This year, 2018, will be the year that a really significant number of people in Africa started HIV pre-exposure prophylaxis (PrEP), the 22nd International AIDS Conference (AIDS 2018) in Amsterdam heard last week.
PrEP was probably the dominant subject at this year’s conference – there were far more sessions devoted to it than any other topic – and even more notable was the fact that the majority of them concerned PrEP in Africa and in populations other than gay men and men who have sex with men (MSM).
Pilot PrEP projects have been underway in some African countries for several years. But it has only been since late 2017 that some countries – notably Kenya and South Africa, and also eSwatini, which is the new name for Swaziland – have started serious PrEP availability programmes for wider populations. In South Africa roughly 25,000 to 30,000 people have started taking PrEP; Kenya has initiated PrEP in about 25,000 people; Zimbabwe in about 5000; and the 2250 in eSwatini who have been assessed for PrEP will, if all of them start it, be about three times the number per head of population compared with the much larger Kenya.
Lesotho, Zambia and, over in west Africa, Senegal have also started programmes, either among targeted populations such as sex workers, or among the general at-risk population.
Right now we only have a few months’ data on PrEP uptake and delivery, and none at all yet on effectiveness. As knowledge of PrEP spreads and as healthcare workers become more experienced in working with their communities, retention and targeting may improve.
PrEP uptake and retention varied considerably from country to country, but a couple of factors stood out.
One was that there was a high drop-out rate in many programmes, especially among female sex workers but also among young women and men in general. In many studies a majority of those who had initiated PrEP did not return after their first visit.
A second factor was that the most frequent reason given for not continuing with PrEP was the experience of side-effects during the first month. Two studies from South Africa and Kenya had similar-enough results to suggest that acute side-effects such as nausea, abdominal pain, headache and dizziness might be more common or more severe than has been reported from MSM in high-income countries, and need to be taken seriously.
Kenya and Zimbabwe
From Kenya, Jillian Pintye of the University of Washington State presented results from the PRIYA programme (PrEP Implementation in Young People and Adolescents). This programme started last November and is piloting PrEP as one of the services offered at 16 Family Planning Centres in Kisumu County, the highest-prevalence province in Kenya.
In the programme’s first seven months, it assessed and offered PrEP to 1122 young women, mainly in their 20s, with an average age of 25. Most were already married (83%). A third of them did not know their partner’s HIV status and 4% (95 women) had a partner they knew had HIV.
Only one in five (21%) of the young women started PrEP. But one in three of those who did not know their partner’s status started it, as did 91% of the women who had a known HIV-positive partner.
Women with positive partners were 3.5 times more likely than average to start PrEP and women with other indicators of vulnerability to HIV even more so: those who had experienced intimate partner violence were 4.8 times more likely, those who had experienced rape and sexual assault 6.6 times more likely, and those who had been diagnosed with a sexually transmitted infection 10.6 times more likely.
The most common reasons given for not taking PrEP were the perception that one was at low risk of HIV, that the pills would be too big or difficult to take, but most importantly of all that women felt that they needed to consult with their partner first.
A study among women and men of all ages in Zimbabwe also found that this was an important reason women hesitated about PrEP. This project, sponsored by the Clinton HIV and AIDS Initiative, offered PrEP at two pilot HIV testing centres, in a family planning clinic in the capital, Harare, and the other 200 miles away in a youth centre in Chimanimani, a rural district near the Mozambican border.
These centres offered PrEP to every person taking an HIV test there (the Harare centre performs 300 a month and there are 175 a month at Chimanimani), but only got a very small proportion agreeing to try it. Between January and May this year, 151 out of 3158 people started PrEP (4.8%: it was 9% at Chimanimani and 2.7% in Harare).
Again, the need to seek a partner’s permission was the reason given most often for declining PrEP. One woman aged 20 said: “What made me decline PrEP is that my husband would accuse me of having another sexual partner while he is away. So I think it is best for me to ask for the permission to take PrEP and if he agrees then I will come.”
Other reasons for declining PrEP were that people were happy with condoms and were afraid of side-effects. However, as in the Kenyan study, PrEP was seized on by those with the highest risk indicators, such as this woman in an abusive relationship: “I will take PrEP for life because I can no longer be infected by HIV. To add on my husband was cruel as he could tear the condoms sometimes and he could pretend as if it had burst. I was really happy that I now have a backup.”
Or another whose husband’s unfaithfulness had resulted in her being infected with STIs: “I saw a lot of messages from different girls on my husband’s phone and I spoke to him about it but I was surprised to be diagnosed of an STI twice, so I realised that I was talking to myself. I therefore decided to take PrEP.”
In short, people including young women will take PrEP if they are in situations of imminent risk, especially if they feel they have no control over that risk.
South Africa’s programme
Alongside and following pilot projects, some presented at the IAS conference in Paris last year, PrEP in South Africa has been introduced so far in four stages at 34 pilot implementing sites. As of May 2018, 5857 people have started PrEP in this scheme – about one in four of South Africa’s estimated total. PrEP was first introduced into sites for female sex workers (FSWs) in June 2016, then into sites for MSM in April 2017, into university sites for young students in October 2017, and most recently in May 2018 into general sites for young people.
The rate at which PrEP was both offered and accepted by these four groups was interestingly different in each case.
Among FSWs, nearly 50,000 have been tested for HIV in the last two years at the PrEP-implementing FSW sites, of which 13% had HIV and were referred to treatment; half of them started antiretroviral therapy (ART). Two-thirds of the remaining 32,500 were offered PrEP. Although only 13% (4109) started PrEP, this is already considerably higher than the 1880 that is the target for PrEP uptake in FSWs in the first two years of South Africa’s 2016-2022 National Strategic Plan for HIV, STIs and TB.
We will look at the South African FSW PrEP programme more closely in another article.
In MSM 10,800 have been tested at the PrEP-implementing MSM sites since their phase started in April 2017. Five per cent had HIV, and all of them started ART. Of the HIV-negative remainder, the proportion offered PrEP was lower than in FSWs – 28% or 2937 individuals – because more gay men are in lower-risk categories. But the uptake among those offered PrEP has been higher, at 54% or 1537 individuals. Again, this exceeded the 818 that is the 2016-2018 target in the national Strategic Plan.
In the third phase, university students were tested for HIV at college implementing sites. Since this phase started in October 2017, just over 14,700 have been tested for HIV and of those 1.5% (219 people) tested HIV positive, of whom 209 (92%) have started ART. Of those testing HIV negative, 15% were offered PrEP of whom only 6% (138 people) have started PrEP.
Finally, the fourth phase is piloting the offer of PrEP to young people at community testing sites and via street outreach. This only started in May 2018 and during that month 185 have been tested for HIV with no positive results, and 73 (39%) have been offered PrEP – with an 100% acceptance rate (i.e. all who were offered PrEP started it).
It’s too early to say whether this high acceptance rate reflects better targeting of at-risk people via outreach, greater knowledge of and acceptance of PrEP with time, or simply that a few ‘early adopters’ who may have wanted PrEP for some time now have a way to get it.
Presenter Yogan Pillay, who is in charge of implementing the PrEP programme at South Africa’s Department of Health, did comment that “With hindsight, the way we rolled out PrEP may have inadvertently stigmatised it” by offering it initially to already stigmatised populations.
Side-effects and stigma – the two most important reasons for discontinuation
Diantha Pillay of South Africa’s Wits Reproductive Health and HIV Institute presented key points from a survey conducted between September to November 2017, of FSWs and MSM at 9 out of the 16 PrEP implementing sites that were providing PrEP at the time..
The researchers recruited 299 FSWs, MSM and general-population members from clinic attendees. PrEP knowledge was widespread among FSWs and MSM: only seven sex workers (4.5%) and three MSM (3.75%) had never heard of it. Among the general population members selected, 46% had never heard of it.
Among the 260 people who had heard of PrEP, 94 were currently using it, 80 had used it but stopped, and 86 had never used it.
The survey showed that even in these PrEP implementation sites, not everyone was being offered PrEP who might take it. Among those who had never used PrEP, nearly half (45%) of FSWs had never been offered it, two-thirds of MSM, and three-quarters of the ‘other’ group.
The most common reason for wanting to start, or to continue, PrEP was that the person was sexually active; “HIV risk” was less often cited as a reason to take PrEP among the MSM and other categories, though it was cited just as often among the FSW.
Among those who had stopped PrEP, side-effects were by far the most common reason to stop among FSWs and MSM: three-quarters of FSWs and 87% of MSM said that side-effects including gastro-intestinal upset, nausea, dizziness and headaches were their main reason for stopping. In contrast, among the ‘other’ category, the most common reason for stopping PrEP was that people felt stigmatised by it.
Among these past users, 83% said side-effects had affected their daily lives and even among current users, 59% said they had experienced them and 31% said they affected their daily lives.
Diantha Pillay commented that although a majority of PrEP users recalled being told about side-effects in pre-PrEP counselling sessions, only a minority received advice on how to manage those side-effects.
Back in Kenya, Jordan Kyongo of the Nairobi-based HIV organisation LVCT Health concurred that side-effects were one of the most common reasons for discontinuing PrEP.
A 2015-2017 PrEP demonstration project was based in the cities of Kisumu and Homa Bay on Lake Victoria and in the capital Nairobi. It enrolled 796 FSWs, 597 MSM and 723 general-population young women.
Although, in a 2013 feasibility study, 85% of potential participants had said they would use PrEP, 25% of those screened for PrEP never turned up for their initial PrEP prescription appointment (34% of FSWs). But what was really striking was the drop-out rate in the first month. Forty per cent of FSWs prescribed PrEP never turned up for their second prescription, 55% of MSM and fully 70% of general-population young women.
The drop-out rate continued and by the six-month appointment, out of those initially screened, only 14% of FSWs, 15% of MSM and 10% of general-population young women returned for their next PrEP prescription.
Side-effects were the most commonly cited reason for dropping out. PrEP takers complained of “‘nausea’, ‘headaches’, ‘constant dizziness’, ‘running stomach’, ‘darkening of the skin’, ‘weight gain’ and ‘loss of appetite’”. “I took the bottle halfway due to the side effects,” said one young woman.
Real side-effects reinforced, and imaginary ones might be induced, by community beliefs about PrEP, such as it causing impotence or sterility or being a population-control measure.
The second most common reason for PrEP drop-out was stigma ranging in its manifestations from social disapproval to violence. One woman said: “When I informed my husband, he refused and told me that he should not find me using it. So I started taking the drug in secrecy. When he came to know about it, when he saw that bottle he beat me to an extent of breaking my nose”. Practical reasons such as transport difficulties were also often given.
Reasons for continuing included wanting to maintain a positive relationship with the healthcare worker and a perception that one could not rely on people’s declaration of this HIV status: one FSW said: “Because of having multiple partners and having unprotected sex you do not know their status; like even those four, I only knew status of one person and they do not want to come to the clinic to test”.
Kyongo, who described himself as “a PrEP researcher and advocate,” said that it was important to take account of the context of PrEP use and to keep in mind that PrEP was a choice: “The end game is HIV prevention, not PrEP use,” he said.
He continued: “The right people on PrEP are the people who want to be on it. If I want to be on PrEP, let me. If I want to take it for a month then stop, let me; from the point of the user, it is not like taking medicine, it is much more like using a condom. And if I don't want to take PrEP, don't tell me I should because I'm 'at risk'."
This report is drawn from the following presentations at the 22nd International AIDS Conference (AIDS 2018), Amsterdam, July 2018.
Cowan FM. Prioritizing populations and positioning PrEP – How has it been working? Key populations. Symposium presentation WESA1303.
Mugwanya K et al (presenter Pintye J). Uptake of PrEP within clinics providing integrated family planning and PrEP services: Results from a large implementation program in Kenya. Oral abstract presentation TUAC0304.
Gombe M et al. Integrating oral HIV pre-exposure prophylaxis (PrEP) in a public family planning facility and youth center to inform national roll out in Zimbabwe. Oral abstract presentation TUAC0307LB.
Pillay Y. Challenges of South Africa’s sex worker PrEP programme: Lessons learned, moving towards other key populations. Non-commercial satellite presentation TUSA1703.
Pillay D. Factors influencing initiation, continuation & discontinuation of oral PrEP at selected facilities in South Africa. Oral abstract presentation WEAE0401.
Kyongo JK et al. How long will they take it? Oral pre-exposure prophylaxis (PrEP) retention for female sex workers, men who have sex with men and young women in a demonstration project in Kenya. Oral abstract presentation WEAE0403.
Update: Following the conference presentation, Mugwanya and Pintye's study was published in a peer-reviewed journal:
Kinuthia J et al. Pre-exposure prophylaxis uptake and early continuation among pregnant and post-partum women within maternal and child health clinics in Kenya: results from an implementation programme. The Lancet HIV, 5 December 2019.
Correction: The section 'Side-effects and stigma – the two most important reasons for discontinuation' was amended in January 2019. Thanks to the researchers for pointing out some errors.