GEMS – September 2017

GEMS informs policies and defines programmatic considerations related to use of ARV-based HIV prevention products and risk of resistance.

• Drug-resistance testing in Kenya progresses.
• GEMS prepares for drug-resistance testing in South Africa and Zimbabwe.
• Genital swabs testing begins and assay development is underway.
• Oral PrEP modeling continues.

Drug-resistance testing in Kenya progresses. The GEMS team is finalizing logistics to support in-country partners in collecting a blood sample from PrEP seroconverters. A sample collection kit has been prepared and will be distributed to high-volume PrEP clinics. In July, the GEMS Kenya team conducted a training of trainers session for county-level health workers to collect, store, and ship a dried blood spot sample to the laboratory. As a result, participants gained the skills to train other health workers in their individual counties.

GEMS prepares for drug-resistance testing in South Africa and Zimbabwe. The GEMS team has been finalizing logistics for dried blood spot (DBS) sample collection and shipment with the South African POWER team. GEMS has also been coordinating with the Anova Health Institute to monitor for HIV drug resistance as part of the national rollout at select Anova sites. GEMS and Anova are currently drafting a drug resistance monitoring protocol.

Meanwhile, GEMS, in collaboration with Pangaea Zimbabwe AIDS Trust (PZAT), has recently presented a proposed resistance monitoring plan to the Ministry of Health and Child Welfare (MOHCC). A GEMS representative met with the MOHCC, PSI, and other PrEP projects in August to plan next steps for drug resistance monitoring.

Genital swabs testing begins and assay development is underway. In collaboration with Partners PrEP and the Microbicide Trials Network (MTN), the GEMS laboratory team is continuing to test vaginal swabs from seroconverters to determine if drug resistance occurred in the genital tract (rather than the plasma) of women who seroconverted on active TDF/FTC product. The lab team is continuing to optimize next-generation sequencing protocols for dried blood spots.

Oral PrEP modeling continues. GEMS modelers have produced preliminary draft results on the impact of drug resistance on PrEP and ART. Modelers are currently performing further analyses and plan to review results with the South Africa National Department of Health and other stakeholders in the coming months.