Topical PrEP gel can be successful in public sector clinics
Providing topical PrEP to women attending government-run family planning clinics could be a successful way to increase access and adherence to PrEP, a trial from South Africa suggests.
A growing number of countries, including South Africa, include pre‐exposure prophylaxis (PrEP) as part of an essential package of combination HIV prevention for people at risk of HIV infection.
The Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial, which ran between 2007 and 2009, was the first to demonstrate that a PrEP microbicide – in the form of a topical gel containing the antiretroviral tenofovir, which is applied inside the vagina before and after sex – could reduce sexually transmitted HIV.
However, evidence from this and other clinical trials have shown that adhering to both topical and oral PrEP can be challenging. Data from non-research settings is also limited, which means the best way to scale‐up PrEP remains unclear.
As women in South Africa are at high risk of HIV and likely to utilise family planning services, this trial (CAPRISA 008) set out to assess the feasibility, acceptability and effectiveness of integrating topical PrEP into public sector family planning clinics used by women in KwaZulu‐Natal, and the impact that providing PrEP via this route would have on adherence.
Between 2012 and 2014, 372 HIV‐negative women from urban and rural parts of the province who had previously participated in CAPRISA 004 were randomly selected to receive tenofovir gel; 189 women accessed the gel through family planning clinics while 183 accessed it through specialist CAPRISA clinics. Around 92% of women in both groups remained in the study throughout its duration.
In the first three months, women attending public family planning clinics visited the clinic monthly to get the gel. Following this, they accessed the gel according to the contraception course they were on – normally every three months.
Women accessing PrEP gel through CAPRISA clinics received it every month, irrespective of the type of contraception they were on. Adherence support and counselling was provided to both groups.
To measure adherence, both groups were asked to return all used and unused gel applicators. If the difference between the mean number of returned used applicators was no more than 20% lower in family planning clinics, this route would be considered feasible. PrEP adherence was also measured by blood and genital specimens, at enrolment, every six months, when clinically relevant and when they left the study.
Around 84,200 gel applicators were dispensed, and around 99% were returned to the clinics (45% in family planning clinics and 55% in CAPRISA clinics). Of these, around 50% of applicators returned to the clinics had been used.
Overall, women returned an average of 5.5 used applicators and reported a mean of 4.1 sex acts per month. This is equal to 5.2 returned used applicators on average each month in the family planning clinics, compared with 5.7 in the CAPRISA clinics; a mean difference of −0.47.
The investigators also measured adherence that accounted for the proportion of reported sex acts covered by two gel doses – given that the dosing regimen used in the trial was to apply the gel before and after sex.
Adherence using this measure was found to be significantly higher in the family planning group compared to the CAPRISA group – at 80% versus 74% respectively, a mean difference of 6%.
After 12 months, tenofovir was detectable in the genital fluid of around 40% of women attending family planning clinics and around 44% of those attending CAPRISA clinics. However, this was not significant as women attending family planning services reported less frequent sex and returned fewer used applicators compared with women in trial clinics.
During the trial, 24 women became HIV-positive; 12 in the control clinics and 12 in the intervention clinics, including 2 women with detectable tenofovir drug levels. HIV incidence in CAPRISA 008 was 44% lower than incidence observed among a placebo group of women from the same communities during CAPRISA 004.
More than 80% of women attending the family planning clinics and 75% attending CAPRISA clinics expressed a preference for receiving HIV prevention services through family planning clinics. More than 95% of those answering questions on the gel (360 women) found it to be acceptable for use. The top five reasons for using the gel were its HIV protective benefits (75%), perceived vaginal cleansing properties (34%), ease of use (26%), enhanced sexual pleasure (22%), and perceived protection against other sexually transmitted infections (19%).
However, around 11% described the gel as ‘messy’, 6% said it gave too much lubrication and 8% said the product leaked. The majority of women (86%) reported disclosing their trial participation to at least one sexual partner.
The trial was originally designed to include 700 women, however only 372 women were eligible to participate. This limitation was a consequence of a lengthy delay between the end of CAPRISA 004 and the start of CAPRISA 008, caused by regulatory approval requirements.
Despite its smaller sample size, this trial suggests that integrating PrEP into existing government-run family planning services would be a feasible way to introduce PrEP into South Africa’s public health system, providing useful evidence for the government as it looks to increase PrEP access in communities with high HIV prevalence.