill of Erythromycin 4 times daily for 14 days  If allergic to penicillin, consult the nurse supervisor, and provide erythromycin 500 mg orally 4 times per day for 14 days. o Set up a treatment schedule with the participant, so they may have available access to the medication and are able to take the medication as advised o Monitor participant for 15-30 minutes for reaction after administering penicillin injection. All teams should have epinephrine pens in their treatment kits o The participant will be counselled on signs of penicillin allergy and the Jarisch-Herxheimer reaction and management 1. After treatment, the participant will be provided with referrals (treatment vouchers) for all of her recent sexual partners (<3 months) 2. Counsel to avoid sexual contact for 1 week and as long as her current sexual partner is not treated. 3. Within 2 weeks after test, follow-up with all participants, after their treatment schedule has been completed based on the agreed upon treatment plan for both syphilis and trichomonas. Their STI test result at follow up and record the informationis recorded on the STI and HIV Follow up Survey Solutions Form If Trichomonas positive For Trichomonas -positive participants, there is need to collect a urine sample for confirmatory testing. In addition, during baseline, midline, endline, and all raffle rounds, Trichomonas quality assurance test will be processed on each tenth participant. Urine sample will be collected and send to NRL. Make sure that the participant’s test results are on the HIV and STI testing Survey Solutions form. 2.2.2.3 Administer Trichomonas treatment  Provide information on management of vaginal discharge syndrome  Set up a treatment schedule with the participant, so they may have available access to the medication and are able to take the medication as advised  Consult patient for allergies- if allergic to any medication consult the nursing supervisor  If no allergies: Give 1. Benzathine Penicillin 2.4 MU IM once, cefixime 400 mg orally once and Metronidazole 2 g orally once, with monitoring. Page 26  Provide a packet of Erythromycin 500 mg orally to take home  Ask the participant to take one pill of Erythromycin 4 times daily for 7 days 1. After treatment, the participant will be provided with referrals (treatment vouchers) for all of her recent sexual partners (<3 months) 2. Counsel the participant to avoid sexual contact for 1 week or until her partner is treated? 3. Avoid alcohol for 48 hours, and to present to the local health clinic if she develops any lower abdominal pain, persistent vaginal discharge, or is unable to complete the 7-day course of medication If positive to both Trichomonas and Syphillis 2.2.2.4 Administer treatment • Provide information on management of vaginal discharge syndrome • Set up a treatment schedule with the participant, so they may have available access to the medication and are able to take the medication as advised • Consult patient for allergies- if allergic to any medication consult the nursing supervisor • If no allergies: Give 1. Metronidazole 2 g orally once, and 2. Ceftriaxone 250 mg IM or cefixime 400 mg orally once, with monitoring. • Provide a packet of Erythromycin 500 mg orally to take home • Ask the participant to take one pill of Erythromycin 4 times daily for 7 days 1. Step 11: For all HIV-positive and/or STI-positive participants, follow up to ensure linkage to treatment and care, follow up on STI treatment, and conduct follow up STI testing, as need be For HIV positive participants: Within 2 weeks after referral, the AFM (BM) will follow-up with those who tested positive and record if they completed confirmatory testing and if they have been enrolled in ART care. Record relevant information in the HIV and STI follow-up survey solutions form. For STI positive participants: Within 2 weeks providing STI treatment, the AFM (BM) will follow-up with those who tested positive and record if they completed their course of STI treatment and provided the referral slips for their sexual partners. Test them for STIs. Record relevant information in HIV and STI follow- up survey solutions form. If they test negative, the Data Manager will make them eligible for the next round of the raffle. If they test STI positive again, they will be provided with another course of treatment and a follow up time and date for a follow up STI test will be agreed on. 2.2.2.5 Step 6.13: Record information in Survey Solutions form Double check the Survey Solutions form to ensure that all information about the participant has been entered correctly including test results. Page 27 End interview and sync survey. 2.2.3 Step 7. Undertake Post-test counseling If HIV positive 1. Make sure that the participant’s test results are on the HIV and STI Testing Survey Solutions Form. 2. Initiate post-test result counseling  Describe what a positive test result means and the risks for the participant and her partner(s) NB: If discordant result, a blood sample will be sent to NRL for ELISA as sensitive confirmatory test.  Describe modes of transmission of the disease to partners and transmission to a baby if they are currently pregnant  Provide information about safe sex, the benefits of HIV care and treatment services, and the need for testing sexual partners  Listen and address adolescent concerns.  Focus on risky behavior and develop risk reduction plans. 3. Provide a list of centers for ART care and teen clubs for support for HIV positive AGYW and ask them which center they would like to visit. 4. Initiate referral process for HIV-positive participants to the HIV clinic for pre-ART care, at the facility that is most convenient for them. 5. Complete the Eswatini Ministry of Health national referral form, and follow the referral Process:  Fill the national referral form in triplicate  Give 1st original form to the client  Send 2nd copy to the next level site or receiving site  Keep the 3rd copy for theimpact evaluation  Give the participant information about the services of the next level of service  Reinforce shared confidentiality to the participant  Emphasize the importance of attendance to the next level of service 6. Provide a list of teen clubs in their area that they can join and provide contact information 7. Provide the benefits of the use of ART. 8. Demonstrate and provide condoms. 9. Encourage them to have their sexual partners tested for HIV too. 10. Inform them that you will follow up with them in 2 weeks to ask if they have any questions and to ensure that they were able to link up with care, treatment and support 11. Provide them with a phone number that they can call, if they have any questions. Specific counseling messages Page 28 Negative at Midline and Endline Positive Test result at Endline  Explanation of window period and  Supporting the emotions arising from test result. recommendation of when to test based on their  Discussion of any immediate concerns. risk profile. Important to not encourage unnecessary re-testing.  Provide information on the availability of chronic HIV care and ART services.  Discussion of partner testing, methods to prevent HIV such as VMMC, correct and  Informing client about benefits of Test and Start consistent use of condoms, PrEP, PEP and and active referral for treatment. reducing number of sexual partners.  Provide information on preventing HIV  Discuss male and female condom use. transmission.  Discuss sero-discordancy and how to stay  Discussion of “positive living.” negative, including availability of PrEP for the negative partner in a sero-discordant couple.  Discuss mutual support and disclosure.  Clarify misconceptions and myths.  Discuss male and female condom use.  Provide information on preventing HIV  Discuss family planning. transmission.  Outline the benefits of partner testing.  Referral for prevention and other health services  Sero-discordancy and how to stay negative, where indicated. including availability of PrEP for the negative partner in a sero-discordant couple.  Clarify misconceptions and myths.  Referral to HIV care services and support groups. Positive and known after Midline Positive at Midline  Provide support for emotions arising from living positively.  Provide support for emotions arising from living positively.  Discussion of any immediate concerns.  Discussion of any immediate concerns.  Strengthening on the availability of chronic HIV care and ART services.  Provide information on preventing HIV transmission.  Provide information on preventing HIV transmission.  Strengthening on the availability of chronic HIV care and ART services.  Discussion of “positive living.”  Discuss mutual support and disclosure.  Emphasize on male and female condom use.  Emphasize on male and female condom use.  Discussion of “positive living.”  Discuss mutual support and disclosure.  Discuss family planning.  Discuss adherence to ARVs Page 29  Discuss family planning.  Outline the benefits of partner testing.  Outline the benefits of partner testing.  Provide information on sero-discordancy  Provide information on sero-discordancy including availability of PrEP for the negative including availability of PrEP for the negative partner in a sero-discordant couple. partner in a sero-discordant couple.  Clarify misconceptions and myths.  Clarify misconceptions and myths.  Referral to HIV care services and support groups.  Referral to HIV care services and support groups. 12. Record outcomes on HIV and STI Testing in Survey Solutions Form. 2.3 STI process for raffle rounds The flow chart below illustrates the testing process during raffle rounds Page 30 Page 31 2.3.1 Step 1. Conduct pre- STI counselling Ensure that the “5 Cs” are respected throughout the process of counseling and testing: 1. Informed consent  PIHTS: An opt-out approach is used where HTS is offered by a HCW and consent is assumed unless the client explicitly declines the HIV test.  CIHTS: Clients request HTS and verbal consent is obtained to conduct the HIV test. 2. Confidentiality  Testing results and any discussions between the HTS provider and the client should not be disclosed to anyone without the expressed consent of the person being tested.  Shared confidentiality among HCWs to promote linkages and further client management should be explained to the client. 3. Counseling  Accompany testing with appropriate, brief and high-quality pre-test information and post-test counselling.  Messages should be tailored to the client’s needs and focused on encouraging notification/disclosure of HIV status to sexual partners and family members or trusted others, where beneficial.  Post-test counselling should also include messages designed to facilitate linkages to prevention and treatment services following HIV testing. 4. Correct test results  Perform testing according to the relevant national testing algorithm including confirmation of all reactive self-test results.  Adhere to national quality assurance standards to ensure correct and accurate results are given to the client. 5. Connection/linkage to prevention, care and treatment  Increased efforts to refer and link all clients to appropriate HIV prevention, treatment, and other support services, according to their result. Personnel: HIV Testing Services (HTS) Counselor (this counselor can also do counseling for STIs) Location: Isolated participant counselling rooms or in a quite secluded and private space (in a more informal setting) When: Before the commencement of the HIV, syphilis and the trichomonas vaginalis test Pre-test information Pre-test information giving and/or counselling shall be offered to all participants who are part of the impact evaluation. This should be done in the form of individual information giving sessions. Pre-test information should include: Page 32  Informed Consent  Obtain informed verbal consent according to guiding Principles of Counseling.  The benefits of STI testing (highlighting the positive benefits).  The meaning of an STI-positive and an STI-negative diagnosis:  The services available case of either a positive/negative syphilis test or a positive/negative trichomonas vaginalis test.  A brief description of HIV and STI prevention options and encouragement of partner testing.  The fact that the test result and any information shared by the client is confidential.  Assurance or recommendation regarding disclosure of STI test results  An offer to answer any question the participant /client may have 2.3.2 Step 2. Provide container and explain vaginal swab and self collection of urine sample 1. In this case the participant has qualified for quality assurance and a urine sample is to be collected. 2. Show the participant the laminated sheet that illustrates the vaginal swab procedure 3. Answer any questions the participant has about the procedure Follow the steps below for collecting urine sample for the trichomonas vaginalis quality 1. Show the participant the private location where she can collect her own urine sample 2. Advise the participant to wash her hands before sample collection 3. Advise her to urinate into the given container, collect a sample of first catch urine (about half the container) and tightly screw back the top of the container. 4. Advise her to wash her hands thoroughly after collection and to return the closed urine sample to you. 2.3.3 Step 3. Execute vaginal swab and self collection of urine sample 1. Label the container with the PID number, site name, date and time of collection 2. Provide her with the provided culture swab and urine specimen jar 3. Allow the participant to conduct the vaginal swab and collect urine sample in privacy with no one watching 4. Store the urine sample in the provided cooler box at 2-8 degrees Celsius when being stored for 4 days and 15-30 degrees Celsius when being stored for 4 hours before the samples reach the laboratory. 2.3.4 Step 4. Explain vaginal swab collection and execute 1. Show the participant the laminated sheet that illustrates the vaginal swab procedure 2. Answer any questions the participant has about the procedure Follow the steps below for collecting vaginal swab specimen for the trichomonas test Page 33 1. Show the participant the private location where she can collect her own vaginal swab sample 2. Advise the participant to wash her hands before sample collection 3. Advise her to insert the supplied culture swab into the vaginal cavity (about 2,5cm of the culture swab) and rotate clockwise or anti-clockwise 5-8 times 4. Advise her that care must be taken to not contaminate the collected specimen by carefully returning it into the sterile opened packet 5. Advise her to wash her hands thoroughly after collection and to return the culture swab to the nurse 2.3.5 Step 5. Administer OSOM Trichomonas Rapid Test Materials Needed:  OSOM Trichomonas Rapid Test  Timer/Stop Watch - Very Important  25 Test Sticks  25 Sterile Swabs  Sample Buffer dropper top  Trichomonas Positive Control Kit  Marker or Pen  Positive control swab  Gloves  Biohazard disposal container  Laminated sheet with image that explains the self-swabbing process Follow steps below  Process the swab as soon as possible after collecting the specimen. Specimens may be held at room temperature for no longer than 24 hours. Swabs may also be stored at 4° C or -20° C for up to 36 hours  Specimens collected with cotton tips or wooden shafts are not acceptable for testing  Specimens collected from any site other than the vaginal cavity are not acceptable for testing. 1. Add sample buffer to test tube by filling the dropper to the line indicated on the barrel and expel entire contents into the tube 2. Add the swab to the test tube and mix vigorously 10 times and allow the swab to soak for 1 minute 3. Squeeze the side of the tube to express as much liquid from the swab as possible d. Squeeze out as much liquid as possible from the swab by pinching the side of the flexible test tube as the swab is removed. e. At least 1/4” of Sample Buffer solution must remain in the tube for adequate capillary migration to occur. f. Discard the swab in a suitable biohazardous waste container. Page 34 4. Place absorbent end of test stick into the solution and allow the solution to incubate/ rest for 10 minutes a. Unused sticks removed from the canister should be discarded after 1 hour 5. Read the test results 6. Rerun test, if inconclusive 7. Record outcomes on HIV and STI Testing Survey Solutions Form. Follow these steps for collecting urine sample for the trichomonas vaginalis confirmatory testing: 1. Label the container with the PID number, site name, date and time of collection 2. Show the participant the private location where she can collect her own urine sample 3. Advise the participant to wash her hands before sample collection 4. Provide her with the container Page 35 5. Advise her to urinate into the given container, collect a sample of first catch urine (about half the container) and tightly screw back the top of the container. 6. Advise her to wash her hands thoroughly after collection and to return the closed urine sample to you. 7. Store the urine sample in the provided cooler box at 2-8 degrees Celsius when being stored for 4 days and 15-30 degrees Celsius when being stored for 4 hours before the samples reach the laboratory. Step 6. Obtain dry blood spots for syphilis testing Personnel: Nurse Location: Isolated participant counselling rooms or in a quite secluded and private space (in a more informal setting) Tools: Panel for dry blood spot collection, lancet, alcohol swabs, sharps container, pipettes, blood collection tubes, bandages, gloves, biohazard bags, tourniquet, timer and gauze Follow these detailed steps for dry blood spot collection: 1. Wash and sanitize nurse’s hands 2. Put on disposable gloves 3. Position hand palm-side up (use less dominant hand) 4. Choose either the ring or middle finger which is least calloused 5. Warm the finger by wrapping with a warm cloth during cold weather or by rubbing the finger with you hand to help the blood flow 6. Clean the fingertip with alcohol 7. Start in the middle and work outward to prevent contamination of the area 8. Allow the area to dry after the alcohol swab 9. Hold the finger and firmly place a new sterile lancet off-center on the fingertip 10. Firmly press the lancet to puncture the fingertip (Do not puncture the center or the tip of the finger) 11. Wipe away the first drop of blood with a sterile gauze pad (This drop contains tissue fluid, so it must not be used for testing) 12. Collect the specimen using a pipette (The blood may flow best if the finger is held lower than the elbow) 13. Gently massage to promote blood flow 14. Apply a gauze pad to the puncture site and have the participant hold the gauze until the bleeding stops 15. Apply a sterile adhesive bandage over the puncture site 16. Discard all used materials in to biohazard bags including disposable gloves 17. Put on a new set of gloves for the next participant Page 36 2.3.6 Step 7: Administer Syphilis Rapid Test Kit Storage:  Kit component are stable until expiration date when handled and stored as directed.  Do not use kit component beyond expiration date. Materials Needed:  Alere Determine Syphilis Rapid test  Chase buffer  Timer/Stop Watch - Very Important  Micropipette and Tips with volume of 10 µL  Disposable plastic pipettes Page 37  Test cassette  Marker or Pen  Blood sample  Gloves  Biohazard disposal container Testing procedure: 1. Use the blood sample obtained by finger prick 2. Apply 20µl of sample (EDTA capillary tube) in the “S” hole. 3. Add 3-4 drops of assay diluent in the “S” hole 4. Wait 5-20 minutes 5. Interpret the results if the test is positive (reactive) 6. Record outcomes on HIV and STI Testing CAPI Form. Disclose results to participant Personnel: HTC Counselor Location: Isolated participant counselling rooms When: Immediately after HIV and STI testing Tools: Referral forms Page 38 2. Disclose the participant’s STI statuses  Give simple and clear test results of STI testing  Give time for the results to sink in  Make sure the participant understands the results  Give the participant an opportunity to ask questions  Review of risk reduction plan including condom and lubricant use skills building  Development of a coping strategy for the participant  Assessment of referral, if need for other services  Discussion of disclosure of test results  Discussion of partner referral for STI testing where appropriate Administer syphilis treatment (Nurse Only)  Syphilis treatment should be done by a nurse only  Consult the participant for allergies  If no allergies: 1. Benzathine Penicillin 2.4 MU IM once.  If allergic to penicillin, consult the nurse supervisor, and provide erythromycin 500 mg orally 4 times per day for 14 days. o Set up a treatment schedule with the participant, so they may have available access to the medication and are able to take the medication as advised o Monitor participant for 15-30 minutes for reaction after administering penicillin injection. All teams should have epinephrine pens in their treatment kits o The participant will be counselled on signs of penicillin allergy and the Jarisch-Herxheimer reaction and management 1. After treatment, the participant will be provided with referrals (treatment vouchers) for all of her recent sexual partners (<3 months) 2. Counsel to avoid sexual contact for 1 week and as long as her current sexual partner is not treated. 3. Within 2 weeks after test, follow-up with all participants, after their treatment schedule has been completed based on the agreed upon treatment plan for both syphilis and trichomonas. 4. Their STI test result at follow up is recorded on the STI and HIV Follow up Survey Solutions Form. Page 39 If Trichomonas positive For Trichomonas positive participants, there is need to collect a urine sample for confirmatory testing. Trichomonas quality assurance test will be processed on each tenth participant. Urine sample will be collected and send to NRL. Make sure that the participant’s test results are on the HIV and STI testing Survey Solutions form. Administer Trichomonas treatment  Provide information on management of vaginal discharge syndrome  Set up a treatment schedule with the participant, so they may have available access to the medication and are able to take the medication as advised  Consult patient for allergies- if allergic to any medication consult the nursing supervisor  If no allergies: Give 1. Metronidazole 2 g orally once, and 2. Ceftriaxone 250 mg IM or cefixime 400 mg orally once, with monitoring.  Provide a packet of Erythromycin 500 mg orally to take home  Ask the participant to take one pill of Erythromycin 4 times daily for 7 days 1. After treatment, the participant will be provided with referrals (treatment vouchers) for all of her recent sexual partners (<3 months) 2. Counsel the participant to avoid sexual contact for 1 week or until her partner is treated? 3. Avoid alcohol for 48 hours, and to present to the local health clinic if she develops any lower abdominal pain, persistent vaginal discharge, or is unable to complete the 7-day course of medication 2.3.7 Step 8. Conduct STI post-test counselling Initiate post-test result counseling (HTS counsellor)  Describe what a positive test result means and the risks for the individual and her partner(s)  Tell the participant that this is a treatable disease and can be cured with medication and the risks if medication is not taken  Describe modes of transmission and risks to pregnancy  Provide information about safe sex, the benefits of care and treatment services, and the need for testing sexual partners 2.3.8 Step 9: Record information in Survey Solutions form Double check the Survey Solutions form to ensure that all information about the participant has been entered correctly including test results. Page 40 List of Youth Friendly ART Centres 1. FLAS Mbabane and Manzini 2. AHF clinics Mbabane and Manzini 3. Litsemba Letfu Clinic PSI Matsapha 4. Baylor Clinic 5. Tri Cash Clinic 6. Sigcineni Clinic 7. Shewula Clinic List of teen clubs for ARV support for adolescents Health facility Hhohho  Pigg’s Peak hospital  Mayiwane clinic  Bhalekane clinic  Herefords clinic Manzini  Cana clinic  Bhekinkosi clinic  Mankayane hospital  Mliba Nazareen  Ngculwini Clinic Lubombo  Good Shepard hospital  Lomahasha clinic  Sithobela clinic  Cabrini  St Phillips Shiselweni  Nhlangano health center  Hlatikhulu hospital  Matsanjeni health center Page 41