Abstract
This study examined feasibility, acceptability, and preliminary effects of a pilot randomized controlled trial (BRIDGES) designed to improve HIV care outcomes among syndemic-affected women living with HIV (WLHA). We enrolled and randomized adult WLHA who were out-of-care or at risk of falling out-of-care and experienced any syndemic condition(s) into BRIDGES (n = 11) or standard of care (n = 13). BRIDGES employed peer navigation one-on-one sessions and six weekly 2-h video psychoeducation group sessions. Feasibility and acceptability were assessed through participant quantitative and semistructured interviews. Intention-to-treat analyses were conducted to evaluate the preliminary effects of BRIDGES. BRIDGES was highly feasible and acceptable. Intervention participants demonstrated improved self-reported adherence to antiretroviral therapy at 3 months, and better engagement and retention in care and viral suppression at 12 months compared to control participants. BRIDGES is a promising program to provide syndemic-affected WLHA with the tools needed to mitigate social and structural barriers to HIV care.
Disparities continue to impact women living with HIV/AIDS (WLHA) in the US. WLHA are less likely to be virally suppressed than men, while Black and Latinx WLHA have lower rates of viral suppression compared to White WLHA (Geter et al., 2018, 2019), and fewer Black and Latinx WLHA are linked to HIV care within three months of diagnosis (Lima et al., 2018). HIV care outcomes are associated with mutually reinforcing, or syndemic conditions, including violence, trauma, substance use, and adverse mental health. Estimates from an inner-city HIV clinic indicate that almost 70% of WLHA seeking care have experienced interpersonal violence (physical, sexual, and/or psychological abuse from a partner or nonpartner) (Illangasekare et al., 2012), approximately 40% of WLHA in a nationally representative sample have a DSM-V psychiatric disorder (Lopes et al., 2012), and 58.1% of WLHA from a large multisite cohort in the US reported risky substance use behaviors, while 49.9% reported drug abuse, and 19.6% reported alcohol abuse (Cook et al., 2018). Each syndemic condition has been associated with decreased antiretroviral therapy (ART) adherence, reduced viral suppression, and/or decreased engagement and retention in HIV care (Carter et al., 2018; Cohen et al., 2004; Dale et al., 2014; Eisenberg & Blank, 2014; Espino et al., 2015; Hatcher et al., 2015; Leddy et al., 2019; Lopez et al., 2010; Machtinger et al., 2012; Rooks-Peck et al., 2018; Rose et al., 2010). More co-occurring syndemic conditions is associated with worse ART adherence among all WLHA (Blashill et al., 2015), and reduced viral suppression among women of color (Sullivan et al., 2015). It is important to acknowledge that these syndemic associations do not capture the complex sociostructural interactions that concentrate the exposure of syndemic conditions and amplify vulnerability to HIV and poorer HIV-related health outcomes among low-income WLHA and WLHA of color in the US, particularly Black women (Smith et al., 2022). Still, exposure to a greater number of syndemic conditions continues to demonstrate a robust dose–response relationship with poorer HIV-related health outcomes (Tsai and Burns, 2015).
Psychoeducation is defined as structured and didactic knowledge transfer for a health condition and its treatment while integrating emotional and motivational aspects to enable coping (Ekhtiari et al., 2017). As an intervention strategy, psychoeducation has emerged as an acceptable (Stockman et al., 2020) and effective method to address syndemic-related affective distress, including PTSD, depression, and trauma-related symptoms (Cloitre et al., 2002, 2010, 2014, 2017). In the context of HIV, psychoeducation improves retention in HIV care and ART adherence (Coyle et al., 2019; Gokhale et al., 2019; Rooks-Peck et al., 2018; Saag et al., 2018), while group-based sessions facilitate support networks associated with improved depressive symptoms, HIV stigma (Cederbaum et al., 2017; Vyavaharkar et al., 2010, 2011), HIV-related health symptoms (Ashton et al., 2005), ART adherence (Edwards, 2006; Gonzalez et al., 2004; Power et al., 2003; Vyavaharkar et al., 2007), perceived ability to engage in HIV care (McDoom et al., 2015), and HIV self-management (Webel et al., 2013). Relatedly, peer navigation is a feasible, acceptable, and efficacious model for improving HIV care outcomes (Cabral et al., 2018; Higa et al., 2012; Hirshfield et al., 2019; Okeke, et al., 2014; Reback et al., 2019; Steward et al., 2018). Through shared lived experience, medication-adherent peer navigators (PNs) can provide social support, model HIV care engagement-supportive behaviors (AIDS United, 2015), help people living with HIV (PLWHA) build self-efficacy in patient–provider communication, and decrease medical mistrust to offset social (e.g., stigma, social support) and structural (housing instability, transportation) barriers to care engagement, or social and structural factors which impede diagnosis, initiating care, and retention in care (AIDS United, 2015; Lang & Bird, 2018). Although in a global systematic review results were mixed and more assessment of peer interventions was called for (Genberg et al., 2016), in a variety of contexts, peer navigation has been shown to improve ART adherence (Deering et al., 2009; Simoni et al., 2007) and viral suppression (Cunningham et al., 2018; Reback et al., 2019); further, a systematic review of interventions in the U.S. cited peer navigation as an evidence-based intervention to improve retention in HIV care (Higa et al., 2012). Further, interactions with support groups and HIV-positive peers consistently demonstrate improvements in mental health, positive relationships, and mitigation of social and structural barriers (Logie et al., 2016; Paudel & Baral, 2015; Warren-Jeanpiere et al., 2017; Wielding & Scott, 2017).
Internet-based interventions have become a feasible and acceptable option for reaching at-risk populations (McKay et al., 2016). Numerous mobile application and SMS-based interventions have been developed for PLWHA (Coleman et al., 2017; da Costa et al., 2012; Duggal et al., 2018; Hightow-Weidman et al., 2015; Ishola & Chipps, 2015; Kalichman et al., 2018; LeGrand et al., 2018; Musoke et al., 2018; Njie-Carr et al., 2018; Ronen et al., 2018; Ye et al., 2018). However, few have focused on WLHA in the US, representing a missed opportunity to improve HIV care outcomes (Lester et al., 2010; Murray et al., 2015; Smillie et al., 2014). WLHA have expressed interest in and acceptability of such interventions (Blackstock et al., 2015; Green et al., 2015; Marhefka, Turner, & Lockhart, 2019; Messias et al., 2006); further, internet-delivered interventions are noted to feel more confidential and perceived to provide safer care, while also feeling more empowering than in-person formats for women with histories of violence/trauma (Bacchus et al., 2016; Glass et al., 2010; Klevens et al., 2012; Koziol-McLain et al., 2015; Tarzia et al., 2016). WLHA feel positive about web-based (as opposed to mobile application- or SMS-based) group interventions, including anticipation of feeling connected with other WLHA (Blackstock et al., 2015).
Psychoeducational interventions have demonstrated effectiveness to address trauma-related syndemics (Cloitre et al., 2002, 2010, 2014, 2017) and peer navigation can improve engagement in HIV care (Cabral et al., 2018; Higa et al., 2012; Hirshfield et al., 2019; Okeke et al., 2014; Reback et al., 2019; Steward et al., 2018). However, to date, the integration of these evidence-based interventions has not been examined among syndemic-affected populations suboptimally engaged in HIV care. To address this gap, we developed the BRIDGES program, a web-based intervention for syndemic-affected WLHA, and sought to test feasibility, acceptability, and preliminary effects of BRIDGES in a non-organizational/clinical research setting. BRIDGES was designed to build syndemic-related affective distress coping skills and activate social support networks, with the goal of improving retention in HIV care and ART adherence among syndemic-affected WLHA. BRIDGES was guided by the Theory of Triadic Influence, a multilevel social cognitive theory that hypothesizes three “streams of influence” (individual, social, and structural) act simultaneously to affect health behaviors (Flay & Petraitis, 2009). Simultaneously, we employed Syndemics Theory as a key conceptual framework focusing on the mutually reinforcing interaction of HIV and social conditions that potentiate the likelihood of poor HIV care outcomes among WLHA (Singer, 1994). Informed by these theories, we anticipated that BRIDGES would operate through mechanisms of change, including emotional awareness, emotion regulation, emotionally engaged living, interpersonal communication (assertive communication and behavior), coping self-efficacy, and social support, to improve HIV care outcomes among enrolled women (Figure 1). The aim of this paper is to present findings relating to the feasibility, acceptability, and preliminary effects of BRIDGES. Implementation of a pilot BRIDGES program is expected to begin to build the evidence base for future efficacy and effectiveness trials.

BRIDGES Conceptual Model.
Method
Study Participants
Through a small pilot grant from the California HIV/AIDS Research Program, between November 2019 and November 2020 we conducted a parallel pilot randomized controlled trial (RCT) to assess feasibility, acceptability, and preliminary effects of the BRIDGES intervention in San Diego, California (n = 24). Participants were required to: (1) self-identify as cis- or transgender women, (2) be aged 18 years or older, (3) report HIV-positive status (confirmed by medical records), (4) be newly diagnosed and/or never in HIV care, have fallen out of HIV care, or be at risk of falling out of HIV care, (5) be able to speak and understand English, (6) report one of the following: lifetime experience of a traumatic event (e.g., natural disaster, death of a loved one, sexual and/or physical violence by an intimate or nonintimate partner, community violence), lifetime experience of adverse mental health (e.g., depression, PTSD), or past year substance use (e.g., methamphetamines, prescription drugs, alcohol) and (7), have access to a computer, tablet, or phone with an internet connection. Having fallen out of HIV care was defined as no past-year (a) filled ART prescription, (b) viral load labs completed, and/or (c) HIV medical care visits with an ART-prescribing provider. At risk of falling out-of-care was defined as being in care but endorsing at least one past-year syndemic condition (e.g., a traumatic event, physical/sexual violence, adverse mental health, substance use) given their known association with care disengagement (Glynn et al., 2019; Meyer, Springer, & Altice, 2011). Participants were recruited using flyers, word-of-mouth, referrals from community-based organizations, and social media (Facebook groups). Study procedures were approved by the University of California San Diego Institutional Review Board. The trial was registered on September 9, 2021, with the ClinicalTrials.gov registry [NCT04295876].
Screening and Enrollment
Women interested in participating were informed that their participation could include three survey assessments, six group psychoeducational sessions, and at least six one-on-one peer navigation sessions. The intervention trial was designed to be delivered in-person but quickly transitioned to virtual amid the COVID-19 pandemic (Stockman et al., 2020). Potential participants were screened by staff over the phone or through a self-administered online screener. Interested and eligible participants completed a baseline study visit using the HIPAA-compliant Zoom videoconference platform, including documented informed consent, completion of HIPAA authorization and release of information forms, and a 60 minute interviewer-administered survey. Following the baseline visit, participants were randomized by study staff using the REDCap randomization model, to either the BRIDGES group or standard of care (self-guided Ryan White case management services). The randomization allocation sequence was independently established by the study biostatistician with a permuted block design, stratified by prior HIV research or intervention program participation. The randomization process was implemented in REDCap. The principal investigator and staff conducting data analysis remained blinded throughout data collection. Follow-up assessments were conducted at 3- and 6 months post-baseline, consisting of a 30 minute interviewer-administered survey. All participants received $35 for completing each visit and an additional $10 for completing all three study visits. Medical records were requested at 12 months post-baseline, and information regarding viral load, CD4 count, and engagement in HIV care was extracted.
Standard of Care
Women randomized to the standard of care (control) group received self-directed (non-peer navigation) treatment as usual at a local HIV service provider following Ryan White case management services. The participant was assigned to a family case worker who conducted a needs (e.g., housing, referrals, insurance) and behavioral (e.g., depression, sexual assault) assessment. Goals were set to create an individual care plan related to medical care, housing, financial, and other support resources, as needed. Referrals were made to appropriate services (e.g., primary care, housing, transportation, mental health, domestic violence) based on the intake interview. The family case worker had phone or in-person contact with participants at least once every 30 days to discuss changes and progress toward meeting the goals of the individual care plan and an in-person meeting at least once every 90 days. It is important to note that the case management approach was self-guided versus intense peer navigation assistance.
BRIDGES Content and Delivery
Peer navigation
Women randomized to the BRIDGES group received support through one-on-one phone, text, or video-based check-ins with a PN. Peer navigation was conducted by a “peer,” defined as a woman living with HIV with a lifetime history of violence, trauma, substance abuse, and/or adverse mental health, who successfully navigates and engages in HIV care and is ART adherent. PNs received training in trauma-informed care (TIC) and intervention activities. Following randomization, participants completed a 90 minute session with their PN to identify areas of need and received assisted referrals to support services. A minimum of six PN contacts through phone, text, or video, occurred and were continued throughout the intervention as needed, including in preparation for HIV care and ancillary service visits and debriefing. Specific to text messages, these were conducted independently, and the content of messages sent to the participant was at the discretion of the PN.
Psychoeducational group sessions
Following the initial one-on-one PN session, which occurred within one week of the baseline visit, participants began a series of six weekly 2 hour psychoeducational group sessions with a cohort 4–5 participants. The group sessions were all completed prior to the 3-month follow-up visit. Sessions were adapted by content experts from the Skills Training in Affective and Interpersonal Regulation (STAIR) Program, an evidence-based program addressing complex PTSD or PTSD and co-occurring disorders designed to build coping skills and assertive communication/behavior (Cloitre et al., 2010, 2014, 2017; Jackson et al., 2019; Weiss et al., 2018). Sessions were co-facilitated by a licensed marriage and family therapist (LMFT) and PN, and included skill-building exercises to support care engagement; homework was assigned between sessions. The topics included were emotional awareness, emotion regulation, emotionally engaged living, identifying and changing relationship patterns, assertive communication and behavior, and flexibility in relationships (Table 1); these sessions targeted the hypothesized mechanisms of change (Figure 1). Prior to the first session, participants received a mailed package with the weekly handouts and were provided with a Zoom videoconference invitation for each session; session-specific documents were color-coded for organizational purposes. In addition, PNs met with each participant via Zoom to provide guidance on how to connect and use the camera and microphone. Additional time was allotted before the start of each session to troubleshoot technical issues with participants. Participants received $10 following attendance at each weekly group session.
BRIDGES Intervention Psychoeducational Group Sessions Content.
BRIDGES was delivered utilizing TIC. Trauma Theory asserts that if traumatic memories cannot be processed, they are stored as physiological reactions to stimuli, situations, or states of arousal that recall the traumatic experience (van der Kolk et al., 1994). WLHA with a history of traumatic life events may become distressed or retraumatized by care experiences. TIC strives to meet the unique needs of trauma survivors and has been successfully applied in the contexts of substance use, mental health (Muskett, 2014; Reeves, 2015), HIV prevention, and HIV treatment (Sales et al., 2016). Through TIC-based delivery of BRIDGES, we expected that the BRIDGES program would be feasible, acceptable, and demonstrate clinically meaningful improvements in HIV care outcomes (i.e., retention and engagement, ART adherence, viral suppression).
Training
The LMFT received 40 hours of training from a coinvestigator and developer of the evidence-based intervention STAIR Program. PNs received 80 hours of initial training by the same coinvestigator and LMFT in the areas of TIC, aspects of one-on-one peer navigation (e.g., fostering relationships with participants, setting boundaries, conducting initial intake session), weekly group sessions, and documentation of intervention activities. One-quarter of the training was devoted to role play and utilization of teach-back methods to ensure that PNs understood the training material. PNs received ongoing supervision from the LMFT which provided opportunities to reinforce concepts and skills from the initial training.
Post-intervention participant evaluation
After completion of participation in the BRIDGES arm, intervention participants were invited to complete a voluntary post-intervention evaluation survey. The post-intervention evaluation survey was comprised of closed- and open-ended questions to assess feasibility and acceptability and took about 10 minutes to complete. Informal discussions between participants and psychoeducation group session facilitators (PNs and LMFT) were audio-recorded and transcribed verbatim.
Measures
Sociodemographics
Sociodemographic characteristics assessed included age, race/ethnicity, education, employment status, marital status, parental status, and current housing situation. HIV-related characteristics included years living with HIV, delays ≥ 1 year in seeking HIV care since diagnosis, and interruptions in HIV care of six months or more. Syndemic conditions included lifetime violence exposure, past-year binge drinking (4+ drinks per day), past-three-months drug use, past two weeks moderate/severe anxiety (score of 10+ based on GAD-7) (Spitzer et al., 2006), past-two-weeks moderate/severe depression (score of 10+ based on PHQ9) (Kroenke et al., 2001), and past-month PTSD (score of 33+ based on the PCL-5)(Weathers et al., 2013). A “syndemic load” variable was constructed that categorized the number of conditions (0, 1–2, 3–4, 5–6).
Feasibility
Feasibility was assessed by (a) the proportion of eligible participants who consented and enrolled into BRIDGES, (b) the proportion of BRIDGES program participants who completed all activities and who found it easy and convenient to participate in the web-based format, and (c) qualitative data on the usability and ease of the web-based format (assessed through open-ended questions).
Acceptability
Acceptability was measured by (a) the proportion of enrolled BRIDGES program participants who “strongly agreed” or “agreed” on a 19-item satisfaction scale adapted from previous studies (Smith et al., 2018; Zauszniewski, 2012); (b) the proportion of homework exercises completed at home and reported helpfulness, and (c) overall satisfaction rating of the BRIDGES program (1 = ‘very low” to 5 = ‘very high”). Qualitatively, we examined the acceptability of the BRIDGES program by asking participants” perspectives on one-on-one PN utility and skills learned in the weekly psychoeducational group sessions (assessed through open-ended questions).
HIV care outcomes
Self-reported ART adherence was collected at baseline, 3 months, and 6 months post-baseline. A validated three-item adherence measure (Wilson et al., 2016) was employed, with the questions (1) “In the last 30 days, how good of a job did you do at taking your HIV medications in the way you were supposed to?” with response options very poor, poor, fair, good, very good, and excellent; (2) “In the last 30 days, how often did you take your HIV medications in the way you were supposed to?” with response options never, rarely, sometimes, usually, almost always, and always; and (3) “During the past 30 days, how much of the time did you take your HIV medications as instructed by your doctor?” with response options from 0% to 100% on a visual analog scale. The last of these questions was adapted from “In the last 30 days, on how many days did you miss at least one dose of any of your ART?” to increase participant ease of response (U.S. Health Resources and Services Administration, 2019a). Item responses were linearly transformed to a scale of 0–100, then averaged across the three items, a method demonstrated to only slightly overestimate adherence in comparison to electronic drug monitoring (Wilson et al., 2016).
For our clinical outcomes, medical record data were extracted at 12 months post-baseline, including number of HIV care visits, viral load, and CD4 count since study enrollment. We assessed the following primary outcomes: (1) retention in care at 12 months, defined as having two or more HIV care visits at least 90 days apart within the past 12 months (U.S. Health Resources and Services Administration, 2019b); (2) continued engagement in care, defined as having attended an HIV care visit at least once every six months post-baseline (Byrd et al., 2015); and (3) having a detectable viral load >20 copies/mL at any point during the 12 months post-baseline (Dale et al., 2014). Additionally, four exploratory outcomes were examined that viewed CD4 cell count as indicative of immune system functioning (2010): healthy immune functioning, defined as having a CD4 count ≥500 cells/mm3 at any point during the follow-up period (0–6, 6–12, and 0–12 months post-baseline) (Lewden et al., 2007); and having additional risk for severe infection by SARS-CoV-2, or COVID-19, defined as having a CD4 count below 350 cells/mm3 during the follow-up period (Hoffmann et al., 2021).
Data Analysis
Qualitative data
Qualitative data were analyzed following a content analysis approach. Using responses from open-ended questions and transcribed discussions between the participant and group session facilitators, SGC entered the data into an excel spreadsheet. During iterative analysis meetings (JKS, SGC, LRS), team members read through the data and applied content analysis, as used in other qualitative assessments of intervention research, which included discussion on how the supporting quotes corresponded to the mechanisms of change for BRIDGES and illuminated facilitators and barriers of intervention components (peer navigation and psychoeducation group sessions). Selected quotes reflect the most robust qualitative feedback from participants. A final Microsoft excel matrix was constructed, facilitating the identification of quotes across the mechanisms of change and intervention components.
Quantitative data
Univariate analyses were conducted using SAS version 9.4 (SAS Institute Inc, 2013) to compute means and standard deviations for continuous data and frequencies and proportions for categorical data. We also conducted univariate analyses to assess the quantitative measures of feasibility and acceptability of the program. We conducted chi-squared tests, t-tests, and paired t-tests in SPSS 26 (IBM Corp, 2020) to assess differences between the intervention and control groups, and within study groups to assess changes between study visits. Intention to treat analyses was conducted on our clinical outcomes; one-sided p-values were used to assess our primary outcomes and two-sided p-values were used to assess our exploratory outcomes. Participants with missing medical record data (BRIDGES n = 3, Standard of Care n = 5) were coded as not retained/engaged in care, having a detectable viral load, not having healthy immune functioning, and having severe COVID-19 risk.
Results
Characteristics of Participants
Of 27 women screened, 26 were eligible to participate in the study, of which 2 were “no-shows” at their scheduled baseline visit (Figure 2). A total of 24 women completed the baseline survey. Of the 11 women randomized to and enrolled in the BRIDGES program (intervention arm), the mean age was 50.6 (SD 7.8) years (Table 2). The sample was racially and ethnically diverse. Although 72.8% of women had at least a high school education, 63.6% were unemployed. Only 27.3% were currently partnered/married. HIV diagnosis was on average 19.9 (SD 7.4) years ago, 27.3% had delayed seeking HIV care ≥ 1 year after diagnosis, 54.6% had experienced no usual source of HIV care for a period > 6 months, and 45.5% had missed at least one dose of ART in the past 30 days. Women experienced numerous syndemic conditions, with over 7 0% reporting one to two, 9.1% reporting three to four, and 18.2% reporting five to six. There were no statistically significant differences in demographic characteristics between intervention and control arm participants.
Demographic Characteristics.
SD, standard deviation; AI/AN, American Indian or Alaskan Native; GED, general equivalency diploma.
Syndemic load includes six questions that ask whether participants have experienced intimate partner violence in their lifetime, have had four or more drinks a day in the past year, have used any illicit drugs in the past three months (e.g., cocaine, prescription stimulants, methamphetamines), have had moderate/severe anxiety symptoms in the past two weeks, have had moderate/severe depression symptoms in the past two weeks, and have had substantial symptoms for PTSD in the past month.
Feasibility
Enrolled women (N = 24) were randomized to the BRIDGES intervention (n = 11) or standard of care group (n = 13) (Figure 2). Of 11 women randomized to BRIDGES, one was lost to follow-up and did not attend any group sessions. The remaining 10 women completed all six group sessions and a minimum of six contacts with a PN, all of which were videoconference calls. On average, the PN sent 20.9 text messages to participants (range: 2–40) and received 8.7 text messages from participants (range: 0–27). The average number of completed phone calls between the PN and participant was 18.1 (range: 10–26). Over the course of the study, there were only 6 incomplete phone contact attempts across all participants and all contact attempts. Nine women enrolled in the BRIDGES intervention completed post-intervention interviews.

Flowchart of the Pilot BRIDGES Randomized Controlled Trial.
Despite most of the interventions occurring during the COVID-19 pandemic, women shared positive perspectives of being able to participate due to the web-based format of the program. All BRIDGES participants who completed a post-intervention interview agreed or strongly agreed that it was easy to participate in the web-based format (data not presented). Women described being able to “fit it into my routine easier” (Imani).
Seven women reported that they could attend more group sessions due to the convenience of online access, while also benefiting from a reduction in anxiety around participation and removal of other barriers. For example, Ebony shared, “Transportation issues usually stop me from participating in studies. Just too much of a headache and unreliable,” and soon after continued, “I’m so happy that this is virtual, being able to participate from home makes me feel safe and I find myself sharing more.” At a later point, she expounded on this, saying, “The anxiety I experience when I have to go somewhere usually prevents my participation in these opportunities.”
All women felt connected to others while participating in the web-based format, particularly the group sessions. Women believed what was learned in the group sessions would have a lasting effect on their lives—Jasmine stated, “I have learned so much. I feel more in control of me and my future.” Overall, women communicated that they were happy to access BRIDGES online, sharing that the “virtual setting is great! It still feels like we are right there” (Aliyah).
Acceptability
Overall, all 9 women who completed a post-intervention interview strongly agreed or agreed that BRIDGES was helpful and personally relevant (Table 3). All women were satisfied with their PN experience and the information provided by the PN. All women expressed that they would be interested in participating in a future PN program. Specific to group sessions, all women strongly agreed or agreed that they felt comfortable, that the PN and LMFT cofacilitating were understanding, and that it was easy to learn the information provided. Homework exercises were viewed as interesting and easy to complete while educational. All women strongly agreed or agreed that the time commitment was reasonable, the activities were worthwhile, that they would recommend BRIDGES to a friend, and would be interested in continuing a similar program. The overall satisfaction rating for BRIDGES was very high.
Acceptability Findings for BRIDGES Peer Navigation and Psychoeducational Group Sessions.
Peer navigation
Strong Sense of Support
Most women viewed having a PN with shared lived experiences as advantageous to their own engagement in HIV care and ART adherence, while fostering a strong sense of support: I think it was absolutely wonderful that my peer has similar life experiences. If it wasn’t for [PN] calling each week, I don’t know where I would be today. I use my tools learned and it’s really helpful. I needed this. (Nia)
Another woman viewed navigation as a lifeline: “The peer navigation was the best part because I could call anytime, if I needed. If it wasn’t for [PN] I don’t know what I would do. You have kept me out of a lot of things” (Ebony).
Most women did not have extensive social support and appreciated the availability of a support outlet. One woman described this, saying: Having a peer navigator really helped me. It gave me more motivation knowing I would be asked on my progress with my goals. My peer navigator checked in with me weekly and if I needed her, she was available at any time. I liked that my peer navigator listened when I had any issues or needed to vent. She gave me great resources. Knowing that I could call or text my peer at any time and she was supportive and helpful. I liked that my peer navigator would remind me of our group sessions and the tools we learned. My peer navigator always reassured me regarding support, help, and resources. Also, to advocate for myself. (Deja)
Some women discussed that having a PN allowed them to feel safe, fostering a trusting relationship: “[PN] is a safe person. I can process with her and come up with a plan” (Jasmine); “[PN] hears me; she doesn’t just listen, she hears me” (Tiara).
Reinforcement of Acquired Skills
Peer navigation also served as reinforcement of the tools learned in the group sessions: [PN] helps me go through the tools. If I’m honest, without her support, I wouldn’t remember them. I’ve always been a 10 with my feelings. She listens and validates me. She reminds me that I have what I need to deal with life. (Kiara)
Psychoeducational group sessions
Group sessions promoted skill-building techniques for women to successfully navigate HIV care and ancillary support services. Of 19 different exercises learned in the group sessions, 14 coping exercises were practiced at home by at least 90% of women; two exercises were practiced by 80% of women and three by 70% of women (data not shown). All women found all 19 exercises to be helpful. All women noted that the group sessions focused on empowering them and allowed for discussions on how trauma affected their emotions. Table 4 and the synthesis below highlight exemplary quotes by the mechanisms of change for the BRIDGES intervention.
Mechanisms of Change Facilitated Through BRIDGES Group Sessions.
Emotional Awareness and Emotional Regulation
Mastering the ability to identify emotions allowed for the employment of tools such as focused breathing to regulate reactions. Knowing that emotions serve as messengers for information needed to successfully navigate the world around them facilitated participants' ability to engage in healthy emotional living. Referencing a recent discussion, Ebony remembered, “If I had behaved the way that I normally do, I would have really screwed up the situation.” Instead, she recalled later, “I was able to hold back, not speak, breathe and figure out what to do and say in a situation that normally I would have exploded.” Reflecting on the situation, Ebony stated, “Finally figuring out my emotions- sounds simple, but this is huge.”
Interpersonal Communication
Discussion of the difference between assertive and aggressive communication allowed women to identify maladaptive coping skills they had developed and use new tools to change their communication and behavior to foster healthier boundaries and trusting relationships. One woman shared this experience, saying: I see that my aggressive communication is not getting the actual outcome that I want. I felt safe being aggressive, and that worked for a long time. Then I found myself all alone. I realize that by forcing my thoughts on people so that they would understand me was just me being aggressive. People hear better when I am assertive. Aggressive just shuts them down. (Imani)
Alexis noted, “I was passive-aggressive because I didn’t know how to communicate in healthy ways. Using “I” statements helps to slow me down- that and breathing.” She later shared, “I still have trouble asking for help, but I am trying now. I would never have done that before this class.”
Coping Self-Efficacy
Building on the tools learned, women were able to find their voices and learn how to use healthy coping skills to self-advocate and work through challenges and social and structural barriers (e.g., food insecurity, housing) that impacted their HIV care. This included learning how to effectively communicate their needs and wants, including to their HIV and other ancillary support providers: I was able to realize that it was my food insecurity, my housing issues, and my mental health that kept getting in the way of my HIV health. Getting a medical case manager has really helped. I needed it. (Kiara)
Social Support
Women noted that living with HIV was associated with shame and fear of judgment, leading to self-isolation and lack of trust in others. Women shared that social support from BRIDGES, coupled with the tools learned, positively affected their capacity to form trusting relationships: “For the first time, I can share my stories without shame. Connecting with the girls is my positive. You are all my strength warriors!” (Kiara)
Preliminary Effects
ART adherence
WLHA in the intervention group reported mean adherence to ART at 3 months post-baseline that was a marginally significant increase from baseline (p = 0.08) and significantly higher compared to WLHA in the standard of care group (p = 0.03) (Table 5). Intervention participants reported a return to lower adherence at 6 months post-baseline, coinciding with the COVID-19 pandemic, while the standard of care participants maintained approximately the same level of adherence at baseline, 3-, and 6 months post-baseline. Across individual ART adherence items, intervention participants demonstrated similar patterns in changes to adherence, with some significance, while the standard of care participants reported more variability across items.
Self-Reported ART Adherence among BRIDGES Intervention and Control Participants.
SD, standard deviation.
Retention, engagement, and viral suppression
A higher percentage of WLHA in the intervention group were retained in care at 12 months post-baseline (36.4% vs. 23.1%) and were engaged in care throughout the 12-month follow-up period (27.3% vs. 15.4%) compared to women in the standard of care group (Table 6). Fewer intervention participants had a detectable viral load at any point during the 12-month follow-up period (27.3% vs. 53.8%). Differences were not statistically significant.
Immune system functioning
A higher percentage of WLHA in the standard of care group were classified as being in good health (having a CD4 count of at least 500 cells/mm3) during the first six and second six months of follow-up (Table 6). However, a low percentage of participants had a CD4 count at or above 500 cells/mm3 between six and twelve months among both intervention (9.1%) and standard of care (15.4%) groups. Finally, a higher percentage of intervention participants had a CD4 count below 350 at any point during follow-up than the standard of care participants (63.6% vs. 46.2%), indicating a higher risk for severe COVID-19 due to compromised immune function. Differences were not statistically significant.
Medical Record-Based HIV Care Outcomes among BRIDGES Intervention and Control Participants.
Discussion
Findings suggest that the BRIDGES program is feasible and acceptable in a research setting and demonstrates meaningful clinical improvements in HIV care continuum outcomes among syndemic-affected WLHA. With over 90% of women completing all six group sessions and a minimum of six contacts with a PN, very minimal incomplete supplemental phone contact attempts with PNs, and an overall intervention satisfaction rating of very high, our peer navigation-psychoeducational intervention also shows promise in terms of scaling up to a larger RCT to determine efficacy. Peer navigation and psychoeducational group sessions were viewed by WLHA as essential, connecting them to a source of reliable support and the tools to navigate how syndemic conditions, including trauma, can strain their ability to access support and engage in HIV treatment. While caution is needed when interpreting the results of a small pilot, WLHA’s descriptions of their experiences in the BRIDGES intervention vividly illustrate the proposed mechanisms of change; emotional awareness and regulation coupled with assertive communication skills promoted effective coping strategies while cultivating social support. Higher mean ART adherence among intervention participants at 3 months post-baseline, in comparison to both the intervention group at baseline and the standard of care group at 3-month follow-up, demonstrates improvements in increasing ART adherence during the 3-month period following completion of the BRIDGES intervention. Further, better retention in care, engagement in care, and viral suppression were documented in intervention participants than standard of care participants, suggesting clinically meaningful effects in improvement of HIV care outcomes.
Our data suggest the intervention may be effective at improving HIV care, ART adherence, and viral suppression. However, our data also suggest that the control participants may have started out with better immune functioning, though immune functioning declined over time in both groups. As a feasibility study that launched at the emergence of the COVID-19 pandemic, it will be important to consider how immune functioning may respond during periods of acute stress among syndemic-affected persons living with HIV in future efficacy trials. Declining CD4 counts in the post-baseline observation period may suggest that the negative impact of COVID-19 pandemic stressors across both arms outpaced potential gains of trauma-responsive coping and social support on immune functioning in our sample of WLHA.
Women’s favorable views of BRIDGES emphasized that the web-based delivery of and access to peer navigation and group sessions enhanced the ability of women to fully engage in the intervention. Specifically, this use of technology was viewed as convenient, easy, and useful in mitigating social and structural barriers that would have otherwise undermined their ability to participate (e.g., transportation access, emotional labor of attending in-person sessions). While the accessibility of the web-based intervention may be difficult for some WLHA such as those who are homeless or lack access to an internet connection (due to financial limitations or residing in rural environments), our findings highlight the utility of web-based interventions among a marginalized group of WLHA. Further, BRIDGES supports studies demonstrating web-based interventions as acceptable to WLHA (Blackstock et al., 2015; Green et al., 2015; Marhefka et al., 2019; Messias et al., 2006), as well as findings that web-based interventions may offer additional acceptability over other delivery formats for WLHA (Bacchus et al., 2016; Glass et al., 2010; Klevens et al., 2012; Koziol-McLain et al., 2015; Tarzia et al., 2016). Of importance, there was no variability in responses to acceptability measures; this may indicate extremely high acceptability within the pilot population, but may also reflect bias resulting from intervention novelty or gravitation toward extreme responses.
As a feasibility and acceptability pilot study, we were unable to assess the efficacy of the BRIDGES intervention on sustained engagement in HIV care and viral suppression, nor was the pilot able to assess organizational implementation outcomes, such as acceptability of the program to implementers, stakeholder/implementer perception of efficacy, or perceived cohesion of the program with organizational context and culture. We were also unable to assess whether WLHA in the intervention maintained the social connections they formed with each other, or continued to apply and build the skills they learned in the group sessions with people in their social networks. Such data would be important to understanding the potential sustainability of longer-term clinically meaningful effects in this population. Our study sample, while small due to budgetary and funding timeline constraints, reflects a social profile reflective of WLHA in the U.S. disproportionately affected by syndemic conditions that undermine the therapeutic benefits of modern HIV treatments. In addition, the demonstrated feasibility in a research context and acceptability of the intervention to WLHA, coupled with the qualitative testimonials, suggest that next steps include a full-scale RCT to assess efficacy and effectiveness, as well as implementation science assessment of facilitators and barriers to implementation of the program in a nonresearch organizational setting, utilizing implementation science theory, such as the Consolidated Framework for Implementation Research (Damschroder et al., 2009). Based on current findings, evaluation of organization implementation feasibility should consider contextual factors such as demographic makeup of the population served, as on average, women in BRIDGES were 50 years old (range: 33–70), had been living with HIV for 19 years, and majority White. Newly diagnosed and younger women might differ from this sample that could affect the acceptability and feasibility of BRIDGES (e.g., more likely to have young children living at home, greater HIV stigma, fewer physical health comorbidities). Given that our sample underrepresented the proportion of Latinx and American Indian or Alaskan Native WLHA, it is necessary to ensure these groups are adequately represented in a future RCT to adequately determine intervention effects across racial and ethnic groups. Additionally, Spanish-speaking women and women without access to the internet may require different intervention efforts to support their HIV care. However, participant reflections on the BRIDGES intervention suggest group session activities may be uniquely positioned to support younger and newly diagnosed women with these unique challenges (e.g., connecting with similar women and feeling less shame around one’s HIV status).
Several important lessons were learned from this feasibility and acceptability pilot study. Although not the original intent of BRIDGES, the research study context provides support for acceptability and feasibility of a virtual research environment, and virtual intervention delivery for research purposes. Women communicated that numerous barriers to research and public health program participation were overcome by the use of a web-based format, including transportation, timing, and anxiety-related barriers, indicating that expansion of interventional research further for WLHA may improve intervention reach. In future implementation science studies to translate research into practice, this will need to be assessed in the context of organization implementation, rather than research. While all women expressing interest in the intervention had smartphones or tablets through which they could access program activities, it was noted that technological literacy was difficult to assess and at times severely limited, prompting the lesson that integration of a standard technological literacy module or session would benefit all participants and standardize ability to participate, increasing the likelihood of successful intervention uptake. Further, women shared that they maintained a sense of connection with other women in the program, even through a virtual group session environment, suggesting that despite the lack of physical communal presence, social support and bonds are still feasible to establish in a web-based program. Finally, we found that providing participants with materials in multiple formats (i.e., digital and a mailed physical copy) increased their engagement with those materials, and allowed flexibility for the extent to which they accessed non-interpersonal program content digitally.
Collectively, these data suggest the BRIDGES intervention is well positioned to engage syndemic-affected WLHA and equip them with the tools needed to mitigate social and structural barriers to engagement in HIV care; further, it is aligned with the National Ending the HIV Epidemic Initiative priority area focused on mitigating gender disparities to achieve equity in HIV care outcomes (Ending the HIV Epidemic in The United States: A Roadmap for Federal Action). The preliminary effects of the BRIDGES web-based intervention should be tested in a larger-scale efficacy trial, while implementation feasibility should be assessed in theory-based implementation science studies.
Footnotes
Acknowledgments
We thank the study participants who generously provided the data for this research. We also thank BRIDGES staff including Lorena Orozco, Janine Lopez, and Melanie Barker, MPH, LCSW.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Institute of Allergy and Infectious Diseases and California HIV/AIDS Research Program, (grant number P30AI036214, H21PC3466, HD15SD059).
