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Care for seroconverters in CONRAD’s Cellulose Sulfate HIV Prevention Trial Lut Van Damme Global Campaign meeting 19-20 June 2008. The trial. Objectives and Endpoints. Primary:
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Care for seroconverters in CONRAD’s Cellulose Sulfate HIV Prevention TrialLut Van Damme Global Campaign meeting 19-20 June 2008
Objectives and Endpoints • Primary: • Effectiveness in preventing male-to-female transmission of HIV-infection through vaginal intercourse by comparing HIV incidence in both arms (ITT) • Secondary: • Effectiveness in preventing male-to-female transmission of gonorrhea and chlamydia infection through vaginal intercourse by comparing the incidence in both arms (ITT – time to first event)
Design and Population • Design: Randomized (1:1 allocation), placebo-controlled, blinded, two-arm, multicenter • Study Population: HIV negative women, 18 years or older, with multiple partners
Organizational Chart and Sites BENIN PI- Michel Alary Co-PI- Fernand Guedou INDIA-CH PI- Suniti Solomon CONRAD FHI ITM INDIA-BA PI- Marissa Becker Co-PI- Reynold Washington UGANDA PI- Florence Mirembe SOUTH AFRICA PI- Roshini Govinden
Sample Size and Power Planned sample size = 2,574 HIV negative women Assumptions: • 50% effectiveness of CS • 2-sided significance level of 0.05 • 80% power • 80% of participants completing 12-month follow up • HIV-incidence in control arm: 4%
(Interim) Analysis and IDMC • One planned interim analysis with Independent Data Monitoring Committee meeting after ~ 33 HIV seroconversions - 26 January 2007 • Guidance from the IDMC requested if p<0.10 in the direction of harm (i.e. stop for harm or futility)
Population Tree Screened 2985 Enrolled 1428 3 PCR Positive
KM Estimates of Incident HIV Infection Probabilities, by Treatment Group CS Placebo
The N9 (COL-1492) experience and impact on my perception of care
Care in the CS trial • Senior management and funders easily agreed with the principal to provide care • Original idea: • 5years (arbitrarily decided) • A rato of seroconverters within a site • Funding based on cost of local care (budgets provided by sites)
Issues • Care is more than ARV alone • Investigators cannot be held responsible for the funds (care needed after trial) • Giving money to individual women was considered not a good option (use of money for other things than her care) • In many countries: ARV are free sites can best decide on how to spend the money in the best way as to benefit care (in general)
Outcome • Funds would be given to referral clinics – transfer via CS study teams • Written agreements necessary • Some sites were ARV clinics
Study closure • CONRAD delegates the care of seroconverters to local study team • Local study team makes agreement with referral clinic(s) • Contract between CONRAD and local study team to transfer the funding – agreement between local site and referral clinic attached to this contract • CONRAD has reserved the right to do financial audits of the contracted (clinical) sites