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HIV Research in International Settings. Wafaa El-Sadr, MD, MPH Columbia University. Overview of Presentation. Status of HIV epidemic HIV-related research where done and who is doing it Priority questions– implementation science Challenges and solutions Conclusions.

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Hiv research in international settings l.jpg

HIV Research in International Settings

Wafaa El-Sadr, MD, MPH

Columbia University


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Overview of Presentation

  • Status of HIV epidemic

  • HIV-related research

    • where done and who is doing it

  • Priority questions– implementation science

  • Challenges and solutions

  • Conclusions


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Adults and children estimated to be living with HIV  2009

Eastern Europe & Central Asia

1.4 million

[1.3 million – 1.6 million]

Western &

Central Europe

820 000

[720 000 – 910 000]

North America

1.5 million

[1.2 million – 2.0 million]

East Asia

770 000

[560 000 – 1.0 million]

Middle East&North Africa

460 000

[400 000 – 530 000]

Caribbean

240 000

[220 000 – 270 000]

South & South-East Asia

4.1 million

[3.7 million – 4.6 million]

Sub-Saharan Africa

22.5 million

[20.9 million – 24.2 million]

Central &

South America

1.4 million

[1.2 million – 1.6 million]

Oceania

57 000

[50 000 – 64 000]

Total: 33.3 million[31.4 million – 35.3 million]

UNAIDS, 2010


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Antiretroviral Therapy by Region--2001


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Number of PLWH receiving ART in low- and middle-income countries, by region, 2002–2009

UNAIDS, 2010


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Change in HIV Incidence

UNAIDS, 2010


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HIV Treatment Coverage in Low & Middle Income Countries

WHO Towards Universal Access 2010


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Coverage of HIV Prevention–Low Resource Countries, 2004-2009

Estimates of Coverage

Unmet HIV Prevention Need

HIV testing

61%

5%

20%

39%

70%

Condom Use

15%

30%

9%

75%

Male Circumcision

10%

25%

Antiretroviral Drugs for

PMTCT

9%

32%

53%

47%

Contraception for PMTCT

72%

20%

14%

28%

0%

40%

60%

80%

100%

20%

2006/7

2004

Unmet HIV Prevention Need

2009

Source: UNAIDS/WHO, 2010

Adapted Ward Cates


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CROI 2011Oral Abstracts


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Oral Posters


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International Scholars


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Implementation Science

The study of methods to improve the uptake, implementation and translation of research findings into routine and common practices with the goal of improving program effectiveness and optimize efficiency

Know-Do

Evidence to Program Gap


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Examples of Implementation Science Questions

Adapted Padian et al, JAIDS 2011


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Countries with ICAP-Supported Programs

TUNISIA

Kazakhstan

MOROCCO

ALGERIA

WESTERN

LIBYA

EGYPT

Uzbekistan

SAHARA

Turkmenistan

Kyrgyzstan

MAURITANIA

MALI

Tajikistan

NIGER

ERITREA

SENEGAL

CHAD

SUDAN

THE

DJIBOUTI

GAMBIA

BURKINA

GUINEA

GUINEA

BISSAU

BENIN

NIGERIA

TOGO

ETHIOPIA

COTE

CENTRAL

SIERRA

DTVOIRE

GHANA

AFRICAN

LEONE

REPUBLIC

LIBERIA

CAMEROON

UGANDA

SOMALIA

DEMOCRATIC

KENYA

EQUATORIAL

REP. OF

REPUBLIC

GUINEA

THE

OF THE CONGO

GABON

CONGO

(ZAIRE)

RWANDA

BURUNDI

TANZANIA

ANGOLA

MALAWI

ANGOLA

ZAMBIA

MADAGASCAR

ZIMBABWE

MOZAMBIQUE

NAMIBIA

BOTSWANA

SWAZILAND

LESOTHO

SOUTH

AFRICA


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ICAP International Research Portfolio

  • 40 active protocols

  • 9 countries

  • 4 studies with a multi-country component


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A range of methodologies…

  • Qualitative methods

    • Key informant interviews

    • Focus group discussions

  • Quantitative methods

    • Group randomized studies

    • Cohort studies

    • Cross-sectional surveys

  • Data collection

    • Questionnaires/interviews with patients and health workers

    • Data abstraction from routinely collected data

    • Site characteristics assessment tools


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GCP Training

  • Barriers

    • Non- Anglophone investigators have difficulty completing GCP training

    • Module content and examples are US focused and not relevant to international research

    • Field internet connections hinder completion of web courses

  • Suggestions

    • Consider translated modules e.g. French and Portuguese

    • Design modules with international focus appropriate for international investigators

    • Adequate local training given at the time of study launch rather than required early in the process


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The Protocol Approval Process

  • Multiple levels

  • Local and international


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Multiple IRBs Review Processes

  • Synchronizing reviews,  comments and versions

    • If submissions are simultaneous, different IRBs will provide feedback at different times

    • If submissions are done consecutively, the process takes more time

    • Deciding which IRB to submit to first:

      • For example, CU IRB usually gives more comments requiring protocol changes yet requires local IRB approval before they provide final approval


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Field implementation of IRB requirements

  • Getting timely approvals when there is national/MoH agenda and imperatives

  • Adhering to required formats e.g. having the international PI name on the consent form, which may conflict with local requirements

  • Using IRB stamped versions of tools

    • Running out of these forms


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Local issues

  • Local IRBs will usually approve first time protocols within reasonable time but

    • Renewals/modifications may take longer in some countries

    • Some countries have several levels of approvals which take more time

  • Getting certified translators to fulfill IRB requirements can be difficult with some local dialects

    • Example: Changana and Macua in Mozambique


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Example: PiCTS study

  • Multi-country multi-site PHE: Kenya and Tanzania under ICAP, + Namibia

  • Initial IRB submission done simultaneously in Oct 08

  • IRB approval dates:

    • Kenya local IRB Jan-09

    • CDC IRB Feb-09

    • CU IRB Feb-09

    • Tanzania

      • Mainland IRB Apr-09

      • Zanzibar IRB Jun-09

  • Several rounds of revisions


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Interpretation of IRB Non Human Subject Research (NHSR) determination

  • Program evaluations can be considered NHSR even if they include interaction with human subjects (with no identifiable information) but

    • the determination will say ‘no interaction with human subjects’

  • Publication of program evaluations may require additional approval but

    • This is not the case where there is no interaction with human subjects?

    • How to deal with publications to share local lessons learned?


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    Conclusions

    • Substantial advances in tackling the HIV epidemic, but many unanswered questions remain

    • Priority of pragmatic questions—implementation science

    • Need to respond to the local circumstances and needs

    • Importance of considering the flow of approvals

    • Clearer definitions and interpretation of NHSR

    • Challenge of non-traditional research

    • Establishing responsive systems for support of international research is a key priority


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