While pre-exposure prophylaxis (PrEP) has been shown to be highly efficacious, with up to 99% protection if the drug is taken as directed, delivering a successful PrEP program is challenging. A recent analysis of the Ashodaya PrEP demonstration project, which provided pre-exposure prophylaxis (PrEP) to female sex workers in south India, provides insights to help strengthen PrEP and HIV prevention programs and accelerate implementation beyond demonstration and pilot projects.

HIV prevention efforts among sex workers have traditionally focussed on condom use, and while a range of successful programs have contributed towards the decline in new HIV infections in the Asia-Pacific region, sex workers still experience a disproportionate burden of infection. In 2019, 9% of the estimated 300,000 new infections in the Asia-Pacific region were among sex workers and the relative risk of HIV infection is 21 times higher among sex workers than the general population globally.

PrEP is a recent addition to the range of HV prevention options available and involves an HIV negative individual taking antiretroviral drugs (usually tenofovir and emtricitabine) prior to exposure to HIV. Although recommended by WHO for all people at substantial risk of HIV since 2015, PrEP is inaccessible to the majority of key populations, including sex workers, and their partners in Asia and the Pacific. There is limited evidence on PrEP use among women, and particularly among female sex workers, in Asia and the Pacific.

The Ashodaya PrEP demonstration project was one of two community-led and -owned initiatives to provide PrEP to female sex workers supported by the Gates Foundation (the other was led by Durbar Mahila Samanwaya Committee (DMSC in Kolkata)). Sex workers in India had been intrigued by the fact that, although condom use was high, some sex workers still acquired HIV and ‘why some of their sisters were not able to use condoms [in some circumstances]’. A feasibility assessment began a stepwise and community-led process of close community consultation, community preparedness, discussion of a demonstration project to integrate PrEP delivery with the existing HIV program and the conduct of the project. WHO supported the process of community preparedness and feasibility assessment.

The PrEP demonstration project, which began on April 2016 and ended on January 2018, reported good results. High levels of continuation on PrEP were reported with 99% of the 647 participants completing the 16-months of follow-up. For women, it is critical to take PrEP daily to maintain protection. Although adherence was only 70% at month 3, this increased to 90% at month 6 and was 98% in the final month of the project. Self-reported adherence was verified in the blood of a subset of participants at months 3 and 6.

The project not only helped to dispel some common fears about PrEP, but showed benefits in bridging the prevention gap. Rather than undermining condom use, it remained stable. Condom use was high for occasional clients at approximately 98%, but lower for repeat clients (87-96%) and regular partners (63%). There were also no increases in symptomatic STIs and no HIV sero-conversions during the follow-up period.

A number of factors likely contributed to the success of the Ashodaya PrEP Project, including:

• Fully integrating PrEP into an existing range of health services, outreach and community mobilisation. This approach recognised that PrEP is not just a drug or a standalone service but is part of a prevention and health package including sexual and reproductive health (SRH) services. Independently of whether an individual was able to access PrEP, efforts were made to connect individuals with Ashodaya’s range of services and to provide access to social, health, and financial support programs.
• Community leading the way: planning, implementation, and monitoring. Ashodaya is a well-established community organization with a track record in mobilisation and innovation in sexual health interventions. Ashodaya leaders had a keen interest in innovations that would benefit the community. Although PrEP was new, community participation in deliberations about introducing PrEP, led to the community engagement and trust with the new prevention tool. Community empowerment and mobilisation has been central to HIV prevention and playing an active role in this new HIV prevention method was a source of pride, as well as new knowledge and skills for the community.
• Preparing the community and ensuring ongoing engagement. An intensive process of community preparedness and on-going engagement allowed sex workers to make informed decisions about participation. Community leaders (part of the implementation team) determined every stage of the project (keeping the requirements in mind). Recruitment was deliberately slow to build acceptance and trust, first enrolling senior community leaders, who then shared their experiences with their peers. Peer educators, outreach workers and mobilisers were able to pass on their knowledge to their peers. Community leaders living with HIV were also engaged early and became champions for PrEP. These testimonials became influential in enrolment and retention.
• Addressing excluded groups early. Recognising that many community members would miss out, the community was proactively informed that not all members would be eligible for PrEP under the demonstration project, given the limited places and scope. Ashodaya gained the community’s support through the endorsement of the project by Ashodaya leaders, proposing to use the project to advocate for national availability, and ensuring that the other services provided by Ashodaya were available to the community.
• Prioritising continued engagement over perfect adherence. Drawing on Ashodaya’s existing network of peer outreach workers allowed for individualised adherence support strategies to best meet the needs of PrEP users, both in terms of scaling up support when dips in adherence were observed and through referrals to Ashodaya’s comprehensive package of health and social services beyond PrEP.

“Our project shows that community- led PrEP delivery can be effectively integrated into the existing HIV prevention and care services for sex workers and result in high retention and adherence. Policy makers need to consult with us, listen to us and trust us as we know what works for us and how to make it work. We have an obligation to make PrEP available as an additional prevention tool in a safe and sustainable way and we are advocating for that” – Bhagya, a sex worker and Secretary of Ashodaya Samithi.

From conceptualizing, planning, implementation and monitoring, the Ashodaya PrEP Demonstration Project was a community-led process. PrEP became an important option for the women who participated in the project and now the community is working with policy makers to ensure PrEP is included as part of prevention package for sex workers in India.

The Ashodaya PrEP demonstration project was conducted by the Community of Ashodaya and the University of Manitoba with support from the National AIDS Control Organization (NACO), India and Karnataka State AIDS Prevention Society, The Bill and Melinda Gates Foundation, the WHO Geneva, WHO SEARO, UNAIDS India, Gilead Sciences, Mylan, the National AIDS Research Institute (Pune, India), Bio-Analytical Technologies (India), Ashakirana Hospital and K.R. Hospital.

References and further information :
Reza-Paul S, Lazarus L, Maiya R, Haldar P, Rewari BB, Venugopal MS, et al. The Ashodaya PrEP project: Lessons and implications for scaling up PrEP from a community-led demonstration project among female sex workers in Mysore, India. Global Public Health 2020,15:889-904.

Lazarus L, Reza-Paul S, Rahman SHU, Ramaiah M, Venugopal MS, Venukumar KT, et al. Beyond remedicalisation: a community-led PrEP demonstration project among sex workers in India. Culture, Health & Sexuality 2020:1-15.

Reza-Paul S, Lazarus L, Jana S, et al. Community Inclusion in PrEP Demonstration Projects: Lessons for Scaling up. How to cite this article: et al. Gates Open Research 2019:1504

Reza-Paul S, Lazarus L, Lorway R, et al. Prioritizing Risk in Preparation for a Demonstration Project: A Mixed Methods Feasibility Study of Oral Pre-Exposure Prophylaxis (PREP) among Female Sex Workers in South India; PLOS ONE | DOI:10.1371/journal.pone.016688

UNAIDS Update: Sex workers often not accessing HIV prevention services (18 November 2019). Available from: https://www.unaids.org/en/resources/presscentre/featurestories/2019/november/20191118_sex-workers

UNAIDS Data 2020. Available from: https://www.unaids.org/en/resources/documents/2020/unaids-data