Several studies presented at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam last month detailed very different approaches to introducing pre-exposure prophylaxis (PrEP) to female sex workers (FSWs) as part of combination HIV prevention.
The studies range from an innovative community-run PrEP study among FSWs in two locations in India, which achieved very high rates of adherence, to a study in clinics in Senegal, a country that allows women to register as sex workers. There were also more details of PrEP implementation among FSWs in South Africa, where they were the first population selected for a national PrEP programme (see this report for more details).
India’s community-led study
Dr Sushena Reza-Paul of the University of Manitoba in Canada presented a PrEP trial that was devised, governed and run by two FSW organisations based in Kolkata and Mysore, India, with funding from the Bill and Melinda Gates Foundation and support from the World Health Organization.
The two organisations are:
- The Durbar Mahila Samanwaya Committee (DMSC – “Women Strong Together”), a pioneering project serving the mainly brothel-based FSWs of West Bengal. Set up in 1995, it now has 60,000 members. As well as working to address the multiple social disadvantages faced by sex workers, it runs 49 health clinics with over 500 staff (80% are sex workers). It also runs the largest co-operative bank for sex workers in Asia, educational centres, children’s hostels and other projects and is recognised as a model for HIV intervention globally.
- Ashodaya (“Dawn of Hope”) was set up in 2005 in Mysore in southern India and has 8000 members of all genders who work mainly in houses, lodges and on the street. It also runs a health programme, community bank and social security facilities and has its own academy that conducts community-based research and capacity building.
The main phase of the study ran for 16 months in 2016 and 2017 with PrEP for study participants continuing to the present.
The two organisations were involved at all stages of the delivery of the PrEP study and had ultimate financial responsibility, though aspects of the trial were conducted by advisory staff. The organisations chose the University of Manitoba as their academic partner from a number of tenders. FSW project workers were involved in all aspects of PrEP delivery, including education, awareness raising and fostering community norms around PrEP and condom use. They provided outreach and created tailor-made drug-delivery plans for members who joined the study.
Recruitment and retention levels were very high. Ninety-seven per cent of the 1369 women who were assessed as eligible enrolled in the study. Of these 1325 women, 93.5% completed 16 months’ follow-up and 73% remained on PrEP as of July 2018.
Participants’ average age was 35, with a range from 18 to 48. Only 41% were literate; 86% had a regular partner and the majority had children. Nearly all took contraception. They had been in sex work on average for six years.
There were no HIV infections whilst women were in the PrEP study, which contrasts with 1.3% testing HIV positive in screening. Thirteen diagnoses of STIs were made at screening and eight occurred during the study alongside three pregnancies.
As evidenced by these comparatively low rates of STIs, condom use was very high among participants. It was almost universal with occasional clients (condoms were used during 98% of sex acts) and frequent with regular clients (ranging from 87% to 95%). However a third of participants did not use condoms with their main partner.
Adherence was high and actually increased during the study: 80% of participants had blood tenofovir levels indicative of protection (over 40 ng/ml) at month three and 90.5% at month six.
This backs up the contention of some FSW organisations that many FSWs who maintain high rates of condom use might not need PrEP. However, it does not support the idea that giving FSWs PrEP might erode their use of condoms.
Even if the participants’ condom use was high enough to be sufficient protection against HIV, they attested to the psychological benefits of PrEP. At the start of the study participants were 3.7 times more likely to feel they were at high risk of HIV than they were at the end.
One thing the study did do was lead to a groundswell of interest in PrEP among the DMSC and Ashodaya members – managing expectations of PrEP availability has now become one of the programme’s challenges.
Dr Reza-Paul added that the success of the study showed how important it was “To stand by the community for them to succeed, and not pass judgement.”
Senegal in west Africa has maintained a low prevalence of HIV in the general population of less than 1%, and has run an enlightened and effective HIV prevention programme, according to UNAIDS. Sex work is legal and regulated in Senegal, and FSWs can register for monthly HIV/STIs visits in clinics run by the Ministry of Health. However, HIV prevalence among FSWs is 30%.
A year-long PrEP demonstration project was therefore implemented in four of the Ministry of Health clinics in the capital, Dakar. The project enrolled both registered and unregistered sex workers (just over a third were unregistered).
There were 267 participants, with an average age of 38 (range: 18-57) and 10% under 24. As with the Indian project, women had very low levels of education with 41% never having attended school and a similar proportion illiterate. Seventy-one per cent of participants described themselves as separated or divorced.
Retention was pretty good, with two-thirds of participants remaining in the study over the year. Once reasons for discontinuation such as death, pregnancy, serious injury or moving out of the area were removed, retention was 75%. As in many other studies, age was a predictor of good retention: women over 45 were 3.9 times more likely to remain in the study than women under 25.
Adherence (100% of doses) was initially 80% but dropped rapidly to 50% in the first couple of months; it then rallied slightly and stayed at 60% for the rest of the study. However, as presenter Moussa Sarr noted, participants reported that despite being advised to take PrEP daily, they tended only to take it during times they felt at risk. “Simply forgot” or “Too busy with other things” were the top two reasons given for non-adherence, but 14% ran out of study pills at some point.
Significantly, among this very high-risk population, there were no HIV infections during the study period.
Group and individual counselling (which was greatly valued by the women) revealed that both fear of stigma and experience of it were disincentives to taking PrEP: the group counselling, the support of peer educators, and the provision of free STI treatment were given as incentives. The clinics also faced workload challenges, especially in matching staff level to demand, and co-ordination between professionals and peer educators. Nonetheless, the Ministry of Health is talking to key population representatives about extending the programme to other clinics and to groups such as men who have sex with men (MSM) and serodiscordant couples, and wants to recruit more young peer educators next time.
In South Africa, female sex workers were the first key population selected for a national programme of PrEP rollout. From June 2016, PrEP has been offered at clinics and mobile health centres.
Up to May 2018, 4109 FSW have initiated PrEP, which is considerably in excess of the 1880 that was the original target for South Africa’s strategic PrEP plan. Nonetheless, this only represents 13% of those who were offered PrEP, which was itself 66% of those testing HIV-negative at a clinic. This is considerably lower than the 54% uptake in MSM who have been offered PrEP in the second phase of the national programme, from June 2017. PrEP uptake did increase somewhat over time, from 9% in 2016 to 15% in 2018.
Facilitators of PrEP uptake included perception of risk (women who felt at high risk had high retention), flexibility in clinic hours, easy access (uptake in mobile clinics was higher than in fixed clinics) and peer-led education programmes, which resulted in higher demand creation and uptake.
Yogan Pillay of the South African Department of Health told the conference, “Non-judgemental, non-stigmatising attitudes from clinic staff members is critical, especially for adolescents and young people.”
This report is compiled from the following presentations at the 22nd International AIDS Conference (AIDS 2018), Amsterdam, July 2018:
Reza-Paul S. Community Led PrEP Delivery: Getting It Right. Satellite presentation WESA1305.
Sarr M. PrEP delivery in public health settings: Successes and barriers. Satellite presentation WESA1306.
Sarr M. Retention in care for HIV pre-exposure prophylaxis (PrEP) among sex workers of four public health centers in Senegal. Oral abstract TUAC0301.
Pillay Y. Challenges of South Africa’s sex worker PrEP programme: Lessons learned, moving towards to other key populations. Satellite presentation TUSA1703.