this presentation and the information contained therein is the sole property of the south african...

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


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


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


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


RESPONSIBILITY OF TRIAL SPONSORS AND RESEARCHERS TO FACILITATE ACCESS TO HIV AND

OTHER CARE


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.


CREATING PARTNERSHIPS FOR PROVISION OF CREATING PARTNERSHIPS FOR PROVISION OF CARECARE

CLINICAL RESEARCH SITE

COMMUNITY/NGO/CBO

DOH

OTHER CARE PROVIDERS

SPONSORS


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

®


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


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


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


•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


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


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


INTEGRATION OF PREVENTION, TREATMENT & INTEGRATION OF PREVENTION, TREATMENT & CARECARE

COMMUNITY, DOH, NGO’s, CBO’s & SOCIO-BEHAVIOURAL COMPONENT

HIV

PR

EV

EN

TIO

N

TR

EA

TM

EN

T

CA

RE


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

this presentation and the information contained therein is the sole property of the south african...

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