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Demonstration projects explore the feasibility of PrEP for adolescents and young women in South Africa
Roger Pebody, 2017-07-26 14:00:00
One of the first studies to explore the acceptability,
safety and use of pre-exposure prophylaxis (PrEP) in adolescents in an African context has found that PrEP
was safe and tolerable, although PrEP usage and adherence did tail off during
the twelve months of the programme.
Presenting the findings of the PlusPills
project to the 9th International AIDS Society Conference on HIV Science (IAS
2017) in Paris yesterday, Katherine Gill of the Desmond Tutu HIV Foundation said
that South African adolescents need access to PrEP with tailored adherence
support and more frequent clinic visits. Less frequent dosing schedules, if
validated, could be of interest to this population, she suggested.
PlusPills is just one of several demonstration projects on PrEP
for adolescents and young women in South Africa that are underway or have
recently been completed. Yogan Pillay, the country’s Deputy Director General
for Health, told the conference that these findings would be considered
together to inform the development of the country’s PrEP programming. South
Africa is further ahead with PrEP provision for sex workers and men who have
sex with men than it is for adolescents and young women.
Adolescent girls and young women aged 15 to 24 account
for 23% of all new HIV infections in sub-Saharan Africa. Females are
much more vulnerable to HIV than their male peers. Whereas 0.7% of adolescent
boys aged 15 to 19 have HIV in South Africa, the equivalent figure for girls is
5.6%. In the 20 to 24 year age group, 5.1% of men and 17.4% of women have HIV. In
some parts of the country, prevalence is even higher.
The primary objective of PlusPills was to evaluate the
acceptability, safety and use of a daily regimen of daily Truvada PrEP as part of a comprehensive HIV prevention package. As
there are not any data on PrEP in adolescents in an African context, such
studies are needed before PrEP can be licensed for use by adolescents, Gill
PlusPills recruited a self-selected cohort in need of HIV
prevention services. It enrolled 148 HIV-negative adolescents (ages 15 to 19
years) at two sites in Cape Town and Soweto. Of note, while 99 of the participants were
female, 49 were male. The median age of study participants was 18, a quarter
had completed formal schooling and 90% were living with their family.
Their median age at sexual debut was 14.5. One in five had
had a partner who was at least five years older. While three quarters had used
a condom the last time they had sex, only a third always used a condom and 41% tested
positive for a sexually transmitted infection (STI) at baseline.
This was a single arm study. In addition to PrEP, the HIV
prevention package that all participants received included HIV testing,
management of STIs, risk reduction
counselling, male and female condoms, post-exposure prophylaxis (PEP), and
circumcision counselling and referrals.
Recognising that many young people struggle to adhere to
daily pill-taking, the programme also provided extra support using SMS,
adherence clubs, and real-time feedback on drug levels.
The study participants were required to take PrEP daily for
the first three months of the study, but could opt out at the three-month mark.
At each study visit after that they could opt in or out of PrEP.
PrEP was reasonably well tolerated with minimal safety
concerns. Sixteen participants (11%) experienced a grade 2 or 3 side-effect,
including headaches, nausea and vomiting, abdominal pain, diarrhoea, skin rash
and weight loss. Participants who stopped PrEP often complained of
side-effects, although Gill said that many participants were starting
contraception at the same time and it could be hard to be sure of the exact cause of
The use of PrEP and adherence to daily dosing dropped off
over time, something that has been seen in PrEP studies conducted with
adolescents in the United States. There was a particular drop off when clinic
visits switched from monthly to quarterly, suggesting that adolescents need
more regular contact and support. Tenofovir (one of the drugs in Truvada) was detectable in blood in 57% of participants at week 12, 38% at week 24 and 38% at the end of the study. Young women had similar levels of adherence
to young men.
Participants continued to be diagnosed with STIs throughout the study. For example at the week 12 visit,
there were 29 herpes diagnoses, 21 chlamydia and 8 cases of gonorrhoea.
One study participant acquired HIV during the study – a 19-year-old woman who had opted out of PrEP 24 weeks before diagnosis. While the
study was not powered to demonstrate the efficacy of PrEP in adolescents, this
population could be expected to have an HIV infection rate of around 7% a year
and the STI data indicate that the participants continued to
take sexual risks. It therefore appears that PrEP as part of a comprehensive
prevention package did provide some protection in this population.