Project Sexual Health Equity (Project SHE): Pre-exposure prophylaxis (PrEP) for women who inject drugs
Project Sexual Health Equity (Project SHE) is a community-based pre-exposure prophylaxis (PrEP) program for cisgender women who inject drugs. Project SHE integrated PrEP services into a needle and syringe program (NSP) at Prevention Point Pennsylvania to try to address barriers to PrEP for this population. Study results showed that 71% of the women who participated in the program accepted a PrEP prescription at the beginning of the study, with 62% staying on PrEP until the end of week 12. Two HIV infections were found; however, both women had suboptimal adherence to PrEP.
Project SHE provided PrEP education and 24 weeks of daily PrEP to women who inject drugs. Participants were recruited from a weekly drop-in program (i.e., Ladies Night) that provides food, showers, clothing and monthly social support to women. Marketing for the program also happened through flyer distribution, word of mouth and peer referrals.
Women who were HIV negative, reported non-prescription injection drug use in the past month and had at least one behaviour associated with increased risk of HIV (e.g., syringe sharing, inconsistent condom use) were eligible to participate. Following recruitment and eligibility determination, assistance with accessing insurance coverage was provided to participants who needed it.
Participants could either take a PrEP prescription to their own pharmacy or have PrEP delivered to Prevention Point Pennsylvania. Participants received PrEP clinical care at weeks 1, 3, 12 and 24. The following tests were completed at baseline and at weeks 12 and 24 (unless otherwise specified):
- HIV point of care test
- self-collected swabs for gonorrhea and chlamydia at genital, oropharyngeal and rectal sites
- syphilis screening
- hepatitis B screening (baseline only)
- creatinine clearance (baseline and week 24)
- pregnancy test
- medical history (baseline only)
A program staff person was located at the NSP to greet women, re-engage women who had missed appointments, remind women of forthcoming appointments and provide any related services (e.g., replacement of lost prescriptions). Appointment reminders via text message or phone were available to those who wanted them. At the end of the study, participants were given a list of PrEP prescribers to continue PrEP, if they were interested.
The program took place between April 2018 and June 2019, and the study included 95 participants at baseline. Participants were predominantly white women (70%); 63% identified as currently homeless and 84% reported having public insurance. More than 70% of participants reported engaging in inconsistent condom use or daily injection drug use. At baseline, 18% of participants screened positive for a sexually transmitted infection.
After follow up, 78% (69/89) of participants accepted a PrEP prescription at week 1. At week 12, 81% (48/59) accepted a PrEP prescription and at week 24, 60% (25/42) accepted a PrEP prescription. Of the 69 participants who accepted a PrEP prescription at week 1, 62% stayed on PrEP, 7% discontinued PrEP and 30% were lost to follow-up by week 12. Of the 20 participants who declined a PrEP prescription at week 1, 30% stayed off PrEP, 25% started PrEP and 45% were lost to follow-up by week 12. Participants could receive up to $155 in compensation if they completed all study visits.
Three variables were significantly associated with increased likelihood of PrEP uptake over the 24 weeks of follow-up: inconsistent condom use, experiencing sexual assault and a greater baseline frequency of NSP access (within 6 months). Women who had a greater baseline frequency of NSP access (within 6 months) also had a significantly greater likelihood of being retained in PrEP at 24 weeks.
There were inconsistencies between self-reported adherence and urinalysis results. About half of the women on PrEP reported taking all their medication at weeks 12 and 24; however, only one woman had enough tenofovir in her urine to prevent HIV at weeks 12 and 24. However, between 15% and 20% had levels of tenofovir in their urine that were consistent with some level of adherence within the past week.
No participant experienced severe PrEP-related adverse events, although one person discontinued PrEP because of her creatinine levels. There were two HIV seroconversions during the study, both from participants who reported inconsistent or no PrEP adherence. At week 12, there were 11 new cases of sexually transmitted infections (19%) and at week 24 there were four (10%).
An acceptability and satisfaction survey was done at study exit, and most women reported that:
- they preferred received PrEP care at the NSP as opposed to other locations (89%)
- they were satisfied with the services they received (97%)
- they felt that most of their program-related needs had been met (97%)
What does this mean for service providers?
This study showed that women who inject drugs and are at a higher risk of contracting HIV are interested in and willing to start and continue to use PrEP. After 12 weeks in the program, more than 60% of the women who started PrEP at week 1 were still taking PrEP despite a variety of potential barriers (e.g., homelessness, high frequency of drug use). The study’s authors suggest that retention in the program was related to integrating services into an already known NSP service.
Other studies have shown suboptimal PrEP adherence in similar programs. Behavioural interventions to increase adherence such as intensive adherence counselling and positive reinforcement (e.g., incentives) could be beneficial. Objectively measuring adherence at more frequent intervals could also help to provide increased and intensive support to those with suboptimal PrEP adherence.
Service providers could consider integrating safer sex messages into similar programs as participants in this study also reported sexual risk factors (i.e., inconsistent condom use). Providing post-assault trauma-informed care may also be an important consideration for the population of women served through similar programs.
Roth AM, Train NK, Felsher MA et al. Integrating HIV pre-exposure prophylaxis with community-based syringe services for women who inject drugs: results from the Project SHE demonstration study. JAIDS. 2020. Epub ahead of print.