PrEP demonstration projects

Demonstration projects are the step between efficacy trials and full scale

implementation (36). As of September 2019, four completed PrEP demonstration projects in the US have published results: 1) the Demonstration Project; 2) HPTN 073; 3) PATH- PrEP; and 4) Project PrEPare. Each are described briefly below.21 _{Though none of these}

projects focused on cisgender WOC, they provide insight into PrEP implementation. The first PrEP demonstration project in the US, known as the “Demo” Project, was conducted in two municipal STI clinics in San Francisco and Miami, and a

community health center in Washington, DC from 2012 to 2015 (67). The Demo Project aimed to assess the uptake, acceptability, safety, and feasibility of PrEP in a real world setting for men who have sex with men (MSM) and transgender women (67). Participants (n = 557) received HIV/STI testing, clinical monitoring, PrEP prescribing, and client- centered risk reduction and adherence counseling by a counselor or clinician at five

21 _{See Appendix A, Supplemental Table 7 for a list of completed and ongoing demonstration projects} as of May 2019.

follow-up visits over 48 weeks (67). Using dried blood spots (DBS), the Demo Project found protective concentrations of PrEP in an estimated 86%, 85%, 82%, 85%, and 80% of participants across the five study visits (67). African American/Black participants were significantly less likely to have protective levels of PrEP (67).22 _{There was significant}

demand for PrEP, with waitlists in both San Francisco and DC (71). This project

demonstrated that PrEP prescribing, along with adherence and risk reduction counseling, can effectively be implemented for MSM and transgender women in similar clinical settings. Additionally, findings suggest that participants of color may require stronger or different adherence support than White participants.

HPTN 073, conducted from 2013 to 2015, assessed initiation, acceptability, safety, and feasibility of PrEP for African American/Black MSM in three cities (68). Participants (n = 266) were recruited from one community health center and two hospital- based clinics, prescribed PrEP, and followed for five visits across one year (68).

Participants received client-centered care coordination known as “C4”: a culturally tailored, theory-based counseling method designed to support PrEP use, provide social services referrals, and address psychosocial needs (68). Nearly 80% of participants accepted PrEP, and 68% of participants remained on PrEP at 26 weeks (68). Participants that accepted PrEP utilized a median of six C4 sessions (range 3-8) compared to a median of four C4 sessions (range 2-6) by participants that did not accept PrEP (68). Sixty-seven percent of participants self-reported adherence of greater than or equal to 90% at the end of the year (68). Even with tailored counseling, the proportion of participants self-

reporting adherence at endline in HPTN 073 was lower than the proportion of

participants with protective concentrations of PrEP in the Demo Project. These findings demonstrate that African American/Black MSM accept PrEP and counseling. However, despite acceptance, adherence remains a concern.

The PATH (PrEP and Testing/linkage to care for HIV Prevention)-PrEP study aimed to evaluate PrEP adherence among a cohort of men who have sex with men or women, and transgender women enrolled from two community-based clinical sites in Los Angeles who received daily oral PrEP (72). Participants (n =301) received guided

motivational counseling focused on sexual health protection and PrEP adherence at five visits over 48 weeks. Adherence was measured by plasma drug levels; low adherence23

triggered an escalated adherence support approach. At endline, 68% of participants had protective concentrations of PrEP (72). Younger PrEP users and African American/Black PrEP users were significantly less likely to achieve adherence (72). Participants of color made up 70% of those who received escalated adherence counseling; among this group, 50% sustained PrEP adherence after escalated counseling (72). Similar to findings from the Demo Project, results from the PATH-PrEP study indicate that participants of color, as well as younger participants, may require stronger or better tailored adherence support.

Project PrEPare (ATN 110) provided PrEP and evidence-based HIV prevention interventions to young MSM for 48 weeks. Prior to initiating PrEP, participants received an evidence-based HIV prevention intervention. After initiation, participants received

23 _{Low adherence was defined as having TFV-DP levels above the lower limit of quantitation (10} ng/mL).

sexual health promotion and adherence counseling at each visit. Participants (n = 200) were enrolled from 12 urban sites in the US (73). Over 90% of participants reported the counseling and the study overall as acceptable (74). As measured by DBS, a majority of participants had protective concentrations of PrEP during the first 12 weeks, but by week 48, this proportion decreased to 28% of participants (74). African American/Black participants’ median levels of PrEP were below the protective threshold throughout the study (74). These findings echo findings from the other demonstration projects,

suggesting that adherence support is needed for young MSM, and young African American/Black MSM in particular.

Though these demonstration projects did not focus on WOC, they offer useful insights into PrEP provision. These projects showcase comprehensive PrEP care that, in addition to following PrEP clinical guidelines, provided client-centered care (i.e., how PrEP fits into their own care plans, or culturally-tailored counseling), and linkages to other social services as needed. Age and race disparities exist in PrEP adherence. Though MSM of color appear to accept targeted adherence counseling and PrEP, adherence was low in this group. In the three demonstration projects that included both African

American/Black and non-African American/Black participants, the former group was less likely to have protective concentrations of PrEP compared to their peers. This finding was particularly evident in Project PrePARE, in which young African American/Black MSM participants never achieved protective levels of PrEP during the course of the study. Tailored adherence counseling, such as the C4 counseling provided in HPTN 073 or the escalated adherence counseling provided in PATH-PrEP, appeared to boost

adherence. When considering PrEP implementation for WOC, health care workers will need to understand not only if WOC find PrEP acceptable, but how to translate

acceptance into uptake and support PrEP adherence.