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Prevention Research

Embedding a Linkage to Preexposure Prophylaxis Care Intervention in Social Network Strategy and Partner Notification Services: Results From a Pilot Randomized Controlled Trial

Teixeira da Silva, Daniel MDa,b; Bouris, Alida PhDc,d; Ramachandran, Arthi PhDd; Blocker, Olivia MPP/AMd; Davis, Billy BAd; Harris, James BAd; Pyra, Maria PhD, MPHd,e; Rusie, Laura K. ScMd; Brewer, Russell DrPH, MPHb,d; Pagkas-Bather, Jade MD, MPHb,d,e; Hotton, Anna PhD, MPHd; Ridgway, Jessica P. MD, MSb,d; McNulty, Moira MD, MSb,d; Bhatia, Ramona MDf; Schneider, John A. MD, MPHb,d,e,g

Author Information

aDepartment of Combined Internal Medicine and Pediatrics, University of Chicago, Chicago, IL;

bDepartment of Medicine, University of Chicago, Chicago, IL;

cSchool of Social Service Administration, University of Chicago, Chicago, IL;

dChicago Center for HIV Elimination, Chicago, IL;

eHoward Brown Health, Chicago, IL;

fUniversity of Illinois at Chicago, Chicago, IL; and

gDepartment of Public Health Sciences, University of Chicago, Chicago, IL.

Correspondence to: John A. Schneider, MPH, MD, Departments of Medicine and Public Health Sciences, University of Chicago, 5837 South Maryland Avenue, MC 5065, Chicago, IL 60637 (e-mail: [email protected]).

Supported by the National Institute of Mental Health (1R34MH104058-01). R.B.'s time was supported by a grant from NIMH (R21MH121187). This publication was made possible with help from the Third Coast Center for AIDS Research (CFAR), an NIH funded center (P30 AI117943). ClinicalTrials.gov Identifier: NCT02749955.

Parts of these data were presented at the 2019 Conference on Retroviruses and Opportunistic Infections; Seattle, WA.

The authors have no conflicts of interest to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jaids.com).

JAIDS Journal of Acquired Immune Deficiency Syndromes: February 1, 2021 - Volume 86 - Issue 2 - p 191-199
doi: 10.1097/QAI.0000000000002548

Abstract

INTRODUCTION

Preexposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is more than 90% effective in preventing HIV transmission1 and, in 2012, was approved by the Federal Drug Administration for HIV prevention in the United States.1 Despite this advance, HIV in the United States continues to disproportionately affect black men who have sex with men (MSM) and transgender women (TW) (BMSM/TW). From 2012 to 2017, HIV incidence decreased by 14% among white MSM while increasing 3% among BMSM.2 The Centers for Disease Control and Prevention estimates an HIV prevalence of 44.2% among black TW compared with 6.7% among white TW.3 Despite high levels of willingness to take PrEP,4–7 numerous studies have documented low PrEP uptake among BMSM/TW.6–10 In 2017, 5.9% of PrEP-eligible black persons aged ≥13 years received a prescription for FTC/TDF compared with 42.1% for whites.11 Racial inequity is a major driver of HIV incidence in the United States, and increasing PrEP uptake among BMSM/TW is an urgent priority in most Ending the HIV Epidemic plans throughout local jurisdictions.12–14

Research investigating the delivery of real-world implementation strategies to support PrEP uptake among BMSM/TW in the United States is limited.15 A recent review of behavioral interventions to enhance PrEP uptake among BMSM found only 7 studies that included BMSM.16 Of those, only one study showed an increase in PrEP adherence but consisted of a primarily white study population, decreasing generalizability to BMSM.16,17 Other open-label studies provide PrEP care at no cost, limiting applicability and relevance to real-world settings.13,18 Thus, there is a lack of evidence-based interventions to support PrEP uptake among BMSM/TW.

Social network approaches may provide important infrastructure to accelerate PrEP uptake among populations most vulnerable to HIV. Network induction stimulates the dissemination of information and behaviors through established social networks.19 Network induction strategies include network referral services, such as partner notification services (PNS)20 and social network strategy services (SNSS),21 hereafter network services, which can identify individuals in HIV transmission networks who may benefit from PrEP. In 2016, 37% of BMSM/TW presenting for PNS across 59 US health departments received a new diagnosis of HIV.20 Accordingly, health departments have integrated PrEP within PNS.22–24 Similarly, SNSS have been shown to increase HIV testing and diagnosis25,26 and identify BMSM at an increased risk of seroconversion.21,27 SNSS have been implemented by health departments alongside PNS27,28 and are promoted by the World Health Organization to increase HIV testing among key populations.28 Given these data, combining linkage to PrEP care interventions with network services may be a promising approach to link BMSM/TW to PrEP care.

We developed the Partner Services PrEP (PS-PrEP) intervention to improve linkage to PrEP care among BMSM/TW presenting for network services. In the current study, BMSM/TW presenting for network services were recruited to receive a brief intervention based on the information–motivation–behavioral skills (IMB) model.29 Several studies have found that IMB has robust empirical support for understanding the determinants of PrEP uptake.29–31 Building on this work, a growing number of IMB-based interventions to improve PrEP continuum of care outcomes have been developed.32–35 Here, we report the preliminary efficacy results of the PS-PrEP study, a pilot randomized controlled trial to increase PrEP uptake among BMSM/TW at an increased risk of HIV seroconversion. The primary outcome was linkage to PrEP care within 3 months of receiving the intervention. We hypothesized that a higher proportion of participants who received the PS-PrEP intervention would be linked to PrEP care within 3 months of the intervention compared with those who received treatment as usual (TAU).

METHODS

Recruitment and Study Population

Recruitment of adult men and TW presenting for network services was conducted between November 2015 and November 2017. PNS are provided through public health departments on a voluntary basis to people diagnosed with sexually transmitted infections (STI), including HIV, and their sex or needle-sharing partners, who are confidentially notified of possible HIV exposure and offered free services, such as HIV testing and counseling.36 SNSS entails enlisting individuals presenting for HIV/STI testing to recruit their social network associates who may be at an increased risk of HIV seroconversion or unaware of their HIV status for testing.25,26,37 In the current study, SNSS were implemented in an academic-affiliated community site that offers HIV/STI testing and is colocated with a federally qualified health center (FQHC) that specializes in sexual health. PNS were implemented by the Chicago Department of Public Health (CDPH) in public STI clinics. Individuals receiving network services were offered routine HIV/STI testing, and those who reported being HIV negative were assessed for eligibility.

Inclusion criteria were (1) assigned male sex at birth, (2) self-identified as black, (3) aged 18–40 years, (4) reported sex with a man or transgender woman in the past 6 months, (5) self-reported being HIV seronegative, (6) English speaking, (7) living in the Chicago metropolitan area at least 6 months of the year, and (8) owning a cell phone and agreeable to text/phone communication. Participants were excluded if they reported taking PrEP in the previous 12 months, planned to move out of the Chicago area within the next 12 months, or were unable to provide informed consent. Figure 1 shows the CONSORT diagram for the study. In total, 357 candidates were assessed for eligibility and a total of 146 eligible BMSM/TW consented and enrolled. Participants were able to enroll in the study before receiving confirmatory HIV test results. If participants were found to be HIV seropositive upon linkage to PrEP care, they were included in the linkage to PrEP care analysis but excluded from the PrEP initiation analysis.

F1
FIGURE 1.:
PS-PrEP study consort flow diagram.

Data Collection, Randomization, and Masking

Survey data were collected at baseline and 3- and 12-month postintervention by trained interviewing staff using RedCap, a secure online survey software.38 Participants received a $25 cash incentive at each assessment. Following the baseline assessment, participants were randomized using block randomization into 1 of the 2 groups: PS-PrEP intervention or TAU. Because of the nature of the intervention, complete blinding of participants, investigators, and interventionists was not possible. All protocols were approved by the University of Chicago, CDPH, and Howard Brown Health Institutional Review Boards. ClinicalTrials.gov Identifier: NCT02749955.

The PS-PrEP Intervention

The PS-PrEP intervention consisted of a 60-minute face-to-face session with a social work interventionist (SWI) who guided participants through 4 components based on the IMB model.31 In the first component, the SWI provided interactive education on HIV and PrEP. Building on this content, the SWI used motivational interviewing techniques39 to assess participant's intrinsic motivation to reduce HIV risk and engage in PrEP care. A motivational scale was used to facilitate a conversation on HIV risk reduction, and the participant and SWI completed a pros and cons worksheet40 to guide a discussion on enacting change. In the third component, the SWI and participant developed a Linkage Roadmap, a personalized plan to navigate linkage to PrEP care. Adapted from the Life Steps intervention, the Linkage Roadmap included a plan to (1) identify a primary care physician or medical home for PrEP care, (2) review the PrEP appointment schedule, (3) manage barriers to care engagement and medication adherence, including stigma, provider communication, transportation, and side effects, and (4) develop skills to maintain a daily medication schedule.41,42 After completing the Linkage Roadmap, participants received a comprehensive list of PrEP care providers in Chicago. In an optional fourth component, the SWI completed problem-solving exercises with participants who identified significant barriers in their Linkage Roadmap and/or decided not to engage in PrEP care linkage.

Participants received up to 4 minibooster sessions via phone or text message from the SWI until they were linked to PrEP care or up to 12-week postintervention. The miniboosters served to check-in with participants about experiences getting linked to PrEP care, answer questions, review the Linkage Roadmap, and problem-solve difficulties enacting the Linkage Roadmap.

Control Condition

The control group received TAU, which included a brief risk assessment, referral for additional STI testing, and provision of HIV prevention programing, including PrEP care, by community-based or CDPH staff.

Measures

Sociodemographic Factors

Sociodemographic measures included Latinx identity, gender identity, sexual orientation, educational achievement, employment status, and health insurance coverage.

Psychosocial Characteristics

Depression was assessed with the Brief Symptom Inventory-18; those with a depression subscale T-score of >62 were categorized as having depression (0 = no, 1 = yes).43 A single item assessed binge drinking, that is, ≥5 alcoholic drinks on the same occasion, in the past 3 months. Heavy marijuana use was categorized as smoking or ingesting marijuana ≥4 times per week or <4 times per week or never. A binary variable for illicit substance use based on affirmative responses to using any other illicit substance to get high or buzzed in the preceding 3 months.

PrEP Awareness and HIV Risk Perception

PrEP awareness was assessed with a single yes–no question: “Before today, have you heard about PrEP?”44 Perception of risk of HIV infection was assessed by 2 items that asked participants about how likely they are to get infected with HIV (0 = almost zero to 5 = very large) and how concerned they are about becoming HIV infected (0 = not concerned to 5 = extremely concerned).45

HIV Serostatus and STIs

HIV and STI testing were completed according to agency protocols. Active syphilis infection was defined as an rapid plasma reagin titer of >1:8. Genital and extragenital gonorrhea and chlamydia, syphilis, and HIV infections were abstracted from participant's electronic medical record (EMR) through release of information and data sharing Memorandums of Understanding with PrEP providing clinics and service programs.

Outcome Measures

The primary outcome was linkage to PrEP care, which was defined as having at least one outpatient clinic visit within 3 months of the baseline session (eg, linkage window) where PrEP was discussed with a PrEP prescriber regardless of whether PrEP was initiated. Secondary outcomes included PrEP initiation within the linkage window and within the study period, as well as linkage to PrEP care, time to linkage to PrEP care, and time to PrEP initiation within the study period. PrEP initiation was defined as receiving a prescription for FTC/TDF. We abstracted visit data from the EMR and evaluated 3-month survey results to evaluate linkage to care within the linkage window (eg, primary outcome) and PrEP initiation within the linkage window. All other outcomes were measured by abstracting clinic data from the EMR.

STATISTICAL ANALYSIS

Primary Analysis

All analyses were completed using R Statistical Software (R Version 3.5.2).46 Because of the pilot nature of the study, statistical significance was set at P ≤ 0.05. The study recruitment goal was 150 participants based on 80% power and 2-sided alpha of 0.05, assuming linkage to PrEP care in the control group of 8% and PS-PrEP intervention group of 25%. To evaluate baseline equivalence across treatment groups, we first conducted χ2 or Fisher exact tests for categorical variables and Wilcoxon rank–sum tests for continuous variables. We calculated the cumulative incidence of STIs and compared difference between groups by estimating risk ratios. To ensure that previous engagement in care at the FQHC colocated with the community site did not influence our results, we also compared the proportion of participants in each group who had non-PrEP clinic visits at the FQHC in the 6 months before baseline.

For the primary outcome, an intent-to-treat analysis using χ2 tests was performed to evaluate the preliminary efficacy of the PS-PrEP intervention on linkage to PrEP care within the linkage window. We also completed a sensitivity analysis excluding participants who were diagnosed with HIV after baseline or who moved away from Chicago after baseline.

Secondary Analysis

Intent-to-treat analysis was also completed for secondary outcomes. We examined treatment effects on the time to linkage to PrEP care and time to PrEP initiation within the study period using Wilcoxon rank–sum tests, and on the proportion linked to PrEP care within the study period and the proportion initiated PrEP within the linkage window using χ2 tests. Time to PrEP initiation analysis was limited to participants linked to care.

RESULTS

Descriptive Characteristics

A total of 136 participants were included in the primary analysis (Fig. 1 and Table 1). The study population was predominantly younger [median = 25.9 years; interquartile range (IQR) = 22.5–28.5], gay-identified (62%) black men and TW with a high school education (92%), and health insurance (83%). There were no significant differences in sociodemographic factors between study groups. At baseline, perception of HIV risk or PrEP awareness did not differ significantly between the groups. Almost all participants (97%) were aware of PrEP and 68% were moderately or extremely concerned about seroconverting; however, only 8% thought their chance of becoming HIV seropositive was large or very large. There was no significant difference between the groups in non-PrEP clinic visits at the colocated FQHC 6 months before the study (8% vs. 6%; P = 0.74).

TABLE 1. - Baseline Characteristics of Study Participants, PS-PrEP 2015–2018, Chicago
Study Population (n = 136) Control Group (n = 65) Intervention Group (n = 71) Test Statistic* P*
Median age in years (IQR) 25.9 (22.5–28.5) 25.9 (23.3–28.4) 25.7 (21.9–28.8) W = 2480 0.45
Latino ethnicity (%) 8 (6) 5 (8) 3 (3) N/A 0.48
Transgender or queergender identity (%) 10 (7) 5 (8) 5 (7) N/A 1.00
Sexual orientation (%) N/A 0.11
 Straight 2 (1) 1 (2) 1 (1)
 Gay 85 (62) 44 (68) 41 (58)
 Bisexual 44 (32) 20 (31) 24 (34)
 Queer 5 (4) 0 (0) 5 (7)
Education (%) 2.3 (3 df) 0.52
 Some high school 11 (8) 6 (9) 5 (7)
 High school 41 (30) 17 (26) 24 (34)
 Some college† 68 (50) 32 (49) 36 (51)
 Bachelors or higher 16 (12) 10 (16) 6 (9)
Employment (%) 4.6 (3 df) 0.21
 Full time 54 (40) 31 (48) 23 (32)
 Part time 36 (26) 13 (20) 23 (32)
 Unemployed 35 (26) 17 (26) 18 (25)
 Other 11 (8) 4 (6) 7 (10)
Health insurance (%) 113 (83) 57 (88) 56 (79) 1.9 (1 df) 0.17
Depression (%) 20 (15) 12 (18) 8 (11) 1.4 (1 df) 0.24
Binge drank alcohol (%) 32 (24) 15 (23) 17 (24) 0.0 (1 df) 0.91
Heavy marijuana use (%)‡ 55 (40) 28 (43) 27 (38) 0.4 (1 df) 0.55
Illicit substance use (%) 17 (12) 7 (11) 10 (14) 0.3 (1 df) 0.56
Sexually transmitted infections (%) 13 (10) 5 (8) 8 (11) 0.5 (1 df) 0.48
*Wilcoxon rank-sum test (test statistic = W) for continuous variables, Fisher exact test (no test statistic) for categorical variables with N ≤ 5, and χ2 test (df = degrees of freedom) categorical variables with N > 5.
†Some college, associate's, or technical school.
‡≥4 times per week.

There were 35 STIs diagnosed during the study period among 27 participants; of which, 13 were diagnosed at baseline. The cumulative incidence of any STI diagnosis among the study population was 26 per 100 person-years and was not significantly different between groups (risk ratio, 1.08; 95% confidence interval: 0.56 to 2.11). Six participants were diagnosed with HIV after completing the baseline survey, 2 of whom were linked to PrEP care and received their diagnosis at their first clinic visit. There were no HIV seroconversions after PrEP initiation. One participant moved out of Chicago after being linked to PrEP care. The 6 participants diagnosed with HIV after the baseline survey and the participant who moved out of Chicago were excluded from the secondary analysis.

Intervention Completion Rates

The initial 60-minute face-to-face session was completed by 97% of participants. Not all participants in the intervention group completed all 4 booster sessions. Because of changes in contact information and client preference, the SWI used Facebook messages and e-mails in addition to calls and texts to deliver booster sessions. During the linkage window, 67% (n = 48) received a median (IQR) of 3.0 (range, 1.0–4.0) booster sessions and 13% (n = 9) received more than 4 booster sessions (maximum = 11).

Primary and Secondary Outcomes

Linkage to PrEP care and PrEP initiation outcomes are described in Table 2. Analysis of the EMR clinic data demonstrated that, compared with control group participants, a significantly greater proportion of participants who received the PS-PrEP intervention were linked to PrEP care within the linkage window (24% vs. 11%; P = 0.04). In the intervention group, 82% (n = 14) of those linked to care within the linkage window and 86% (n = 12) of those who initiated PrEP within the linkage window received at least 1 booster session. Among those linked to PrEP care within the study period, participants who received the PS-PrEP intervention were linked to PrEP care significantly sooner [median (IQR): 26.5 (6.0–141.8) days vs. 191.5 (21.5, 297.0) days; P = 0.05] than those in the control group.

TABLE 2. - Linkage to PrEP Care and PrEP Initiation Outcomes of the PS-PrEP Study, 2015–2018, Chicago
Study Population (N = 136), n (%) or Med (IQR) Control Group (n = 65), n (%) or Med (IQR) Intervention Group (n = 71), n (%) or Med (IQR) Test Statistic* P
Initiated PrEP within linkage window†§ 21 (15) 7 (11) 14 (20) 2.1 (1 df) 0.15
Linked to PrEP care within linkage window† 24 (18) 7 (11) 17 (24) 4.1 (1 df) 0.04
Initiated PrEP within study period†§ 41 (32) 17 (27) 24 (37) 1.3 (1 df) 0.25
Linked to PrEP care within study period† 46 (34) 20 (31) 26 (37) 0.5 (1 df) 0.47
Days to PrEP care linkage within study period†‖ 61.0 (9.8–258.8) 191.5 (21.5–297.0) 26.5 (6.0–141.8) W = 349.5 0.05
Days to PrEP initiation within study period†§‖ 93.0 (9.0–287.0) 209.0 (20.0–327.0) 61.0 (6.0–253.0) W = 244 0.30
Initiated PrEP within linkage windowठ23 (18) 7 (11) 16 (24) 3.8 (1 df) 0.05
Linked to PrEP care within linkage window‡ 28 (21) 9 (14) 19 (27) 3.5 (1 df) 0.06
The significance for the bolded value is P ≤ 0.05.
Med = median; linkage window = 3 months after baseline; study period = 12 months after baseline.
*Wilcoxon rank-sum test (test statistic = W) for continuous variables, and χ2 test (df = degrees of freedom) for categorical variables.
†Clinic data abstracted from the EMR.
‡Self-reported 3-month survey data.
§PrEP initiation analysis excluding the 6 participants who tested seropositive after study enrollment and the one participant who moved out of Chicago (N = 129; control group n = 63; intervention group n = 66).
‖Among participants linked to PrEP care within the study period.

One hundred eight participants (79%) complete the 3-month follow-up survey. Analysis of the 3-month survey data demonstrated that, compared with control group participants, a significantly greater proportion of participants who received the PS-PrEP intervention initiated PrEP (11% vs. 25%; P = 0.05). There was no significant difference in self-reported linkage to care at 3 months. A significantly smaller proportion of participants who completed the 3-month follow-up survey had depression, compared with those who did not (see Table 3, Supplemental Digital Content, https://links.lww.com/QAI/B561). The sensitivity analysis did not demonstrate significant differences in linkage to PrEP care outcomes between groups but did demonstrate the same significant PrEP initiation outcomes (see Table 1 and 2, Supplemental Digital Content, https://links.lww.com/QAI/B561).

DISCUSSION

We investigated the preliminary efficacy of PS-PrEP to increase linkage to PrEP care among BMSM/TW accessing network services. Compared with the control group, we found that a significantly higher proportion of BMSM/TW who received the PS-PrEP intervention were linked to PrEP care and initiated PrEP within the 3-month linkage window. We also found a lower median time for linkage to PrEP care over the 12-month study period between the intervention and control groups. Our results demonstrate that the PS-PrEP intervention can increase PrEP uptake among BMSM/TW presenting for network services. PS-PrEP offers a novel approach to achieving health equity and eliminating HIV transmission among BMSM/TW, the 2 populations most impacted by HIV47 and least likely to be engaged in PrEP care in the United States.48

Although BMSM/TW who received the PS-PrEP intervention had improved outcomes, linkage to PrEP care and PrEP initiation remained low across our study population. At the 3-month follow-up, the most common reason for not attending a scheduled PrEP care appointment was being busy (data not shown), which suggests competing needs and priorities. Although most participants were concerned about HIV, very few thought that they were at risk for HIV infection. Low self-perceived risk of HIV infection has previously been identified as a barrier to PrEP care among BMSM49 and may have influenced our results. Other identified barriers to PrEP uptake among BMSM include racism,50 stigma,13,50,51 mistrust in medical care,50,51 concern about side effects,13 cost,13,18 and insurance status.52 Some barriers, such as stigma, side effects, low-risk perception, and insurance status, were addressed in the PS-PrEP intervention. However, barriers such as mistrust in medical care51 and racism50 were not directly addressed. At baseline, 10% of participants reported not knowing where they would sleep every night, 30% reported spending time in jail or a juvenile detention facility, and 33% reported not feeling safe walking in their neighborhood (results available from first author). Housing instability, criminal legal system involvement, and exposure to community violence are prevalent among BMSM/TW in Chicago53 and may have contributed to limiting PrEP uptake among our study population. Finally, depression and substance use were prevalent among our study population. Depression has been associated with increased PrEP uptake among BMSM,10,49 but the association between substance use and PrEP uptake has been less clear.54–56 Future research should elucidate the role of structural barriers, racism, medical mistrust, depression, and substance use in PrEP-related decision making among BMSM/TW.

HIV testing was not required for enrollment in the PS-PrEP study. There were 6 participants who were diagnosed with HIV; of whom, 2 were diagnosed when they presented for PrEP care. Participation in PrEP linkage to care programs may require HIV testing;22,57 however, successful same-day start PrEP programs do not complete confirmatory HIV testing before starting PrEP.58–61 Similar to the PS-PrEP study, a concurrent CDPH intervention (PrEPLine) also included clients who self-reported negative HIV status.24 Confirmatory HIV testing may be an unnecessary barrier to linkage to PrEP care. Our results indicate that PrEP linkage programs may also need to be prepared to provide HIV care to people found to have newly seroconverted.

Implementation of the PS-PrEP intervention provides useful insights into how future programs may successfully integrate behavioral interventions into network services. The face-to-face component was highly acceptable and completed by 97% of participants in the intervention group. Booster session completion, however, was less than originally planned, with two-thirds of the intervention group completing at least 1 minibooster. Participant cell phone information was often inaccurate or out-of-date, which likely contributed to limited fidelity to this component of the protocol. Program staff addressed this issue by using other methods to contact participants, such as through private Facebook and e-mail communication. Most participants in the intervention group who were linked to PrEP care or initiated PrEP within the linkage window received booster sessions, which suggests that boosters were an important component of the PS-PrEP intervention. Additional qualitative research with BMSM/TW to examine which components of the intervention may be more acceptable and/or appropriate are needed.

In addition, the PS-PrEP study was designed to be integrated into CDPH PNS and target clients presenting for HIV testing at public STI clinics. However, most enrolled study participants were recruited from SNSS. Over the study period, CDPH implemented PrEPLine, a low-threshold phone-based linkage to PrEP care intervention at public STI clinics.24 Clinic clients were recruited directly to the in-house intervention.24 Consequently, nearly all the participants enrolled in the current study were recruited via SNSS. Our results revealed barriers at the individual, for example, consistent cell phone numbers, and setting levels to implementing the PS-PrEP intervention in different clinical sites. Formal metrics or methods examining implementation science were beyond the scope of the study. Future studies may benefit from incorporating an implementation science component guided by existing models35,62–64 to promote linkage to PrEP care for BMSM/TW into routine network services across diverse contexts.

These results should be interpreted in the context of the study limitations. A small number of black TW were enrolled in the study, thus limiting our ability to determine preliminary efficacy specifically among this subgroup of participants. The study population is likely subject to selection bias as candidate participants were identified when presenting for HIV or STI testing via network services. BMSM/TW not engaged in HIV or STI testing may represent an even higher risk population than those in the present study. In addition, although the initial design was to integrate PS-PrEP into CDPH PNS, most participants were recruited from a community site providing HIV and STI testing via SNSS21 that is colocated with an FQHC specializing in sexual health.65 Colocation52 of the community site and FQHC in the same building may not be available in other contexts. To compare with real-world settings, the control group received TAU rather than time matched sessions, which limited interpretation of how separate components of PS-PrEP impacted outcomes. Lastly, Illinois expanded Medicaid in 2014, before the current study, which likely contributed to the high rate of health insurance among participants. Thus, the PS-PrEP intervention may require health insurance assistance if implemented in states that have not expanded Medicaid. In the current study, there was staff turnover across study sites and changes in participant cell phone numbers over time. These issues have been documented in prior research.66–68 Thus, our results demonstrate a real-world implementation of the PS-PrEP intervention, which may be subject to similar limitations in other settings. Although clinic data were overwhelmingly from the largest PrEP provider in Chicago, it was limited to a single FQHC network, and 21% of participants did not complete the 3-month follow-up survey. As such, we may have underestimated linkage to PrEP care. A larger trial of the PS-PrEP intervention is necessary to fully evaluate the effect of the PS-PrEP intervention on linkage to PrEP care at a population level.

Racial inequity is a major driver of the HIV epidemic in the US. Prevention of HIV transmission with PrEP is a central component of eliminating HIV in the US14 and lower uptake of PrEP among BMSM/TW could worsen racial inequity in HIV incidence.12,13 Network services are effective in identifying BMSM/TW at an increased risk of seroconversion20,21,27 and are promising strategies to accelerate PrEP uptake. To our knowledge, the PS-PrEP study is one of the first efficacious network service linkage to PrEP care interventions tailored to BMSM/TW. PS-PrEP significantly increased PrEP uptake among BMSM/TW but linkage to PrEP care and PrEP initiation remained low. Future studies using the PS-PrEP strategy may further improve PrEP outcomes by addressing structural barriers, racism, and medical mistrust, as well as adapting booster sessions to facilitate continued engagement between PrEP care clinics and participants.

ACKNOWLEDGMENTS

The authors thank the study participants, as well as the staff at Howard Brown Health, the Chicago Department of Public Health and the University of Chicago.

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Keywords:

preexposure prophylaxis; HIV; linkage; black; men who have sex with men; randomized control trial

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