LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care Across the Continuum for Black Women Affected by Interpersonal Violence
Phase: NA
Conditions: HIV/AIDS
Sponsor: University of California, San Diego

 
 
LinkPositively: A Technology-Delivered Peer Navigation and Social 
Networking Intervention to Improve HIV Care 
 
 
 
 
NCT04199052 
 
 
 
 
May 1, 2025 
 
 

 
 
Biomedical IRB Application Instructions 
Page 2 
 
UCSD Human Research Protections Program 
New Biomedical Application 
RESEARCH PLAN 
Instructions for completing the Research Plan are available on the HRPP website. 
The headings on this set of instructions correspond to the headings of the Research Plan. 
General Instructions: Enter a response for all topic headings.  
Enter “Not Applicable” rather than leaving an item blank if the item does not apply to this project. 
Version date: 9/30/2013 
1. 
PROJECT TITLE 
IRB Project #: 191398 
LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV 
Care Across the Continuum for Black Women Affected by Interpersonal Violence 
2. 
PRINCIPAL INVESTIGATOR  
Jamila K. Stockman, PhD, MPH 
Associate Professor 
Vice Chief, Global Public Health Section 
Director, Disparities Core, Center for HIV/AIDS Research (CFAR) 
Division of Infectious Diseases and Global Public Health, Department of Medicine 
University of California, San Diego  
 
3. 
FACILITIES 
Primary study activities will take place at the following locations: 
 
San Diego County: UC San Diego AntiViral Research Center, located at  220 Dickinson St., Suite A, San 
Diego, California 92103 
 
Los Angeles County: Charles R. Drew University of Medicine and Science, Clinical and Translational Science 
Institute, 1731 East 120th St., Los Angeles, California 90059 
 
Alameda County: WORLD, located at 389 30th St., Oakland, California 94609 (Recruitment ONLY, no 
participant enrollment or human subjects interaction) 
 
Oklahoma City County: Guiding Right, Inc., offices at multiple locations including 1420 NE 23rd Oklahoma 
City, Oklahoma 73111, 2809 NW 31st Oklahoma City, Oklahoma 73112, and 2809 NW 31st Oklahoma City, 
Oklahoma 73112 
 
Tulsa County: Guiding Right, Inc., 4619 S. Harvard Tulsa, Oklahoma 74135 
 
The study is a collaborative project between UC San Diego (UCSD), and San Diego State University. UCSD is 
the primary institution. San Diego State University, Charles Drew University, and Guiding Right, Inc. will rely 
upon the University of California San Diego IRB approval for UCSD IRB Project #191398, in accordance with 
the SDSU/UCSD Agreement and Process for Joint IRB Review of Faculty Protocols and the Basic Health and 
Human Services Policy for Protection of Human Research Subjects, 45 CFR 46.114, which states, 
“Cooperative research projects are those projects covered by this policy which involve more than one 
institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the 
rights and welfare of human subjects and for complying with this policy. With the approval of the department or 
agency head, an institution participating in a cooperative project may enter into a joint review arrangement, 
rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.” 

 
 
Biomedical IRB Application Instructions 
Page 3 
Charles Drew University and Guiding Right, Inc. will participate in human subjects enrollment and data 
collection, and has agreed to use the UCSD Consent Form under the Reliance Agreement. 
4. 
ESTIMATED DURATION OF THE STUDY 
3 Years (12/01/2019 – 11/30/2022) 
5. 
LAY LANGUAGE SUMMARY OR SYNOPSIS (no more than one paragraph) 
We will develop and pilot test a culturally tailored, trauma-informed 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. Guided by the 
Theory of Triadic Influences and Syndemic Theory, the study will be conducted in 2 phases with 
corresponding aims. In Phase 1 (Aim 1), 4 focus groups with Black WLHA with experiences of interpersonal 
violence, one focus group with peer navigators, and 4-6 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. Aim 1 will culminate in usability testing by Black WLHA 
affected by interpersonal violence (n=8), to finalize intervention components and procedures. In Phase 2 (Aim 
2), we will pilot test LinkPositively to assess feasibility and acceptability and determine preliminary effects of 
the intervention on HIV care outcomes (i.e., retention in care, ART adherence, viral suppression) and 
mechanism of change variables (i.e., social support, self-efficacy). Through a randomized control trial (RCT), 
participants will be randomly assigned to either the intervention arm (n=40) or control arm (Ryan White 
standard of care, n=40), 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. 
6. 
SPECIFIC AIMS 
 
Aim 1: Develop the LinkPositively mobile intervention through focus groups (FGs) with Black WLHA 
affected by interpersonal violence, peer navigators, and service providers, and refine iterations 
through input from the San Diego CFAR Disparities Core CAB. 
Four FGs, with 6-8 HIV-positive Black WLHA reporting a lifetime history of interpersonal violence by an 
intimate partner (n=2 FGs) and non-intimate partner (n=2 FGs); one FG with 4-6 Peer Navigators 
employed at HIV clinics/service agencies; and 4-6 key informant interviews with service providers will be 
conducted in San Diego, CA. Group differences will be explored to optimize LinkPositively across 
different types of reported perpetrators. The outcomes will be feedback on proposed intervention 
components and suggestions for new features, as well as recommendations for how to address 
challenges to engagement with LinkPositively. Aim 1 will culminate in usability testing by Black WLHA 
affected by IPV (n=8), to finalize intervention components and procedures. 
 
Aim 2: Conduct a pilot randomized controlled trial to assess the feasibility, acceptability and 
preliminary 
impact of the LinkPositively intervention for Black WLHA affected by interpersonal violence, in 
preparation for a large-scale R01. 
Eighty Black WLHA ever experiencing interpersonal violence will be randomly assigned (1:1) to receive 
LinkPositively or standard of care Ryan White services, with self-reported, biological, and clinical 
outcomes collected at baseline, 3- and 6-month follow-up visits. Intervention use data will be collected 
throughout the intervention period to examine feasibility, acceptability, and the associations between 
components used and study outcomes. Primary outcomes are retention in HIV care, ART adherence, 
and viral suppression, whereas socio-structural mechanism of change variables are social support and 

 
 
Biomedical IRB Application Instructions 
Page 4 
activation of social support networks, self-efficacy, and utilization of ancillary support services. To 
minimize recall bias and/or social desirability bias, that may occur with the use of audio computer-
assisted self-interviews, we will use objective data to measure the main outcomes. Retention in HIV 
care and viral suppression will be based on medical record data and ART adherence will be measured 
using hair samples assayed for tenofovir and emtricitabine. The proposed study will benefit the 
advancement of HIV prevention science by harnessing mobile technology to promote retention in HIV 
care and ART adherence among US Black WLHA affected by interpersonal violence and co-occurring 
adverse mental health and substance abuse – an underserved, marginalized population. If the 
LinkPositively intervention is efficacious through an eventual R01 mechanism, it will change the 
paradigm for addressing the unique HIV treatment needs for Black women dually affected by HIV and 
interpersonal violence. 
 
7. 
BACKGROUND AND SIGNIFICANCE 
 
Background and Significance 
Black women are disproportionately affected by HIV and interpersonal violence. Black women living with 
HIV/AIDS (WLHA) in the US are less likely to be engaged in HIV care and adherent to antiretroviral therapy 
(ART) compared to other racial/ethnic groups (1-3). Black WLHA account for 61% of diagnoses among women 
of all races and ethnicities (4), only 56% are retained in care (1), and 49% virally suppressed (1). Black WLHA 
are particularly affected in San Diego County, CA, with HIV prevalence rates 8 times higher than that observed 
for White WLHA (5) and are underserved and understudied. Blacks on ART in San Diego are less likely to be 
virally suppressed than Latinos or Whites (6). Concurrently, Black women are disproportionately affected by 
interpersonal violence, defined as ever experiencing physical (e.g., hit, slapped, choked), sexual (e.g., forced 
vaginal/anal sex), and/or psychological (e.g., yelled at, belittled, controlling behaviors) abuse by a male 
intimate partner (e.g., spouse, boyfriend, dating partner) or non-intimate partner (e.g., relative, friend, 
stranger). Interpersonal violence is comprised of commonly reported forms of violence (i.e., intimate partner 
violence (IPV), rape, contact sexual violence, childhood abuse). Whereas the national prevalence of lifetime 
IPV is 45% (7), Black women report 35% higher IPV than White women (8). Moreover, although national data 
estimates the lifetime prevalence of rape among Black women at 21% (7), community-based samples estimate 
prevalence rates of rape as high as 38-54% (9-12). 
Interpersonal violence and co-occurrence of adverse mental health and substance abuse contribute 
to poor HIV care continuum outcomes. WLHA experience high rates of lifetime physical, sexual, or 
psychological abuse (67%) (13), lifetime IPV (55%) (14-15), and past year IPV (27%) (16), a rate double the 
US national average. A history of abuse or trauma among WLHA is also associated with ART non-adherence, 
lower CD4 counts, reduced viral suppression, and increased mortality (14, 17-20). A recent study found that 
among HIV-positive women, those who reported recent trauma had over 3 times the odds of antiretroviral 
failure compared to their counterparts (17, 21). WLHA also experience co-occurring syndemic conditions with 
15-24% reporting heavy or hazardous drinking of alcohol (22-23), 11-15% reporting active drug use (24-25), 
and 30% suffering from post-traumatic stress disorder (PTSD) (15). Black women are more likely to 
experience these conditions (26) than their White or Latina counterparts. In the few studies that account for co-
occurring syndemic conditions using a summative score, higher syndemic scores (i.e., IPV, substance abuse, 
binge drinking, adverse mental health, and sexual risk-taking) were associated with poor ART adherence 
among HIV-positive men and women (27), and HIV-positive youth (28), and reduced viral suppression among 
HIV-positive women of color (29).  
 
Socio-structural barriers contribute to poor HIV care outcomes, whereas social support mitigates the 
effect. In addition to interpersonal violence and co-morbid adverse mental health and substance abuse, 
Black WLHA also face socio-structural barriers affecting retention in care and ART adherence, such as HIV-
related stigma and medical mistrust (30). HIV stigma is the most noted barrier to consistent access to and 
utilization of HIV care services for Black women (30-31). Experiences of racism, conspiracy beliefs, and the 
quality of relationships impact engagement in HIV medical care (32). Race-based medical mistrust predicts 

 
 
Biomedical IRB Application Instructions 
Page 5 
lower ART adherence among Black WLHA (33). However, social support through formal and informal 
networks may be important to address these complex issues, and has improved engagement in HIV care 
among Black WLHA (34-37). Specifically, women with abuse histories are more likely to seek formal help at 
service agencies, after seeking support and encouragement from informal social networks (38). Studies 
collectively suggest that socio-structural factors, including lack of social support and HIV-related stigma, need 
to be considered by providers and underscore the importance of relationships and communication between 
patients, providers, and the support networks of Black WLHA (30). 
 
Mobile technology interventions to address HIV prevention are limited among women. Given high 
rates of Internet access and smartphone infiltration across genders and races/ethnicities, mobile health 
(mHealth) technology interventions have emerged as one approach to support lifelong engagement in HIV 
care (32,39). Mobile technology such as mobile phones and other wireless computing devices offers 
advantages for women with a history of interpersonal violence such as confidentiality, more efficient and safer 
care, and empowerment (40-44). A majority of women (88%) in the US use the internet, with no differences in 
internet use by race/ethnicity (89% of Whites; 87% of Blacks) (45). In the US, cellphone ownership is highest 
among Black adults (98% vs 94% of White adults), and approximately three-quarters of adults across all 
races/ethnicities own a smartphone. Smartphone use is highly prevalent among Black individuals overall 
(72%) (46) and those with low socioeconomic status (85%-90% for Black women) (46-47). Moreover, 52% of 
Black women use a smartphone to access health information at least weekly. However, based on a 2013 
review solely focused on smartphone applications (apps) for HIV/sexually transmitted disease care and 
prevention, most smartphone apps failed to create engaging and attractive apps (48), provided limited 
psychological and emotional support resources, and miss important opportunities for intervention (e.g., did not 
include messages about HIV prevention or medication adherence (48)). Unfortunately, these limitations to 
realizing the potential impact of mHealth interventions persist. 
 
Peer Navigation has been highlighted as a successful model of care in improving outcomes along the 
HIV care continuum (49). Peer Navigators are HIV-positive, medication-adherent role models living with a 
similar shared experience and community membership as their target populations. Peer navigators provide 
social support and positive modeling of engagement-supportive behaviors to their clients, helping to build 
clients’ self-efficacy in patient-provider communication and increase clients’ trust and confidence in the health 
care system; offsetting the negative impact of socio-structural barriers (i.e., fear of gender-/racial-bias driving 
medical mistrust, stigma, and discrimination (50)) on HIV care. Peer Navigators also build clients’ self-efficacy 
for future engagement in the HIV care system. Peer Navigation for improving retention in care among WLHA 
has been found to be feasible, acceptable, and efficacious in the US and low- and middle-income countries 
(51-55). Peer navigation has improved ART adherence and viral suppression (55-57), although some studies 
have found no effect (58), perhaps due to small samples or the lack of informal social support. Peer navigation 
with other forms of informal peer support, would likely provide greater opportunities to reduce social isolation, 
build community, and share strategies for addressing syndemic and other (e.g., risky sexual behavior) factors 
for Black WLHA. A recent analysis of messages posted on a closed Facebook group for a young adult HIV 
program showed that members provided high levels of emotional and social network support. 
 
Preliminary Data 
 
mHealth Interventions. Dr. Keith Horvath (mPI) is currently PI on four mHealth intervention studies 
addressing the HIV prevention and care continuum. Thrive with Me (TWM; R01DA039950) is a responsive 
(i.e., adjusts to fit most devices) website that uses: informal peer support (similar to Facebook); tailored ART 
adherence and HIV-related information; self-monitoring of ART adherence, mood and drug use; and 
gamification components to improve ART adherence among HIV-positive adult MSM. Based on encouraging 
results of a pilot trial (59), an efficacy trial of TWM is underway in which 400 adults (age ≥18 years) HIV-
positive MSM in New York City with sub-optimal ART adherence will be randomized to receive TWM for 5 
months or an information-only control, and followed for 17 months. An interim analysis of community wall posts 
found that HIV-positive MSM spontaneously initiated discussions with each other on sensitive topics, such as 
ART adherence and sexual risk reduction strategies, and provided informational and emotional support to one 

 
 
Biomedical IRB Application Instructions 
Page 6 
other (60). As part of the UNC/Emory Center for Innovative Technology (iTech), within the new Adolescent 
Trials Network (ATN), TWM is being adapted for and subsequently tested among 350 HIV+ youth (15-17 
years) and young adults (18-24 year; U19 HD089881). Also, as part of ATN’s iTech, the team is leading a 
technology-based stepped care intervention for transgender and gender non-binary youth to reduce sexual 
risk behavior and increase PrEP uptake through tailored SMS messages, a culturally-tailored mobile app, and 
individualized e-coaching (U24 HD5109014). Finally, Dr. Horvath recently completed a native app (available 
on iOS and Android) intervention to increase regular HIV testing. 
 
Peer Navigation. The BRIDGES Project (PI: Dr. Stockman; Consultant: Dr. Cloitre; California HIV/AIDS 
Research Program; HD15-SD-059) is a Peer Navigation RCT intervention among Black and Latina women in 
San Diego, CA that provides trauma-informed Peer Navigation to improve linkage to and retention in HIV care 
and ancillary support services. Upon completion of the pilot test, women reported improvements in coping self-
efficacy, self-efficacy to activate social support networks, and had increased retention in HIV care over a 3-
month period (61). Ms. Dillard Smith (Consultant) leads an HIV service organization (WORLD) in Oakland, CA, 
that has implemented peer navigation services into their programs. The Peer Advocate program at WORLD 
hires Peer Navigators, including Black WLHA – with life experiences similar to the women they serve (e.g., 
histories of physical, sexual, and psychological abuse; adverse mental health; substance abuse) – who 
provide emotional and practical support to WLHA, and help them navigate the medical and social services 
systems. Ms. Dillard Smith and WORLD led a peer navigation intervention (Kaiser-funded study) to improve 
engagement in HIV care and ART initiation among out-of-care HIV-positive women of color. Of the 84 women 
enrolled (62), 48% experienced lifetime physical abuse, 42% experienced lifetime sexual assault, 29% used 
substances in the past month, and 29% had attempted suicide. At 6-month follow-up, women in the 
intervention group had less missed HIV care visits and more access to ancillary services than women in the 
control group (Ryan White case management services). In both groups, there were increases in the proportion 
of women initiating ART. These findings demonstrate the utility of a peer-based navigation program in 
improving retention in HIV care and ART uptake. 
 
8. 
PROGRESS REPORT 
N/A. 
 
9. 
RESEARCH DESIGN AND METHODS 
 
Study Overview: This study will be conducted in 2 phases, corresponding to the study aims: 
 
Phase 1 (Aim 1): Developing LinkPositively with input from Black WLHA with a lifetime history of interpersonal 
violence, peer navigators, and providers, and the San Diego Center for AIDS Research (CFAR) Disparities 
Core Community Advisory Board (CAB). Phase 1 will culminate in usability testing, Beta Testing, by Black 
WLHA affected by interpersonal violence (n=8), to finalize intervention components and procedures.  
 
Phase 2 (Aim 2): Piloting an RCT to evaluate feasibility, acceptability, and the preliminary effect of 
LinkPositively among Black WLHA with a lifetime history of interpersonal violence. This multi-component, 
culturally tailored, and trauma-informed mHealth intervention will primarily aim to increase retention in HIV 
care, ART adherence, and viral suppression for Black WLHA affected by interpersonal violence. The four 
components of LinkPositively will achieve these aims directly by improving self-efficacy for coping, social 
support networks, and utilization of ancillary support services (i.e., domestic violence, mental health, 
substance abuse), and indirectly by reducing HIV stigma and medical mistrust. 
  
Study Setting: The study will take place in three California counties (San Diego, Los Angeles, and Alameda) 
and two Oklahoma counties (Oklahoma and Tulsa). In San Diego County, between 1981 and 2011, the 
proportion of AIDS cases among White persons dropped (70% to 42%) while the proportion of cases among 
people of color increased considerably (19% to 58%).While African American persons represent 5% of the 
county’s population, they make up 13% of individuals diagnosed with HIV. Moreover, the AIDS rate is almost 8 
higher among African American women, compared to White women. Similar HIV prevalence rates are 

 
 
Biomedical IRB Application Instructions 
Page 7 
observed for African American women in other counties in California (Los Angeles and Alameda) and 
Oklahoma (Oklahoma City and Tulsa), with African American women disproportionately affected.  
 
Study Population:  
 
AIM 1 
 
In Phase 1 (Aim 1), eligible participants for the focus groups and interviews will be: (1) Black WLHA (including 
transgender women) with a history of interpersonal violence (n=6-8 per FG; total of 4 FGs); (2) Black WLHA 
(including transgender women) with a history of interpersonal violence who act in a professional capacity as a 
Peer Navigator (n=4-6; one FG); and (3) Key Informants (n=4-6) will be leadership at local clinics and 
community-based organizations known to provide services to women in the areas of HIV/AIDS care and 
domestic violence services, such as UCSD Owen Clinic and Mental Health America. Phase 1 will culminate in 
usability testing, Beta Testing, by Black WLHA affected by interpersonal violence (n=8; 4 with histories of 
interpersonal violence perpetrated by a current or former intimate partner and 4 with histories of interpersonal 
violence perpetrated by a non-intimate partner [e.g., family member, friend, stranger]), to finalize intervention 
components and procedures.    
 
AIM 2 
 
In Phase 2 (Aim 2), eligible participants for the RCT will self-report: (a) female gender (including transgender 
women), (b) Black or African American racial/ethnic background, (c) aged 18 years or older, (d) HIV-positive 
status, (e) ever experienced physical, sexual, and/or psychological abuse by a current or former partner or 
non-partner (e.g., relative, friend, stranger), (f) owner of a smartphone with internet browsing capabilities, and 
(g) English speaking. Purposive sampling will be used to ensure that groups are balanced with respect to type 
of perpetrator (current or former intimate partners [e.g., spouse, boyfriend, dating, casual] and non- intimate 
partners [e.g., family member, friend, stranger]) and retention in HIV medical care status (linked to care but 
have fallen out of care [i.e., no ART prescription filled, no viral load labs, or no HIV care visits with an ART-
prescribing provider in the past year] versus linked to and retained in care [i.e., ART prescription filled, viral 
load labs, or HIV care visits with an ART prescribing provider in the past year]). 
 
Study Screening and Enrollment:  
 
AIM 1 
 
In Phase 1 (Aim 1), three separate recruitment strategies will be imposed based on the distinct types of focus 
groups, key informant interviews, and beta testing. 
• 
Black WLHA with a history of interpersonal violence (n=6-8 per FG; total of 4 FGs and n=8 Beta 
Testing) will be recruited from organizations in San Diego, CA that provide HIV testing and/or treatment 
to WLHA, all of which are represented through membership in the San Diego CFAR Disparities Core 
CAB. We will also recruit Black WLHA through presentations at organizations providing HIV-related 
services such as Mental Health America San Diego and the Center for Community Solutions Rape 
Crisis Center. Finally, we will distribute flyers and advertisements through street outreach efforts, 
community events, and newspapers such as the Voice and Viewpoint, an African American local 
newspaper. We have successfully utilized these recruitment efforts in previous studies. Interested 
women be screened over the phone. They will provide verbal consent to be screened, then asked 
questions regarding eligibility, demographics, and computer literacy.  
• 
Peer Navigators (n=4-6; one FG) will be identified by Dr. Stockman’s contact with leadership at local 
clinics and CBOs known to employ peer navigation approaches and represented on the CAB (e.g., 
UCSD Mother, Child and Adolescent HIV Program and San Ysidro Health Center). Invitations will be 
extended to each organization with a flyer to be provided to PNs.  
• 
Key Informants (n=4-6) will be identified by Dr. Stockman’s in-person or phone contact with leadership 
at local clinics and community-based organizations known to provide services to women in the areas of 

 
 
Biomedical IRB Application Instructions 
Page 8 
HIV/AIDS care and domestic violence services such as UCSD Owen Clinic and Mental Health 
America. Print and electronic promotional materials will include a brief description of the study and the 
study phone number to call for more information about the study. 
 
For all focus groups, interviews, and beta testing, participants will be asked to provide Dr. Stockman and Dr. 
Tsuyuki with contact information. Focus group and interviews will be scheduled for dates and time convenient 
for the participants. All participants will review informed consent documentation and provide informed consent 
prior to commencement of the focus groups or interviews. 
 
AIM 2 
 
In Phase 2 (Aim 2), we will conduct the pilot RCT with 80 women from the study population. Potential 
participants will be recruited through community contacts across San Diego County, Los Angeles County, 
Alameda County, Oklahoma City County, and Tulsa County. Members of the research team have established 
relationships with the following key organizations that provide HIV testing and/or treatment to WLHA and these 
organizations are represented through membership in the San Diego CFAR Disparities Core CAB: UCSD 
Owen Clinic, UCSD Mother, Child and Adolescent HIV Program, Family Health Centers of San Diego, San 
Ysidro Health Center. We will also extend recruitment to Black WLHA through presentations at organizations 
providing HIV-related services such as Mental Health America San Diego, Neighborhood House Association, 
and the Center for Community Solutions Rape Crisis Center. In Los Angeles County, we will recruit from the 
following community-based organizations: UCLA Family AIDS Network, AIDS Project Los Angeles, Maternal 
Child Adolescent Clinic, OASIS Clinic, East LA Women’s Center, Alta Med, and JWCH Institute. In Alameda 
County, we will recruit from WORLD, an HIV service organization for women of color. In Oklahoma City and 
Tulsa Counties, we will recruit from Guiding Right, Inc., a Black-focused community-based organization. In all 
counties, we will distribute flyers and advertisements through street outreach efforts, community events, and 
newspapers such as the Voice and Viewpoint, an African American locally based newspaper. Finally, we will 
employ Facebook Advertising to recruit women through social media, including on the platforms Facebook and 
Instagram, and using the Facebook Audience Network to run advertisements on other websites the target 
population is likely to utilize. We have successfully utilized these recruitment efforts in previous studies. 
Further, we will employ Build Clinical, an organization that assists academic researchers in study enrollment 
through technology and novel data-driven approaches. 
 
Depending on the recruitment source, the following initial contact method may be employed: (1) Women may 
see the study advertisements in the community. Women interested in participating in the study will contact the 
study staff using the study phone number and email address listed in order to receive study information. At the 
time of the initial contact, women will be provided information regarding LinkPositively. Women will then 
express whether or not they are interested in the study. (2) Women may be recruited via service agencies or 
enrolled participants. By reviewing the study advertisement, interested women may request that their contact 
information be provided to the study team in order to initiate the first contact. At the time of the initial contact, 
women will be provided information regarding LinkPositively. Women will then express whether or not they are 
interested in the study. (3) Women may see the study advertisement on social media. By following the link on 
a social media advertisement, women can review the study website and complete the screener online (see 
below) and provide contact information for the Project Coordinator to directly contact them.  At the time of the 
initial contact, women will be provided information regarding LinkPositively. Women will then express whether 
or not they are interested in the study. 
 
Depending on the preference of the potential participant, the following screening method may be employed: 
(1) If a potential participant would like to be screened by phone for eligibility, the study staff will seek verbal 
consent to screen the participant. If consent is obtained, then a 10-minute screener will be conducted to 
assess eligibility. Screening questions will include age, biological sex, preferred gender identity, pregnancy 
status, HIV status, and sexual and reproductive history. (2) If a potential participant would like to be screened 
digitally for eligibility, the potential participant can follow a link on the advertisement, the study website, or via a 
link sent to them directly by the study staff. This link will take them to an eligibility screener via REDCap survey 

 
 
Biomedical IRB Application Instructions 
Page 9 
or to a secure survey via Build Clinical. The survey link will first notify potential participants that by continuing 
to the study screener, they are providing consent to be screened digitally. If consent is obtained, then a 10-
minute screener will be conducted to assess eligibility. Screening questions will include age, biological sex, 
gender identity, self-reported HIV status, and measures pertaining to lifetime trauma, mental health, post-
traumatic stress, past year physical and/or sexual violence, and substance and alcohol use. Due to the highly 
sensitive nature of this study, ability of potential participants to screen digitally will reduce participant burden in 
the screening process and increase participant options in the screening process, as is aligned with a trauma-
informed approach to working with WLHA. 
 
 
After eligibility is determined, eligible participants who screened through REDCap will be asked to provide the 
study staff with their contact information (phone number, email address), along with the names and 
corresponding contact information (e.g. phone number) of up to 3 individuals who may be contacted if the 
research team is unable to contact the participants for study initial visits and/or follow-up visits. The research 
team will only contact these alternative contacts if we cannot reach the participants through 10 attempts (total) 
on different days and times using the contact details that the participants provided the research team. Eligible 
participants who are recruited through Build Clinical will provide contact information through the secure 
participant management platform, which is kept secure using server authentication and data encryptions that 
are the same as those used in healthcare institutions. Data is transmitted via HTTPS, and Build Clinicals uses 
a Transport Layer Security (TLS) 1.2 with a 2048-but server key lengths and industry-leading modern 
browsers. No subject data other than eligibility screening data is stored by Build Clinical. All servers are based 
in the US, and data will be deleted upon request from the UCSD research upon closing of the study. The 
screening survey used through Build Clinical is identical to that used in REDCap. 
 
Participants deemed eligible for the study will then be linked to the Project Coordinator to schedule a baseline 
study visit at the UCSD Antiviral Research Center in San Diego County, the Charles R. Drew University 
Clinical and Translational Science Institute in Los Angeles County, WORLD in Alameda County, and at 
Guiding Right, Inc. offices in Oklahoma City and Tulsa Counties. At the baseline visit, participants will review 
and sign informed consent documentation to be enrolled in the study. 
 
Study Visit Procedures 
 
AIM 1 
 
In Phase 1 (Aim 1), interested WHLA, Peer Navigators, and Key Informants will participate in one focus group 
or in-depth interview, lasting approximately 90-120 minutes. All FGs will be held at the UCSD research field 
office location in Hillcrest (The Webster Building), a centrally located neighborhood in San Diego. Key 
Informant Interviews will occur at a location convenient for the key informant, such as their office. Each 
session will last approximately 2 hours and will be conducted in English. Participants will be asked to review 
and sign the informed consent form, which will explain the study procedures, confidentiality, risks and benefits 
of participation, and payment incentives. Participants will be given the opportunity to ask questions about 
interview procedures, and “group rules” will be reviewed prior to beginning the session (in the case of the 
FGs). To ensure confidentiality, participants will be asked to use a pseudonym in lieu of their name. 
Participants will also be asked to sign a confidentiality clause and encouraged to use and refer to each other 
by pseudonym only. FG and key informant interview questions will be developed by the research team and 
reviewed by the CAB. Questions specific to smartphones and apps will include: (1) experiences with 
smartphones and apps; (2) important features in an app; (3) influences of decisions to download, use, and 
maintain apps; features desired in regularly used apps; (4) suggestions for content and features of an app to 
help engage women in HIV medical care and ancillary support services; (5) prompts provided based on 
proposed app components: video function, social networking, educational tips, and GPS-based locator 
service. 
Topics and questions specific to HIV care, interpersonal violence, and associated mental illness and/or 
substance abuse will include: (1) aspects of HIV care most challenging to navigate as Black WLHA; (2) how 
barriers have been overcome, such as interpersonal violence, leading to improved engagement in HIV care or 

 
 
Biomedical IRB Application Instructions 
Page 10 
other support services; (3) intersectional stigma due to being Black, a woman, HIV-positive, and affected by 
interpersonal violence, and distrust of the health care system; (4) type of appointments that clients would need 
support in; and (5) types of support needed after appointments (e.g., managing medication side effects). Next, 
participants will be informed that the research team is building a smartphone app to improve retention in HIV 
medical care and ART adherence, while linking to other ancillary support services (e.g., domestic violence, 
mental health, substance abuse). Participants will be asked to reflect on the following topics: (1) features and 
functions that would attract them to the app; (2) visual look of the app; (3) importance of photos or characters 
of people on app look like them or their friends; (4) thoughts on proposed name, LinkPositively and suggested 
changes; (5) feedback on notifications (usually called push notifications) that may pop up on the home screen 
or near the app; and (6) suggestions to address privacy and safety concerns. The FG or key informant 
interview will end by asking participants to comment on anything else to consider during the app 
development process, thanking them for their time, and compensating them $50 cash. 
 
In Phase 1 (Aim 1), we will conduct beta testing to obtain feedback from a small group of women on 
intervention components, and to identify any navigation problems. Beta testing will be informed by the Health 
and Human Services Agency guidelines for best practices to assess user reaction to content, design, and 
functionality of the LinkPositively app. Screening and written informed consent will be 
conducted in-person. The consent will describe the purpose of usability testing and a description of the 
LinkPositively app to be tested. Women will be asked to download and navigate the LinkPositively app and 
reflect upon their experiences over a 2-week period. Specifically, we will ask women to provide feedback on 
their experiences with: 1) completion of a profile to be effectively linked to a matched virtual PN; 2) ease of 
initial text or videoconference with virtual PN; 3) use and functionality of the social networking platform with 
other users; 4) use of the resource center to identify one HIV service provider or organization, outside of the 
clinic or organization they frequent, and 2 ancillary support service agencies (i.e., domestic violence, mental 
health, substance abuse), and 5) educational tip functionality in terms of receiving tips and submitting 
questions. 
 
At the end of two weeks, Dr. Stockman or Dr. Tsuyuki will conduct a semi-structured qualitative exit interview 
soliciting participant and Virtual PN feedback and suggestions specific to each intervention feature, noting 
suggestions for improvement. Participants will be asked to assess the LinkPositively app’s features usability, 
design, content, and functionality. Participants will also complete the 10-item system usability scale (SUS), a 
validated, industry standard scale used to evaluate a variety of products and services, including websites, 
mobile phones, and computer software. Virtual PNs will also participate in a FG where we will obtain feedback 
on navigating the Coach-User interface (e.g., video and phone feature to speak with women, texting 
appointment reminders and private messages to women), difficulties with session content, satisfaction with the 
process (e.g., linkage to external support services, support networks, match between PN and client), and 
suggestions for improvements. Upon completion of a qualitative exit interview, participants will receive $50 for 
their participation and to cover the cost of data used during beta testing. A usability report will include compiled 
data from participants and PNs, list of common problems, and recommended design-improvements that will be 
used in the final iterative stages of app development. 
 
After beta testing is completed, we will share findings with the CAB and improve the LinkPositively app design, 
content, and functionality based on findings from the usability testing process. Drs. Horvath and Stockman will 
meet with RCG to discuss refinements centered on the identified usability study findings.  
 
AIM 2 
 
In Phase 2 (Aim 2), Participants enrolled in the study will attend three data collection study visits: Baseline 
(Month 0), Follow-Up 1 (Month 3), and Follow-Up 2 (Month 6).  
 
Baseline Study Visit. Women who meet eligibility criteria and are interested in participating in the study will 
undergo the written informed consent process at their baseline visit. After consenting, participants will provide 
contact information (e.g., name, cell phone number, email address, and/or social media username) to be 

 
 
Biomedical IRB Application Instructions 
Page 11 
contacted for follow-up assessments. Informed consent, completion enrollment paperwork, and assessments 
will occur in field offices in San Diego County (UC San Diego AntiViral Research Center, located at  220 
Dickinson St., Suite A, San Diego, California 92103), Los Angeles County (Charles R. Drew University of 
Medicine and Science, Clinical and Translational Science Institute, 1731 East 120th St., Los Angeles, 
California 90059), Alameda County (WORLD, located at 389 30th St., Oakland, California 94609), Oklahoma 
City (Guiding Right Offices, 1420 NE 23rd Oklahoma City, Oklahoma 73111, 2809 NW 31st Oklahoma City, 
Oklahoma 73112, and 2809 NW 31st Oklahoma City, Oklahoma 73112) and Tulsa County (Guiding Right, 
Inc.,4619 S. Harvard Tulsa, Oklahoma 74135). Following the baseline visit, participants will be randomized 
using a randomization sequence at a 1:1 ratio into the intervention or control arm on a rolling basis.  
 
All Study Visits. At all study visits (Baseline, Follow-Up 1, Follow-Up 2), participants will undergo an 
interviewer-administered quantitative survey and biological sample collection (hair). An increasing payment 
schedule will be used to enhance motivation to complete surveys. Specifically, women will receive $25 for 
completing the baseline visit, $30 for completing the 3-month follow-up visit, and $40 for completing the 6-
month follow-up visit, with a $10 bonus for completing all 3 visits. Due to the ongoing COVID-19 pandemic, 
follow-up study visits may occur virtually, over the secure video conference platform Zoom. For all in-person 
study activities, participants and staff will be required to wear face masks and physically distance when 
feasible. If participants do not have access to a face mask, one will be provided to them upon entry to the 
private research office space. Additionally, all participants will be screened for symptoms of COVID-19 by the 
Research Associate one day in advance of all in-person study visits, and again upon arrival at the private 
research office space. 
 
Quantitative Survey. The quantitative survey will include the following sections: (1) Demographic questions 
(e.g. age, biological sex at birth, gender identity, race/ethnicity, education, sexual orientation, marital status, 
employment, number of children, housing status, medical insurance status, food insecurity); (2) 
Socioeconomic status; (3) Mental health and behavioral health history (e.g. depression, anxiety, alcohol and 
substance use diagnosis and/or abstinence, lifetime history of trauma); (4) HIV care and treatment history (e.g. 
obtaining medical care, usual source of medical care, treatments, medications, insurance status, barriers to 
HIV treatment, self-reported adherence, adherence self-efficacy); (5) Support and Coping (e.g. social support, 
coping self-efficacy, ancillary support utilization); (6) Health care interactions (e.g. HIV stigma, medical 
mistrust) (7) Syndemic factors (e.g. interpersonal violence). [See Quantitative Survey]. 
 
Biological Sample Collection. After completion of the interviewer-administered survey at baseline, 3- and 6-
month follow-up, the Project Coordinator or Research Associate (trained in hair sample collection by Dr. 
Gandhi) will retrieve a hair sample from participants. All participants will be compensated $25 per visit, upon 
completion of hair sample collection. The hair sample collection kit is comprised of scissors, piece of tin foil, 
two patient labels, plastic (e.g., Ziploc) bag, alcohol swabs, and desiccant pellet. The following steps will be 
followed for hair sample collection: (1) Clean the blades of a pair of scissors with an alcohol pad; (2) Lift up the 
top layer of hair from the occipital region of the scalp at the back of the participant’s head. Isolate a small 
thatch of hair (~100 fibers of hair) from underneath this top layer; (3) Cut the small hair sample as close to the 
scalp as possible. For short or cropped hair, the Project Coordinator can let hair fall directly into the piece of tin 
foil. For braided hair, cut hair thatch from in-between braids or dread locks; (4) Keep fingers on the part of the 
hair that was furthest away from the scalp and put the hair sample down on an unfolded piece of tin foil; (5) 
Put a thin label over the end of the hair sample that was furthest away from the scalp; (6) Refold the foil over 
to completely enclose the hair and place a study ID label on the folded piece of foil; (7) Place the folded piece 
of foil inside the plastic bag and seal the bag. Hair samples will then be securely mailed to the UCSF Hair 
Analytical Laboratory, led by Dr. Gandhi, where liquid chromatography/tandem mass spectrometry will be used 
to assess antiretroviral concentrations in hair samples over the past 3 months (3cm of hair). Given the ongoing 
COVID-19 epidemic, all participants will also be trained in hair self-collection at their first (baseline) visit, and 
given labeled kits for self-collection of hair samples at home should the participant’s follow-up visit occur 
virtually. If the follow-up visits occur virtually, study staff will arrange a date and time to pick up the hair 
samples at a location convenient and safe for the participant, shortly after the virtual study visit.  
 

 
 
Biomedical IRB Application Instructions 
Page 12 
Medical Record Chart Abstraction 
During the passive follow-up period (7-12 months post-baseline), the research team will utilize the signed 
Release of Information (ROI) forms and HIPAA Authorization Forms of all study participants (participant 
consent collected at Baseline Study Visit), in order to request medical chart data for all participants from local 
HIV care providers to obtain data on clinic visits, HIV viral load, and CD4 values. Data will be entered into the 
REDCap Electronic Data Capturing System. These medical chart data extractions will be conducted 
periodically, given the staggered enrollment period. 
 
To safeguard confidentiality, for the quantitative data collection, each participant will receive a unique patient 
identification number (PID) and names will never be used in conjunction with PID numbers. This unique PID 
number will appear on the survey, tracking forms (e.g., scrip payment receipt, cell phone tracking form), 
locator and screening forms. Participant confidentiality will be maintained through use of the unique PID and 
secure networks where data are stored. All laboratory data will be electronically transferred to the UCSD Data 
Management Center via password protected electronic files. At the UCSD Data Management Center, all 
computer files will be identifiable only by the PID number. 
 
Intervention Trial: 
 
Treatment Conditions. Following the Baseline Visit, participants will be randomized at a 1:1 ratio to an 
intervention arm or control arm. The Biostatistician team will generate the randomization sequence to ensure 
that randomization occurs independent of the core research team. Participants will be informed of their study 
group assignment immediately after completion of their baseline survey. 
 
Control Arm. Women assigned to the control arm will be connected with and will receive self-directed (non-
Peer Navigation supported) treatment as usual at agencies and institutions in San Diego, Los Angeles,  
Alameda, Oklahoma City, or Tulsa County following the Ryan White HIV/AIDS Program standard of care (i.e., 
referrals to physical, dental, and mental health services; medical case management; and ancillary services 
[e.g., alcohol/substance use recovery, family support]). Women who are not already receiving services and do 
not have other means of receiving services or are not under medical case management elsewhere will be 
referred to care. Alternatively, women may request case management services via Ryan White HIV/AIDS 
Program at a preferred location. 
 
Using the Ryan White standards of care, goals will be set to create an individual care plan related to medical 
care, housing, financial, and other resources as needed. Referrals will be made to appropriate services (e.g., 
primary care, housing, benefits counseling, transportation, food, legal services, support services) based on 
intake interview. Women who require a higher level of care (e.g., significant mental health concern, at risk or 
falling out of care) and do not have other means of receiving services or are not under medical case 
management elsewhere may request case management services via Ryan White HIV/AIDS Program in San 
Diego, Los Angeles, Alameda, Oklahoma City, or Tulsa County.  
 
Participants requiring medical case management will have a case file that provides appropriate participant 
follow-up and tracking information. Case Managers will have in-person contact with all participants at least 
every 90 days to assess further need for services. Either the participant or the Case Manager may initiate a 
given contact. The case manager will have in-person or phone contact with participants at least every 30 days 
to discuss changes and progress towards meeting goals of the individual care plan and an in-person meeting 
with each participant at least once every 90 days. Participants will be re-assessed at least once every 120 
days. It is important to note that the medical case management approach is self-guided versus intense peer 
navigation assistance, meaning that participants will learn the responsibility to move toward autonomy with 
their HIV care.  
 
Intervention Arm. Women assigned to the LinkPositively intervention arm will have access to all four 
components of the LinkPositively app, as described below. At the baseline visit, women will be introduced to 
the LinkPositively application. Study staff will train participants on how to download the app onto their 

 
 
Biomedical IRB Application Instructions 
Page 13 
smartphone, explain the five components, utilizing each component, with emphasis on contacting their 
assigned PN. Within the first week of participants being assigned, virtual PNs will schedule and complete a 
one-on-one, video intake session with the participant. During this one-on-one intake session, the PN will 
conduct a thorough participant needs assessment to connect her to HIV medical care via local health clinics 
and identify other areas of need, services of need, and assisted referrals. These areas include but are not 
limited to domestic violence services, mental health care, substance abuse treatment, and housing and legal 
support. PNs will provide trauma-informed, intensive emotional and informational support, including guidance 
on accessing information (e.g., agency name, address, website, contact information) about referred services. 
 
The LinkPositively App will deploy the following interactive components: 
 
1. Social Networking. We will develop a platform for Black WLHA with a lifetime history of interpersonal 
violence to connect with each other via a social networking feed (similar to Facebook). Users will 
create a user Social Networking Profile by choosing an alias name, avatar (virtual character to 
represent themselves), and include any information they wish to share about themselves. The user 
profiles will be monitored and protected from personal-identifying information, in order to maintain the 
participant’s confidentiality. Within the feed, users will have the opportunity to share information, 
stories, and successes, as well as ask questions and advice from the other women via posts. The 
platform will be interactive, as users will be able to react to (via icons including thumbs up, heart, smile 
emoji’s) and comment on user’s posts. The platform content (including posts and information shared) 
will be monitored daily by study staff to ensure confidentiality is maintained and appropriate behavior, 
language, and actions are upheld. The feed will not be accessible to the PNs, in order to allow all 
participants to engage with each other without the bias of PNs and to limit contamination in the 
evaluation on the preliminary effects of the separate components of LinkPositively. 
 
2. Education and Self-Care Tips. We will create 200-250 brief educational, self-care, and healthy living 
tips, as well as tips for best strategies for overcoming the effects of interpersonal violence (e.g., 
adverse mental health, substance abuse). Tips will rotate daily; such that 2-3 daily tips will appear in 
the users feed. Also, users will be able to search the database of tips using keywords. Women will be 
able to submit questions to study staff regarding additional education on the HIV care continuum or 
interpersonal violence, which will be answered by expert investigators and posted anonymously on the 
social networking feed for all participants to see. Additionally, to motivate participants to engage with 
LinkPositively, women will earn points based on use and engagement. Distinct levels with 
corresponding points will then unlock new features in the app. Such features will include videos that 
promote self-care (e.g., guided mindfulness meditation, yoga as therapy, exercise, etc.), as well as 
education and empowerment (e.g., testimonials from survivors of interpersonal violence), which will be 
embedded into the app at designated levels. These features will be unlocked for users as they meet 
each level. Women will be able to see their current level status and how many points they need to 
unlock additional self-care and educational videos and testimonials in the profile area to encourage use 
and engagement. 
 
3. Resource Locator. A resource database will be developed by the study team to assist women to 
identify HIV, domestic violence, and other ancillary support service agencies nearby. Women will be 
able to search the database for specific services (e.g., HIV care; Financial, Mental Health; Substance 
Abuse) in a specified radius (e.g., 5 miles, 20 miles, 50 miles), which will generate a list of 
organizations and their characteristics, such as address, phone number, type of organization (i.e., HIV, 
interpersonal violence [e.g., domestic violence shelters], mental health, substance use), website URL, 
days/hours of operation, service eligibility requirements (if any), fee information, clinical and support 
services offered (e.g. HIV testing, HIV treatment, STD testing, domestic violence shelters, rape crisis 
centers, mental health counseling/therapy, support groups, substance use programs). By clicking on 
the address, the smartphone’s GPS mapping app will be enabled to show user’s location relative to the 
agency locations. Users will have the option to apply filters to the resource list by the aforementioned 

 
 
Biomedical IRB Application Instructions 
Page 14 
characteristics, in order to display specific agencies based on desired needs or characteristics. There 
will also be the opportunity for users to comment and rate the agency, similar to Yelp functionality. 
 
4. ART Self-monitoring and Reminders. Within the notification center of the app, users will receive 
automated medication reminders and appointment reminders, and will be prompted to respond in real 
time to whether or not they took their medications that day and whether or not they attended their 
scheduled appointments. 
 
5. Virtual Peer Navigation. Study participants will be matched with a trained, trauma-informed virtual PN— 
based on shared lived experiences —who deliver this component of the intervention using a HIPPA-
compliant videoconferencing software, Zoom Conference. Participants can link to their Zoom PN 
meeting by clicking on a link within the LinkPositively app to connect with their matched PN. First, the 
assigned PNs will conduct an intake/needs assessment and create goals, case plan with their assigned 
clients, discuss ways to maximize the effectiveness of the LinkPositively app, and link clients to HIV 
medical care and ancillary support services, as well as other local resources. Next, a total of 5 
structured PN sessions will occur over a five-week period. Two sessions will focus on emotional 
intelligence: (a) increasing emotional awareness, understanding trauma and other co-occurring 
syndemic conditions (e.g., mental health disorders, substance abuse) including emotional responses to 
them, and (b) cultivating emotional regulation and distress tolerance, specific to PTSD following 
interpersonal violence. The third session will focus on activating social support networks, specifically, 
identifying and changing relationship patterns (i.e., understanding negative relationship patterns based 
on interpersonal violence experiences and other syndemic conditions and identification of alternative 
and more adaptive interpersonal schemas). The fourth session will address how interpersonal violence 
(e.g., power and control dynamics, disclosure of violence) can impact existing socio-structural barriers 
(e.g., HIV stigma, medical mistrust) and developing strategies to obtain care and support while 
accounting for these issues. The fifth and final session will focus on aspects of medical mistrust and 
discrimination in the context of HIV care and discuss skills to improve patient-provider communication. 
Each session will last 1 hour and occur at a convenient time for the participant. Women will be able to 
text/call their PN during and after the 5-week period if they have questions or seek to debrief after 
sessions or appointments. In the backend of the website app, PNs will enter case notes on PN 
sessions and check-ins, set notifications and appointment reminders, and send their assigned 
participants direct messages that will show up only on that participant’s profile. PNs will also be able to 
view women’s responses in the real time data on medication and appointment outcomes, to inform 
their upcoming session and/or check-in. In addition to video conference/phone sessions and check-ins, 
participants will receive automated daily medication reminder text messages, scheduled appointment 
alerts, and access daily postings in the education and self-care tips component of the app. 
 
After completion of each intervention activity, participants enrolled in the intervention group will receive an 
email with a link to complete a brief evaluation of the intervention. Completion of this evaluation is voluntary.  
 
Retention of Participants 
 
AIM 1 
 
Given that participation is only for one-time point, no retention is required for this portion of the study. 
 
AIM 2 
 
We expect to reach our sample size utilizing partnerships established through the UCSD Center for AIDS 
Research (CFAR) Disparities Core Community Advisory Board (CAB), of which Dr. Stockman is Director, and 
through standard outreach methods. Following other projects led by Dr. Stockman and other members of the 
investigative team, we expect a retention rate of at least 85% in the first follow-up visit and another 80% in the 
second follow-up visit. Nevertheless, we will strive to engage and maintain our sample. To do this, we will 

 
 
Biomedical IRB Application Instructions 
Page 15 
implement tactics to improve retention. Specifically, we will: (1) Utilize an increasing payment schedule to 
enhance motivation to complete study visits. Specifically, women will be offered $30 and $40 for completing 3- 
and 6-month study visits, with a $10 bonus for completing all 3 study visits (2) collect contact information for 
three people (e.g., friends, family members) who would likely have knowledge of participants’ whereabouts; (3) 
provide study cell phone number for ease of study staff calling or texting participants and participants calling or 
texting study staff with any questions or concerns; (4) maintain frequent contact with participants to check in 
about their service needs which include any linkages the study team can provide to resources in the 
community; and (5) as appropriate, sending text messages on participants’ personal cell phone or assigned 
study cell phone with birthday and holiday greetings, and congratulations messages for graduations and other 
important events. We also will make it easy for participants to stay in touch with our team by providing a toll-
free phone number, email and web addresses (in addition to the study cell phone). Given our target sample 
size and short follow-up period, we are confident that the aforementioned approaches will maximize retention 
in our study. 
 
Data Management 
Quantitative data will be managed by Dr. Jain. The study staff will be responsible for questionnaire 
development and coding of the survey. Through the UCSD Central and Translational Research Institute 
(CTRI), the research team will utilize REDCap (Research Electronic Data Capture) application for quantitative 
data. REDCap is a secure, password protected, HIPAA compliant web-based application for building and 
managing online surveys and databases. Laptop and/or tablets will be used for survey data collection using 
the REDCap application. Each survey file will be digitally stamped with the user, date and time of use, 
machine information. All computer files in the field will be automatically backed up. The project coordinator will 
be trained to extract and compile survey files; encrypted, password protected files will be sent weekly to Dr. 
Jain.  Each study participant will have a unique identifier. No personal information will be recorded in the 
surveys. A UCSD data manager will merge all REDCap datasets together, reconcile them into a standard 
version, and export a final REDCap dataset into SAS or SPSS data sets, instantly ready to use by any 
statistical software. To ensure quality of the data collection, the data manager will make bi-weekly tracking and 
missing data reports. Hard copies of field notes will be maintained by the Project Coordinator in a locked filing 
cabinet, available to study personnel if data concerns arise. Study investigators will refer to these field notes 
as necessary in the coding and analysis stages. All data will be backed up daily and stored using password 
protection. Dr. Jain will merge data, reconcile them into a standard version, and export into a SAS dataset. 
Biomarker data from UCSF’s HAL laboratory (hair samples), will be sent weekly to the UCSD research team 
via password protected electronic files. 
 
 
10. 
HUMAN SUBJECTS 
 
Human Subjects 
Anticipated WLHA demographics to be enrolled in LinkPositively.  
 
AIM 1 
 
In Phase 1 (Aim 1), we will conduct focus groups (FGs) and in-depth interviews. Eligible participants will be 
Black WLHA (including transgender women) with a History of Interpersonal Violence (n=6-8 per FG; total of 4 
FGs); Black WLHA (including transgender women) with a History of Interpersonal Violence who act in a 
professional capacity as a Peer Navigator (n=4-6; one FG). Key Informants (n=4-6) will be leadership at local 
clinics and community-based organizations known to provide services to women in the areas of HIV/AIDS care 
and domestic violence services such as UCSD Owen Clinic and Mental Health America. Phase 1 will 
culminate in usability testing, Beta Testing, by Black WLHA affected by interpersonal violence (n=8; 4 with 
histories of interpersonal violence perpetrated by a current or former intimate partner and 4 with histories of 
interpersonal violence perpetrated by a non-intimate partner [e.g., family member, friend, stranger]), to finalize 
intervention components and procedures.    
 

 
 
Biomedical IRB Application Instructions 
Page 16 
AIM 2 
 
In Phase 2 (Aim 2), we will conduct a randomized control trial study design with follow-up. Eligible participants 
will self-report: (a) female gender (including transgender women), (b) Black or African American racial/ethnic 
background, (c) ages 18+ years, (d) HIV-positive status, (e) ever experienced physical, sexual, and/or 
psychological abuse by a current or former partner or non-partner (e.g., relative, friend, stranger), (f) owner of 
a smartphone with internet browsing capabilities, and (g) English speaking. Purposive sampling will be used to 
ensure that groups are balanced with respect to type of perpetrator (current or former intimate partners [e.g., 
spouse, boyfriend, dating, casual] and non- intimate partners [e.g., family member, friend, stranger]) and 
retention in HIV medical care status (linked to care but have fallen out of care [i.e., no ART prescription filled, 
no viral load labs, or no HIV care visits with an ART-prescribing provider in the past year] versus linked to and 
retained in care [i.e., ART prescription filled, viral load labs, or HIV care visits with an ART prescribing provider 
in the past year]).The total possible sample size for the study will be 80 women living with HIV/AIDS (WLHA). 
Of 80 enrolled women, 40 will be randomized to the intervention arm and 40 will be randomized to the control 
arm.  
 
Eligibility  
The following eligibility criteria will apply to all WLHA enrolled into the study, including WHLA FGs, Peer 
Navigator FGs, Beta Testing, and the Randomized Control Trial: 
 
Inclusion criteria: 
• 
Aged 18 years or older 
• 
Self-identification as a cis-gender or transgender woman  
• 
Self-identification as Black or African American 
• 
Living with HIV/AIDS 
• 
Ability to speak and understand English 
• 
Ever-experienced physical, sexual, and/or psychological abuse by a current or former partner or non-
partner 
• 
Owner of a smartphone with internet browsing capabilities 
 
Exclusion criteria: 
• 
Unwillingness to participate in the study 
• 
Cognitive impairment that would limit participation with study procedures 
 
The interviewer will assess cognitive impairment. If during the consent process, a participant appears to be 
suffering from paranoia, auditory hallucinations, has sporadic outbursts, or is not capable of comprehending 
the interview or materials, she will be excluded from the study. Although we may enroll transgender women 
due to ethical service-delivery considerations, we recognize that trans-tailored PN-based programs may be 
more ideal for this population. Additionally, although our sample is heterogeneous in terms of where they fall 
on the HIV care continuum, they share similar experiences with interpersonal violence, which are the 
communality and focus of LinkPositively- to ultimately improve outcomes along the care continuum. 
 
11. 
RECRUITMENT AND PROCEDURES PREPARATORY TO RESEARCH 
 
Recruitment of Participants 
Eligible WLHA will be identified through the following methods:  
 
Social Media. Social media outlets, including posting information about the study on an open Facebook group 
(e.g., local support groups for WLHA) and online ads that appear on Facebook and Instagram. Our study team 
has previously been successful in recruiting hard-to-reach populations through this method. When running 
advertisements on social media, the comment option on advertisements will be turned off, so as to avoid 
inadvertently “outing” women with HIV. Additionally, Build Clinic will provide support for distribution of 

 
 
Biomedical IRB Application Instructions 
Page 17 
advertisements via social media, using IRB-approved advertisements. Both will link interested women to a 
secure survey with the exact same screening content. 
 
San Diego Center for AIDS Research (CFAR) Disparities Core. Outreach methods employed by the San 
Diego Center for AIDS Research (CFAR) Disparities Core will include distribution of flyers to community-based 
agencies that have been identified as potential recruitment locations of HIV-related research and have been 
included in a community partner database (n=20) housed within the San Diego CFAR Disparities Core. We will 
also utilize the recruitment and retention subcommittee of the Disparities Core Community Advisory Board 
(CAB) to promote and advertise the study and our need for Latina and Black women. The Disparities Core 
CAB is composed of Black and Latino health community leaders in San Diego. Specifically, the recruitment 
and retention subcommittee holds targeted outreach events at local community events and health fairs to 
speak to underserved groups, particularly, Blacks, Latinos, and American Indian/Native Americans about 
ongoing research and the need for their participation to address disparities in HIV research. 
 
Newspaper Advertisements. Advertisements will be run in local newspapers. Dr. Stockman has previously 
had significant success with the recruitment of women of color utilizing the San Diego Reader. 
 
Traditional Advertisements. Flyer advertisements (ads) will include banner ads and flyers that will be posted 
at bus stops, libraries, transitional housing facilities, social service agencies, and businesses located in central 
San Diego, Los Angeles, Alameda, Oklahoma City, and Tulsa communities that have at least 10% or more 
Black and Latino residents.  
 
12. 
INFORMED CONSENT 
Verbal consent to screen potential participants for eligibility will be sought from all potential participants, and 
receipt of verbal consent to screen will be documented by study staff. Screening will occur using a telephone 
screening script.  
  
For eligible participants who choose to enroll, we anticipate that written informed consent will be obtained from 
all enrolled participants at the time of their in-person baseline study visit. the informed consent process will 
follow all relevant regulatory guidelines and will generally include both verbal and written components obtained 
by authorized and trained study personnel at UCSD. Documents and other communications will be developed 
to inform each potential research participant as clearly as possible about the potential risks, benefits and 
alternative approaches available for each research study. In all currently foreseeable circumstances, 
documentation of informed consent will be in the form of a signed and witnessed written document in a 
language and at a level that is appropriate to the patient population recruited. The informed consent procedure 
is designed to maximize the potential participant’s comprehension of study procedures and to ensure that 
participation is voluntary. Prior to study implementation, we will seek approval from the UCSD Institutional 
Review Board (IRB) Committee on Human Research. The informed consent process, along with data 
collection will only occur in San Diego, Los Angeles, Alameda, Oklahoma City, and Tulsa counties. 
 
In scenarios of high risk of infection (COVID-19), we are additionally requesting a Waiver of Documented 
Consent/Assent to obtain oral consent/assent, should we be unable to proceed with in-person data collection 
and consenting processes. The UCSD Human Resources Protection Program (HRPP) Institutional Review 
Board has classified this research as involving no more than minimal risk. Additionally, no procedures within 
the study require written consent outside of the research project. This will allow for the research team to enroll 
participants and focus groups and interviews via phone or video conference, significantly reducing the 
potential for exposure to infectious disease. Consent will be obtained by trained and authorized research staff. 
Consent will be documented by study staff obtaining informed verbal consent using an oral consent form. 
 
13. 
ALTERNATIVES TO STUDY PARTICIPATION 
Participants will have the option to not participate in the study. Participants who are not interested in 
participating in the study are welcome to take a referral list of local resources in the San Diego, Los Angeles, 
Alameda Oklahoma City, or Tulsa County community (e.g., legal, support groups, childcare, etc.). 

 
 
Biomedical IRB Application Instructions 
Page 18 
 
14. 
POTENTIAL RISKS 
 
Potential Risks  
The risks associated with participation in the study are primarily psychological, given the nature of factors 
associated with Black WLHA with a history of interpersonal violence. These risks are discussed below: 
 
Psychological Risks: In the treatment group (intervention arm), participants may experience psychological 
distress while talking about issues (e.g., adverse mental health, intimate partner violence, HIV disclosure) 
raised during one-on-one sessions with virtual peer navigators and phone/text check-ins. Distress may also 
occur when participants are not interacting with the virtual peer navigator. In the standard of care group 
(control arm), participants may also experience distress. Participants will be asked questions about mental 
health and intimate partner violence. As a result, participants may be uncomfortable or experience stress or 
emotional pain in responding to these questions. Participating in the intervention could also lead to self-
awareness about the limitations of one’s knowledge of HIV care and treatment, as well as barriers (e.g., 
substance use, adverse mental health, discrimination, etc.). Participants may also disclose their HIV status for 
the first time to peers who are enrolled and interacting on the social networking platform, which may cause 
psychological distress.  
 
Physical Risks: We will collect hair samples at 3- and 6-month follow-up assessments, which could cause 
some physical discomfort. However, the amount of hair collected is equivalent to the daily amount of hair 
strands that are lost and the hair sample collection procedure itself is considered noninvasive. All research 
staff members will be trained by Dr. Gandhi (Consultant) in hair sample collection procedures. Confidentiality: 
There is potential for violation of participant confidentiality if others find out about participants’ HIV status or 
study participation. In addition, women who may be in an abusive relationship, may be concerned that their 
partner will find out about their participation in the intervention. For eligible participants, as a result of 
participating in this study, it is possible that these participants may be identified by others, including law 
enforcement, such as those who may be a victim or perpetrator of violence. 
 
There is also some risk that the study personnel will receive reports of physical abuse and violence 
perpetrated against participants. These incidences will be handled per mandatory reporting protocols.  
 
Per IRB policy—violence that is related to the conduct of the protocol will be reported to the IRB as an adverse 
event. Violence unrelated to the protocol that is communicated during the information gathering associated 
with the protocol will be reported to the authorities under state law, but would not be reportable as a research-
related adverse event. In the event of violence related to the study protocol, an incident report will be filed with 
the UCSD IRB. Also, if during the course of participating in any phase of the research study, the participant 
reveals current abuse/neglect or planned danger to self or others, the study personnel will report this to Dr. 
Stockman, who will make the appropriate referral as required by law. 
 
Loss of Confidentiality: For eligible participants, as a result of participating in this study, it is possible that 
these participants may be identified by others, including law enforcement or healthcare personnel, as being a 
woman living with HIV/AIDS. We will conduct interviews in private locations (i.e., UCSD clinic offices). There is 
also a slight risk that confidentiality may be breached in the management of data, although multiple safeguards 
will be implemented to avoid this risk. Participants will be made aware of this risk during the consent procedure 
(see Data and Safety Monitoring Plan, below).  
 
COVID-19: Given the ongoing COVID-19 epidemic, there is a risk associated with in-person study activities, 
during which participants could come in contact with staff or other individuals in the Webster Building who may 
have COVID. To mitigate this risk, all staff will undergo weekly COVID-19 testing, as per UCSD guidelines, 
complete a daily symptoms attestation, and utilize all appropriate personal protective equipment (facemask, 
faceshield, gloves, etc.). Additionally, all participants will be asked to wear at least a facemask (if the 
participant does not have access to a facemask, one will be provided to them), and any other protective 

 
 
Biomedical IRB Application Instructions 
Page 19 
equipment they would like. Further, surfaces will be disinfected between all participant visits, physical 
distancing will be maintained whenever feasible, and no more than one participant and one staff member will 
occupy the study space at a given time.  
 
15. RISK MANAGEMENT PROCEDURES AND ADEQUACY OF RESOURCES 
 
Protections Against Risks: 
 
Procedures for minimizing potential risk to research participants will be directed and adapted to the 
participants, local agencies, and interventions required for each participant. Anticipated risks include increased 
stress or emotional pain from study participation. Research participants will be closely monitored by 
experienced clinical and research staff with the goal of minimizing, recognizing and mitigating these risks to 
the best of our abilities throughout the conduct of the project.  
 
There is the possibility of physical risk to other during the course of the study. Previous UCSD IRB-approved 
research has established procedures to manage participant reports of violence affecting WLHA. The IRB 
policy at UCSD is that violence that is related to the conduct of the protocol must be reported to the IRB as an 
adverse event, whereas violence unrelated to the protocol that is incidentally communicated during the 
information-gathering procedures associated with the protocol may be reportable to civil authorities under 
applicable laws (e.g., harm to adult or minor dependents), but would not be reportable as a research-related 
adverse event. In the event of violence related to our study, an incident report would need to be filed with the 
UCSD IRB. To date, our team has not had a single report of violence related to our other projects that have 
been conducted with WLHA. If, during the course of an interview, assessment, or intervention session, a 
participant reveals current abuse or planned danger to others, the staff member will make the appropriate 
referral as required by law, and immediately inform the PI, Drs. Stockman within 12 hours. Typically, the 
participant would be referred to mental health counseling. Dr. Stockman would file a report with the UCSD IRB 
within 24 hours. 
 
Additional risks might include the loss of privacy of individuals and confidentiality of data. Procedures to 
minimize these risks include maintaining storage of hard copies of personally identifiable private information in 
limited access secure locations; assigning alphanumeric codes without personally identifiable information to all 
recorded or transmitted data; maintaining strict electronic data security protocols for the management of all 
study related electronic data. Although there is inherent risk associated with the systematic collection of any 
personal data, the data management protocols that have been developed within our university have been 
extremely effective over the past three decades. We will remain vigilant about data security and will modify our 
procedures in response to any perceived or real risks to breaches in the security of our data. Additionally, all 
audio recordings for data collection purposes will be destroyed one year after completion of the study.  
 
We will adhere to all applicable regulatory guidelines and local laws and regulations for patient confidentiality 
and safety monitoring and protection. We are aware of (and have substantial experience in) the DHHS 
regulations and OHRP guidance (45 CFR 46) required for research involving human subjects. All research 
staff have been trained and certified in human subjects’ protection, and certifications are updated every two 
years by the UCSD Office of HRPP and every three years through on-line CITI training, as required by the 
NIH/NIAID. 
 
Our research and clinical staff will monitor all participants for adverse events. The first level of safety involves 
direct observation of and interaction with research participants by trained research personnel throughout the 
conduct of the study. In addition to interactions at protocol-specified visits, study participants are provided with 
multiple avenues of communication with research investigators and staff. These include unscheduled visits at 
the discretion of the study participant, telephone and internet-facilitated communication. The second level of 
safety involves protocol-specified visits and laboratory studies that are tied to objective severity grading scales 
for assessment of adverse events. All adverse events are monitored by trained research staff and reviewed 
with study investigators. Adverse events of protocol-specified severity grade are reported to the institutional 

 
 
Biomedical IRB Application Instructions 
Page 20 
IRB of record, to the data management center, if applicable to the NIH and the Food and Drug Administration 
in accordance with institutional, regulatory and funding guidelines. Aggregated adverse events for each 
protocol are reviewed at specified intervals in scheduled meetings at the research unit and are reported to the 
IRB of record as appropriate based on regulatory guidance described above. 
  
All investigators have completed the Human Subjects Training and Certification Program. We will ensure that all 
hired staff complete the same program as well, and will be provided in-depth training on all study procedures, 
emphasizing our roles to minimize risk to participants and study data, across all study activities. Dr. Stockman 
(PI), an epidemiologist, has over 15 years of experience training staff to conduct confidential and sensitive 
interviews with vulnerable populations, including drug users and abused women. She will oversee all aspects of 
the study and ensure effective dissemination of findings. Additionally, she will provide guidance on the design, 
implementation, data analysis, and dissemination of findings, as well as provide expertise on evaluation 
techniques and study implementation. In addition, the Research staff will receive extensive training in mixed 
methods research (e.g., informed consent, data collection, qualitative interviewing techniques, etc.) and 
approach questions with sensitivity and in a supportive manner.  All staff are trained to connect participants to 
local resources (e.g., legal, support groups, childcare, etc.) that are available at reduced or no cost.   
 
The UCSD team are established in training staff to conduct study activities (data collection and intervention 
sessions) in a confidential and sensitive manner that is responsive to the variability associated with interpersonal 
violence experiences among WLHA. Dr. Stockman will work closely with staff to support and monitor the study’s 
activities. All project staff will be trained to approach questions with sensitivity, in a supportive manner and to 
provide appropriate referrals when needed. All staff conducting interviews will be trained not to press participants 
to answer questions that seem to be distressing to them, and sessions will be terminated if the participant 
becomes too distressed, too fatigued, and/or too frustrated by the effort.  If participants feel they are in need of 
psychological/mental health services, interviewers will refer the participant to counseling services or make 
arrangements to connect them with another local service agency, so that they may speak with someone about 
their concerns. Also, if during the course of the interview, the participant reveals planned danger to self or others, 
or child or elder abuse, the research team will report to San Diego, Los Angeles, Alameda, Oklahoma City, or 
Tulsa County law enforcement officials (police department and/or Child Protective Services) in accordance with 
State mandated reporter timelines and procedures.   
 
16. PRIVACY AND CONFIDENTIALITY CONSIDERATIONS INCLUDING DATA ACCESS AND 
MANAGEMENT 
Data will be managed by the research team and at CFAR Biostatistics and Modeling Core, which has 
substantial experience with managing and analyzing data from Dr. Stockman’s research projects. The 
following provisions will be taken depending on the data source.  
 
Participant Data 
Participant privacy will be protected during screening, study enrollment, and study sessions by conducting all 
procedures in a private office or meeting space at the following locations:  
 
San Diego County: UC San Diego AntiViral Research Center, located at  220 Dickinson St., Suite A, San 
Diego, California 92103 
 
Los Angeles County: Charles R. Drew University of Medicine and Science, Clinical and Translational Science 
Institute, 1731 East 120th St., Los Angeles, California 90059 
 
Alameda County: WORLD, located at 389 30th St., Oakland, California 94609 
 
Oklahoma City County: Guiding Right, Inc., offices at multiple locations including 1420 NE 23rd Oklahoma 
City, Oklahoma 73111, 2809 NW 31st Oklahoma City, Oklahoma 73112, and 2809 NW 31st Oklahoma City, 
Oklahoma 73112 
 

 
 
Biomedical IRB Application Instructions 
Page 21 
Tulsa County: Guiding Right, Inc., 4619 S. Harvard Tulsa, Oklahoma 74135 
 
All data collected from enrolled participants, including both hard copy and electronic data, will be identified only 
by the participant’s study ID and will be protected against access by anyone except authorized staff connected 
to the study. Hard copy data will be stored in locked cabinets in secure offices at the Webster Building, Suite 
302. Hard copy data forms and Peer Navigators notes collected will be shredded 12 months after the 
completion of the study. Audio recordings will be stored on an encrypted, cloud-based, secure drive. Audio 
records will be transcribed verbatim and de-identified, and transcriptions will be stored in the same manner as 
all electronic data. Audio recordings will be destroyed one year after the completion of data collection.  
 
Electronic data, specifically participant personal information will be kept in Ripple™, a secure web application 
designed for the storing and management of personal identifying information of research participants. Ripple 
was initially developed at the University of Michigan to provide a user-friendly, web-based secure interface 
where research teams can centralize the storage and management of research participants’ personal 
information, including name, participant ID, demographics, and study workflow (e.g., appointments). 
Participant information managed with Ripple is private and secure. This information is kept in fully encrypted 
format inside dedicated databases that are segregated from other Ripple accounts and thus only authorized 
study staff will have access to the study data. Likewise, Ripple infrastructure complies with the privacy and 
security guidelines of the Health Insurance Portability and Accountability Act (HIPAA), including 2048-bit data 
encryption in transit and at rest, automatic logoff, audit trail, daily backups in triplicate dedicated servers, 
firewall, custom access permission for lab members, zxcvbn password strength estimation, and enterprise 
administrative safeguards to prevent unauthorized staff from accessing participant information. Furthermore, 
Ripple is used only for storing personally identifiable information of participants and is not used to capture 
other research data (e.g., questionnaires, health records, etc.). This ensures that the personally identifiable 
information and research data are segregated. No data electronic data shall be stored on any desktop 
computers, laptop computers, and/or agency computers in order to maintain confidentiality of participant data 
and project data integrity. 
 
All identified study records will be destroyed three years following completion of the study.  
 
Quantitative Survey Data 
The quantitative survey questionnaire development, management, and data entry will be conducted in 
Research Electronic Data Capture (REDCap), which is a secure web application for building and managing 
online surveys and databases. REDCap is provided and managed by UC San Diego Altman Clinical and 
Translational Research Institute (ACTRI). REDCap is available to all UC San Diego faculty and staff, and to 
users outside the organization who have sponsorship from UC San Diego faculty. Tablets and laptops will be 
used for de-identified data and quantitative survey data collection using REDCap. Each study participant will 
have a unique study identifier. No personal information will be recorded in the survey questionnaires. The 
Statistician and the Project Coordinator will be trained to extract and compile quantitative data. The Statistician 
will merge all data warehouses together, reconcile them into a standard version, and export a final data 
warehouse into a SAS dataset. No data electronic data shall be stored on any desktop computers, laptop 
computers, and/or agency computers in order to maintain confidentiality of participant data and project data 
integrity. 
 
17. POTENTIAL BENEFITS 
There may be no benefit to you from participating in this research. Some participants may experience 
improved health as a result of linking to HIV treatment and ancillary support services. The potential benefit to 
others is substantial, in terms of reduced HIV-related morbidity/mortality and HIV infections averted via HIV 
Treatment as Prevention (TasP) methods that could become measurably more effective as a result of this 
research. Although our study is not designed to reduce alcohol or drug use, WLHA who request it will be 
referred to substance abuse treatment services. All participants will be provided with facilitated referrals for 
additional services (e.g., childcare, social services). Study participants may benefit from this study by gaining a 
sense of community and empowerment. Additionally, participants may acquire skills to learn to cope with 

 
 
Biomedical IRB Application Instructions 
Page 22 
interpersonal violence and navigate HIV care and ancillary support service agencies, self-confidence to 
navigate social support networks from other peers utilizing LinkPositively, knowledge from the 
EducatedPositively database (that contains healthy living and self-care tips), and social support from other 
peers utilizing LinkPositively. The study investigators will regularly review the unique risk-benefit ratio for each 
participant, with both global and local considerations in mind. 
 
18. RISK/BENEFIT RATIO 
The PI judges the potential benefits to society (through linking Black WLHA also affected by interpersonal 
violence to HIV treatment needed for decreases in overall HIV incidence, and supporting the deployment of 
coping mechanisms to better attend to the effects of interpersonal violence experiences) to outweigh the risks 
to participants, which have been shown to be effectively manageable through our prior research. 
19. EXPENSE TO PARTICIPANT 
There will be no charge to participants for any of the procedures conducted for the study or at the study office. 
Participants may incur treatment costs if they choose to link to medical care for their HIV diagnosis. Those 
costs will vary depending upon where the participant seeks care and her insurance coverage. For most 
participants, HIV medical care will be available at little-to-no charge through programs offered by MediCaid, 
MediCal, and local Ryan White-funded services. Neither the participant nor anyone else will be billed for 
participation in this research study. 
 
20. COMPENSATION FOR PARTICIPATION 
Participants will receive compensation, once completing each of the following: 
 
Phase 1 (Aim 1): 
• 
Focus Groups ($50) [24-32 participants] 
• 
Key Informant Interviews ($50) [4-6 participants] 
• 
Beta Testing ($50) [8 participants] 
 
Compensation for Phase 1 participants will be $50 total.  
 
Phase 2 (Aim 2):  
• 
Baseline Study Visit ($25) [All participants] 
• 
Follow-Up 1 Study Visit (3 months post-Baseline) ($30) [All participants] 
• 
Follow-Up 2 Study Visit (6 months post-Baseline) ($40) [All participants] 
• 
Completion of all Study Visits ($10) [All participants] 
• 
Hair Sample Collection at Baseline, Follow-up 1, and Follow-up 2 ($25 at each visit) [All participants] 
 
Compensation for Phase 2 participants will be up to $180.  
 
Additionally, we will provide assistance to participants in accessing transportation to study visits in the form of 
a) a public transportation day pass that can be used on local buses and light rail trains throughout San Diego, 
Los Angeles, Alameda, Oklahoma City, or Tulsa County or b) a scheduled ride between a location of the 
participant’s choosing to the study visit location, using rideshare service Lyft Concierge, provided via the 
existing University of California San Diego contract with Lyft Concierge. Should a participant choose to be 
provided with a ride by Lyft Concierge, the reason for the participant’s visit to the study visit location will not be 
disclosed. 
 
21. PRIVILEGES/CERTIFICATIONS/LICENSES AND RESEARCH TEAM RESPONSIBILITIES 
 
Investigators and Consultants 

 
 
Biomedical IRB Application Instructions 
Page 23 
Jamila K. Stockman, PhD, MPH (Multiple Principal Investigator). Dr. Stockman is an infectious disease 
epidemiologist, Associate Professor, and Vice Chief in the Division of Infectious Diseases and Global Public 
Health in the Department of Medicine at the University of California, San Diego. She is also Director of the San 
Diego Center for AIDS Research Disparities Core. For the past 15 years, she has conducted quantitative, 
qualitative, mixed methods, and intervention research on gender-based violence, mental health, substance 
use, and HIV/STIs in Black women in the United States (US), Caribbean, and US-Mexico border region. Dr. 
Stockman’s ethnic minority background has been advantageous to working with Black/African-American 
women in urban cities (e.g., Baltimore, Washington, DC) and Black/African-Caribbean women (e.g. US Virgin 
Islands) through the cultural competence and trust often required in conducting research with such 
populations. Specifically, Dr. Stockman served as co-investigator on the Abuse Status and Health Effects 
among African-Caribbean and African-American Women Study (ACAAWS; #P20MD002286), an NIMHD-
funded study in collaboration between Johns Hopkins University and the University of the Virgin Islands. For 
the ACAAWS, Dr. Stockman created and executed the study design, data collection, analysis, and publication 
of data on the ACAAWS study, which examined health risk behaviors among Black/African-American women 
and Black/African-Caribbean women. Currently, Dr. Stockman serves as principal investigator for The 
ESSENCE Project (#R01HD077891), in collaboration between UC San Diego and Johns Hopkins University to 
evaluate the impact of environmental and physiological factors on the association between sexual violence 
and HIV among Black women in Baltimore, MD. Dr. Stockman has also participated in a number of health 
disparities-focused mentoring programs and completed a NIDA-funded Mentored Scientist Career 
Development Award (#K01DA031593), which provided training in the areas of qualitative, mixed methods, and 
intervention research. Taken together, this training and previous research experience has prepared her for this 
R01 grant proposal. As m-PI of the LinkPositively study, Dr. Stockman will be responsible for managing the 
research budget and timeline, supervising the research team, liaising with the study mPI (Dr. Horvath), co-
investigator (Dr. Tsuyuki) and expert consultants (Dr. Cloitre and Dr. Gandhi), leading team meetings, 
overseeing the field-based research activities and troubleshoot problems occurring on-site, ensuring adequate 
protection of human subjects, overseeing quantitative and biological data collection, overseeing data analysis 
of quantitative data based on survey data, interpreting scientific findings, and disseminating scientific findings 
at local, national and international meetings, as well as in peer-reviewed journals.  
 
Keith J. Horvath, PhD (Multiple Principal Investigator). Dr. Horvath is an Associate Professor in the 
Department of Clinical Psychology at San Diego State University. Dr. Horvath has served as PI and Co-
Investigator on multiple NIH-, CDC-, and foundation-funded grants and has over a decade of experience in 
mHealth intervention research, HIV primary and secondary interventions, and technology use assessment. Dr. 
Horvath currently leads the Thrive with Me (PI: Horvath) and YouTHrive (PI: Horvath & Amico) studies, both of 
which are mobile responsive Web Apps that include peer support, HIV and ART informational content, and 
adherence self-monitoring. He recently was awarded funding from NICHD for TechStep (PI: Horvath & 
Reback), which is a technology-based stepped care intervention to reduce HIV risk behavior and increase 
PrEP uptake among transgender and other gender nonconforming youth. He is currently co-PI of a NIMH-
funded pilot study, called PrEP iT!, to develop and test a mobile app to improve PrEP adherence and 
engagement in PrEP care among young adult MSM taking PrEP (PI: Horvath & Baker). He recently completed 
a NIDA-funded pilot study of a mobile app to improve ART adherence among stimulant-using MSM. 
Preliminary results showed strong feasibility, acceptability and significant improvement on self-reported ART 
adherence and reductions in stimulant use. For these studies, Dr. Horvath has worked closely with the 
technology development team, and therefore is highly experienced in overseeing the development of mHealth 
interventions from conception to the final version used in the RCT. He is experienced in administering projects 
(e.g., staffing, research protections, budget), collaborating with other researchers on multidisciplinary teams, 
and authoring peer-reviewed publications. As mPI of the LinkPositively study, he will attend weekly in-person 
or virtual (using Zoom) meetings with Dr. Stockman to discuss study progress and address any problems as 
they arise. Dr. Horvath will lead the development of the LinkPositively mobile web app, including the 
integration of feedback from women into the UX design of the app, the development of the back-end data 
capture databases, guiding internal testing of the app, creating the usability testing plan and writing the 
usability report, creating the onboarding protocol (i.e., the protocol for how users will be trained on the app) for 
the RCT, and overseeing the monitoring of the app during the RCT. Dr. Horvath will collaboratively work with 

 
 
Biomedical IRB Application Instructions 
Page 24 
Dr. Stockman to ensure that the mobile app is community tailored and responsive, in the conduct and analysis 
of focus groups data, in the development of study instruments, and in analyzing and reporting of data from the 
RCT. 
 
Kiyomi Tsuyuki, PhD, MPH (Co-Investigator). Dr. Tsuyuki is an Assistant Professor in the Division of 
Infectious Diseases and Global Public Health in the Department of Medicine at the University of California, 
San Diego. Dr. Tsuyuki’s research aims to elucidate how social stress and violence victimization cause HPA 
axis dysregulation and disparities in HIV and substance use among racial and ethnic minorities. She was 
awarded an NIAAA Mentored Scientist Career Development Award (#K01AA025009) aimed to integrate HPA 
axis biomarkers with behavioral science research; this research aims to elucidate mechanisms by which social 
stress “gets under the skin” to cause HPA axis dysregulation and enhance susceptibility to substance misuse, 
violence, and HIV among Latinos. Dr. Tsuyuki also has extensive research experience examining the 
association between violence against women and HIV. Specifically, Dr. Tsuyuki is currently Co-I of ESSENCE 
Project (#R01HD077891; PI: Stockman) which is a clinical sample of Black women in Baltimore, MD. Also, she 
was Co-I of a study examining violence and HIV among women in Brazil (World Bank/Sexual Violence 
Research Initiative (PI: Stockman). Dr. Tsuyuki is an emerging investigator with expertise in community-based 
participatory research (CBPR) and over 10 years of health programmatic experience working with women in 
the U.S. and Latin America. She has expertise in socio-structural and syndemic barriers to HIV care 
engagement and outcomes among racial and ethnic minorities in the U.S., including Black women. Dr. Tsuyuki 
is involved in several social network interventions to improve HIV outcomes among marginalized populations 
delivered via mobile phone apps. Dr. Tsuyuki is also an active member of the Community Advisory Board for 
UCSD’s Center of AIDS Research Disparities Core. In this role, she serves as an academic liaison for 
community-based organizations that conduct HIV disparities research. Relevant to the proposed project, Dr. 
Tsuyuki will provide expertise in community-based research, violence, and women living with HIV. Dr. Tsuyuki 
will be responsible for overseeing participant recruitment, assisting in data collection and statistical analyses, 
and the active dissemination of scientific findings via presentations at research conferences and manuscript 
publications. 
 
Sonia Jain, PhD (Co-Investigator). Dr. Jain is a Professor in the Division of Biostatistics & Bioinformatics in 
the Department of Family Medicine and Public Health at UCSD. She earned a Ph.D. in Statistics at the 
University of Toronto in Toronto, Canada and has been at UCSD since 2002. Dr. Jain’s specialty is clinical 
trials, the Bayesian statistical analysis of medical data and developing new methodology to analyze complex 
data. She is currently serving as the lead Biostatistician on several NIH-funded studies in HIV, substance 
abuse, Kawasaki Disease, and was Director of the Biostatistics Core of the DOD-funded INTRuST Consortium 
in PTSD/TBI. She is currently Director of Biostatistics in the Biostatistics and Modeling (BAM) Core for the 
Center for AIDS Research (CFAR) at UCSD and is involved in several HIV research collaborations, including 
serving as the Director of the Biostatistics Core of the CCTG (California Collaborative Treatment Group) 
clinical trial network and the “Preventing Injecting by Modifying Existing Responses” (PRIMER) study. Dr. 
Jain’s serves as a key collaborator in these investigations and works closely in conjunction with the PIs and 
study team on issues related to design, conduct, monitoring, and analysis of the study. Dr. Jain currently 
collaborates with Dr. Stockman on a California HIV/AIDS Research Program funded Enhanced Peer 
Navigation Intervention for Women Living with HIV/AIDS and the ESSENCE Project (#R01HD077891). Her 
statistical lab has biostatistical expertise in the following areas: nonparametric Bayesian statistics, Bayesian 
biostatistical methods, design and analysis of clinical trials and observational studies, statistical genetics and 
genomics, neuroimaging, longitudinal analysis (including mixed effects modeling and generalized estimating 
equations), missing data imputation, time-to-event analysis, analysis of high-dimensional data, computational 
statistics (e.g. Markov chain Monte Carlo techniques), smoothing statistics, etc. Dr. Jain’s lab has extensive 
collaborative experience in areas such as pulmonary disease, HIV/AIDS, substance abuse, infectious 
diseases, 
Alzheimer’s Disease, Stroke, PTSD, TBI, cancer, and radiology. Dr. Jain’s unique experience makes her 
uniquely suited to oversee the statistical and analytical needs of LinkPositively. Relevant to the proposed 
project, Dr. Jain will coordinate the CFAR BAM Core to coordinate randomization, data monitoring and 
analysis for this study. Additionally, the BAM Core under the guidance of Dr. Jain will lead statistical design 

 
 
Biomedical IRB Application Instructions 
Page 25 
and statistical considerations, and will oversee the randomization process, data cleaning and analyses. Lastly, 
the BAM Core will contribute to the interpretation and dissemination of study findings for the proposed 
intervention. 
 
Marylene Cloitre, PhD (Consultant). Dr. Cloitre is Clinical Professor of Psychiatry and Behavioral Sciences 
in the School of Medicine at Stanford University and Associate Director of Research in the Division of 
Dissemination and Training at the National Center for Post-Traumatic Stress Disorder (PTSD) located at the 
Palo Alto VA Health Care Service. For the past 20 years, her research and clinical work has focused on PTSD 
and the long-term effects of trauma on social and emotional functioning. She has received funding from federal 
agencies continuously for the past fifteen years on the assessment and treatment of adolescents and adults 
who have experienced childhood abuse and traumatic loss. Additionally, Dr. Cloitre is the creator of the Skills 
Training in Affect and Interpersonal Regulation STAIR Program, which is an evidence-based cognitive 
behavioral therapy for individuals suffering from chronic and complicated forms of PTSD, as well as for 
individuals with PTSD and co-occurring disorders (i.e., syndemic factors such as substance use and adverse 
mental health). Dr. Cloitre has an ongoing collaboration with Dr. Stockman with the goal of incorporating skills 
training in affect and interpersonal regulation to help women living with HIV. For the proposed project, Dr. 
Cloitre will provide guidance in the development phase of the project as it relates to the intervention 
component 
focusing on helping participants develop skills to cope with trauma and syndemic-related affective distress and 
training of Virtual Peer Navigators in this area. This intervention component will be adapted from Dr. Cloitre’s 
ongoing work in this area. Dr. Cloitre will also provide guidance on the implementation and evaluation phases 
of the intervention. Dr. Cloitre will lend her expertise in the area of interpretation of study findings (working with 
Drs. Stockman and Horvath) and contribute to the preparation of manuscripts.  
 
Monica Gandhi, MD, MPH (Consultant). Dr. Gandhi is a Professor of Medicine and Associate Division Chief 
(Clinical Operations/ Education) of the Division of HIV, Infectious Diseases, and Global Medicine at University 
of California, San Francisco (UCSF). She also serves as the Medical Director of the HIV Clinic ("Ward 86") at 
San Francisco General Hospital. Dr. Gandhi is a leading HIV physician, researcher and Director of the Hair 
Analytical Laboratory (HAL) at UCSF where she has pioneered the use of small hair samples to monitor 
patient antiretroviral (ARV) adherence and exposure. Given the limitations of self-report to monitor adherence, 
our methods to analyze antiretroviral concentrations in small hair samples provide an objective biomarker of 
adherence and exposure to treatment in HIV infected individuals. Dr. Gandhi has found that hair levels of 
ARVs are the strongest independent predictor of treatment outcomes in the context of HIV and have also 
shown a dose-dependent relationship between numbers of doses of ARVs consumed per week and 
concentrations in hair, enabling us to estimate the average level of adherence to ARVs based on hair levels. 
Moreover, Dr. Gandhi has examined the acceptability and feasibility of hair collection in a number of health 
settings and found hair collection and analysis to be highly feasible. Finally, she and her team have found hair 
levels of ARVs to increase pre-and-post adherence interventions in multiple settings. For the proposed project, 
Dr. Gandhi will provide guidance on the appropriate collection methods for the hair samples and training of 
research team staff. UCSF’s HAL, led by Dr. Gandhi, will conduct the assays of antiretroviral concentrations in 
hair samples using sensitive methods employing liquid chromatography/tandem mass spectrometry. Lastly, 
Dr. 
Gandhi will help in the interpretation of the ARV drug concentration data in the analytic phase of the study. 
 
Carla Dillard Smith, MPA (Consultant). Ms. Smith is the Interim Executive Director of Women Organized to 
Respond to Life-threatening Disease (WORLD), a community-based HIV service organization in Oakland, CA. 
Since 1992, an on the ground researcher and public policy guru, Ms. Smith intimately understands the 
challenges facing communities to fully address the epidemic and WORLD’s mission. In her role as Interim 
Executive Director of WORLD, Ms. Smith supports the organization’s commitment to mobilize and sustain a 
comprehensive and inclusive HIV/AIDS support services and advocacy for women in Oakland and the East 
Bay. Prior to joining WORLD, Ms. Smith served as Deputy Director at CAL-PEP, where she oversaw strategic 
partnerships resulting in significant HIV resources in local East Bay communities, helped to launch and 
implement 15 community-based HIV/AIDS prevention and education projects leading to national best practice 

 
 
Biomedical IRB Application Instructions 
Page 26 
models, and doubled as the agency’s Research Director, serving as principal investigator on several 
behavioral research projects, including longitudinal studies, and co-authoring 10 articles recognized as 
evidence based practice. For the proposed project, Ms. Smith will provide her expertise in the trauma-informed 
and peer navigation components of the intervention. Additionally, she will provide guidance in the development 
and implementation of the LinkPositively smartphone web app, be available for routine meetings through the 
duration of the project, as well as participate in the interpretation and dissemination of scientific findings 
related to the pilot intervention. 
 
Additional Research Team 
 
Katherine M. Anderson (Clinical Research Coordinator). Ms. Anderson will serve as the liaison between 
the research team and the technology partners, such as communicating feedback about technical problems 
and functionality of the LinkPositively web app during development. She will also assist with focus group and 
RCT protocol development, and IRB submission. Ms. Anderson will provide feedback on the overall study 
implementation, lead and/or co-lead abstracts and manuscripts submitted for scientific meetings and 
publication, respectively.   
 
Danielle M. Campbell (Doctoral Student). Ms. Campbell is a doctoral student in the UCSD/SDSU Joint 
Doctoral Program (JDP) in Public Health and Site Investigator at Charles R. Drew University of Medicine and 
Science and Guiding Right, Inc.. She will assist with development of the educational tips component of the 
smartphone app, standard operating procedures manual, and baseline and follow-up surveys. Ms. Campbell 
will also assist with reporting activities (e.g., progress reports to NIH and IRB continuing review), active 
monitoring of the intervention during the RCT, conducting periodic data checks during the RCT, data cleaning 
and de-identification, data analysis, and assisting with manuscript preparation and dissemination. 
 
Alexandra Fernandez DeSoto (Research Associate). Ms. Fernandez Desoto is a Bilingual Research 
Associate in the Division of Infectious Diseases and Global Public Health, Department of Medicine at the 
University of California, San Diego. She received her Bachelor’s degree in Public Health at the University of 
California, San Diego in 2018 and is currently enrolled in an MPH degree program at San Diego State 
University. Ms. Fernandez DeSoto will be responsible for administering field work activities including 
participant enrollment, data collection, and tracking study participants. Ms. Fernandez DeSoto will also assist 
with abstract and manuscript preparation and dissemination. 
 
Wanda London (TBN), Virtual Peer Navigator. Ms. London will have a case load of 20 women each at any 
given time. Ms. London has a wealth of experience working with women living with HIV and navigating 
services for women living with HIV/AIDS in community-based organizations and HIV clinics. She has been 
trained by Dr. Cloitre (Consultant) in trauma-informed care. These women will function as Virtual Peer 
Navigators for the project via the mobile application for Black WLHA with lifetime experiences of interpersonal 
violence, with the goal of improving retention in care and adherence to antiretroviral medication. She will 
conduct initial intake assessments with participants enrolled into the intervention arm of the pilot trial. She will 
then provide support to participants through four weekly one-on-one video support sessions designed to build 
coping skills. Each session will last 1 hour. Peer Navigators will be available to participants through text 
messages or calls during and after the 5-week period if they have questions or would like to debrief. She will 
complete CITI training prior to working on the study. 
 
To Be Named (TBN), Virtual Peer Navigator. The Peer Navigator will have a case load of 20 women each at 
any given time. The TBN Virtual Peer Navigator hired for this project will have previous experience serving as 
a Peer Navigator for women living with HIV/AIDS in community-based organizations or HIV clinics and will be 
trained by Dr. Cloitre (Consultant) in trauma-informed care. These women will function as Virtual Peer 
Navigators for the project via the mobile application for Black WLHA with lifetime experiences of interpersonal 
violence, with the goal of improving retention in care and adherence to antiretroviral medication. Specifically, 
she will conduct an initial intake assessment with participants enrolled into the intervention arm of the pilot trial. 
She will then provide support to participants through four weekly one-on-one video support sessions designed 

 
 
Biomedical IRB Application Instructions 
Page 27 
to build coping skills. Each session will last 1 hour. Peer Navigators will be available to participants through 
text messages or calls during and after the 5-week period if they have questions or would like to debrief. The 
Virtual Peer Navigator will complete CITI training prior to working on the study. 
 
22. BIBLIOGRAPHY 
1. Dailey AF, Johnson AS, Wu B. HIV care outcomes among blacks with diagnosed HIV—United States, 
2014. MMWR Morbidity and Mortality Weekly Report. 2017;66(4):97. 
2. Centers for Disease Control and Prevention, Prevention. HIV among African Americans fact sheet. Atlanta: 
Author Retrieved from http://www cdc.gov/nchhstp/newsroom/docs/CDC-HIV-AA-508 pdf. 2014. 
Accessed February 20, 2019. 
3. CDC. HIV Continuum of Care, U.S., 2014, Overall and by Age, Race/Ethnicity, Transmission Route and 
Sex. CDC.  Published 2014. Updated July 27, 2017. Accessed February 15, 2019. 
4. Center for Disease Control and Prevention. HIV Surveillance Report. CDC.  Published 2016. Updated 
February 14, 2018. Accessed February 5, 2018. 
5. County of San Diego. HIV/AIDS Surveillance Program Epidemiology Report, 2016. San Diego County 
Health and Human Services Agency, Public Health Services, Epidemiology & Immunization Services 
Branch, San Diego, CA. 
6. Moore, David. Personal Communication. University of California, San Diego, HIV Neurobehavioral 
Research Program. March 1, 2019. 
7. Breiding MJ, Smith SG, Basile KC, Walters ML, Chen J, Merrick MT. Prevalence and characteristics of 
sexual violence, stalking, and intimate partner violence victimization--national intimate partner and sexual 
violence survey, United States, 2011. MMWR Surveill Summ. 2014;63(8):1-18. 
8. Hien D, Ruglass L. Interpersonal partner violence and women in the United States: an overview of 
prevalence rates, psychiatric correlates and consequences and barriers to help seeking. Int J Law 
Psychiatry. 2009;32(1):48-55. 
9. Basile KC, Smith SG, Fowler DN, Walters ML, Hamburger ME. Sexual Violence Victimization and 
Associations with Health in a Community Sample of African American Women. J Aggress Maltreat 
Trauma. 2016;25(3):231-253. 
10. Campbell JC, Lucea MB, Stockman JK, Draughon JE. Forced sex and HIV risk in violent relationships. 
Am J Reprod Immunol. 2013;69 Suppl 1:41-44. 
11. Stockman JK, Hayashi H, Campbell JC. Intimate Partner Violence and its Health Impact on Ethnic 
Minority Women [corrected]. J Womens Health (Larchmt). 2015;24(1):62-79. 
12. Draughon JE, Lucea MB, Campbell JC, et al. Impact of Intimate Partner Forced Sex on HIV Risk Factors 
in Physically Abused African American and African Caribbean Women. J Immigr Minor Health. 2014. 
13. Cohen MH, Cook JA, Grey D, et al. Medically eligible women who do not use HAART: the importance of 
abuse, drug use, and race. Am J Public Health. 2004;94(7):1147-1151. 
14. Dale S, Cohen M, Weber K, Cruise R, Kelso G, Brody L. Abuse and resilience in relation to HAART 
medication adherence and HIV viral load among women with HIV in the United States. AIDS Patient Care 
and STDs. 2014;28(3):136-143. 
15. Machtinger EL, Wilson TC, Haberer JE, Weiss DS. Psychological trauma and PTSD in HIV-positive 
women: a meta-analysis. AIDS Behav. 2012;16(8):2091-2100. 
16. Illangasekare S, Tello M, Hutton H, et al. Clinical and mental health correlates and risk factors for intimate 
partner violence among HIV-positive women in an inner-city HIV clinic. Women's Health Issues : official 
publication of the Jacobs Institute of Women's Health. 2012;22(6):e563-569. 
17. Machtinger EL, Haberer JE, Wilson TC, Weiss DS. Recent trauma is associated with antiretroviral failure 
and HIV transmission risk behavior among HIV-positive women and female-identified transgenders. AIDS 
Behav. 2012;16(8):2160-2170. 

 
 
Biomedical IRB Application Instructions 
Page 28 
18. Schafer KR, Brant J, Gupta S, et al. Intimate partner violence: a predictor of worse HIV outcomes and 
engagement in care. AIDS Patient Care and STDs. 2012;26(6):356-365. 
19. Meade CS, Hansen NB, Kochman A, Sikkema KJ. Utilization of medical treatments and adherence to 
antiretroviral therapy among HIV-positive adults with histories of childhood sexual abuse. AIDS Patient 
Care and STDs. 2009;23(4):259-266. 
20. Hatcher AM, Smout EM, Turan JM, Christofides N, Stockl H. Intimate partner violence and engagement in 
HIV care and treatment among women: a systematic review and meta-analysis. AIDS (London, England). 
2015;29(16):2183-2194. 
21. Anderson JC, Campbell JC, Glass NE, Decker MR, Perrin N, Farley J. Impact of intimate partner violence 
on clinic attendance, viral suppression and CD4 cell count of women living with HIV in an urban clinic 
setting. AIDS Care. 2018;30(4):399-408. 
22. Cook RL, Zhu F, Belnap BH, et al. Longitudinal trends in hazardous alcohol consumption among women 
with human immunodeficiency virus infection, 1995-2006. American journal of epidemiology. 
2009;169(8):1025-1032. 
23. Cook RL, Zhu F, Belnap BH, et al. Alcohol consumption trajectory patterns in adult women with HIV 
infection. AIDS Behav. 2013;17(5):1705-1712. 
24. Cook JA, Burke-Miller JK, Steigman PJ, et al. Prevalence, Comorbidity, and Correlates of Psychiatric and 
Substance Use Disorders and Associations with HIV Risk Behaviors in a Multisite Cohort of Women 
Living with HIV. AIDS and Behavior. 2018:1-14.  
25. Cook JA, Grey DD, Burke-Miller JK, et al. Illicit drug use, depression and their association with highly 
active antiretroviral therapy in HIV-positive women. Drug and Alcohol Dependence. 2007;89(1):74-81. 
26. Beckett M, Collins R, Burnam M, et al. Mental health and substance abuse issues among people with 
HIV: Lessons from HCSUS. Retrieved March 2019;1:2009. 
27. Blashill AJ, Bedoya CA, Mayer KH, et al. Psychosocial Syndemics are Additively Associated with Worse 
ART Adherence in HIV-Infected Individuals. AIDS Behav. 2015;19(6):981-986. 
28. Kuhns LM, Hotton AL, Garofalo R, et al. An Index of Multiple Psychosocial, Syndemic Conditions Is 
Associated with Antiretroviral Medication Adherence Among HIV-Positive Youth. AIDS Patient Care and 
STDs. 2016;30(4):185-192. 
29. Sullivan KA, Messer LC, Quinlivan EB. Substance abuse, violence, and HIV/AIDS (SAVA) syndemic 
effects on viral suppression among HIV positive women of color. AIDS Patient Care and STDs. 2015;29 
Suppl 1:S42-48. 
30. Geter A, Sutton MY, Hubbard McCree D. Social and structural determinants of HIV treatment and care 
among black women living with HIV infection: a systematic review: 2005-2016. AIDS Care. 
2018;30(4):409-416. 
31. Sangaramoorthy T, Jamison AM, Dyer TV. HIV Stigma, Retention in Care, and Adherence Among Older 
Black Women Living With HIV. The Journal of the Association of Nurses in AIDS Care : JANAC. 
2017;28(4):518-531. 
32. Gaston GB, Alleyne-Green B. The impact of African Americans' beliefs about HIV medical care on 
treatment adherence: a systematic review and recommendations for interventions. AIDS Behav. 
2013;17(1):31-40. 
33. Pellowski JA, Price DM, Allen AM, Eaton LA, Kalichman SC. The differences between medical trust and 
mistrust and their respective influences on medication beliefs and ART adherence among 
AfricanAmericans living with HIV. Psychology & Health. 2017;32(9):1127-1139. 
34. Kalichman SC, Ramachandran B, Catz S. Adherence to combination antiretroviral therapies in HIV 
patients of low health literacy. Journal of General Internal Medicine. 1999;14(5):267-273. 

 
 
Biomedical IRB Application Instructions 
Page 29 
35. Gardner LI, Marks G, Metsch LR, et al. Psychological and behavioral correlates of entering care for HIV 
infection: the Antiretroviral Treatment Access Study (ARTAS). AIDS Patient Care and STDs. 
2007;21(6):418-425. 
36. Knowlton A, Hua W, Latkin C. Social support networks and medical service use among HIV-positive 
injection drug users: implications to intervention. AIDS Care. 2005;17(4):479-492. 
37. Hall BJ, Sou KL, Beanland R, et al. Barriers and Facilitators to Interventions Improving Retention in HIV 
Care: A Qualitative Evidence Meta-Synthesis. AIDS Behav. 2017;21(6):1755-1767. 
38. Bent-Goodley TB. Health disparities and violence against women: why and how cultural and societal 
influences matter. Trauma Violence Abuse. 2007;8(2):90-104. 
39. Jongbloed K, Parmar S, van der Kop M, Spittal PM, Lester RT. Recent Evidence for Emerging Digital 
Technologies to Support Global HIV Engagement in Care. Curr HIV/AIDS Rep. 2015;12(4):451-461. 
40. Bacchus LJ, Bullock L, Sharps P, et al. Infusing Technology Into Perinatal Home Visitation in the United 
States for Women Experiencing Intimate Partner Violence: Exploring the Interpretive Flexibility of an 
mHealth Intervention. J Med Internet Res. 2016;18(11):e302. 
41. Klevens J, Sadowski L, Kee R, Trick W, Garcia D. Comparison of screening and referral strategies for 
exposure to partner violence. Womens Health Issues. 2012;22(1):e45-52. 
42. Glass N, Eden KB, Bloom T, Perrin N. Computerized aid improves safety decision process for survivors of 
intimate partner violence. J Interpers Violence. 2010;25(11):1947-1964. 
43. Tarzia L, Murray E, Humphreys C, et al. I-DECIDE: An Online Intervention Drawing on the Psychosocial 
Readiness Model for Women Experiencing Domestic Violence. Womens Health Issues. 2016;26(2):208-
216. 
44. Koziol-McLain J, Vandal AC, Nada-Raja S, et al. A web-based intervention for abused women: the New 
Zealand isafe randomised controlled trial protocol. BMC Public Health. 2015;15:56. 
45. Pew Center. Internet/broadband fact sheet. Internet, Science & Tech. 2017. 
46. Perrin A. Smartphones help blacks, Hispanics bridge some - but not all - digital gaps with whites. August 
31, 2017. Website: https://www.pewresearch.org/fact-tank/2017/08/31. Accessed March 20, 2019. 
47. Jabour SM, Page A, Hall SF, Rodriguez L, Shields WC, Alvanzo AA. Information and Communication 
Technologies Interest, Access, and Use: Cross-Sectional Survey of a Community Sample of Urban, 
Predominantly Black Women. J Med Internet Res. 2018;20(8):e248. 
48. Muessig KE, Pike EC, Legrand S, Hightow-Weidman LB. Mobile phone applications for the care and 
prevention of HIV and other sexually transmitted diseases: a review. Journal of Medical Internet 
Research. 2013;15(1):e1. 
49. National HIV/AIDS Strategy for the United States –Updated to 2020. 
https://obamawhitehouse.archives.gov/sites/default/files/docs/national_hiv_aids_strategy_update_2020 
.pdf: White House;2015. Accessed February 15, 2019. 
50. Best Practices for Integrating Peer Navigators into HIV Models of Care. 
https://www.aidsunited.org/data/files/Site_18/PeerNav_v8.pdf: AIDS United;2015. 
51. Shacham E, López JD, Brown TM, Tippit K, Ritz A. Enhancing adherence to care in the HIV care 
continuum: the Barrier Elimination and Care Navigation (BEACON) project evaluation. AIDS and 
Behavior. 2018;22(1):258-264. 
52. Cabral HJ, Davis-Plourde K, Sarango M, Fox J, Palmisano J, Rajabiun S. Peer Support and the HIV 
Continuum of Care: Results from a Multi-Site Randomized Clinical Trial in Three Urban Clinics in the 
United States. AIDS Behav. 2018. 
53. Steward WT, Sumitani J, Moran ME, et al. Engaging HIV-positive clients in care: acceptability and 
mechanisms of action of a peer navigation program in South Africa. AIDS Care. 2018;30(3):330-337. 

 
 
Biomedical IRB Application Instructions 
Page 30 
54. Okeke NL, Ostermann J, Thielman NM. Enhancing linkage and retention in HIV care: a review of 
interventions for highly resourced and resource-poor settings. Curr HIV/AIDS Rep. 2014;11(4):376-392. 
55. Higa DH, Marks G, Crepaz N, Liau A, Lyles CM. Interventions to improve retention in HIV primary care: a 
systematic review of U.S. studies. Curr HIV/AIDS Rep. 2012;9(4):313-325. 
56. Cunningham WE, Weiss RE, Nakazono T, et al. Effectiveness of a Peer Navigation Intervention to 
Sustain Viral Suppression Among HIV-Positive Men and Transgender Women Released From Jail: The 
LINK LA Randomized Clinical Trial. JAMA Intern Med. 2018;178(4):542-553. 
57. Cabral HJ, Davis-Plourde K, Sarango M, Fox J, Palmisano J, Rajabiun S. Peer Support and the HIV 
Continuum of Care: Results from a Multi-Site Randomized Clinical Trial in Three Urban Clinics in the 
United States. AIDS Behav. 2018;22(8):2627-2639.  
58. Genberg BL, Shangani S, Sabatino K, et al. Improving Engagement in the HIV Care Cascade: A 
Systematic Review of Interventions Involving People Living with HIV/AIDS as Peers. AIDS Behav. 
2016;20(10):2452-2463. 
59. Horvath KJ, Oakes JM, Rosser BS, et al. Feasibility, acceptability and preliminary efficacy of an online 
peer-to-peer social support ART adherence intervention. AIDS and Behavior. 2013;17(6):2031-2044. 
60. Amico K, Shato, T, Ecklund, A, Horvath, KJ. A qualitative analysis of anonymous posts and comments 
from the Thrive with Me (TWM) ART Adherence Intervention for HIV-positive Men who have Sex with 
Men (MSM) 12th International Conference HIV Treatment and Prevention Adherence; 2017; Miami, FL. 
61. Stockman JK, Falvey E, Saito J. Preliminary findings from pilot phase of EmPower Women. 2018. 
62. Carey-Grant C, Dillard Smith C, and WORLD. HIV Test and Treat Initiative: 2nd CHANCE (Creating a 
Healthy and Nurturing Community Environment). Kaiser Research Foundation;2016. 
 
23. FUNDING SUPPORT FOR THIS STUDY 
Funding for this project is provided by the National Institute of Mental Health (NIMH), R34 MH122014-01.  
 
The fiscal contact for this study is: Kelley Wilson  
lwilson@ucsd.edu or (858) 822-1926. 
 
24. BIOLOGICAL MATERIALS TRANSFER AGREEMENT 
 
We plan to collect hair samples from participants at all study visits. The following steps will be followed for hair 
sample collection: (1) Clean the blades of a pair of scissors with an alcohol pad; (2) Lift up the top layer of hair 
from the occipital region of the scalp. Isolate a small thatch of hair (~100 fibers of hair) from underneath this 
top layer; (3) Cut the small hair sample as close to the scalp as possible. For short or cropped hair, the Project 
Coordinator can let hair fall directly into the piece of tin foil. For braided hair, cut hair thatch from in-between 
braids or dread locks; (4) Keep fingers on the part of the hair that was furthest away from the scalp and put the 
hair sample down on an unfolded piece of tin foil; (5) Put a thin label over the end of the hair sample that was 
furthest away from the scalp; (6) Refold the foil over to completely enclose the hair and place a study ID label 
on the folded piece of foil; (7) Place the folded piece of foil inside the plastic bag and seal the bag.  
 
The hair samples will then be securely mailed to the UCSF Hair Analytical Laboratory, led by Dr. Gandhi, 
where liquid chromatography/tandem mass spectrometry will be used to assess antiretroviral concentrations in 
hair samples over the past 3 months (3cm of hair).  
 
Given the above plan, a biological materials transfer agreement (MTA) will be secured prior to any biological 
sample transfer between UC San Diego and UC San Francisco.     
 
25. INVESTIGATIONAL DRUG FACT SHEET AND IND/IDE HOLDER 
This study does not involve investigational drug(s). 

 
 
Biomedical IRB Application Instructions 
Page 31 
 
26. IMPACT ON STAFF 
This study does not involve nursing, laboratory, pathology, or pharmacy staff from UCSD. 
The Principal Investigator, Co-Investigator, and staff are employees of the UC San Diego Department of 
Medicine. The co-Principal Investigator and staff are employees at the San Diego State University. The 
remaining Co-Investigator and Consultants are faculty at UC San Francisco, Stanford University, and 
leadership at WORLD (non-profit agency) in Oakland, CA. 
 
27. CONFLICT OF INTEREST 
The Principal Investigator, Co-investigators, Consultant, Project Coordinator, and staff do not have any 
conflicts of interest to report. 
28. SUPPLEMENTAL INSTRUCTIONS FOR CANCER-RELATED STUDIES 
This study is not cancer-related. 
 
29. OTHER APPROVALS/REGULATED MATERIALS 
The study does not require additional UCSD approvals or authorizations. 
 
30. PROCEDURES FOR SURROGATE CONSENT AND/OR DECISIONAL CAPACITY ASSESSMENT 
This study does not require Surrogate Consent or Decisional Capacity Assessment. 
 
 

 
 
Biomedical IRB Application Instructions 
Page 32 
Statistical Analysis Plan 
 
The statistical plan includes measuring feasibility of delivering the intervention, the acceptability 
of the LinkPositively intervention, and the impact of the intervention. 
 
Feasibility The first step in assessing feasibility of delivering the intervention was by creating a 
Consort flow diagram tracking screening, eligibility, decision to participate, participation at 
baseline, and participation at 3-month and 6-month follow-ups. The second step in assessing 
feasibility was to compute the percentage of participants at baseline who were retained at 3-
month follow-up and 6-month follow-up, and comparing proportion trends between the 
intervention and control groups. We used the following retention cut-off percentages to assess 
feasibility: a) 90+% = strong feasibility; b) 80-89% = acceptable feasibility; c) 70-79% = modest 
feasibility with a need for improvement; d) <70% = unacceptable. 
 
Acceptability We assessed acceptability of the intervention by asking participants in the 
LinkPositively group about: 1) the quality rating of the program/app, 2) whether or not they 
received the type of program/app they were anticipating, 3) to what extent the program/app met 
their needs, 4) whether or not they would recommend the program/app, 5) level of satisfaction 
with the help received; 6) whether or not the program helped them deal more effectively with 
their problems, 7) level of satisfaction with the program received, and 8) whether or not they 
would seek help from the program/app again.  
 
These measures of acceptability were assessed at both 3-month and 6-month follow-ups. At 
each timepoint, we computed mean scores and standard deviations, as well as median scores 
and interquartile ranges, for all continuous variables. We calculated frequency and percentages 
for all categorical variables. 
  
Intervention Impact To estimate the preliminary effect of the intervention on primary outcomes 
we examined differences by group (intervention vs control) in responses to HIV care outcomes 
over time, ART adherence over time, and mental health outcomes over time. Responses were 
collected at baseline, 3-month follow-up, and 6-month follow-up. Due to the small n’s, we 
calculated median scores and interquartile ranges for all continuous variables, and 
frequency/percentages for categorical variables. These statistics were stratified by group, and 
trends were compared, but significance could not be calculated due to low power.