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- convertors’care 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 treatment All were very supportive and happy with the approach

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

Sponsor’s 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

Challenges 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 agreements Uganda National Council for Science and Technology 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 staffs 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.

Conclusion 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 standardise 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 articulated 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 participation. 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.

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