Country ministries of health, project implementers, and policy makers are developing and implementing PrEP national programs to introduce, rollout, and ensure PrEP access to those individuals at risk of HIV infection. When planning for PrEP implementation, these same groups are establishing methods to monitor PrEP clients for safety and to evaluate the overall success of their national programs. HIV drug resistance among PrEP seroconverters has implications for both client safety and program evaluation. The following toolkit materials are designed to assist ministries of health, project implementers and policy makers review current data on drug resistance, consider options for ongoing resistance monitoring, and offer support materials to aid in the collection and testing of blood samples for HIV drug resistance. The toolkit materials have been arranged into three categories:
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What is known about HIV drug resistance? These documents include research and available data on drug resistance and PrEP use from clinical trials, demonstration projects, and PrEP rollout programs:
- FEM-PrEP
- iPrEx
- TDF2
- Partners PrEP
- VOICE
- Should we Fear Resistance from Tenofovir/Emtricitabine PrEP?
- Policy brief on GEMS modeling results: ART considerations for Individuals with Recent PrEP Use
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Policy brief on GEMS lab results (in development)
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What key aspects of program design should be considered for a drug resistance monitoring program? Here you will find decision making tools to assess capacity and formation of a drug resistance monitoring program:
Item | Intended Audience | Purpose |
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Project Planner Template Guide (in development) | Policy makers and PrEP Program Implementers | To review activities that will inform stakeholders on country specific resistance monitoring needs, costs and resource gaps, and key considerations for planning a monitoring project |
HIV Drug Resistance and PrEP: Options for Establishing a Monitoring Program (in development) | Policy makers and PrEP Program Implementers | To review options for establishing a monitoring program that best suits the needs of the country/project team. To be used in conjunction with the Project Planner Template Guide. |
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What support tools exist for planning a drug resistance monitoring program? This section includes links to job aids, SOPs, and training materials to support sample collection and testing. It also includes tools for national-level planning:
Resistance Monitoring Program Planning
Item | Intended Audience | Purpose |
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PrEP project implementers/ policy makers | To provide an adaptable protocol for stakeholders who wish to implement a drug resistance monitoring protocol |
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Healthcare workers | To standardize collection and shipment of DBS samples |
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Healthcare workers | A “how-to” video that demonstrates procedures for collection and shipment of DBS samples |
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Healthcare workers | To standardize procedures across facilities for collection and shipment of DBS samples |
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Laboratory personnel | To standardize procedures at the laboratory for receipt and testing of DBS samples |
Healthcare workers | To provide training materials to health care workers and project implementers involved with managing a drug resistance monitoring project, collecting blood samples, or counseling clients on their drug resistance test results | |
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Healthcare workers | A clinical assessment of PrEP clients based on symptoms; to limit drug resistance risk in cases of undetected infection |
National Program-level Planning
Item | Intended Audience | Purpose |
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Policy makers | To provide a brief overview of the risk of drug resistance while using PrEP and implications for overall PrEP rollout |
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Health care workers | To provide a brief overview of the risk of drug resistance while using PrEP; including key counseling messages for PrEP users and health care workers |
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Policy makers | To provide M&E indicators for ongoing, long-term, assessment of drug resistance risk |
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Policy makers and project implementers | To provide an overview of current point of care HIV testing methods for consideration when developing testing algorithms for PrEP programs |
Drug Resistance Testing Factsheet (in development) | Laboratory managers and project implementers | To provide an overview of current drug resistance testing methods for consideration when developing laboratory infrastructure |
If you have any questions about the above toolkit items please contact the GEMS team at gems@pitt.edu. Additional toolkit materials will be posted as they are finalized.