Ibis Reproductive Health

MIRA Standard of Care Impact Evaluation

The Methods for Improving Reproductive Health in Africa (MIRA) trial was a randomized controlled trial to determine whether the diaphragm with non-contraceptive, lubricant gel might reduce HIV/sexually transmitted infection (STI) acquisition among women. The trial, which began in 2003, came to an end in 2006.

In 2005, the MIRA trial investigators initiated an intensive program to ensure that women who became HIV positive during the trial received the care they needed, which included individual case management, formalization of agreements with referral sites regarding service provision and tracking systems, and, in some cases, direct provision of or payment for services (that were not previously provided at the trial sites). The ultimate goal of this approach, referred to as the Standard of Care (SOC) program, was to actively facilitate the linking of trial seroconverters to existing care and treatment—not to assume responsibility for care and treatment.

The SOC Impact Evaluation was conducted at the three MIRA trial sites in Durban and Johannesburg, South Africa, and Harare, Zimbabwe. The specific aims of this work were to:

Describe the process through which the MIRA researchers and the referral sites established and maintained an agreement (verbal or written) regarding the care and treatment of MIRA trial participants;
Identify both actual and perceived, potential benefits and challenges presented by the existence of a study such as the MIRA trial in the referral site community;
Assess the impact of the referral site-MIRA trial relationship on referral site service provision as a whole and for MIRA trial participants specifically;
Elicit recommendations for future collaborations between researchers and the referral sites (and possibly the larger community).

Collaborators included the Women’s Global Health Imperative at RTI International, the University of Zimbabwe-UCSF Collaborative Research Programme, the Medical Research Council of South Africa, and the Perinatal HIV Research Unit of South Africa.

Analysis of the data is underway, and results are expected in 2008.

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