Peter Makuhunga

Experience

PROFESSIONAL EXPERIENCE


PPD, Johannesburg, South Africa SCRA II 2012 - present

Accompanier: Authorised to conduct PAV s (Performance Assessment Visits) to provide ongoing training, evaluation and development of the PPD monitor.

SCRAII: Mentor Group Coordinator – A CRA Development Initiative for PPD Non-USA that aims to Promote CRA Accelerated Development, Systems Mastery, Continual Improvement and CRA Movement towards Peak Performance through establishing shared knowledge, Core CRA values and Excellence in the CRA Development Model at PPD non USA.

SCRAII: Authorised to train new CRAs to ensure they cover the US National Institute of Health (NIH) contract requirements for new CRAs before they embark of training trips.

SCRAII: Authorised to mentor new CRAs to ensure their proper integration into PPD and speedy familiarisation with PPD systems, processes and procedures

SCRAII: Senior Clinical Research Associate on a global multicenter, international trial on a pediatric prospective, pharmacokinetic (PK) study to investigate the drug-drug interaction between the ant malarial treatment XXX and XXX)-based antiretroviral (ARV) treatment for HIV, in co-infected children in resource limited settings.

SCRAII: Senior Clinical Research Associate on a global multicenter, international trial to evaluate the comparative efficacy of maternal antepartum triple ARV prophylaxis versus antepartum XXX + XXX + XXX tail to reduce antepartum and intrapartum HIV transmission, as measured by the transmission rate through 1 week of age, when regimens are initiated XX weeks gestation and prior to the onset of labor.

SCRAII: Senior Clinical Research Associate on a global multicenter trial phase III, dual-arm, open-label, randomized, non-inferiority study for participants who are on a failing non-nucleoside reverse transcriptase inhibitor (NNRTI)-containing first-line regimen, evaluating the difference in virologic failure rate between two treatment arms: XXX plus XX + XX) and XXX plus best available nucleos(t)ide reverse transcriptase inhibitors (NRTIs). Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global multicenter trial randomized, open-label, phase IV strategy trial, for participants from resource-limited settings who present with advanced HIV disease and no probable or confirmed tuberculosis (TB), as defined in the current XXX diagnosis appendix, and who are initiating antiretroviral treatment (ART). Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global multicenter trial of a randomized evaluation of antiretroviral therapy alone or with delayed chemotherapy versus antiretroviral therapy with immediate adjunctive chemotherapy for treatment of limited stage AIDS-XX in resource-limited settings. Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global multicenter trial international trial of the maternal and infant monitoring for evidence of toxicity related to XXX exposure: the bone and kidney health substudy of the XXX Protocol. Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global multicenter trial, randomized, double-blind, placebo-controlled phase 3 safety and effectiveness trial of a vaginal matrix ring containing XXX for the prevention of HIV-1 Infection in women. Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global, multicentre, international trial for maternal and infant monitoring for evidence of toxicity related to XXX exposure: the bone and kidney health substudy of the promoting maternal and infant survival everywhere protocol. Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global randomised evaluation of antiretroviral therapy alone or with delayed chemotherapy versus antiretroviral therapy with immediate adjunctive chemotherapy for treatment of limited stage aids- Kaposi’s sarcoma in resource-limited settings. Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global multi-site, three-arm, randomised acute HIV infection - a key link for transmission prevention: A randomised pilot study. Performed a site initiation visit.

SCRAII: Senior Clinical Research Associate on a global randomised trial to evaluate the effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV-1 in serodiscordant couples. Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global phase II, clinical trial comparing the responses to initiation of NNRT-based versus PI Based antiretroviral therapy in HIV-infected infants who have and have not previously received single dose nevirapine for prevention of mother-to-child HIV transmission. Performed interim monitoring visits.
SCRAII: Senior Clinical Research Associate on a global phase IIB safety and effectiveness study of xxx gel, xxx tablet and xxxx tablet for the prevention of HIV infection in women. Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global observational cohort study of women following HIV-1 seroconversion in microbicide trials. Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global HIV prevention agent pregnancy exposure registry: evaluation of maternal and baby outcome registry after chemoprophylactic exposure study. Performed interim monitoring visits.
SCRAII: Senior Clinical Research Associate on a global bone mineral density substudy ancillary study to a phase IIB safety and effectiveness study of xxx, xxx tablet and xxx tablet for the prevention of HIV infection in women. Performed interim monitoring visits.

SCRAII: Senior Clinical Research Associate on a global, multicentre, international trial for promoting maternal and infant survival everywhere study. Performed interim monitoring visits.


PPD, Johannesburg, South Africa SCRA I 2010-2012

Accompanier: Authorised to conduct PAV s (Performance Assessment Visits) to provide ongoing training, evaluation and development of the PPD monitor.

SCRAI: Authorised to mentor new CRAs to ensure their proper integration into PPD and speedy familiarisation with PPD systems, processes and procedures

SCRAI: Senior Clinical Research Associate on a global phase IIB safety and effectiveness study of xxx gel, xxx tablet and xxxx tablet for the prevention of HIV infection in women. Performed interim monitoring visits.

SCRAI: Senior Clinical Research Associate on a global observational cohort study of women following HIV-1 seroconversion in microbicide trials. Performed interim monitoring visits.

SCRAI: Senior Clinical Research Associate on a global HIV prevention agent pregnancy exposure registry: evaluation of maternal and baby outcome registry after chemoprophylactic exposure study. Performed interim monitoring visits.
SCRAI: Senior Clinical Research Associate on a global bone mineral density substudy ancillary study to a phase IIB safety and effectiveness study of xxx, xxx tablet and xxx tablet for the prevention of HIV infection in women. Performed interim monitoring visits.

SCRAI: Senior Clinical Research Associate on a global, multicentre, international trial for promoting maternal and infant survival everywhere study. Performed interim monitoring visits.

SCRAI: Senior Clinical Research Associate on a global, multicentre, international trial for maternal and infant monitoring for evidence of toxicity related to tenofovir exposure: the bone and kidney health substudy of the promoting maternal and infant survival everywhere protocol. Performed interim monitoring visits.

SCRAI: Senior Clinical Research Associate on a global randomised evaluation of antiretroviral therapy alone or with delayed chemotherapy versus antiretroviral therapy with immediate adjunctive chemotherapy for treatment of limited stage aids- Kaposi’s sarcoma in resource-limited settings. Performed interim monitoring visits.

SCRAI: Senior Clinical Research Associate on a global multi-site, three-arm, randomised acute HIV infection - a key link for transmission prevention: A randomised pilot study. Performed a site initiation visit.

SCRAI: Senior Clinical Research Associate on a global randomised trial to evaluate the effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV-1 in serodiscordant couples. Performed interim monitoring visits.

SCRAI: Senior Clinical Research Associate on a global phase II, clinical trial comparing the responses to initiation of NNRT-based versus PI Based antiretroviral therapy in HIV-infected infants who have and have not previously received single dose nevirapine for prevention of mother-to-child HIV transmission. Performed interim monitoring visits.

Aeras Global TB Vaccine Foundation, Cape Town, South Africa
CRA 2010
CRT&PD Manager 2010
IP Manager 2009-2010

CRA: Clinical Research Associate on a global phase II study to evaluate the protective efficacy against TB disease, safety and immunogenicity of a candidate TB vaccine. Conducted site management, inclusive of - facilities development for the conduct of the trial and assisting site with development of SOPs and, regulatory submissions. Facilitated in the review of Aeras work procedure documents.

CRA: Clinical Research Associate on a global phase II study in BCG-vaccinated, HIV-uninfected infants without evidence of Tuberculosis. Performed review of study progress through meetings and, screening & enrollment reports from site.

CRT & PD Manager: Clinical Research Training & Professional Development Manager: Managed the implementation of the professional development strategy for building the human capacity and ensuring the quality of work through training at the field sites in conducting epidemiology and clinical research studies in compliance with national and international guidelines. Ensured that staff gained adequate skills in GCPs and other guidelines as they related to protection of participants rights, prevention and detection of fraud and the use of sound scientific principles. Trained site personnel to promote avoidance of error, disruptions and re-work as well as to facilitate adoption of new tools to improve on technical know-how. Managed a Professional Development Programme that fostered skills enhancement and career-growth for each individual staff member in clinical research. Compiled an Aeras GCLP Training Manual intended for training clinical research sites. As part of a team, wrote, reviewed/edited a variety of policies/SOPs and tools/checklists for Aeras Laboratory Capacity Development, Aeras Quality Assurance and Aeras Clinical Operations departments.

IP Manager: Investigational Product Manager established, managed and coordinated all aspects of investigational product (IP) inventory and supply chain activities for all Aeras sponsored clinical studies. Projected IP requirements to support an entire development plan of multiple vaccine candidates, as well as managing the day to day activities for global clinical trials to meet study time lines and budgets. Worked closely with cross-functional representatives from manufacturing/collaborators, regulatory, quality assurance, clinical development, and clinical operations to accurately forecast and facilitate project logistics. Initiated and wrote SOPs for IP Management.

PPD, Johannesburg, South Africa CRA I 2008-2009

CRAI: Clinical Research Associate on a global strategy study of immediate versus deferred initiation of antiretroviral therapy for aids disease-free survival in HIV-infected persons treated for Tuberculosis. Performed interim monitoring visits.

CRAI: Clinical Research Associate on a global randomised trial to evaluate the effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV-1 in serodiscordant couples. Performed interim monitoring visits.

CRAI: Clinical Research Associate on a global phase II, clinical trial comparing the responses to initiation of NNRT-based versus PI Based antiretroviral therapy in HIV-infected infants who have and have not previously received single dose nevirapine for prevention of mother-to-child HIV transmission. Performed interim monitoring visits.

CRAI: Clinical Research Associate on a global phase IV, randomised, open label evaluation of the efficacy of once daily protease inhibitor-and once daily non-nucleoside reverse transcriptase inhibitor containing therapy combinations for initial treatment of HIV-1 infected individuals from resource-limited settings. Performed interim monitoring visits.

CRAI: Clinical Research Associate on a global study on optimal combination therapy after Nevirapine exposure, a NNRTI and PI-based ARV treatment in women with/without single-dose NVP MTCT prophylaxis. Performed interim monitoring visits.

CRAI: Clinical Research Associate on a global phase III trial to determine the efficacy and safety of an extended regimen of nevirapine in infants born to HIV-infected women to prevent mother to child HIV transmission during breastfeeding. Performed interim monitoring visits.

CRAI: Clinical Research Associate on a global phase II/IIb safety and effectiveness study of the vaginal microbicides buffer gel and PRO 2000/5 (P) for the prevention of HIV infection in women. Performed interim monitoring visits.

UZ-UCSF, Zimbabwe
Research Director 2006 - 2008 QA/QC & Training Director 2004 – 2006
HPTN QA/ QC Co-coordinator 2003 - 2004

Research Director (RD): Coordinated research activities for four DAIDS sponsored Clinical Trials Unit network studies under HPTN, ACTG, IMPAACT and MTN. Wrote and revised (annually), the DAIDS approved cQMP for the Clinical Trials Unit (CTU) and used the plan to monitor regulatory records, CRFs and participant charts/Source Documents for the following multi-site global trials: phase II/IIb vaginal microbicides trial for the prevention of HIV infection in women; Phase III trial to determine the efficacy and safety of an extended regimen of nevirapine in infants born to HIV positive mothers; Effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care to prevent sexual transmission of HIV-1 in serodiscordant couples; Phase II, clinical trial, comparing responses to initiation of NNRT-based versus PI based antiretroviral therapy in HIV-infected infants who are nevirapine naïve; a phase IV, evaluation of the efficacy of once daily protease inhibitor and once daily non nucleoside reverse transcriptase inhibitor containing therapy combinations for initial treatment of HIV-1 infected individuals; Optimal combination therapy after nevirapine exposure; A phase III trial for reduction of HIV acquisition among HSV-2 sero-positive, HIV sero-negative individuals using acyclovir. Performed in house CRF reviews, participants chart/source document reviews and regulatory files review. Wrote monitoring reports after debrief meetings and submitted reports to study personnel and investigators. In the RD’s position, offered strategic management to the Community Manager, the Counseling Manager, the Data Manager, the QA/QC Coordinator, the Lab Director and the Pharmacy team. Developed and implemented short- and long-range plans to improve and standardize the conduct of research by assuring efficient and cost-effective results. The position monitored research activities to assure desired retention rates and timely achievement of plans. Developed action plans for remedial efforts when required.

QA/QC & Training Director: The QA/QC & Training Director developed a Training policy & Manual for GCP (ICH-GCP), Quality Awareness and Team Building for clinical research sites. Successfully offered GCP and Source documentation training to over 400 (cumulative) key research personnel in Zimbabwe, South Africa and Tanzania. Developed (and annually revised) and implemented a PPD, FHI & DAIDS approved cQMP for internal audit of DAIDS sponsored HPTN clinical trials. Clinical trials audited are:- A phase II/IIb vaginal microbicides trial for the prevention of HIV infection in women; Phase III trial to determine the efficacy and safety of an extended regimen of nevirapine in infants born to HIV positive mothers; Effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care to prevent sexual transmission of HIV-1 in serodiscordant couples; A phase III reduction of HIV acquisition among HSV-2 sero-positive, HIV sero-negative individuals using acyclovir. Performed internal pre-study and interim audits in accordance with GCPs, sponsor SOPs, the protocol and regulatory requirements. Carried out facilities inspection, study initiation audits; screening, enrolment and follow-up audits. Discussed findings with study personnel and followed issues raised until they were resolved. Recommended appropriate training to improve data quality, lower QC errors and improve teamwork. Achieved low QC error rates (to within planned levels) through cause-effect analyses and appropriate team building strategies. As the lead auditor, facilitated & carried out internal quality audits, and analyzed internal audit reports, CRO monitoring reports (PPD), and Data Management QC reports from sponsor or sponsor’s agent for gap analysis, strategy & advice to the QA/QC Coordinator, QA/QC Officers and Protocol Directors/Coordinators for the HPTN protocols listed above. Summarised monitoring reports into Quarterly Management Reports sent to Principal Investigators & Sponsor – DAIDS. Carried out site lab audits to ensure the lab met regulatory requirements, GCLP and requirements of the ISO 15189, Medical Laboratory Quality Standard and ISO/IEC 7025, General Requirements for the Competence of Testing and Calibration Laboratories. Ensured each Project Coordinator/Director maintained an efficient and current filing system for all CRFs, source documents, and regulatory documents.

HPTN QA/ QC Co-coordinator: Developed, implemented, and managed DAIDS approved cQMP. Conducted QA/QC activities for four HPTN trials (listed in above). Planned and carried out internal audits for the four DAIDS sponsored HPTN clinical trials. Audited the Site Laboratory to ensure it met regulatory requirements for analysis of participant samples through planned quarterly lab audits. Assisted project coordinators maintain an efficient and current filing system for all source and essential documents through planned quarterly monitoring audits. Compiled quarterly clinical quality management reports for the USA based Division of AIDS on the performance of four HPTN studies and the laboratory. Audited regulatory documents, CRFs and participant source documents. Successfully Developed, Implemented & Assessed the first clinical Quality Management Plan for the HIV Prevention Trials Network research unit in Zimbabwe. Successfully trained study personnel in Quality Awareness.

Disease areas

Other information

EDUCATION


Executive Management Development Programme, 2003
University of Zimbabwe, Harare, Zimbabwe

Further Education Teachers' Certificate, 2002
Harare Polytechnic College Harare, Zimbabwe

Diploma in Business Management/Administration, 1996
College of Professional Management, London, United Kingdom.

M.Sc. Analytical Chemistry, 1992
University of Zimbabwe, Harare, Zimbabwe.

B.Sc., Biochemistry & Chemistry, 1988
University of Zimbabwe, Harare, Zimbabwe.


THERAPEUTIC EXPERIENCE

Infections/Parasitic Diseases: HIV/AIDs, Tuberculosis, Malaria
LICENCES & CERTIFICATIONS

• Certificate in Coordination & Implementation of Clinical Research, University of Alabama School of Nursing, University of Alabama at Birmingham – 2006.
• Certificate of Training in Laboratory Quality Management System Internal Quality Auditing Course – 2005.
• Monitoring and Evaluation Training Course for International Research - University of California San Francisco Global Health Sciences – 2005.
• Human Participant Protections Education (Certificate) at University of California-2005.
• Competence in Team Building (Certificate) at the International Business School, Zimbabwe – 2005.
• Internal Quality Auditing (Certificate) at Det Norske Veritas, Harare, Zimbabwe – 2001.
• Statistical Techniques (Certificate) at Det Norske Veritas, Harare, Zimbabwe -1999.
• Quality System Development (Certificate) at Det Norske Veritas, Zimbabwe- 1998.
• Executive Certificate in Strategic HIV/AIDS Project Management University of Zimbabwe, Faculty of Commerce, Business Studies Department – 2006.


PROFESSIONAL DEVELOPMENT

Completed PPD Clinical Foundation Programme, June 2008
Further training while employed at PPD is available upon request.
Completed Aeras Global TB Vaccine Foundation on the job training on Investigational Product Management, Rockville, MD, USA, (22nd February – 19th March 2010.

Prior to PPD, attended the following professional meetings:
• HIV Prevention Trials Network (HPTN) Annual Training & Meeting in Washington DC, USA, February 2006. Attended an advanced train the trainer GCP course.
• HIV Prevention Trials Network (HPTN) Annual Conference in DC Washington, USA, February 2005. Attended a train the trainer GCP course.
• Overlap Twinning Meeting, for the Twinning Programme held in Harare, June 2005 as a facilitator in Monitoring & Evaluation.
• HPTN Operations Meeting in Bethesda, Maryland, USA, October 2004. Attended a beginners’ train the trainer GCP course.
• HPTN Annual Conference on in DC Washington, USA, February 2004.


TRAINING ACCOMPLISHMENTS
• Conducted GCP & Source Documentation workshop for over 20 participants from 23-24 June 05, Mutoko, Zimbabwe.
• Conducted GCP & Source Documentation workshop for over 50 participants from 13-14 July 05, Harare
• Conducted GCP & Source Documentation workshop for over 50 participants from 30-31 Aug 05, Harare, Zimbabwe.
• Conducted GCP & Source Documentation workshop for 14 participants from 8-9 Sep 05, Mutoko, Zimbabwe.
• Conducted GCP & Source Documentation workshop for 31 participants from 9-10 Nov 05, Perinatal Research Unit, Baragwanath Hospital, Soweto, Johannesburg, South Africa.
• Conducted GCP & Source Documentation workshop for 32 participants from 22-23 Nov, 2005, Harare.
• Conducted GCP & Source Documentation workshop for 35 participants from 27-28 Jan, 2006, Harare.
• Conducted GCP & Source Documentation workshop for 32 participants from 1-3 Feb, 2006, Muhimbili Hospital, Dar es Salaam, Tanzania.
• Conducted GCP & Source Documentation workshop for 33 participants from 30-31Mar, 2006, Harare, Zimbabwe.
• Conducted GCP & Source Documentation workshop for 36 participants from 29-30Jun, 2006, Harare, Zimbabwe.
• Conducted GCP & Source Documentation workshop for 22 participants from 23-25Aug, 2006, Johannesburg, South Africa.
• Conducted GCP & Source Documentation workshop for 19 participants from 28-29Sep, 2006, Harare, Zimbabwe.
• Conducted GCP & Source Documentation workshop for 30 participants from 29-30Nov, 2006, Harare, Zimbabwe.
• Conducted GCP & Source Documentation workshop for 11 ZAPP Programme participants from 18-19 Jan 2007, Harare, Zimbabwe.
• Conducted GCP & Source Documentation workshop for 23 participants from 25-26 Jan, 2007, Harare, Zimbabwe.
• Conducted GCP & Source Documentation workshop for 32 participants from 08-09 Mar, 2007, Harare, Zimbabwe.
• Facilitated training in Group Dynamics & Team Building; and in Quality Audit Awareness to over 60 study researchers for a study called Methods of Improving Reproductive Health in Africa (MIRA), sponsored by the Gates Foundation.
• Facilitated training in Group Dynamics & Team Building, and in Quality Audit Awareness to over 45 participants for a research team for a Microbicides Study – HPTN 035.
• Facilitated training in Group Dynamics & Team Building, and in Quality Audit Awareness to over 27 participants for a research team for the site’s Research Laboratory team, 03 – 05 January 2006.
• Facilitated training in Group Dynamics & Team Building, and in Quality Audit Awareness to over 30 participants for a research team for a prevention Clinical Study – HPTN039, 4 May 06.
• Facilitated training in Group Dynamics & Team Building, and in Quality Audit Awareness to over 50 participants for a research team for an adolescence behavioral prevention study, 13 Jun 06.
• Facilitated in several site capacity building training activities, in quality control tips and strategy.
• Facilitated a Training Workshop on Internal Audit for Competence held for 6 participants from UZ-UCSF, Medicines Control Authority of Zimbabwe & Medical Research Council of Zimbabwe on 7 March 2007.
• Facilitated a Training Workshop in HEALTH RESEARCH ETHICS EDUCATION for 23 participants drawn from the Bulawayo’s University of Science & Technology’s lecturing staff including health educators from 28 – 30 March 2007.
• Facilitated a Training Workshop in HEALTH RESEARCH ETHICS EDUCATION & GCP for 19 participants drawn from the Bulawayo’s University of Science & Technology’s lecturing staff including health educators from 12 - 14 Sep 2007.
• Conducted a GCP & Source Documentation workshop for over 30 participants from1-2 Feb, 2008, Harare, Zimbabwe.

PROFESSIONAL AFFILIATIONS

• Member of the South Africa Clinical Research Association (SACRA) since 2009

PUBLICATIONS AND PRESENTATIONS

Publications:


a. Makuhunga Peter (Jan-Mar/2012)Towards Peak Performance - CRA Improvement & Continuous Development Efforts - Monitoring Tips/Tricks. Clinical Site and Study Monitoring News Publication.


b. Makuhunga Peter (Jan 2012) Sharing Best Practice In Co-Monitoring, Presented during the CSSM Clinical Operations Training, PPD

c. Makuhunga Peter and Shinners Dore (Jan 2012) Effective Pre-Visit Planning-Monitoring-Report Writing Presented during the CSSM Clinical Operations Training, PPD.

d. Makuhunga Peter (Jul-Sep/2011) System Design and the Mind –Effect on Efficiency and Effectiveness in Clinical Monitoring –an approach from Gestalt psychology. Clinical Site and Study Monitoring News Publication.

e. Makuhunga Peter and Wangati Kenneth, (May 2011) HIV Therapy: The Treatment Journey, Presented during a CSSM Monthly Team Meeting, PPD

f. Makuhunga Peter, (November-December 2006) Dilemmas in Motivating Project Staff and Observing Ethical Considerations in Recruitment and Retention in Zimbabwe. Thomson Centre for Clinical Research Practice (CCRP); 22 Thomson Place, Mail Stop 47F1, Boston, MA 02210. Research Practitioner / VOLUME7 NUMBER 6, 214.

g. Zaranyika M.F. & Makuhunga P, (1997) A possible steady state kinetic model for atomization process during flame atomic spectroscopy: Application to mutual atomization interference effects between group 1 elements. Fresenius Journal of Analytical Chemistry, 357: 249-257.

h. Mebe Paul & Makuhunga Peter, (1992) (11-(E)-p-Coumaric Acid Ester of Bergenin from Peltophorum Africanun. Phytochemistry, Vol. 31, No. 9, pp. 3286-3287

Presentations:
a) University of Zimbabwe – University of California San Francisco (UZ-UCSF) Clinical Trails Unit: Presented an abstract on: Role of Data & Clinical Quality Management Systems in Clinical Trials Research, at the CDC – UZ-UCSF Conference on “Coming Together to Overcome HIV & AIDS in Zimbabwe, June 2005, Harare, Zimbabwe.

COMPUTER EXPERIENCE

MS Word, Excel, Access, PowerPoint

LANGUAGES

Mother tongue: Shona. Proficient in English


CLINICAL TRIAL EXPERIENCE

Infections/Parasitic Diseases: A global phase IIb safety and effectiveness study of xxx, xxx tablet and xxx tablet for the prevention of HIV infection in women.

Infections/Parasitic Diseases: An global observational cohort study of women following HIV-1 seroconversion in microbicide trials.

Infections/Parasitic Diseases: A global HIV prevention agent pregnancy exposure registry: Evaluation of maternal and baby outcome registry after chemoprophylactic exposure study.

Infections/Parasitic Diseases: A global bone mineral density substudy ancillary study to a phase IIB safety and effectiveness study of xxx, xxx tablet and xxx tablet for the prevention of HIV infection in women.

Infections/Parasitic Diseases: A global, multicentre, international trial for promoting maternal and infant survival everywhere study.

Infections/Parasitic Diseases: A global, multicentre, international trial for maternal and infant monitoring for evidence of toxicity related to tenofovir exposure: the bone and kidney health substudy of the promoting maternal and infant survival everywhere protocol.

Infections/Parasitic Diseases: A global randomised evaluation of antiretroviral therapy alone or with delayed chemotherapy versus antiretroviral therapy with immediate adjunctive chemotherapy for treatment of limited stage aids- Kaposi’s sarcoma in resource-limited settings.

Infections/Parasitic Diseases: A global multi-site, three-arm, randomised acute HIV infection - a key link for transmission prevention: A randomised pilot study.

Infections/Parasitic Diseases: A phase II, proof of concept, randomised, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of xxx in healthy, HIV-infected adults.

Infections/Parasitic Diseases: A phase II, double-blind, randomised, placebo-controlled, multi-centre, proof-of-concept study to evaluate the safety and efficacy of xxx in BCG-vaccinated, HIV-uninfected infants without evidence of tuberculosis.

Infections/Parasitic Diseases: Phase II/IIb safety and effectiveness study of the vaginal microbicides buffer gel and xxx for the prevention of HIV infection in women

Infections/Parasitic Diseases: Phase III trial to determine the efficacy and safety of an extended regimen of nevirapine in infants born to HIV-infected women to prevent mother to child HIV transmission during breastfeeding

Infections/Parasitic Diseases: A phase III, two-arm, randomised, controlled, multi-centre trial to evaluate the effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV-1 in serodiscordant couples

Infections/Parasitic Diseases: Phase II, parallel, randomised, clinical trials, comparing the responses to initiation of NNRT-based versus PI based antiretroviral therapy in HIV-infected infants who have and have not previously received single dose nevirapine for prevention of mother-to-child HIV transmission

Infections/Parasitic Diseases: A phase IV, prospective, randomised, open label evaluation of the efficacy of once daily protease inhibitor-and once daily non-nucleoside reverse transcriptase inhibitor containing therapy combinations for initial treatment of HIV-1 infected individuals from resource-limited settings

Infections/Parasitic Diseases: Optimal combination therapy after Nevirapine exposure (OCTANE) (i.e. NNRTI and PI-based ARV treatment in women with/without single-dose NVP MTCT prophylaxis)

Infections/Parasitic Diseases: Effect of hormonal contraception on HIV genital shedding and disease progression among women with primary HIV infection.

Infections/Parasitic Diseases: A phase III, randomised, double blind, placebo-controlled trial of acyclovir for the reduction of HIV acquisition among high-risk HSV-2 seropositive, HIV sero-negative individuals.

Infections/Parasitic Diseases: A strategy study of immediate versus deferred initiation of antiretroviral therapy for aids disease-free survival in hiv-infected persons treated for Tuberculosis with CD4 < 250 Cells/mm3

Documents