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The sustainability of care beyond HIV prevention trials: an evaluation of the MIRA standard of care programme
K. Clouse1, E.T. Montgomery2, C. Milford3, C. Watadzaushe4, B. Nkala5, N. Lince6, A. van der Straten2
1University of North Carolina Gillings School of Global Public Health, Department of Epidemiology, Chapel Hill, NC, United States, 2RTI International, San Francisco, United States, 3Medical Research Council, Durban, South Africa, 4University of Zimbabwe-UCSF Collaborative Research Programme in Women's Health, Harare, Zimbabwe, 5Perinatal HIV Research Unit, Johannesburg, South Africa, 6Ibis Reproductive Health, Johannesburg, South Africa
Background: The debate over the ethical obligation to provide ongoing healthcare to seroconverting participants after the close of HIV prevention trials has evolved as treatment options have expanded. The Methods for Improving Reproductive Health in Africa (MIRA) trial (2003-2006), a Phase III randomised controlled trial, evaluated the effectiveness of the diaphragm and Replens® lubricant gel in preventing heterosexual acquisition of HIV among women in South Africa and Zimbabwe. During the study, seroconverters received counselling and referrals for further care. Towards the end of the study, MIRA implemented the Standard of Care (SOC) programme, which enabled participants who had seroconverted to receive additional HIV-related clinical and psychosocial care at study clinics, and facilitated links to long-term, sustainable care and ARV treatment from available public health facilities.
Methods: We attempted to re-contact all exited HIV-positive participants and invite them to return for SOC services. We examined the frequency of eligible participants' uptake of these optional, expanded services during the SOC period from October 2006 to May 2007.
Results: 185 (57%) of 327 HIV-positive participants accepted some form of follow-up care, 57 (17%) declined and 81 (25%) were lost to follow-up. 123 women (38%) received a CD4 test at a MIRA clinic, which facilitated their entry into government treatment programmes. 142 (43%) women received referrals to public health facilities and 90 (28%) enrolled in treatment programmes.
Conclusions: Special services for seroconverters should be offered at the onset of HIV prevention trials and fully integrated into studies from the start to promote high rates of continued care and to avoid losing seroconverters to follow-up for further care. Additional research is needed to identify and understand perceived barriers to establishing a continuum of care for trial seroconverters and to define the best practice SOC in HIV prevention trials.
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