GEMS Research

Toolkit

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:

 

  1. 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:

 

  1. 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
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.

 

  1. 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
Generic drug resistance monitoring protocol PrEP project implementers/ policy makers To provide an adaptable protocol for stakeholders who wish to implement a drug resistance monitoring protocol
DBS collection Job Aid Healthcare workers To standardize collection and shipment of DBS samples
Training video on DBS collection Healthcare workers A “how-to” video that demonstrates procedures for collection and shipment of DBS samples
SOP for DBS Preparation from Venipuncture Blood Healthcare workers To standardize procedures across facilities for collection and shipment of DBS samples
SOP for Receiving DBS Sample Cards Laboratory personnel To standardize procedures at the laboratory for receipt and testing of DBS samples
Training modules on HIVDR (key concepts), DBS collection, interpreting test results and key counseling messages 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 
Acute seroconversion assessment 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
PrEP and HIVDR fact sheet for policy makers Policy makers   To provide a brief overview of the risk of drug resistance while using PrEP and implications for overall PrEP rollout
PrEP and HIVDR fact sheet for healthcare workers 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
Monitoring and Evaluation (M&E) plan    Policy makers   To provide M&E indicators for ongoing, long-term, assessment of drug resistance risk
HIV Testing Factsheet (in development) 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.