The TLC intervention includes a drop-in center providing a “one stop shop” of bundled housing, employment, legal, and outreach-based health services (i.e., triage, health education, and referral), in addition to HIV prevention services(Center for Disease Control and Prevention, 2016). The drop-in center provides a safe space to socialize and to be connected to these services to meet basic needs. The TLC intervention addresses the specific structural and social factors that impact outcomes along the prevention and care continuum among transgender women(Hotton et al., 2020), drawing on a social determinants theoretical model of HIV risk(Beltran et al., 2011; Sharpe et al., 2010). A key aspect of the TLC multi-component intervention is the transgender-specific nature of services (i.e., developed for and by transgender women), delivered by transgender staff, whenever possible. In addition, TLC services are provided to transgender women regardless of HIV status(Kuhns et al., 2021), although participation in the program evaluation, detailed herein, was restricted to HIV-uninfected participants(Rhodes et al., 2021).

The TLC program facilitates direct access to basic services (e.g., housing, employment, legal aid, and health services), and may promote other protective processes through its drop-in center, including affirmation of gender identity and collective and supportive experiences to reduce behaviors associated with HIV transmission (Hendricks & Testa, 2012; Testa et al., 2015). Similar to the impact of multiple psychosocial conditions on HIV risk factors, resiliency processes may be additive in risk-reduction (Hendricks & Testa, 2012; Testa et al., 2015). A detailed description of TLC services can be found in prior publications.(Kuhns et al., 2021; Rhodes et al., 2021)

Between January 2019 and February 2020, transgender women were enrolled in this evaluation of the TLC intervention at Chicago House and Social Service Agency in Chicago, Illinois, using a convenience sampling approach. New registrants in the TLC were approached to participate in the evaluation and were enrolled, if eligible and interested. Eligibility criteria included: (a) identifying as transgender, transfeminine, and/or female and assigned male sex at birth; (b) ≥ 17 years of age; (c) self-reported history of sex with men in the past 4 months; (d) negative/non-reactive HIV screening test at baseline; (e) able to speak/understand English; (f) willing and able to provide informed consent; (g) intend to reside in the local area throughout the 8-month follow-up period; and (h) had no exposure to any component of the TLC intervention in the prior 4 months. Individuals were excluded if they were unable to provide informed consent due to severe mental or physical illness, or intoxication at the time of interview (those excluded could re-screen if symptoms resolved).

At the point of enrollment, participants completed a baseline questionnaire via computer-assisted interviewing, which included demographic characteristics, health behaviors, and psychosocial factors. Participants were followed with measures repeated at 4- and 8-months post-enrollment, respectively. Data for the enrollment visit were collected on-site at the TLC via self-administered web-based questionnaire (i.e., participants were provided a private space to complete it on site) and at follow-up were collected primarily remotely due to the COVID-19 pandemic (as of March 2020), captured in web-based format. Due to changes in the assessment due to COVID-19 (a truncated assessment for remote deployment), for a period of 3 months (mid-March to mid-June 2020), data on secondary outcomes for housing and employment were not collected, resulting in missing data for that period. Participants received $50 token of appreciation for completion of each study visit.

Sociodemographic information collected included age (in years), race/ethnicity, sexual orientation/identity, highest level of education, current income, current employment, history of incarceration, and current housing status.

We measured recent (past 30 days) condomless anal/vaginal sex (Yes, No) with items from the AIDS Risk Behavior Assessment (ARBA), adapted for trans women (Garofalo et al., 2018). In addition, recent protective PrEP use was measured as consistent (daily) PrEP use in the prior 30 days (NB: no participants reported use of other PrEP dosing). We used a series of items: Have you taken PrEP in the last month?” “Please indicate whether or not you have taken PrEP on each day during the past month, beginning with yesterday (timeline follow-back approach with calendar; coded on a scale of 0–100% adherent). The primary outcome was coded as any reported condomless anal or vaginal sex without protective levels of PrEP (defined as report of PrEP use less than 4 days per week in the past month).

We assessed employment status with the item, “Please indicate which of the following is true for you regarding your current work status? The responses were coded with “working for pay at a job or business,” versus all others. We assessed housing status with the item, “Which of the following best describes your current living situation? By current living situation, we mean where have you been staying during the past seven days?” Responses coded to reflect “your own place, a room, apartment, or house that is your home” versus all others (e.g., jail/prison, drug treatment, transitional housing, hotel/motel).

All participants were registered as TLC program participants, which includes an initial evaluation of needs and referrals to services, but not all sought out and/or received related services. Intervention exposure was abstracted from TLC program records at 4-month intervals by type of intervention component (e.g., assistance with housing, employment, on-site medical care and education, legal services) and total hours of exposure across all intervention components for each period. We also calculated the cumulative number of hours of intervention exposure through the end of each 4-month period for descriptive purposes but analyze intervention effects as time varying so that the timing of intervention receipt and study outcomes were more closely aligned. Due to the COVID-19 pandemic, the in-person TLC intervention was paused for the duration of the study observation period on March 13, 2020, thus only remote intervention services were provided to participants thereafter, e.g., via phone call/email/web evaluation and referral, which were also tracked as intervention activities (in each service category, respectively).

This analysis was conducted to assess the effectiveness of the TLC for reducing condomless sex, except in the context of consistent PrEP use. The primary outcome was any report of past-month condomless anal or vaginal sex (CAVS) without consistent PrEP use. We used mixed effects logistic regression with random intercepts to assess the impact of the intervention across all follow-up time points. Models include an indicator for intervention group, time, and a group by time interaction term. Additionally, due to the non-randomized design, all models controlled for the baseline value of the outcome and age, race/ethnicity, sexual identity, and history of sexually transmitted infections at baseline to account for imbalances between those who did and did not receive the intervention. We also controlled for calendar time, defined as time in months from January 1, 2019, to account for confounding due to trends related to the COVID-19 pandemic. The primary intervention effect was assessed via the statistical significance of the group by time interaction, which indicates whether the difference between groups varies over time. Data were analyzed using Stata/SE version 17.0 (Stata Corp, College Station, TX).

A total of 103 of 120 TLC participants screened were eligible for the evaluation, and of those, 99 non-duplicated individuals were enrolled between January 2019 and February 2020. Two participants were withdrawn for non-completion of the baseline, for a total of 97 in the final sample. Follow-up assessments continued through August 2021. Participants included transgender women between the ages of 18 and 59 (median age= 24); 54.6% identified as non-Hispanic Black and 21.7% as Hispanic/Latina. Other demographic characteristics are shown in Table 1.

Of the 97 participants, 48 received any intervention components and 49 received no intervention. Among those who received any TLC component, the most utilized services were drop-in services and medical care (Table 2). At baseline, characteristics of those who received vs. did not receive the intervention were visually inspected for imbalance. Compared to those who did not receive the intervention, participants who received the intervention were less likely to identify as gay or lesbian or as Latina/x or Hispanic and to report any STI history (Table 1).

In terms of retention, overall, 89 (91.8%) completed at least one study follow-up visit; and 65 (67.0%) completed all three study visits. Those who received the intervention were more likely to complete at least one follow up visit than those who did not (100% vs. 83%; Table 1).