Medical Research Council - Global Campaign for Microbicides
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Transcript Medical Research Council - Global Campaign for Microbicides
This presentation and the information contained therein is the sole property of the South African Medical Research Council
TREATMENT ACCESS IN
TRIALS AND BEYOND
Gita Ramjee
HIV Prevention Research Unit
WHO-ICMR-CONRAD-IPM Meeting on Regulatory
Issues in Microbicide Research
October 28-31, 2007, New Delhi, India
This presentation and the information contained therein is the sole property of the South African Medical Research Council
GLOBAL STATUS OF HIV PREVENTION TRIALS
TRIAL
COUNTRY
STATUS
END DATE
Population Council, Carraguard
South Africa
3602
Results end 2007
MDP 301, 0.5% & 2% PRO2000
South Africa, Tanzania, Uganda,
Zambia
5726/9673
Dec 2009
South Africa, Malawi, Zambia,
Zimbabwe, USA
3100/3220
Mid 2009
9 sites (USA, Peru, Africa)
3277/3277
2008
14 African sites
3408/3408
2009
Tanzania
1305
Completed 2007
CDC, Oral Tenofovir (TDF)
Thailand
1762/2000
2008
CDC, Oral Tenofovir (TDF)
USA
400/400
2008
Botswana
167/1200
2009
NIAID, Truvada (FTC/TDF)
Peru
100/3000
Dec 2009
Gates, Oral Tenofovir (TDF)
Ghana, Cameroon, Nigeria
936/1200
Ended
South Africa
605/3000
End 2008
Thailand
16200/16200
Results Q3 2009
MICROBICIDES
MTN (HPTN) 035, BufferGel & 0.5% PRO2000
CAPRISA 004 Tenofivir
South Africa
HSV-2 SUPPRESIVE THERAPY
HPTN 039
Gates, Partners in Prevention
AMREF HSV Project
PrEP
CDC, Truvada (FTC/TDF)
Switched to TDF-Plus March 2007
VACCINE
HVTN 503
Thailand study
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HIV PREVENTION TRIALS
High HIV prevalence and incidence areas
Resource-poor settings
Clinical trial setting – provision of high standard of
reproductive health care
This presentation and the information contained therein is the sole property of the South African Medical Research Council
PROVISION OF CARE IN MICROBICIDE TRIALS
CARE
REPRODUCTIVE
HEALTH
HIV-RELATED
CARE
SAFETY (PRODUCTRELATED)
Treatment of STIs/RTIs
VCT
Colposcopy
Cervical smears
Condom promotion
Treatment of UTIs
Safe-sex counselling
Systemic absorptionsafety bloods
Testing for pregnancy
Referral for treatment of HIV
and opportunistic infections
Contraception provision
Partner testing, treatment,
referral
AE/SAE
Visual inspection
This presentation and the information contained therein is the sole property of the South African Medical Research Council
RESPONSIBILITY OF TRIAL
SPONSORS AND RESEARCHERS TO
FACILITATE ACCESS TO HIV AND
OTHER CARE
This presentation and the information contained therein is the sole property of the South African Medical Research Council
Role of Regulators
• Require well defined plans for care prior to study approval
• Ethics committee – approval granted if issues of care clearly
stated
• MCC – require indication regarding idemnity against trial injury
• Product assurance and insurance.
This presentation and the information contained therein is the sole property of the South African Medical Research Council
CREATING PARTNERSHIPS FOR PROVISION OF CARE
COMMUNITY/NGO
/CBO
OTHER CARE
PROVIDERS
CLINICAL
RESEARCH SITE
DOH
SPONSORS
This presentation and the information contained therein is the sole property of the South African Medical Research Council
SITUATIONAL ANALYSIS OF AVAILABLE
HEALTHCARE IN COMMUNITIES
HIV-related care – ARV programmes, counselling, etc
Reproductive health care – local hospitals/clinics
Other medical care – local hospitals/clinics
Population Council Phase III Study of the Efficacy and Safety of the Microbicide Carraguard ® in Preventing
HIV Seroconversion in Women
SCHOOLS, HEALTH FACILITIES AND NGO's (CENSUS '01) AROUND ISIPINGO MEDICAL TOWERS, DURBAN
Luganda
Luganda
Chatsworth
Chatsworth
1100
Adams
Adams Mission
Mission
Main Places
Sub Places
KwaZulu
Natal
SOUTH
AFRICA
Data Sources:
Sub and main places - Statistics SA
Roads - KZN Dept. of Transport
Heath Facilities - KZN Dept. of Health
NGO's and CBO's - HSRC
Map produced by the
Amanzimtoti
Amanzimtoti
Health GIS Centre
Medical Research Council of SA
Tel. +27 (31) 203 4700
URL. www.mrc.ac.za
Maphunulo
Maphunulo
KwaMakhutha
KwaMakhutha
Main
District
National
Community / Local
Isipingo Medical
Medical Towers
Towers Hospital
Hospital
Isipingo
Malagazi
Malagazi
Combined
Unknown
Secondary
Primary
Folweni
Folweni
Health Facilities
NGO's and CBO's
Roads
Umlazi
Umlazi
apumulo
Mapumulo
Schools
Lamontville
Lamontville
Sobonakhona
Sobonakhona
kkm
m
10 km Buffer
Isipingo Medical
Towers
Durban
Durban
Klaarwater
Klaarwater
Cele
Cele //
Vumengazi
Vumengazi
11
Legend
This presentation and the information contained therein is the sole property of the South African Medical Research Council
REFERRAL FOR CARE- Durban
Centre
Services Provided
Primary Health Care and VCT
Prince Mshiyeni Hospital
VCT, PMTCT, STI treatment, support group, CD4, ARV, reproductive health care
Wentworth Hospital
VCT, PMTCT, STI treatment, support group, CD4, ARV
Primary Health Clinics x 23
VCT, PMTCT, STI treatment, family planning (some), CD4 (some), infant feeding
programme (some), income-generating projects (some), support group (some)
HIV Treatment & Care
Prince Mshiyeni VCT
VCT, PMTCT, support group, ARV
Ithembalabantu Clinic
VCT, CD4, ARV (including children)
Sinikithemba
VCT, ARV, support group, income-generating projects, drop-in centre
Wentworth Hospital
VCT, PMTCT, CD4, support group, ARV
Support Services
Support services x 32
VCT, counselling, rape counselling, workshops, home-based care, orphan care,
support group, income-generating projects, education & awareness, assist with
grants, community development, youth programmes, PMTCT, nutrition, violence
Social & Psycho-social Care
KZN Hospices
End of life care and support
Welfare
Family support, orphans, social support, grants
Other: FAMSA, NICRO, DBN
Trauma, AIDS Helpline
Counselling, support, information, advise, etc
This presentation and the information contained therein is the sole property of the South African Medical Research Council
TREATMENT AND CARE IN TRIALS AND BEYONDEVOLVING PROCESS
Issues to consider:
Standard of care at trial sites- may not differ greatly from the standard of
care in the country
Sustainability of care e.g. Cervical smears, STI treatment, VCT,
contraceptive provision etc
Care of seroconvertors – in trials and beyond
Provision of care beyond trial – evolving process with increasing
availability of ARV therapy in resource poor setting
This presentation and the information contained therein is the sole property of the South African Medical Research Council
HIV RELATED CARE IN MICROBICIDE TRIALS
Women
VCT
HIV +ve
HIV - ve
HIV
Seroconversion
•Women who
volunteer for VCT
•What is the
responsibility of the
researcher?
Short-term
care
Long-term
care
Ongoing counselling
HIV counselling
Monitoring of HIV
infection
Continued monitoring of
infection
Screening and Treatment
of OI
Screening and Treatment of
co-infection
Reproductive health care
Initiation of treatment – ARV
STI treatment and care
Adherence counselling and
long-term support
This presentation and the information contained therein is the sole property of the South African Medical Research Council
CARE FOR HIV+VE WOMEN AT ENROLLMENT HPRU MODEL –
Facilitating linkages to care in partnership with local health care providers
HIV Positive women
at Screening
Development of memorandum of
understanding (MOU) between
trial site and government referral
hospital
•Assess participant’s need for ARV
treatment
•Women with CD4 <200 will be
counselled to go on treatment
programme
•On-going monitoring of HIV infection
among those women not in need of
treatment
•Trial site – provide with update of
research statistics
Scaling up of treatment efforts
Development of partnership with
external donor, e.g. PEPFAR
Aurum Health
(PEPFAR recipient)
Set up sites adjacent to
prevention trial sites
Wellness clinic
CD4 monitoring
Counselling
Preparation for ARV
Treatment of OI
Referral to ART clinic
IMPORTANT: Local health providers need to be informed of the partnership
with PEPFAR and updated scaling up systems – feed into local clinics/hospitals
This presentation and the information contained therein is the sole property of the South African Medical Research Council
ENSURING TREATMENT ACCESS IN TRIALS
AND BEYOND
PEPFAR
MOU
(Scaling up ARV)
Provincial Department of Health
2 sites
McCords
Hospital
Prince
Mshiyeni
Osindsweni
Hospital
Mahatma
Gandhi
G J Crooks
Hospital
Hlabisa
Hospital
Assess HIV + participant need for ART
Counselling and initiation of ART for participants with CD4 <200
Treatment of opportunistic infections including chest x-ray
On-going monitoring of infection
Regular reporting to MRC on number of women seen and care provided
NB: MOU to be set up prior to study initiation
HIV-related network of care services
management of non-trial related
events/medical conditions
Assessment of HIV + participant
need for ART
Enrolment in ARV programme for
participants with CD4 <200
Treatment of opportunistic infections
and chest x-rays
R K Khan
Hospital
KZN
Hospice
Tongaat
Clinic
This presentation and the information contained therein is the sole property of the South African Medical Research Council
HPRU MODEL – FACILITATING LINKAGES TO CARE
HIV Seroconvertors
Short-term Care
(Trial Site)
Memorandum of
Understanding
On-going counselling
•Assess participant’s need
for treatment
•Women with CD4 < 200
will be counselled to go on
treatment programme
•On-going monitoring of
HIV infection among those
women not in need of
treatment
•Provide regular report on
number of women seen
from the trial and the care
provided
•Trial site – ongoing
communication
Baseline CD4
Treatment of STIs
Enter treatment
trial or other
studies
PEPFAR
programme
•Ongoing HIV
counselling
•Ongoing HIV
counselling
•Monitoring of CD4
•Monitoring of CD4
•Treatment of OI
•Treatment of OI
•Safe sex counselling
•Safe sex counselling
Condom promotion
Assist referral site with
capacity building
Partnering with local health providers for
short/long-term referral
This presentation and the information contained therein is the sole property of the South African Medical Research Council
CARE
TREATMENT
HIV PREVENTION
INTEGRATION OF PREVENTION, TREATMENT & CARE
COMMUNITY, DOH, NGO’s, CBO’s & SOCIOBEHAVIOURAL COMPONENT
This presentation and the information contained therein is the sole property of the South African Medical Research Council
CONCLUSION
Difficult to conduct HIV prevention trials without consideration for
treatment and care
There should be country-specific acceptable Standards of Care
Partnership and on-going communication with local DoH is
essential
Effective and acceptable strategies need to be developed between
local DoH, sponsors, NGO/CBO and researchers
Creating MOUs at outset with DoH and facilitating care at the trial
sites with support from sponsors and donors
Provision of care – moving target as more treatment available in
resource poor settings.