Providing%20Care%20and%20Treatment%20for%20HIV%20Sero-convertors%20in%20the%20Cellulose%20Sulfate%20Trial - PowerPoint PPT Presentation

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Providing Care and Treatment for HIV Seroconvertors in the Cellulose Sulfate Trial – PowerPoint PPT presentation

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Title: Providing%20Care%20and%20Treatment%20for%20HIV%20Sero-convertors%20in%20the%20Cellulose%20Sulfate%20Trial

Providing Care and Treatment for HIV
Sero-convertors in the Cellulose Sulfate Trial
  • Issues for discussion
  • Preparation process for care and treatment of
    trial participants
  • Identified Organisations
  • Issues agreed upon in the agreements
  • Sponsor responsibility
  • Government policies in shaping agreements
  • Challenges
  • Current status of the sero-convertors
  • Conclusion

Trial Issues
  • Recruitment
  • From Communities
  • Trial run for 18 months
  • 527 participants screened
  • 306 participants recruited and followed up

Preparation for Sero-convertorscare and treatment
  • Identified care and treatment centres
  • Made agreements with them
  • a) To refer to them all screened out
  • participants
  • b)To take on sero- convertors in the
  • trial for follow up and subsequent
  • treatment when the need arises.

Development of specific Agreements
  • Was a long process
  • Had to meet with the organisation Directors one
    by one
  • Went through the reach protocol and explained the
    need for study participant follow up and
  • All were very supportive and happy with the

What was agreed upon?
  • To provide continuing counseling and support
  • Continue monitoring for disease progression
  • a) Using DC4s
  • b) Monitoring for opportunistic Infections
  • c) Treatment of OIs
  • d) Provision of ARVs when need arises

Sponsors Contribution
  • Support monitoring for disease progression, i.e
    CD4, X-rays of chest etc
  • Contribute to availing OIs drugs if institution
    is having constraints
  • Contribute to purchase of ARVs in case of stake
    outs or need to change combinations that may not
    be available.
  • Agreed to have special identifier and allocate
    them to special field workers

  • Each organisation had its own procedures and
    follow up protocols
  • Issue of having Identifiers for individual trial
    participants outside their routine follow up
  • Participants changing clinics without informing
    Clinic staff
  • Participants having diseases and do not notify
    the clinic
  • Keeping trial participants under surveillance

Which were the organisations that were chosen
  • Those near and around Kampala
  • Well established in terms of care , treatment and
    follow up systems.
  • Those we already had working relationship with.
  • Were research oriented to easily appreciate
    research participants

Who was involved in the selection
  • Researchers
  • and
  • Field workers

Government policies that influenced the
  • Uganda National Council for Science and
  • Institutional Review Board
  • Rights for HIV/ AIDs Research Participants as
    viewed in Uganda under the Human Rights Policy.
  • Good Clinical Practice
  • Human Subject Guidelines
  • National policy does not give time limits.
  • Sponsor and researchers decided on follow up for
    Five years

Status of Trial participants
  • All sero-convertors were personally registered
    with an organisation of their choice by the trial
  • We are still in tough with them except one who
    disappeared right at the start.
  • All have been attending their respectful clinics
  • Been monitored according to national guidelines.
  • None so far has needed ARVs
  • None has had serious illness.

Challenges with time
  • Study staffs moved on
  • In two of the organisations , the Directors moved
    on .
  • Need to revisit the agreements with the new
    Directors, after the study has even closed
  • PI might move on with time, that then leaves a
    gap in the follow up process since all other
    staffs left.
  • Distributing the funds and accountability of
    small amounts of money in big institutions with a
    lot of funds.

  • Care for trial participants is a huge task but an
    absolute need.
  • We need well developed guidelines and these
    should apply for all trial in an effort to
  • There is a problem of communication especially in
    low resource settings with poor communication
    facilities .
  • Trial participants are used to researches and the
    need for follow up is not well understood and
  • Finally, HIV/AIDs research participation is
    stigmatised. So individuals participate privately
    and therefore there no community support for
    individuals in the researches as the participants
    do not usually want others to know of their
  • Therefore there is real need to involve
    communities to appreciate that such a research is
    ongoing within their society without revealing
    identity .This may offer indirect support.

  • Thank you