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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 GLOBAL STATUS OF HIV PREVENTION TRIALSTRIALS
TRIAL COUNTRY STATUS END DATE
MICROBICIDES
Population Council, Carraguard South Africa 3602 Results end 2007
MDP 301, 0.5% & 2% PRO2000 South Africa, Tanzania, Uganda, Zambia
5726/9673 Dec 2009
MTN (HPTN) 035, BufferGel & 0.5% PRO2000 South Africa, Malawi, Zambia, Zimbabwe, USA
3100/3220 Mid 2009
CAPRISA 004 Tenofivir South Africa
HSV-2 SUPPRESIVE THERAPY
HPTN 039 9 sites (USA, Peru, Africa) 3277/3277 2008
Gates, Partners in Prevention 14 African sites 3408/3408 2009
AMREF HSV Project Tanzania 1305 Completed 2007
PrEP
CDC, Oral Tenofovir (TDF) Thailand 1762/2000 2008
CDC, Oral Tenofovir (TDF) USA 400/400 2008
CDC, Truvada (FTC/TDF)
Switched to TDF-Plus March 2007
Botswana 167/1200 2009
NIAID, Truvada (FTC/TDF) Peru 100/3000 Dec 2009
Gates, Oral Tenofovir (TDF) Ghana, Cameroon, Nigeria 936/1200 Ended
VACCINE
HVTN 503 South Africa 605/3000 End 2008
Thailand study Thailand 16200/16200 Results Q3 2009
This presentation and the information contained therein is the sole property of the South African Medical Research Council
HIV PREVENTION TRIALSHIV 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 PROVISION OF CARE IN MICROBICIDE TRIALSTRIALS
CARE
HIV-RELATED CARE
REPRODUCTIVE HEALTH
SAFETY (PRODUCT-RELATED)
Treatment of STIs/RTIs
Cervical smears
Treatment of UTIs
Testing for pregnancy
Contraception provision
VCT
Condom promotion
Safe-sex counselling
Referral for treatment of HIV and opportunistic infections
Partner testing, treatment, referral
Colposcopy
Systemic absorption-safety bloods
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 CREATING PARTNERSHIPS FOR PROVISION OF CARECARE
CLINICAL RESEARCH SITE
COMMUNITY/NGO/CBO
DOH
OTHER CARE PROVIDERS
SPONSORS
This presentation and the information contained therein is the sole property of the South African Medical Research Council
SITUATIONAL ANALYSIS OF AVAILABLE SITUATIONAL ANALYSIS OF AVAILABLE HEALTHCARE IN COMMUNITIESHEALTHCARE IN COMMUNITIES
HIV-related care – ARV programmes, counselling, etc
Reproductive health care – local hospitals/clinics
Other medical care – local hospitals/clinics
SobonakhonaSobonakhonaSobonakhonaSobonakhonaSobonakhonaSobonakhonaSobonakhonaSobonakhonaSobonakhona
ChatsworthChatsworthChatsworthChatsworthChatsworthChatsworthChatsworthChatsworthChatsworth
UmlaziUmlaziUmlaziUmlaziUmlaziUmlaziUmlaziUmlaziUmlazi
KwaMakhuthaKwaMakhuthaKwaMakhuthaKwaMakhuthaKwaMakhuthaKwaMakhuthaKwaMakhuthaKwaMakhuthaKwaMakhutha
LamontvilleLamontvilleLamontvilleLamontvilleLamontvilleLamontvilleLamontvilleLamontvilleLamontville
MalagaziMalagaziMalagaziMalagaziMalagaziMalagaziMalagaziMalagaziMalagazi
Cele /Cele /Cele /Cele /Cele /Cele /Cele /Cele /Cele /VumengaziVumengaziVumengaziVumengaziVumengaziVumengaziVumengaziVumengaziVumengazi
FolweniFolweniFolweniFolweniFolweniFolweniFolweniFolweniFolweni
AmanzimtotiAmanzimtotiAmanzimtotiAmanzimtotiAmanzimtotiAmanzimtotiAmanzimtotiAmanzimtotiAmanzimtoti
MapumuloMapumuloMapumuloMapumuloMapumuloMapumuloMapumuloMapumuloMapumulo
LugandaLugandaLugandaLugandaLugandaLugandaLugandaLugandaLuganda
Adams MissionAdams MissionAdams MissionAdams MissionAdams MissionAdams MissionAdams MissionAdams MissionAdams Mission
MaphunuloMaphunuloMaphunuloMaphunuloMaphunuloMaphunuloMaphunuloMaphunuloMaphunulo
DurbanDurbanDurbanDurbanDurbanDurbanDurbanDurbanDurban
KlaarwaterKlaarwaterKlaarwaterKlaarwaterKlaarwaterKlaarwaterKlaarwaterKlaarwaterKlaarwater
Isipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers HospitalIsipingo Medical Towers Hospital
Roads
Schools
11
Legend
Sub Places
Main Places
Main
District
National
Community / Local
Secondary
Primary
Combined
Unknown
Health Facilities
NGO's and CBO's
Isipingo MedicalTowers
10 km Buffer
Population Council Phase I I I Study of the Efficacy and Safety of the Microbicide Carraguard in PreventingHIV Seroconversion in Women
SCHOOLS, HEALTH FACILITIES AND NGO's (CENSUS '01) AROUND ISIPINGO MEDICAL TOWERS, DURBAN
S O U T H
A F R I C A
KwaZulu Natal
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
Health GIS Centre
Medical Research Council of SA
Tel. +27 (31) 203 4700
URL. www.mrc.ac.za
®
This presentation and the information contained therein is the sole property of the South African Medical Research Council
REFERRAL FOR CARE- Durban 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
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
TREATMENT AND CARE IN TRIALS AND BEYOND- TREATMENT AND CARE IN TRIALS AND BEYOND- EVOLVING PROCESSEVOLVING PROCESS
This presentation and the information contained therein is the sole property of the South African Medical Research Council
HIV Seroconversion
Short-term care
Long-term care
Ongoing counselling
Monitoring of HIV infection
Screening and Treatment of OI
Reproductive health care
STI treatment and care
HIV counselling
Continued monitoring of infection
Screening and Treatment of co-infection
Initiation of treatment – ARV
Adherence counselling and long-term support
•Women who volunteer for VCT
•What is the responsibility of the researcher?
Women
HIV +ve HIV - veVCT
HIV RELATED CARE IN MICROBICIDE TRIALSHIV RELATED CARE IN MICROBICIDE TRIALS
This presentation and the information contained therein is the sole property of the South African Medical Research Council
•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
Wellness clinic
Aurum Health (PEPFAR recipient)
Set up sites adjacent to prevention trial sites
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
HIV Positive women at Screening
Development of memorandum of understanding (MOU) between trial site and government referral hospital Development of partnership with
external donor, e.g. PEPFAR
Scaling up of treatment efforts
CARE FOR HIV+VE WOMEN AT ENROLLMENT HPRU CARE FOR HIV+VE WOMEN AT ENROLLMENT HPRU MODEL – Facilitating linkages to care in partnership with MODEL – Facilitating linkages to care in partnership with local health care providerslocal health care providers
This presentation and the information contained therein is the sole property of the South African Medical Research Council
MOU
Provincial Department of Health
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 <200Treatment of opportunistic infections and chest x-rays
PEPFAR
(Scaling up ARV)
2 sites
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
ENSURING TREATMENT ACCESS IN ENSURING TREATMENT ACCESS IN TRIALS AND BEYONDTRIALS AND BEYOND
Prince Mshiyeni
Osindsweni Hospital
Mahatma Gandhi
G J Crooks Hospital
Hlabisa Hospital
R K Khan Hospital
KZN Hospice
Tongaat Clinic
McCords Hospital
This presentation and the information contained therein is the sole property of the South African Medical Research Council
HIV Seroconvertors
•Ongoing HIV counselling
•Monitoring of CD4
•Treatment of OI
•Safe sex 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
•Ongoing HIV counselling
•Monitoring of CD4
•Treatment of OI
•Safe sex counselling
Partnering with local health providers for short/long-term referral
Memorandum of Understanding
Enter treatment trial or other
studies
PEPFAR programme
Short-term Care (Trial Site)
On-going counselling
Baseline CD4
Treatment of STIs
Condom promotion
Assist referral site with capacity building
HPRU MODEL – FACILITATING LINKAGES TO HPRU MODEL – FACILITATING LINKAGES TO CARECARE
This presentation and the information contained therein is the sole property of the South African Medical Research Council
INTEGRATION OF PREVENTION, TREATMENT & INTEGRATION OF PREVENTION, TREATMENT & CARECARE
COMMUNITY, DOH, NGO’s, CBO’s & SOCIO-BEHAVIOURAL COMPONENT
HIV
PR
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EN
TIO
N
TR
EA
TM
EN
T
CA
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This presentation and the information contained therein is the sole property of the South African Medical Research Council
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.
CONCLUSIONCONCLUSION
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