Current State of HIV/AIDS Prevention Trial Research Capacity in Africa Prof. Souleymane Mboup

Background Africa : highest rates of prevalence and incidence of HIV/AIDS Research Capacity Crucial for HIV/AIDS Prevention trial Thereore Need conduct prevention trials in Africa Challenges : research capacity

Barriers to conduct of international stand HIV Prevention trials in SSA Lack of adequate and sustainable research funding Lack of a critical mass of well trained researchers Lack of adequate research infrastructure Lack of enabling environment for research (e.g. poor ethics and regulatory standards) Isolation of well trained cadres Lack of sharing of facilities and expertise Lack of mapping and synergising efforts Lack of common advocacy Invisible role of public sector

HIV Prevention trials in Africa randomized HIV/AIDS prevention or treatment intervention trials in North America 80 conducted in Africa 20% led by african

Kaleebu, 2011 Significant increase of Africa’s participations in HIV prevention trials in recent years.

The EDCTP strategy for funding research and capacity development

EDCTP funded HIV prevention studies in SSA Benin Botswana Burkina Faso Cameroon Congo Cote d’Ivoire Democratic Republic of Congo Ethiopia Gabon Ghana Guinea Guinea-Bissau Guinea-Conakry Kenya Liberia Madagascar Malawi Mali Mozambique Namibia Nigeria Rwanda Senegal South Africa Sudan Tanzania The Gambia Uganda Zambia Zimbabwe Austria Belgium Denmark France Germany Greece Ireland Italy Luxembourg Netherlands Norway Portugal Spain Sweden Switzerland United Kingdom EDCTP-EEIG member states Sub-Saharan African countries

Vaccine projects PITitle of study and locationStudy productStatus as of 2011 Bakari HIV vaccine trial capacity building in Tanzania and Mozambique by continued exploration of optimal DNA priming and MVA boosting strategies N/aOn going Bekker Feasibility of and capacity building for adolescent vaccine trials in South Africa HPV vaccineCompleted Hanke Building capacity of Infant HIV-1 Vaccine Clinical Trial Centres in Nairobi, Kenya and Fajara, The Gambia DNA MVA-HIVA On going Kaleebu Strengthening of long term clinical and laboratory research capacity, cohort development, and collection of epidemiological and social science baseline data in Uganda and Malawi to prepare for future HIV vaccine trials N/aOn going Kapiga Capacity development and strengthening in preparation for HIV vaccine trials in Tanzania and Burkina Faso N/aCompleted Lyamuya HIV vaccine trial capacity building in Tanzania and Mozambique by continued exploration of optimal DNA and MVA boosting strategies; TaMoVac II DNA – MVA boostOn going WeberAfrican-European HIV Vaccine Development Network (Mozambique)N/aOn going.

Microbicide projects. PITitle of study and locationStudy product Status as of 2011 Hayes Site preparation and capacity strengthening for trials of vaginal microbicides in Tanzania and Uganda N/aCompleted Mandaliya Characterisation of novel microbicide safety biomarkers in East and South Africa (Rwanda and Tanzania) N/a (Biomarkers)On going McCormack Establishing HIV microbicide clinical trial capacity in Mozambique and expanding and existing site in South Africa 0.5% and 2% PRO 2000/5 gelsCompleted WijgertPreparing for Phase III vaginal microbicide trials in Rwanda and Kenya: Preparedness studies, capacity building, and strengthening of medical referral systems N/aCompleted

PMTCT projects PITitle of study and locationStudy product Status as of 2011 Katzenstein Back-up with Combivir (AZT/3TC) or single dose Truvada (FTC/TDF) in order to avoid Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) resistance after single dose Nevirapine for the prevention of mother-to- child transmission in Tanzania Combivir (AZT/3TC) or single dose Truvada (FTC/TDF) On going Kisanga Improving the balance between efficacy and development of resistance in women receiving single dose nevirapine (VIramune®, NVP) for the prevention of mother-to-child transmission in Tanzania & Zambia (VITA studies) Niverapine / Carbamezapine On going Leroy International phase 2b randomized clinical trial to study a once-a-day maintenance strategy after a 15-month induction antiretroviral therapy among HIV-infected children diagnosed early between age 6 and 52 weeks and in virologic success in Africa – Uganda, Cote d’Ivoire, Bukina Faso ABC/3TC/EFV or TDF-FTC-EFV) vs AZT/3TC/NVP On going Newell Impact of HAART during Pregnancy and Breastfeeding on MTCT and Mother’s Health: The Kesho Bora Study – South Africa, Kenya and Burkina Faso ZDV, 3TC, LPV/r, NVP Completed Van der Perre A phase III double blind placebo/controlled trial of the efficacy and safety of infant periexposure prophylaxis with lamivudine to prevent HIV-1 transmission by breastfeeding (PROMISE-PEP trial) – Burkina Faso, Uganda, Zambia and South Africa 3TC, LPV/rOn going.

Funded projects : Lessons Southern, Eastern Africa +++ Increased scientific knowledge Infrastructure upgrade Training and mentorship of African researchers Networking (N-N, N-S and S-S) Provision of lessons and practical experience to ethics and regulatory bodies

Countries involved in NoE Western Africa: WANETAM Project Coordinator: Prof. Soleymane Mboup Website: Burkina Faso The Gambia Ghana Guinea-Bissau Mali Nigeria Senegal United States Southern Africa: TESA Project Coordinator: Dr Alexander Pym Website: Botswana Malawi Mozambique South Africa Zambia Zimbabwe France Germany Netherlands United Kingdom Eastern Africa: EACCR Project Coordinator: Dr Pontiano Kaleebu Website: Kenya Sudan Ethiopia Tanzania Uganda Germany Sweden United Kingdom United States Central Africa: CANTAM Project Coordinator: Prof. Francine Ntoumi Website: Cameroon Congo, Republic of the Gabon France Germany

Background West Africa sub-region characterized by: – Absence in conducting clinical trials of potential HIV vaccines and/or microbicides – Poverty or lack of data on drug resistant Mycobacterium tuberculosis – Need to expand and strengthen the malaria sites in anticipation of testing vaccine candidates

Objectives Capacity building and technology transfer to prepare West African institutions for the successful conduct of clinical trials. Creation of a network for sub- regional scientific collaborations: to facilitate and expedite the development of trial-specific expertise

WANETAM Partnership 7 West-African countries (Burkina Faso, The Gambia, Ghana, Guinea Bissau, Mali, Nigeria, and Senegal) Bring together scientists from anglophone, francophone and lusophone countries in West Africa.

MalariaTB N. Ibadan, COL.M G-B, BANDIM Gh. KORLEBU Senegal, LBV MRC- the Gambia Le Dantec University Senegal B. F Centre MURAZ N. Keffi Inn.B N. Lagos NIMR African Sister Institutions Established African Institutions Project Coordinator Disease Coordinators Le Dantec Senegal HIV Bioethics, GCP, GCLP, Quality control, Writing grant applications, Trial monitoring MRTC- Mali & Burkina Faso CNRFP Senegal, IPD Gh. NMIMR Burkina Faso The Gambia NPHL B. F CNRFP

CROSS CUTTING Bioethics GCP GCLP Quality control Writing grant applications Trial monitoring Le Dantec University- Senegal Molecular virology HIV resistance typing Assay standardization MRTC- Mali Malaria specific techniques Molecular biology – Haplotyping of parasites Drug-resistant mutations New diagnostic tools Malaria Immunology MRC- the Gambia Conventional and molecular TB diagnostics and drug susceptibility testing TRAININGS TB Malaria HIV

Achievements More than 180 people trained on Ethics, GCP, GCLP, Grant Writing and Data analysis, TB diagnostics, HIV drug resistance, etc. Sustainability +++ Sub-regional scientific collaboration is in progress with different institutions submitting together study proposals for funding Infrastructural upgrade in many institutions Partnership and expansion through WANETAM +,WAPHIR

WAPHIR West African Platform for HIV Intervention Research WAPHIR West African Platform for HIV Intervention Research

Challenges and Gaps in Capacity Strengthening – WAPHIR Experience Challenges and Raison d’etre 1.Infrastructure: Building and Maintaining Cohort structure and resources (Strengthen databases and Bio-banking etc) – platform for ongoing research and training; ensures preparedness for trial Laboratory Capacity (platforms for analyses) Institutional Communication Investment Gaps T rained Clinical epidemiologists & Biostatistics Lack of stake holder investment; core activity funding Capacity for Ethics- sharing and harmonisation Acquisition and Replacement of equipments Skills for maintenance and repair of equipments, Inadequate technical skills Improved access to internet, Electronic literature sources

Gaps Insufficient Re-entry Grants Immediate post-doctoral & post-clinical research grants for developing countries Lack of drive & skills by Africans for joint research ventures Lack of effective & cheap communication tools Lack of culture of joint Ethics consultations & training (for data and resource sharing etc) Non-existence of Coordinating Committees at funders & partners levels Challenges and Raison d’etre 2. Human Resources Building skills for clinical trial research and retention of young Researchers (Achieving critical mass of African Research Leadership and ownership) 3.Sustaining partnerships across Institutions and Countries (sustainable development of linkages

Challenges and Raison d’etre 4.Monitoring and Evaluation 5.Training on Ancillary Research Support for visible output Gaps Skills for monitoring and assessing indicators Capacity for Scientific writing English training for non-English speaking countries Capacity for Project Management, Financial reporting & Grants administration etc

Conclusion Capacity weaker in Central and Western Africa compared to Eastern and Southern Africa Innovative ways to identify what is needed for an effective participation of African sites and investigators, fill the gaps identified and find ways forward are needed

Acknowledgments EDCTP and Thomas Nyrienda Dr Moussa Sarr Dr Assan Jaye WANETAM CHVI