A Trauma-Informed HIV Intervention (LinkPositively) to Improve HIV Care Among Black Women Affected by Interpersonal Violence: Protocol for a Pilot Randomized Controlled Trial

Background Black women bear a disproportionate burden of HIV, accounting for nearly 60% of new diagnoses among US women. Black women living with HIV often experience mutually reinforcing epidemics, known as syndemics, including interpersonal violence and substance use. Syndemics are associated with decreased HIV care engagement and treatment adherence and worsening HIV outcomes. Few HIV services and resources are tailored to be culturally and gender-responsive and trauma informed for Black women living with HIV. Technology-based, psychoeducational, and peer navigation programs offer promising pathways to tailored HIV support and improved HIV care outcomes. Therefore, the web-based, trauma-informed intervention LinkPositively was developed in collaboration with Black women living with HIV to promote uptake of HIV care and ancillary support services. Objective This study primarily determines the feasibility and acceptability of the LinkPositively intervention among Black women living with HIV affected by interpersonal violence. The secondary aim is to examine the preliminary impact of the LinkPositively intervention on retention in HIV care, antiretroviral therapy adherence, and viral suppression while evaluating the role of mechanism of change variables (eg, social support) in the associations. Methods The LinkPositively trial is a pilot randomized controlled trial conducted in California, United States, among 80 adult Black women living with HIV who have experienced interpersonal violence. Core components of LinkPositively include one-on-one peer navigation with phone and SMS text message check-ins; 5 weekly one-on-one video sessions to build coping and care navigation skills; and a mobile app that contains a peer support social networking platform, an educational database with healthy living and self-care tips, a GPS-enabled HIV and ancillary care resource locator, and a medication self-monitoring and reminder system. Participants are randomly assigned to the intervention (n=40) or control (Ryan White standard of care; n=40) arm, with follow-up at 3 and 6 months. At each assessment, participants complete an interviewer-administered survey and submit hair samples for the assessment of HIV medication adherence. All research staff and investigators adhere to ethical principles and guidelines for conducting research activities. Data will be analyzed using generalized estimating equations. Results Final development and testing of the LinkPositively app were completed in July 2021. As of May 2023, we have screened 97 women for eligibility. Of the 97 women screened, 27 (28%) were eligible and have been enrolled in the study. The dissemination of preliminary results will occur in 2024. Conclusions This trial will advance HIV prevention science by harnessing technology to promote engagement in HIV care while improving social support through peers and social networking—all while being trauma informed for Black women living with HIV with experiences of interpersonal violence. If shown to be feasible and acceptable, LinkPositively has the potential to improve HIV care outcomes among Black women, a marginalized key population. International Registered Report Identifier (IRRID) DERR1-10.2196/46325

1 R34 MH122014-01 3 ZRG1 AARR-N (53) STOCKMAN, J of care, n=40) arm, with follow-up at 3-and 6-months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking -all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence. PUBLIC HEALTH RELEVANCE: Black women living with HIV/AIDS (WLHA) who are also impacted by interpersonal violence and co-occurring mental health and/or substance use disorders, suffer from poor outcomes along the HIV care continuum. Although peer navigation improves HIV care outcomes, this requires resources that HIV medical and service organizations often lack, calling for the need for more sustainable and scalable approaches. We propose to develop and pilot test LinkPositively, a culturallytailored, trauma-informed smartphone app for Black WLHA with lifetime experiences of interpersonal violence, with the goal of improving retention in care, antiretroviral therapy adherence, and viral suppression.

CRITIQUE 1
Significance: 2 Investigator(s): 2 Innovation: 1 Approach: 3 Environment: 1 Overall Impact: The proposed application is to develop and pilot test LinkPositively, a culturallytailored, trauma-informed smartphone app for Black women living with HIV (WLHA) with lifetime experiences of interpersonal violence, with the goal of improving retention in care, anti-retroviral therapy adherence, and viral suppression. Core components of the program include virtual peer navigation, social networking, healthy living and self-care tips, GPS-enabled resource locator for HIV care, and ART self-monitoring and reminder system. The program is guided by the Theory of Triadic Influences and Syndemics and the study will be conducted in two phases. The first will be a developmental phase whereby qualitative approaches will be used to help inform intervention development and usability testing will be conducted to finalize intervention components and procedures. The second phase will consist of a randomized controlled trial to assess the feasibility, acceptability and impact of the intervention. Primary study outcomes are retention in HIV care, ART adherence, and viral suppression. Secondary outcomes described as socio-cultural mechanism of change variables are social support and activation of social support networks, self-efficacy, and utilization of ancillary support services. Strengths of the study include the intended audience as a critical population of interest that experiences high rates of violence, the collective expertise of the MPI team of Stockman and Horvath, the innovative methodologies and novel theoretical concept to be tested. The proposed study has the potential to lay the foundation for a scalable mHealth intervention to address the HIV treatment needs of Black women impacted by interpersonal violence (IPV)and HIV.

Strengths
• The investigators present clear evidence that Black women are disproportionately affected by HIV and IPV.
• The investigators note potential correlations between violence and other psychosocial factors that commonly occur with violence. • The proposed study has the potential to lay the foundation for a scalable mHealth intervention to address the HIV treatment needs of Black women impacted by IPV and HIV.

Weaknesses
• There is limited focus on the different types of violence exposures that will be addressed in the study.

Strengths
• The investigative team is comprised of experienced, interdisciplinary collaborators in the areas of HIV prevention and treatment, mHealth intervention development, epidemiology, psychology (specifically PTSD, trauma, and loss), and statistics.
• The prior work of the MPIs is complementary and will contribute to the success of the proposed project.

Weaknesses
• There is no evidence of extensive prior collaboration between the MPIs.

Strengths
• The investigators identify several aspects of the proposed work that contribute to the innovative nature of the project: (1) pilot testing an mHealth intervention for Black WLHA who have experienced interpersonal violence; (2) incorporating multiple components in the intervention, namely virtual peer navigation, social networking, education and self-care tips, resource locator, and ART self-monitoring and reminders; (3) addressing structural barriers to healthcare seeking via GPS resource locator; (4) testing a new conceptual model to address the co-occurrence of interpersonal violence, co-morbidities, and socio-cultural barriers to the HIV care continuum. This reviewer agrees.

Strengths
• The overall strategy is clearly articulated, sufficiently thorough, and well-reasoned to achieve the study aims.
• Qualitative assessments of phase 1 including input from the CFAR Disparities Core CAB is an asset to the proposed work.

Weaknesses
• For the randomized controlled trial phase of the study, the control condition is a self-directed usual care treatment. It is unclear how the investigators will be sure that any differences noted 1 R34 MH122014-01 5 ZRG1 AARR-N (53) STOCKMAN, J between conditions are due to the content of the interventions rather than the delivery method (i.e. face-to-face usual care versus mHealth intervention).
• The investigators identify the critical need for culturally-relevant, gender-specific, mhealth interventions tailored for Black WLHA; however, the intervention content or components do not exploit this need. This is a significant shortcoming of the proposed approach.

Strengths
• Structural support (i.e., facilities and resources) for the proposed work is sufficient. Additionally, investigative team members have successfully recruited and retained participants using similar study approaches.

Strengths
• Timeline is adequate for the proposed work.

Weaknesses
• None noted. Overall Impact: This is a well written proposal by a strong investigative team that aims to address an important public health issue: retention in care and clinical outcomes for Black and African women who are HIV positive. There are several innovative aspects of the proposal and it is motivated by compelling previous studies. Questions in the approach, particularly in terms of how the intervention content would be tailored to the target population; and potential issues of significance dampened enthusiasm slightly.

Strengths
• Black and African American women are disproportionately impacted by HIV in the United States. Improving retention to care, medication adherence, and sustained viral load suppression for this subpopulation could have public health impact.

Weaknesses
• That participants need to be compensated for their data use during the study raises concerns about intervention feasibility in the 'real world'.
• While hiring the 2 PNs full time increases the likelihood of success for the proposed R34, what are the potential implications for sustainability longer term?

Strengths
• This is a very strong research team. MPI Horvath has extensive experience developing and testing technology-based interventions related to HIV behaviors. MPI Stockman has extensive research experience working with HIV positive Black and African American women, including Peer Navigation programs.

Strengths
• Given the lack of tailored programming for HIV positive Black and African American women, the target population is innovative.
• The combined use of an automated website and digital peer support is innovative as well.
• The use of hair screening to measure adherence is somewhat novel.

Strengths
• The intervention development process is stepwise and well described.
• Although not required for an R34, the previous studies motivating the current proposal are compelling and demonstrate reason for optimism for the current proposal.
• The use of a mobile-optimized website, as opposed to an app, increases the number of people who can access it.
• The plans to gamify the experience to encourage ongoing engagement with the program are well described and interesting.
• The training of PNs is well described.
• The aim of the focus groups and planned discussion topics are well articulated.
• Objective measures are proposed for the clinical outcomes. The plans to operationalize feasibility and acceptability are also well described.
• Program use data will be examined to explore whether different program components were used more, and how usage relates to program impact.

Weaknesses
• The description of the 4 structured PN sessions is useful but it's unclear how the topics map to the intervention underpinnings articulated at the top of page 75. More broadly, more could be said about how the intervention will be specific to experiences of Black and African American women.
• It might be helpful to include people from the target population during the design and development of the intervention. While the CAB will be consulted, they might have different feedback than the women. And while the women are included in the beta test, it usually is too late to make bigger changes that could have easily been integrated during the design phase.
• Measurement of the main outcomes could be better justified. It's unclear why both self-report and clinic / biological data are being used to measure the same constructs. It's also unclear what data will be abstracted from the medical charts -on page 80, it says viral load; on page 82, it says retention in care o Also, the measure for retention in care may need to be reconsidered. It is described as at least 2 lab tests dated at least 90 days apart, but it also says that outcomes will be the post 3 months (i.e., 90 days; pg. 82). • Also, while it is a core aspect of the gamification experience, it would be helpful if the researchers could speak to any potential implications of providing more -and potentially more relevant -content (e.g., videos) to those who are more engaged. Does this in some way give those who are more likely to engage in care greater access, while excluding less engaged women from features they might find useful?
• Given the stratification of women based upon the perpetrator type in the FGs and beta test, I was surprised that this was not included as a stratification variable in the randomization. It also would be helpful to provide a brief justification about why perpetration type is the important factor that creates the most heterogeneity of experience among women who have been victims of IPV • It would be helpful if the researchers talked briefly about the potential implications of including women who have a lifetime history as opposed to recent history of IPV • Female gender is an eligibility criterion. Please clarify whether this means that both cisgender female and trans women will be eligible.
• As part of the secondary analyses, it might be useful to examine the number of PN meetings the participant attended (Range: 0-4) in addition to the number of self-initiated outreaches they made to the PN • While it's clear that the CAB will be a useful source of recruitment, an important piece of the flow seems to be missing. It's unclear if people will in the beta test and pilot RCT will be referred to the study team, if flyers will be made available in waiting areas, if providers will be asked to discuss the study with their patients, etc. In short: how do attendees of these CBOs learn about the study?

Strengths
• The environment can well support the proposed research.
• The CAB provides a proven resource to support recruitment goals.

Strengths
• The timeline is feasible.

CRITIQUE 3
Significance: 2 Investigator(s): 1 Innovation: 2 Approach: 4 Environment: 1 Overall Impact: This R34 application seeks to develop and pilot test a culturally tailored, traumainformed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system. Investigators will conduct focus groups with Black WLHA with experiences of interpersonal violence, peer navigators, and conduct key informant interviews with providers will be conducted to determine which app features, content, and functions are most likely to support downloading, initiating use, and sustaining engagement over time. Investigators will then conduct usability testing by Black WLHA affected by interpersonal violence (n=5), to finalize intervention components and procedures. Investigators will pilot test LinkPositively to assess feasibility and acceptability and determine preliminary effects of the intervention on retention in care, ART adherence, viral suppression. 80 participants will be randomly assigned to either the intervention 1 R34 MH122014-01 10 ZRG1 AARR-N (53) STOCKMAN, J (n=40) or control (Ryan White standard of care, n=40) arm, with follow-up at 3-and 6-months. This proposal is highly responsive to the RFA and has many strengths including focus on understudied and underserved population of Black women living with HIV and experiencing violence. However, while exciting and innovative it is not entirely clear from the application that an app-based intervention is currently perceived as needed, helpful, acceptable, or something these women anticipate using. More preliminary data on the perceived likelihood of use would have greatly bolstered this well-written application.

Strengths
• Focus on HIV CoC outcomes among Black women experiencing interpersonal violence is well justified and warranted.
• Review of both social-structural barriers and buffering effect of social support is a strength.
• Provide evidence and justification for success of prior peer navigation programs in improving HIV CoC outcomes.
• Application largely responsive to RFA.

Weaknesses
• While substance use and mental health disparities are discussed it is not clear how focal these targets will be in the development of the app-based intervention over and above the focus on violence. A presentation of prior app-based interventions that address substance use and mental health among populations affected by HIV would have bolstered this section.
• Not clear how app will address stigma and medical mistrust among Black women experiencing violence. A review of how prior app-based interventions have addressed these barriers and the strengths/weakness and rigor of the prior projects would have greatly

Strengths
• PIs have content expertise and previous experience leading similar NIH-funded projects.
• Preliminary evidence presented is comprehensive and bolsters confidence that the investigators can carry out the proposed project in a culturally competent and appropriate way.

Strengths
• First app-based intervention tailored for Black women living with HIV.
• Integration of peer navigation on a mHealth platform is novel for Black women living with HIV.
• GPS technology for easy location of culturally competent, trauma-focused, HIV, mental health, substance use, and HIV providers as well as other resources for Black women experiencing violence is a strength. • App functions and features while, innovative, seem quite ambitious.

Strengths
• Use of existing CFAR CAB is a strength.
• Focus on addressing violence and other related syndemic conditions is a strength.
• Proposed design appropriate for R34 mechanism and highly responsive to RFA.
• Use of Tridic and Syndemic as guiding theories are strengths in this application.
• Adherence measures (hair samples) are appropriate, acceptable, and less invasive than traditional blood draws.
• Proposed survey measures are appropriate and comprehensive.
• Analysis plan is solid and appropriate for meeting study aims.

Weaknesses
• 6-month follow up period is less than ideal time-frame for assessing long-term results but OK for R34.
• App functions and features seem quite ambitious and will not be possible to determine which components are most responsible for any observed changes in CoC outcomes.
• A major goal of app is linkage to ancillary support services. Will be difficult to delineate any observed changes in CoC outcomes due to app features and functions over and above the utilization of these ancillary support services.
• It is not clear that Black women living with HIV and experiencing interpersonal violence see need for an app-based intervention. Any data on perceived need and acceptability, and perceived likelihood of use would greatly bolster this application.
• Not clear how app will address stigma and medical distrust specifically.
• Not clear how much of a focus app will have on substance use and the mental health needs of these women.
• Extent to which virtual peer navigators will have capacity and training to deliver trauma-informed care is questionable.
• Extent to which these women would engage in social networking on this app rather than using existing apps like Facebook or Instagram is questionable.

Strengths
• UCSD and SDSU provide excellent resources and environment conducive to conducting the proposed project.