(introduction...)

The MOH of Cd'Ivoire requested the support of RETRO-CI for the implementation and evaluation of the UNAIDS/MOH Drug Access Initiative. To establish the implementation of the program, standard data collection forms were developed and used since August 1998 to collect information on the following: demographic characteristics, socioeconomic status, previous medications taken, therapy currently prescribed, clinical information, status of follow-up and the results of pertinent laboratory results. All the data collected are sent along with biologic samples to Projet RETRO-CI for data entry and laboratory testing. Persons accessing the UNAIDS/MOH Drug Access initiative follow a three-stage process: eligibility screening, initiation of therapy, and follow-up to monitor and evaluate the response to therapy.

1. Eligibility screening

A social worker in each of the accredited centers collects sociodemographic information upon presentation of each patient. Then, a physician assesses the patient's past medical history including prior and current ARV drug use, and a physical exam is performed. To determine biologic eligibility, a blood sample is then drawn. The specimen is sent to Projet RETRO-CI laboratory for serum chemistry, hematology, CD4 count and viral load. CD4 count was performed by flow cytometry (Facscan, Becton Dickinson, Aalst-Erembodegem, Belgium). HIV-1 RNA viral load was quantified in the plasma by reverse transcriptase PCR (RT-PCR) Amplicor HIV-1 Monitor Assay, version 1.5 (Roche Diagnostics Systems, Branchburg, NJ). This assay accurately quantifies HIV-1 subtype A/G recombinant viruses which are the predominant subtypes in Cd'Ivoire. The limit of viral detection was 200 copies/ml.

Upon request of the physician, Projet RETRO-CI submits a standardized anonymous summary report to the national committee for application and deliberation regarding the subsidy.

2. Initiation of therapy

If the patient meets the sociodemographic and biologic eligibility criteria and the committee has agreed to allocate a subsidy, the physician initiates ARV therapy. If the patient experiences an acute medical problem preventing him/her from initiating ARV therapy, the patient is seen in follow-up for treatment and reassessment of the problem. In such a case, patient will initiate therapy only if the medical problem is cleared.

3. Follow-up

Following the initiation of therapy, a patient is seen regularly at 1 month, and then every three months by his/her physician at the accredited center to assess response to therapy. Blood samples are drawn and sent to Projet RETRO-CI's laboratory for serum chemistry, hematology, CD4 counts and other immunological markers, and viral load testing. The clinician may modify the ARV regimen according to these results, if necessary.

The following procedures have been implemented to facilitate the transfer of forms and specimens between the six participating centers and Projet RETRO-CI. Each patient entering the initiative has a personal identification number. Data from the questionnaires are entered into one database; names and personal identifiers are entered into a separate database; access to this latter database is strictly limited to two persons.

Thereafter, any additional questionnaires and specimens collected will be identified by the personal identification number and not by any other personal identifier. Each time that a questionnaire is administered, taken to Projet RETRO-CI, and entered into the database, a copy is sent to the attending physician for the patient's hospital record.

The staging process used in this Initiative distinguishes three different populations:

1) patients who want to access this initiative,
2) patients who return after the eligibility screening to find out the result of their request, and
3) patients who have been successful in obtaining ARV therapy.

In order to evaluate this program, information from patients belonging to these three different populations was collected since August 1998. All this information has been centralized at Projet RETRO-CI and monthly reports have been generated. These reports are discussed during regular meetings with representatives of the different centers involved in this evaluation.