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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Establishing a continuum of care between HIV prevention trials and public healthcare systems: The MIRA Standard of Care program
Clinical Trials, Volume 7, No. 3, Year 2010
Notification
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Description
Background The ability of researchers to provide sustainable care to individuals who acquire HIV during participation in HIV prevention trials has rapidly expanded along with national treatment options. The Methods for Improving Reproductive Health in Africa (MIRA) trial (2003-2006), a phase III multi-site randomized controlled trial, measured the effectiveness of the diaphragm used with Replens® lubricant gel in preventing heterosexual acquisition of HIV among women in Zimbabwe and South Africa. The MIRA Standard of Care program, which started towards the end of the trial period and continued for 5 months after trial closeout, enabled women who acquired HIV during the trial to receive additional counseling and clinical care and facilitated links to long-term HIV-related care and treatment from public health facilities. Purpose To describe eligible participants uptake of these optional services and evaluate the programs strengths and limitations. Methods All women who acquired HIV during their MIRA participation were re-contacted and invited to return to the study clinics for additional care and referrals. Sites reported monthly statistics of uptake of services. Results From start to end, 185 of 323 (57%) HIV-positive participants accepted additional care; 81 (25%) could not be relocated. 142 (44%) women received referrals to government healthcare facilities and 90 (28%) enrolled in wellness/ treatment programs. Fifty-seven (18%) declined further care, but reasons for doing so were not recorded systematically. Limitations The program began after most participants had exited from the MIRA trial and required re-contacting women, resulting in difficulty in locating some participants. Conclusions In the future, care for participants who seroconvert should be offered at the trial onset and fully integrated into clinical trials to avoid losing these participants for further care. More research is needed to identify and understand perceived barriers to establishing a continuum of care between clinical trials and public sector health facilities. © 2010 The Author(s).
Authors & Co-Authors
Clouse, Kate A.M.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Montgomery, Elizabeth T.
United States, Research Triangle Park
Rti International
Milford, Cecilia
South Africa, Tygerberg
South African Medical Research Council
Watadzaushe, Connie
Zimbabwe, Harare
Uz-ucsf Collaborative Program in Women's Health
Nkala, B.
South Africa, Johannesburg
Perinatal Hiv Research Unit
Fancher, Heidi
United States, San Francisco
University of California, San Francisco
Lince, Naomi
United States, Cambridge
Ibis Reproductive Health
Cheng, Helen Y.
United States, Research Triangle Park
Rti International
Thompson, Marin
South Africa, Johannesburg
Perinatal Hiv Research Unit
van der Straten, Ariane
United States, Research Triangle Park
Rti International
United States, San Francisco
University of California, San Francisco
Statistics
Citations: 10
Authors: 10
Affiliations: 7
Identifiers
Doi:
10.1177/1740774510368299
ISSN:
17407745
e-ISSN:
17407753
Research Areas
Health System And Policy
Infectious Diseases
Sexual And Reproductive Health
Study Approach
Quantitative
Study Locations
South Africa
Zimbabwe
Participants Gender
Female