It includes doing the wash, minding the kids, calling before the holidays with reminders to make sure to stay in touch . . . “Whatever it takes to get the job done, we will do,” Bekker said.
The job is furthering practical biomedical HIV prevention science, the relationship is between researchers and clinical trial participants, and she was talking at the Emavunleni Centre, a Desmond Tutu HIV Foundation site housed in slender solid building in the midst of New Crossroads, a densely settled place of small crowded homes, unemployment, both petty and violent crime, and a history of tragedy, oppression and violence visited upon it during South Africa’s Apartheid years. To get there, you leave the shiny buildings and iconic views of downtown Cape Town and its waterfront behind, and drive close to the airport, where makeshift homes made of scraps of other people’s homes, with tin roofs held down with rocks, and jammed against each other, line the road.
The burden of infectious diseases, HIV, other sexually transmitted diseases, TB is high here. Roughly one in three women coming to a pre-natal (or as they say here ante-natal) care clinic here is HIV positive. By primary school about 20 percent of children have become infected with tuberculosis, by high school about 50 percent of teenagers, and by their 20s, Bekker said today, from 80 to 85 percent of young residents here will be infected with TB. Accepted local wisdom, Bekker says, is that people infected with TB but not infected with HIV have about a 10 percent chance of getting sick from tuberculosis in their lifetimes. For a person who lives with HIV the odds multiply greatly — to a ten percent chance of getting sick from tuberculosis each year. “But we really think it’s closer to 30 to 40 percent per annum,” Bekker added. When HIV damages the immune system of a person living with HIV enough (to under previous World Health Organization treatment criteria guidelines of 350 CD4 cells per cubic litre of blood) in a person infected with tuberculosis, sickness from the disease is nearly inevitable, Bekker said.
All of these numbers and more brought researchers to this township 10 years ago, to both seize the opportunity they offered to search for scientific solutions, and to be able to offer them, as they become available, where they are needed.
The center’s housing, goals, and the population with whom it works have grown since — its space, in which staffers maneuver delicately around each other, least of all. As science, in recent years has produced promising leads, this place has become a home to a vast array of clinical trials to test the safety and effectiveness of HIV vaccine, microbicide and antiretroviral pre-exposure prophylaxis candidates. It is home now to the ASPIRE trial to see if a ring containing antiretroviral drugs, remaining inside the vagina for a month can protect women from getting infected with HIV and the HVTN 097 trial to see if RV144, the vaccine regimen which showed modest effectiveness in protecting against HIV infection in Thailand might work in Africa.
The course of finding potential pools of trial participants is lengthy and involves multiple exchanges of information — from community members to researchers and researchers to community members, and once a participant is enrolled in a trial, screening for the health conditions that threaten the residents here becomes routine, and freed of lines, waits and hostility from overburdened health staff that can make going to a public health center a day-long investment.
For all of that, being a trial participant is not easy either. Participants in the ASPIRE trial for example will over the course of the research pay 27 monthly visits to the center. And Bekker notes, while participants are healthy to begin with, any trial participation can include side effects from the medicines being tested. “We’re really not giving them anything that they directly benefit from,” she added.
Thus the relationship — the meeting in a restroom at a store to make providing a product more convenient, the laundry, the watching the kids. But she and other staffers at the center agree, what draws participants, at least in part, is a desire to be part of the eventual solutions to the diseases that threaten them. From all of that, they say, comes the relationship. It paid off, Bekker said, when the Phamibili trial of a vaccine candidate was stopped, because it not only had proven futile in other locations, but shown slightly higher numbers of people on the product than on the trial’s placebo, becoming infected with HIV in the course of the trial.
While the news devastated staffers, “the community was extraordinarily reaffirming,” Bekker said, recalling participants reminding staffers: “You told us it was experimental. You told us there was a placebo.”
She concluded, “There are no shortcuts to informed consent. Full stop. The time you put into informed consent pays dividends.”