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The Last About "AT LAST"

Summer 2001

The first attempt to outline what happened (from an insider perspective).
  1. Introduction:

    • The beginning: how it all started and after 18 months of negotiations . . . who were the advocates, how the meeting came into place, the sponsors, the clinical investigators, the protocol design.

    • The Peer Advocate Component and Women Alive.

    • The announcement of the AT LAST trial, submitting to the FDA for approval (not once, not twice, but three times).

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  2. The AT LAST trial and the Peer Advocate Component:

    • The design of the Peer Advocate Component.

    • Hiring and training of Peer Advocates.

    • Meeting with sites and introducing the Peer Support Advocates.

  3. Trials and tribulations of the AT LAST and the PSAs:

    • Major resistance from the sites about PSAs. [Why do we need them? We have our own staff, you can't come in here. We have a peer (she does our transportation report).]

    • Breaking the barriers between peers and principal investigators.

    • Sites are established and supposedly ready for patient enrollment. More conference calls, and meetings.

  4. Waiting for patient enrollment and waiting for sites to be ready for enrollment.

    • Waiting, waiting, patiently waiting, not so patiently waiting.

    • Finally the Puerto Rico training yields cooperation and a model for others to follow.

    • Negotiating recruitment strategies of patients through peers. (Our job is retention, not recruitment, but we will help if you need help. Help? We don't need any help from you!)

    • Reviewing patients' charts for eligibility . . . nothing . . . no one.

  5. The first patients, and the last ones . . .

    • How did it work with peers, sites and patients? The triage at work.

    • The surveys.

    • Sites ready for enrollment? Sites not ready, yet! Damn, how long is it going to take? Clock's ticking here -- wake up!

  6. The awakening . . . it isn't going to work. It's the regimen, dummy.

    • Conference call about so few patients, nobody qualifies, and some sites are not ready.

    • Making the decision of "to be or not to be," with each site. How many patients can you get? Uuuhh, I don't know . . . if we can . . . um maybe three? Uh no, maybe half that.

    • Some sites sign the contract, and some of the investigators are bored and make a decision to not participate.

  7. The smooshing . . . talking to the PIs trying to keep the AT LAST trial alive . . .

    • The survey, the result, the decision.

  8. Guess what? It's over . . . no go. The bail out!

    • Who jumped ship first? Let's see -- it was not Women Alive!

    • We have other trials . . .

    • Opportunity for women in Puerto Rico to receive state of the art treatment is gone.

    • One year and a half, poof! The trial disappears. The PSAs gone!

  9. Lessons from the front lines:

    • What we learned: The PSA program works, trials should include PSAs in outreach.

    • Peer components for each trial or a peer for each site? Which can work best.

    • Money can do a lot of things!

    • Who is really committed to doing women's research? Hmmm . . . very few and it may not be as high of a priority as you might think.

    • Start smaller? Perhaps it can be best instead of a grand national scale . . . more money, more jobs. Hey, at least I'm employed!

    • The big bureaucracies . . . how can we help?

  10. What does it mean for the future?

    • Can CBOs, members of the community, pharmaceuticals and doctors really make a difference? Can we all get along?

    • Is women's clinical research going to continue? Who's going to carry the torch, now that the fire is smoldering?

    • More questions, less answers, still, 20 years, humm!

    • Women's conference 2003? Will it happen -- who will make it happen? If it does happen -- "Doctor can you tell me how these meds work in my body? Is it different for men?" Ah, good question! We are looking into that. At this time we don't know yet . . . we need to do more research in that area . . . and we really don't know, we suspect there could be a difference. Yeah there was the AT LAST trial, but it didn't happen, we didn't have enough women enrolled in the trial . . . blah, blah, we tried, blah blah. You know it's a relatively new virus, you know we don't know everything about this virus, you know it's a retrovirus and it acts differently than other viruses. It's only been 20 years, we don't understand the urgency.

      Is enrollment of HIV-positive women a problem? Can you find them? Are they "hard to find?" Are they hiding? Or do they qualify for your clinical trial? . . . Oh, no, she's of childbearing potential! . . . Next!

  11. The good thing about the AT LAST: Women Alive developed a comprehensive training curriculum for training HIV-positive women to be Peer Advocates with other HIV-positive women who are enrolled in a clinical trial. Women Alive trained over 15 HIV-positive women. Women Alive developed a comprehensive survey for entry, midway, and exiting a clinical trial with peer support to measure how and if it works for retention. (It worked for the three patients.) Women Alive continues to provide peer-to-peer support, treatment information, a sense of community, and a powerful voice for women living with HIV and AIDS. We wrote this article!

We got the inside scoop. And we are not giving up, not yet, not ever! We need to fine tune this article and give our readers and our constituents a solid explanation of what happened. We promise to do that in the next issue of Women Alive. You have not heard the last about AT LAST.

As we go to print, some local efforts are underway to study dosages in women diagnosed with HIV/AIDS.





  
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This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.
 

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