The world has spent nearly a quarter of a century
wondering whether Africa’s most widely used birth control method could make
women more likely to contract HIV.
Now, new research, conducted in four countries,
including South Africa, has solved the riddle.
The three-month shot Depo-Provera does not increase
a woman's risk of HIV infection; prove the results of the Evidence for
Contraceptive Options and HIV Outcomes (Echo) study.
The findings were released at the South African Aids
Conference in Durban Thursday and published in The Lancet.
For decades, it was like there was a spectre among
the data - something researchers thought they saw but couldn't entirely be
sure.
From South Africa to Tanzania, studies kept picking
up what seemed like an association between the widely used three-month birth
control shot marketed as Depo-Provera and HIV infection.
A 2016 review of nearly three dozen studies
published in the journal Aids suggested Depo-Provera users could be 20% to 60%
more likely to contract the virus compared to women who didn't rely on this
hormone-based contraceptive method.
The
problem was, none of this research proved it. Why?
Because it was never designed to do that, Scientists
couldn’t tell if what they thought they saw in the numbers was right - whether
it was the shot or if they were picking up on something else that was putting
women at risk such as the lower rates of condom use that a 2005 study by the
Guttmacher Institute detected among some DEPO users.
The findings of the Echo study are the product of a
three-year study conducted among about 7 800 women in eSwatini, South Africa,
Kenya and Zambia.
As part of this, women wanting birth control agreed
to be randomly assigned one of three contraceptive methods a three-monthly shot of Depo-Provera, a copper
implant inserted into the uterus; or a small, hormone-based upper arm implant
known as Jadelle.
Although women were allowed to change the type of
contraception they were assigned to if they wished, most didn't.
And because scientists believed it was unethical to
withhold contraception from women who wanted it, everyone got one of the three
choices.
Randomisation like this helps ensure that any
factors, such as age, that could affect the study's results are spread equally
among all groups, making these kinds of "gold standard" studies the
best at determining cause and effect relationships.
The Echo found no substantial difference in the
rates of HIV infection among the three groups.
So
what should South African women know?
"From what we can see there is no increased
risk from any of those three methods in terms of increasing your chances of
contracting HIV", says executive director of the Wits Reproductive Health
Institute Helen Rees. Rees is also a member of the five-person committee that
led the study.
"However, none of these methods will protect
you against HIV… and you still need to protect yourself from HIV
infection", she explains. "But if you want to protect yourself
against unplanned pregnancy, these methods are a real option for you."
Its simple messages like this that will now need to
filter down to women and communities in languages and ways they can understand.
But their voices will also have to be represented in
the high-level discussions that will follow Thursday's results.
Historically, the world has done neither well, and
there may be a price to pay for that.
In October 2011, The Lancet published a study that
suggested a possible link between Depo-Provera and HIV risk.
It prompted a high-level World Health Organisation
(WHO) committee to see if it should issue warnings to doctors and women about
the contraception that forms the backbone of birth control programmes in much
of the Global South.
But with the kind of conclusive evidence Rees' trial
provided this week, the WHO was left without much to say and not a very clear
way of saying it: It advised women using Depo-Provera to also use condoms.
Activists
were not impressed.
In reality, most women who opt for long-acting
contraception like Depo-Provera do so because they are often unable to
negotiate condom use, co-director of the international organisation Aids-Free
World Paula Donovan pointed out at the time.
Lillian Mworeko is the East Africa regional
coordinator of the International Community of Women Living with HIV/Aids.
At the time, Mworeko was one of the few women with
HIV who was invited to the high-level WHO consultations on Depo-Provera and
HIV.
At one point, the Ugandan activist and others were
made to sign a confidentiality agreement that would have prevented them from
reporting back to their networks back home, Donovan argued.
Mworeko called the WHO out for issuing a lack of
clear guidance at the time: "Women at high risk of or living with HIV
still have a right to informed consent, which includes the right to information
that affects their health."
By 2017, the WHO had changed its tune, telling women
that for most, Depo-Provera works well enough, but for some, it may be risky.
It would be another four years before Rees could
fundraise the US$50-million (R746-million) needed to finance Echo, the world's
first study that investigated whether Depo-Provera fueled HIV infections.
In total, Rees and her fellow researchers spent 15
years planning - and finding money - for the Echo study.
"Was it easy to raise money for this
trial?" she asks. "The answer is no, it wasn't, and we have to ask
why that is.”
Rees told Bhekisisa in November 2018: “‘if there was
a product that men were using that had a question like this hanging over it. We
would have had an answer by now."
We
have the science, what now?
By 2017, the WHO had begun to tell women that
Depo-Provera could make them more likely to contract HIV in hopes that it would
allow those already at high risk for HIV - including many women in South Africa
- make an informed decision about their choice.
In practice, however, few women in the Global South
would have been given panoply of other options.
The WHO is preparing to issue updated guidance on
Depo-Provera by late August, WHO spokesperson Tarik Jašarević told Bhekisisa.
As part of this, a 28-person expert panel, including
clinical experts and outreach workers from countries such as South Africa and
Zimbabwe will review the evidence.
Their nominations were put forth for public comment
in May as part of the body's move towards greater transparency.
But only one of the participants is a woman openly
living with the virus, according to biographies posted online.
The final composition of this committee is still
being finalised.
Meanwhile, years without clear evidence and waffling
about what to say to women about contraception and HIV risk, and how to say it,
may have taken its toll.
Echo's findings come amid ongoing contraception
stock outs that have run into their second year: "At the moment with stock
outs, I could be given Depro-Provera one month if it's available and the next
time I come to the clinic I might only be able to get [birth control pills].
People are being switched between methods without
even being consulted on the side effects", activist Nomfundo Eland says.
Weeks ahead of this week's release of the Echo
results, The Lancet accidentally released the Echo research online briefly.
Both the journal's media relations manager Emily
Head and Rees confirmed to Bhekisisa that the early release was an
administrative error.
Rees explains: "It was absolutely nothing more
sinister than that."
But longtime HIV activist Nomfundo Eland argues it's
raised suspicions among women who may already be sceptical of the findings
despite the study's rigorous methods.
"We are going to have a hectic time [getting]
women to believe it, especially women and activists who have been following the
Echo agenda because the results were leaked", she says.
"We are asking ourselves questions - who leaked
it? For what purposes? What information got out, and who has it?"
Eland warns activists also remain concerned that the
early release led some study sites to rush feedback of results to participants,
leaving them confused.
Rees,
however, says that although the release did push some time frames forward, each
of the 12 sites had already developed its own plan to let women know what the
study found at the same time results were made public.
In some cases, sites let women know of the findings
before this week.
But Rees admits some scepticism is perhaps to be
expected.
"We hope that this study for most people will
be massively reassuring.
This was the
gold standard in terms of studies, and it was a study that was very well
executed", she explains.
"But this is an issue that has been discussed
backwards and forwards for years because no one was able to do a definitive
study until now. That's left ambiguity, and when you have ambiguity, people build
up a view."
Rees concludes: "There were certainly many
people of the view, looking at the data that existed [before]... that there was
a trend towards increased risk." Rees continues.
That some people won't believe the results even
three years of research may be unavoidable.
It's probably inevitable because of the strength of
view that has been built up over the years."
Echo solved one riddle, but it left many more.
About one in 20 women contracted HIV during over the
course of the study’s three years - not because of their birth control, but
because they face the same social and economic issues that lead 1300 young women
in South Africa to contract the virus every week, show the country's latest
household survey.
We need better and more contraception choices for
women, Rees and Eland warn.
And more ways to reach women with the tools they
need to prevent HIV.
"If women go for family planning, they get
family planning", Rees explains. "If they go into HIV services, they
get HIV services.
"We're not integrating our services… these are
women who are presenting themselves and who are sexually active they need both.
Together."
