A SouthSouth Collaborative Network for Monitoring and Surveillance

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A South-South Collaborative Network for Monitoring and Surveillance of HIV Drug Resistance The LAASER

A South-South Collaborative Network for Monitoring and Surveillance of HIV Drug Resistance The LAASER program Raphael Hamers, MD Program Manager, Pharm. Access Foundation On behalf of the LAASER partnership International Civil Society Support

‘Building capacity on surveillance & monitoring of HIV drug resistance in Asia & Africa’

‘Building capacity on surveillance & monitoring of HIV drug resistance in Asia & Africa’ Dutch Ministry of Development Cooperation SAC Grant € 10. 2 million (US$ 12. 5 million) 2006 -2010 Aids Fonds S C Pharm. Access TREAT Asia PASER Africa ICSS TASER Asia Aids Fonds Civil Society Round Table International Civil Society Support

Aids Fonds implementing partners Not-for-profit NGO; Dedicated to scaling-up access to HIV/AIDS care in

Aids Fonds implementing partners Not-for-profit NGO; Dedicated to scaling-up access to HIV/AIDS care in sub-Saharan Africa, promoting public-private partnerships Therapeutics Research, Education, and AIDS Training in Asia; Network of clinics and research institutions, facilitated by The Foundation for Aids Research (amf. AR) International Civil Society Support In collaboration with: To strengthen and coordinate the reponse of civil society in the global fight against AIDS, in collaboration with national governments, private sector and international institutions University MC Utrecht University of Witwatersrand Stanford University International Civil Society Support

Capacity building & Research • Support to a multi-country HIVDR monitoring program • Surveillance

Capacity building & Research • Support to a multi-country HIVDR monitoring program • Surveillance surveys in recently infected (transmitted HIVDR) • Quality assurance network of laboratories • Training of medical and laboratory professionals • Support to policy makers on optimal ART program practices • International observational database International Civil Society Support

PASER network § 15 countries § 1 - 2 sites per country Mali Senegal

PASER network § 15 countries § 1 - 2 sites per country Mali Senegal Nigeria Ethiopia Benin BF Rwanda e iqu mb Namibia Zim za Selected sites Tanzania Zam bia Zambia Angola § 3 reference laboratories Mo Pharm. Access activities Kenya Uganda § 15 - 20 clinical sites Planned/Potential sites Reference laboratory RSA International Civil Society Support

TASER network § 10 countries § 1 - 2 sites per country § 11

TASER network § 10 countries § 1 - 2 sites per country § 11 - 18 clinical sites § 10 reference laboratories Selected sites Planned/Potential sites International Civil Society Support

Monitoring: patients on HAART Prospective cohort study Inclusion Criteria • Confirmed HIV+ test •

Monitoring: patients on HAART Prospective cohort study Inclusion Criteria • Confirmed HIV+ test • ≥ 18 years of age • Initiate 1 st line HAART (criteria from clinic, based on CD 4/AIDSdefining condition) or • Switching to 2 nd line HAART due to treatment failure (after ≥ 6 months 1 st line containing ≥ 3 ARVs) Exclusion Criteria • HIV-2 infection Viral load and Genotypic testing - Baseline - Annual follow-up - Switch/Stop HAART Prospective cohorts of 200 consecutive patients per site International Civil Society Support

Monitoring: enrolment projections Africa Yr 1 Yr 2 Yr 3 Yr 4 Yr 5

Monitoring: enrolment projections Africa Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 5 11 15 15 15 Participants enrolled/region - Southern - Eastern - Western 250 - 750 300 500 200 - Total participants enrolled/yr 250 1350 1000 400 - Number of countries International Civil Society Support Total participants 1000

Surveillance: transmitted HIVDR Cross-sectional surveys Inclusion Criteria • ART naϊve; and • Newly diagnosed

Surveillance: transmitted HIVDR Cross-sectional surveys Inclusion Criteria • ART naϊve; and • Newly diagnosed with a confirmed HIV+ test and ≥ 18 but <25 years of age; or • Confirmed HIV+ test with evidence of recent infection Exclusion Criteria • Known previous AIDS-defining illness • HIV-2 infection Repeat surveys In each site One-time Viral load and Genotypic testing 70 -80 consecutive patients per site International Civil Society Support

Lab logistics Africa: tracking protocol HARDCOPY+DIGITAL lab log form checked on all levels Facilitated

Lab logistics Africa: tracking protocol HARDCOPY+DIGITAL lab log form checked on all levels Facilitated through web-based HAART MONITORING SYSTEM (HMS) Clinic Specimen Collection INFO ON TUBE: PRELABELLED BARCODE PATIENT CODE DATE AND TIME BLOOD DRAW Master Clinic Storage -80 C Shipment on dry ice in batches Ref Lab Viral load + Sequencing Pharm. Access Data management International Civil Society Support

HAART Monitoring System Pharmaccess patient data management system: simple & web-based International Civil Society

HAART Monitoring System Pharmaccess patient data management system: simple & web-based International Civil Society Support

Achievements to date • Clinical databases (HMS and TAHOD) • P/TASER clinical site selection

Achievements to date • Clinical databases (HMS and TAHOD) • P/TASER clinical site selection • QA laboratory network (TAQAS) • Study protocols • Harmonization with WHO HIV Res. Net • Launch TASER (July 2006) and PASER (October 2006) • Logistical challenges in Africa: – Tracking protocol – R&D project proposal: dried fluid spot technology • Start patient enrollment scheduled October 2006 International Civil Society Support

Collaboration • Eligible clinical and laboratory HIV sites • Eastern and Western Africa •

Collaboration • Eligible clinical and laboratory HIV sites • Eastern and Western Africa • Preferably from NGO and private sector are kindly invited to contact Pharm. Access Foundation International Civil Society Support

Contacts Treat. Asia – TASER www. treatasia. org Jeff. Smith@amfar. org IAC: Booth G

Contacts Treat. Asia – TASER www. treatasia. org Jeff. [email protected] org IAC: Booth G 438 Aids Fonds www. aidsfonds. nl IAC: Booth F 422 Pharm. Access – PASER ICSS www. pharmaccess. org R. [email protected] org IAC: Booth G 458 [email protected] org IAC: Round table meeting & Launch International Civil Society Support