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.”