- Slides: 18
Management of Seroconverters
HIV Testing in HOPE • HIV testing will be performed at every scheduled visit and at interim visits, if indicated
HIV Testing in HOPE • Participants should be counseled on signs/symptoms of acute HIV infection and encouraged to contact the clinic if they have suspected infection or exposure to HIV between study visits – Especially relevant during quarterly visit schedule
Procedures in the Event of HIV+ Rapid Test • Counsel the participant regarding her HIV status per SSP Section 12 and site SOPs • On the same day as a positive rapid test, from a new draw/sample, collect blood for: – Plasma storage – Confirmatory Testing (Geenius) – HIV RNA – CD 4+ testing
Product Management: Hold • If during product use period: – Vaginal Ring Request Slip to pharmacy (only if prescription previously completed) – Clinical Product Hold/Discontinuation Log Form to SCHARP (regardless of acceptor/non-acceptor)
If subsequent testing confirms the participant is not HIV-infected: • Product use may be resumed, if desired by participant • Inform pharmacy using VR request slip marked “resume” (or prescription if participant was not previously accepting product) – Note: if participant declines ring resumption, still inform pharmacy with a slip marked “resume” and on the same slip also mark “decline” • Update applicable items on Product Hold/Discontinuation CRF and HIV Test Results CRF • Moving forward, sites must adhere to all guidance provided by the LC for follow-up HIV testing plans for these participants (e. g. using alternate approved HIV rapid tests).
Procedures in the Event of Confirmed HIV Infection Counsel participant of her confirmed HIVinfection status
Procedures in the Event of Confirmed HIV Infection • Permanently discontinue participant from study product – VR Request Slip marked ‘permanent discontinuation’ (only if prescription previously completed) – Update Clinical Product Hold/Discontinuation Log CRF with date of permanent discontinuation – Update final HIV status on HIV Test Results CRF
Procedures in the Event of Confirmed HIV Infection • Administer PUEV/Discontinuers ACASI – At the visit when participant is provided confirmation of her HIV result, or as part of a split visit within approximately 1 month • Participants will continue on original MTN-025 study visit schedule through PUEV, and be offered enrollment into MTN-015
Modified Procedures for HIV+ Participants Discontinue: • HIV-1 counseling & testing • Vaginal ring use, instructions, VR adherence counseling • Note: HIV prevention options counseling should continue and can be tailored to discussions of secondary prevention, risk reduction, retention, and residual drug data only
Modified Procedures for HIV+ Participants Discontinue: • Complete blood count, Blood chemistries • Plasma collection for DPV testing and storage • Hair and Vaginal fluid collection • Scheduled MTN-025 Study Exit Visit.
Modified Procedures for HIV+ Participants • If the participant does NOT enroll in MTN-015, ADD at ALL scheduled follow-up visits: – Seroconverter plasma storage – CD 4+ T cell count – HIV-1 RNA PCR • HIV-1 Genotyping (standard resistance testing), will be performed on the stored plasma closest to the time of HIV-1 infection
Care and Support for Seroconverters • Participants with confirmed HIV infection will be counseled and actively referred to available sources of medical and psychosocial care and support, per site SOPs • Actively follow-up on referrals and outcome of referrals at each follow-up visit
Care and Support for Seroconverters • If a participant is HIV-infected and pregnant, refer for PMTCT – Inform PSRT if a pregnant participant seroconverts or if a participant has a positive pregnancy test and positive rapid HIV results.
Care and Support for Seroconverters • While neither MTN-025 nor MTN-015 can provide clinical care and treatment for HIV infection, protocol -specified examinations and laboratory tests will provide information upon which appropriate clinical care decisions can be made. – Information on participants’ stage of HIV disease, HIV RNA PCR, and CD 4+ T cell count – Information on HIV drug resistance
HIV Drug Resistance Testing Resistance Category Definition Potential low-level resistance The virus is likely to be fully susceptible yet it contains mutations that may be indicative of previous exposure to the ARV class of the drug Low-level resistance Virus isolates of this type have reduced in-vitro drugsusceptibility and/or patients with viruses of this genotype may have a suboptimal virologic response to treatment compared with the treatment of a wildtype virus Intermediate resistance The genotype suggests a degree of drug resistance greater than low-level resistance but lower than high-level resistance High-level resistance The genotype is similar to that of isolates with the highest levels of in vitro drug resistance and/or patients infected with isolates having similar genotypes generally have little or no virologic response to treatment with the drug Susceptible No evidence of reduced susceptibility compared with wildtype
Seroconverter Visit Checklist Will be available on HOPE website soon (this example is from the ASPIRE study)
MTN-015 • All potentially eligible participants should be referred to MTN-015 • Written referral not required, but must document referral in chart notes • Consider strategies to encourage/facilitate high uptake of MTN-015 from the start of HOPE!