Establishing a continuum of care between HIV prevention trials and public healthcare systems: the MIRA Standard of Care program.
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.


OBJECTIVE
To describe eligible participants' uptake of these optional services and evaluate the program's 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.


CONCLUSIONS
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. Clinical Trials 2010; 7: 256-264. http:// ctj.sagepub.com.
Clouse
Kate
K
Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA. kclouse@unc.edu.
Montgomery
Elizabeth T
ET
Milford
Cecilia
C
Watadzaushe
Connie
C
Nkala
Busi
B
Fancher
Heidi
H
Lince
Naomi
N
Cheng
Helen
H
Thompson
Marin
M
van der Straten
Ariane
A
D017326:Clinical Trials, Phase III as Topic; D003266:Continuity of Patient Care; D003274:Contraceptive Devices, Female / Q000592:standards; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D006679:HIV Seropositivity / Q000453:epidemiology; D006801:Humans; D010353:Patient Education as Topic; D011634:Public Health; D016032:Randomized Controlled Trials as Topic; D012017:Referral and Consultation; D018456:Reproductive Medicine; D013019:South Africa / Q000453:epidemiology; D015030:Zimbabwe / Q000453:epidemiology