TABLE 2.
HIVDR Monitoring Project Initiation by Country
| Country | HIVDR Monitoring Approach | Implementing Partners | Timeline for IRB/EC Approvalsa | Training Strategy | Laboratory Location and Sample Type |
|---|---|---|---|---|---|
| Eswatini | National seroconverter protocol, led by MOH | MOH, CHAI, private, and public national health facilities offering PrEP | 3 months | Regional training approach (11 trainings/ 231 participants) and 5 add-on trainings (143 participants) | Johannesburg, South Africa; DBS and whole blood collected |
| Kenya | National seroconverter protocol, led by Kenyan investigators including MOH | MOH, CASCOs, POWER, Partners-Scale Up, PrIMA, PrIYA, LVCT Health, Jilinde, SWOP, CHAK, CHS, IRDO, PATH, APHIA, KEMRI Welcome Trust, Kilifi, NRHS, NOPE, I Choose Life, EGPAF, KENSHE, DPEP | 3 months | Train-the-trainer approach (20 individual trainings conducted at county level and with individual partner organizations); additional training of PrEP service providers in the 10 highest incidence counties | Kisumu Kenya; DBS is primary method; however, plasma samples collected where possible, in case of DBS testing challenges |
| Zimbabwe | National seroconverter protocol, led by Zimbabwean investigators including MOHCC | MOHCC, PZAT, PSI, Zim-TTECH, CeSSHAR, OPHID, and national health clinics | 4 months | Train-the-trainer approach (25 individual trainings conducted across project partners) | Johannesburg, South Africa; DBS is primary method; however, plasma samples collected where possible, in case of DBS testing challenges |
| South Africa | Individual demonstration projects providing PrEP to a limited number of health facilities | POWER, CHARISMA, Project PrEP Wits RHI/Unitaid, Wits RHI/Key Populations, Wits RHI/PrEP SMART | Approximately 4-5 months for various projects | Comprehensive approach; all sites trained through project partners (9 individual trainings conducted across project partners) | Johannesburg, South Africa; whole blood sample collected and sent to laboratory for any site with laboratory pick up capabilities within one day; DBS samples collected at all other clinics |
Abbreviations: APHIA, AIDS, Population & Health Integrated Assistance; CASCO, County AIDS and Sexually Transmitted Infection Coordinator; CeSSHAR, Centre for Sexual Health and HIV AIDS Research Zimbabwe; CHAI, Clinton Health Access Initiative; CHAK, Christian Health Association of Kenya; CHARISMA, Community Health Clinical Model for Agency in Relationships and Safer Microbicide Adherence; CHS, Center for Health Solutions-Kenya; DBS, dried blood spot; DPEP, doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections; EGPAF, Elizabeth Glaser Pediatric AIDS Foundation; HIVDR, HIV drug resistance; IRDO, Impact Research and Development Organization; KEMRI, Kenya Medical Research Institute; The KEN-SHE Study, KENya Single-dose HPV-vaccine Efficacy; MOH, Ministry of Health; MOHCC, Ministry of Health and Child Care; NOPE, National Organization of Peer Educators; NRHS, Nyanza Reproductive Health Society; OPHID, Organization for Public Health Interventions & Development; POWER, Prevention Options for Women Evaluation Research; PrEP, pre-exposure prophylaxis; PrIMA, PrEP Implementation for Mothers in Antenatal Care, PrIYA, PrEP Implementation in Young Women and Adolescents; PSI, Population Services International; PZAT, Pangaea Zimbabwe AIDS Trust; SWOP, Sex Workers Outreach Project; Wits RHI/Unitaid, Project PrEP Wits Reproductive Health and HIV Institute Wits RHI/PrEP SMART (Sequential multiple assignment randomized trial); Zim-TTECH, Zimbabwe Training, Technical Assistance and Education Center for Health.
Time from initial protocol submission to final institutional review board (IRB)/ethics committee (EC) approval.