Report from Mali – Part Four

It’s been several months since our last report from Mali, primarily because enrollment in the LDN study has been much slower than we expected. We need 147 participants that will complete the protocol and have set the goal of 171 in order to adjust for those who may drop out towards the end. If possible we will enroll even more…up to 200… in order to increase the reliability of the results.

We have finally cleared some significant hurdles (see below) and in just this past two weeks have enrolled 11 new people, with at least that number ready to be enrolled this week. We should be approaching 50% enrollment by the second or third week of August and full enrollment by the end of September. This spurt of activity is very encouraging after a very slow April, May and June. This is what happened:

  1. We had to adjust the CD-4 criteria for inclusion in the study to reflect new HIV/AIDS standards and also to broaden the range for the group of participants only receiving LDN. The range for this group is now 350 to 600 mgs. The CD-4 inclusion criterion for the two other groups, one of which receives both LDN and the HAART meds and the other only the HAART meds are defined by a CD-4 count less than 350. Individuals with any signs of AIDS symptoms (based on a clinical evaluation at intake) are excluded from the protocol even if their CD-4 count is above 350 mgs. Getting these important changes approved by the Mali National Board of Ethics for Health and Science took time.

    These changes have increased the rate of enrollment in the Program significantly

  2. The capability to enroll participants at one of the two medical facilities involved in the Program (Point G Hospital in Bamako) was seriously curtailed by the lack of testing facilities and office space for the Program Co-Principal Investigator. As a consequence a third facility, “Centre de Soins. D’Animation et de Conseil pour les personnes vivant avec le HIV/AIDS” (“CESAC”), has been added to the program, supported by two of its intake staff members. This addition also had to be approved by the Mali Authorities and, again, that took time.

    Now that CESAC has been officially approved as an intake facility the rate of enrollment should increase by at least 15 participants a week

  3. The stigma of being HIV positive, particularly before the onset of any symptoms is still a powerful force in the Mali Culture. Many HIV + individuals do not come in for testing until they have symptoms and by that time they are no longer eligible for the Program. We have suggested the Mali Team initiate a stronger outreach program but, even this type of activity met with a lot of resistance since the Team is concerned that publicity will keep people away. The stigma issue is a world-wide dilemma and we are planning to ask Mali Authorities to step up their national campaign when we next visit Mali in November. Meanwhile, the medical and GECP teams are doing their best to get the word out in an informal manner.
  4. There have been 17 participants enrolled in the LDN only Group for three months now so we are beginning to collect important data for this third of the eventual 47 participants in the group. Nine more participants have recently been added to this group as well, so it is now more than half enrolled. Enrollment in the two other groups is slower for the reasons mentioned above.
  5. The Gender Education and Communication Program was initiated in March and April with two council-groups involving both men and women. The discussions have been lively and remarkably open and honest. The cultural issues involved with the HIV/AIDS epidemic are being discussed along with issues of intimacy among men and women. The participants who have come forward to join the Program seem to be at the progressive edge of the Mali Culture. That Malian men and women—albeit a still small number—are beginning to talk openly about family, gender and even sexual issues is most encouraging and we trust this core of people will spread the word to friends and family in a way that will support the enrollment of new participants and the initiation of additional council groups in the near future.
  6. Because of the delays in the Program, it was necessary to adjust the budget and financial agreements with the Mali Team to avoid significant cost overruns. This has been accomplished with their full cooperation. The existing team has absorbed the salaries of the two new staff members from CESAC by agreeing to a uniform 4% salary cut. In addition, the whole team has formally agreed to continue working on the program after March 31st of next year—without compensation—even if several more months are needed to complete the clinical program. We are pleased with this agreement and feel the Mali and US teams are working as a unified intercultural entity.
  7. Assuming no significant surprises arise, the new budget indicates we will need just under $114,000 to complete the program—a third of the total. A revised detailed budget has just been posted on the “Donate Now” page of the web site. We invite all of our past supporters and those newly interested in the Mali Program to make a contribution soon, so that we can meet our goal and complete the first quantitative clinical trial of LDN as a way of preventing HIV+ individuals from developing full-blown AIDS.

It has not been an easy road to travel–and we have learned a lot this past year and a half–but now we feel the team is functioning quite well and the program is poised to accomplish the original vision.

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