scholarly journals Relationship Between Patient Engagement and Depressive Symptoms Among People Living With HIV in a Mobile Health Intervention: Secondary Analysis of a Randomized Controlled Trial

10.2196/20847 ◽  
2020 ◽  
Vol 8 (10) ◽  
pp. e20847
Author(s):  
Yu Zeng ◽  
Yan Guo ◽  
Linghua Li ◽  
Y Alicia Hong ◽  
Yiran Li ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Health Outcomes ◽  
Patient Engagement ◽  
Repeated Measures ◽  
Controlled Trial ◽  
People Living With Hiv ◽  
Mhealth Intervention ◽  
The Mean ◽  
Living With Hiv ◽  
The Relationship

Background Associations between higher levels of patient engagement and better health outcomes have been found in face-to-face interventions; studies on such associations with mobile health (mHealth) interventions have been limited and the results are inconclusive. Objective The objective of this study is to investigate the relationship between patient engagement in an mHealth intervention and depressive symptoms using repeated measures of both patient engagement and patient outcomes at 4 time points. Methods Data were drawn from a randomized controlled trial (RCT) of an mHealth intervention aimed at reducing depressive symptoms among people living with HIV and elevated depressive symptoms. We examined the association between patient engagement and depressive symptoms in the intervention group (n=150) where participants received an adapted cognitive-behavioral stress management (CBSM) course and physical activity promotion on their WeChat social media app. Depressive symptoms were repeatedly measured using the Patient Health Questionnaire (PHQ-9) at baseline and 1 month, 2 months, and 3 months. Patient engagement was correspondingly measured by the completion rate, frequency of items completed, and time spent on the program at 1 month, 2 months, and 3 months. Latent growth curve models (LGCMs) were used to explore the relationship between patient engagement and depressive symptoms at multiple time points in the intervention. Results The mean PHQ-9 scores were 10.2 (SD 4.5), 7.7 (SD 4.8), 6.5 (SD 4.7), and 6.7 (SD 4.1) at baseline, 1 month, 2 months, and 3 months, respectively. The mean completion rates were 50.6% (SD 31.8%), 51.5% (SD 32.2%), and 50.8% (SD 33.7%) at 1, 2, and 3 months, respectively; the average frequencies of items completed were 18.0 (SD 14.6), 32.6 (SD 24.8), and 47.5 (SD 37.2) at 1, 2, and 3 months, respectively, and the mean times spent on the program were 32.7 (SD 66.7), 65.4 (SD 120.8), and 96.4 (SD 180.4) minutes at 1, 2, and 3 months, respectively. LGCMs showed good model fit and indicated that a higher completion rate (β at 3 months=–2.184, P=.048) and a greater frequency of items completed (β at 3 months=–0.018, P=.04) were associated with fewer depressive symptoms at 3 months. Although not significant, similar trends were found in the abovementioned relationships at 1 and 2 months. There was no significant relationship between time spent on the program and depressive symptoms. Conclusions This study revealed a positive association between patient engagement and health outcomes at 3 months of an mHealth intervention using LGCMs and repeated measures data. The results underscore the importance of improving patient engagement in mHealth interventions to improve patient-centered health outcomes. Trial Registration Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://tinyurl.com/yxb64mef International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5693-1

scholarly journals Relationship Between Patient Engagement and Depressive Symptoms Among People Living With HIV in a Mobile Health Intervention: Secondary Analysis of a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Yu Zeng ◽  
Yan Guo ◽  
Linghua Li ◽  
Y Alicia Hong ◽  
Yiran Li ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Health Outcomes ◽  
Patient Engagement ◽  
Repeated Measures ◽  
Controlled Trial ◽  
People Living With Hiv ◽  
Mhealth Intervention ◽  
The Mean ◽  
Living With Hiv ◽  
The Relationship

BACKGROUND Associations between higher levels of patient engagement and better health outcomes have been found in face-to-face interventions; studies on such associations with mobile health (mHealth) interventions have been limited and the results are inconclusive. OBJECTIVE The objective of this study is to investigate the relationship between patient engagement in an mHealth intervention and depressive symptoms using repeated measures of both patient engagement and patient outcomes at 4 time points. METHODS Data were drawn from a randomized controlled trial (RCT) of an mHealth intervention aimed at reducing depressive symptoms among people living with HIV and elevated depressive symptoms. We examined the association between patient engagement and depressive symptoms in the intervention group (n=150) where participants received an adapted cognitive-behavioral stress management (CBSM) course and physical activity promotion on their WeChat social media app. Depressive symptoms were repeatedly measured using the Patient Health Questionnaire (PHQ-9) at baseline and 1 month, 2 months, and 3 months. Patient engagement was correspondingly measured by the completion rate, frequency of items completed, and time spent on the program at 1 month, 2 months, and 3 months. Latent growth curve models (LGCMs) were used to explore the relationship between patient engagement and depressive symptoms at multiple time points in the intervention. RESULTS The mean PHQ-9 scores were 10.2 (SD 4.5), 7.7 (SD 4.8), 6.5 (SD 4.7), and 6.7 (SD 4.1) at baseline, 1 month, 2 months, and 3 months, respectively. The mean completion rates were 50.6% (SD 31.8%), 51.5% (SD 32.2%), and 50.8% (SD 33.7%) at 1, 2, and 3 months, respectively; the average frequencies of items completed were 18.0 (SD 14.6), 32.6 (SD 24.8), and 47.5 (SD 37.2) at 1, 2, and 3 months, respectively, and the mean times spent on the program were 32.7 (SD 66.7), 65.4 (SD 120.8), and 96.4 (SD 180.4) minutes at 1, 2, and 3 months, respectively. LGCMs showed good model fit and indicated that a higher completion rate (β at 3 months=–2.184, <i>P</i>=.048) and a greater frequency of items completed (β at 3 months=–0.018, <i>P</i>=.04) were associated with fewer depressive symptoms at 3 months. Although not significant, similar trends were found in the abovementioned relationships at 1 and 2 months. There was no significant relationship between time spent on the program and depressive symptoms. CONCLUSIONS This study revealed a positive association between patient engagement and health outcomes at 3 months of an mHealth intervention using LGCMs and repeated measures data. The results underscore the importance of improving patient engagement in mHealth interventions to improve patient-centered health outcomes. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://tinyurl.com/yxb64mef INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-018-5693-1

scholarly journals Dose–Response Effects of Patient Engagement on Health Outcomes in an mHealth Intervention: Secondary Analysis of a Randomized Controlled Trial

10.2196/25586 ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. e25586
Author(s):  
Yiran Li ◽  
Yan Guo ◽  
Y Alicia Hong ◽  
Yu Zeng ◽  
Aliza Monroe-Wise ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Perceived Stress ◽  
Dose Response ◽  
Patient Engagement ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Group Differences ◽  
People Living With Hiv ◽  
Mhealth Intervention

Background The dose–response relationship between patient engagement and long-term intervention effects in mobile health (mHealth) interventions are understudied. Studies exploring long-term and potentially changing relationships between patient engagement and health outcomes in mHealth interventions are needed. Objective This study aims to examine dose–response relationships between patient engagement and 3 psychosocial outcomes in an mHealth intervention, Run4Love, using repeated measurements of outcomes at baseline and 3, 6, and 9 months. Methods This study is a secondary analysis using longitudinal data from the Run4Love trial, a randomized controlled trial with 300 people living with HIV and elevated depressive symptoms to examine the effects of a 3-month mHealth intervention on reducing depressive symptoms and improving quality of life (QOL). We examined the relationships between patient engagement and depressive symptoms, QOL, and perceived stress in the intervention group (N=150) using 4–time-point outcome measurements. Patient engagement was assessed using the completion rate of course assignments and frequency of items completed. Cluster analysis was used to categorize patients into high- and low-engagement groups. Generalized linear mixed effects models were conducted to investigate the dose–response relationships between patient engagement and outcomes. Results The cluster analysis identified 2 clusters that were distinctively different from each other. The first cluster comprised 72 participants with good compliance to the intervention, completing an average of 74% (53/72) of intervention items (IQR 0.22). The second cluster comprised 78 participants with low compliance to the intervention, completing an average of 15% (11/72) of intervention items (IQR 0.23). Results of the generalized linear mixed effects models showed that, compared with the low-engagement group, the high-engagement group had a significant reduction in more depressive symptoms (β=−1.93; P=.008) and perceived stress (β=−1.72; P<.001) and an improved QOL (β=2.41; P=.01) over 9 months. From baseline to 3, 6, and 9 months, the differences in depressive symptoms between the 2 engagement groups were 0.8, 1.6, 2.3, and 3.7 points, respectively, indicating widening between-group differences over time. Similarly, between-group differences in QOL and perceived stress increased over time (group differences in QOL: 0.9, 1.9, 4.7, and 5.1 points, respectively; group differences in the Perceived Stress Scale: 0.9, 1.4, 2.3, and 3.0 points, respectively). Conclusions This study revealed a positive long-term dose–response relationship between patient engagement and 3 psychosocial outcomes among people living with HIV and elevated depressive symptoms in an mHealth intervention over 9 months using 4 time-point repeat measurement data. The high- and low-engagement groups showed significant and widening differences in depressive symptoms, QOL, and perceived stress at the 3-, 6-, and 9-month follow-ups. Future mHealth interventions should improve patient engagement to achieve long-term and sustained intervention effects. Trial Registration Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://www.chictr.org.cn/showproj.aspx?proj=21019

scholarly journals Effect of a WeChat-Based Intervention (Run4Love) on Depressive Symptoms Among People Living With HIV in China: A Randomized Controlled Trial

10.2196/16715 ◽  
2020 ◽  
Vol 22 (2) ◽  
pp. e16715 ◽  
Author(s):  
Yan Guo ◽  
Y Alicia Hong ◽  
Weiping Cai ◽  
Linghua Li ◽  
Yuantao Hao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
People Living With Hiv ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Hair Samples ◽  
Living With Hiv

Background People living with HIV (PLWH) have high rates of depressive symptoms. However, only a few effective mental health interventions exist for this vulnerable population. Objective The aim of this study was to assess the efficacy of a WeChat-based intervention, Run4Love, with a randomized controlled trial among 300 people living with HIV and depression (PLWHD) in China. Methods We recruited PLWH from the HIV outpatient clinic in South China. Participants were screened based on the Center for Epidemiologic Studies-Depression (CES-D) scale. Those who scored 16 or higher were eligible to participate. A total of 300 eligible patients were enrolled. After obtaining informed consent from the participants, completion of a baseline survey, and collection of participants’ hair samples for measuring cortisol, the participants were randomly assigned to an intervention or a control group in a 1:1 ratio. The intervention group received the Run4Love program, delivered via the popular social media app WeChat. Cognitive behavioral stress management courses and weekly reminders of exercise were delivered in a multimedia format. Participants’ progress was monitored with timely and tailored feedback. The control group received usual care and a brochure on nutrition for PLWH. Data were collected at 3, 6, and 9 months. The primary outcome was depression, which was measured by a validated instrument. Results Participants in the intervention and control groups were comparable at baseline; about 91.3% (139/150), 88.3% (132/150), and 86.7% (130/150) participants completed the 3-, 6-, and 9-month follow-ups, respectively. At the 3-month follow-up, a significant reduction in CES-D score was observed in the intervention group (from 23.9 to 17.7 vs from 24.3 to 23.8; mean difference=−5.77, 95% CI −7.82 to −3.71; P<.001; standard effect size d=0.66). The mean changes in CES-D score from baseline to the 6- and 9-month follow-ups between the two groups remained statistically significant. No adverse events were reported. Conclusions The WeChat-based mobile health (mHealth) intervention Run4Love significantly reduced depressive symptoms among PLWHD, and the effect was sustained. An app-based mHealth intervention could provide a feasible therapeutic option for many PLWHD in resource-limited settings. Further research is needed to assess generalizability and cost-effectiveness of this intervention. Trial Registration Chinese Clinical Trial Registry ChiCTR-IPR-17012606; http://www.chictr.org.cn/showproj.aspx?proj=21019 (Archived by WebCite at https://www.webcitation.org/78Bw2vouF)

scholarly journals Dose–Response Effects of Patient Engagement on Health Outcomes in an mHealth Intervention: Secondary Analysis of a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Yiran Li ◽  
Yan Guo ◽  
Y Alicia Hong ◽  
Yu Zeng ◽  
Aliza Monroe-Wise ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Perceived Stress ◽  
Dose Response ◽  
Patient Engagement ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Group Differences ◽  
People Living With Hiv ◽  
Mhealth Intervention

BACKGROUND The dose–response relationship between patient engagement and long-term intervention effects in mobile health (mHealth) interventions are understudied. Studies exploring long-term and potentially changing relationships between patient engagement and health outcomes in mHealth interventions are needed. OBJECTIVE This study aims to examine dose–response relationships between patient engagement and 3 psychosocial outcomes in an mHealth intervention, Run4Love, using repeated measurements of outcomes at baseline and 3, 6, and 9 months. METHODS This study is a secondary analysis using longitudinal data from the Run4Love trial, a randomized controlled trial with 300 people living with HIV and elevated depressive symptoms to examine the effects of a 3-month mHealth intervention on reducing depressive symptoms and improving quality of life (QOL). We examined the relationships between patient engagement and depressive symptoms, QOL, and perceived stress in the intervention group (N=150) using 4–time-point outcome measurements. Patient engagement was assessed using the completion rate of course assignments and frequency of items completed. Cluster analysis was used to categorize patients into high- and low-engagement groups. Generalized linear mixed effects models were conducted to investigate the dose–response relationships between patient engagement and outcomes. RESULTS The cluster analysis identified 2 clusters that were distinctively different from each other. The first cluster comprised 72 participants with good compliance to the intervention, completing an average of 74% (53/72) of intervention items (IQR 0.22). The second cluster comprised 78 participants with low compliance to the intervention, completing an average of 15% (11/72) of intervention items (IQR 0.23). Results of the generalized linear mixed effects models showed that, compared with the low-engagement group, the high-engagement group had a significant reduction in more depressive symptoms (<i>β</i>=−1.93; <i>P</i>=.008) and perceived stress (<i>β</i>=−1.72; <i>P</i>&lt;.001) and an improved QOL (<i>β</i>=2.41; <i>P</i>=.01) over 9 months. From baseline to 3, 6, and 9 months, the differences in depressive symptoms between the 2 engagement groups were 0.8, 1.6, 2.3, and 3.7 points, respectively, indicating widening between-group differences over time. Similarly, between-group differences in QOL and perceived stress increased over time (group differences in QOL: 0.9, 1.9, 4.7, and 5.1 points, respectively; group differences in the Perceived Stress Scale: 0.9, 1.4, 2.3, and 3.0 points, respectively). CONCLUSIONS This study revealed a positive long-term dose–response relationship between patient engagement and 3 psychosocial outcomes among people living with HIV and elevated depressive symptoms in an mHealth intervention over 9 months using 4 time-point repeat measurement data. The high- and low-engagement groups showed significant and widening differences in depressive symptoms, QOL, and perceived stress at the 3-, 6-, and 9-month follow-ups. Future mHealth interventions should improve patient engagement to achieve long-term and sustained intervention effects. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://www.chictr.org.cn/showproj.aspx?proj=21019

scholarly journals Effect of probiotic consumption on increasing the CD4+ T cell counts among Iranian patients living with HIV

2019 ◽  
Vol 34 (2) ◽  
pp. 123-133
Author(s):  
Hamid Emadi-Koochak ◽  
Zeinab Siami ◽  
Jayran zebardast ◽  
SeyedAhmad SeyedAlinaghi ◽  
Ali Asadollahi-Amin
Keyword(s):  
Repeated Measures ◽  
Antiretroviral Drugs ◽  
Cd4 Count ◽  
People Living With Hiv ◽  
Content Type ◽  
Cd4 Counts ◽  
Cell Counts ◽  
Significant Difference ◽  
The Mean ◽  
Living With Hiv

Purpose During the ART era, persistent immune activation remains a significant challenge in people living with HIV (PLWH). Microbial translocation play an essential role in this setting. Probiotics have several immunological benefits which can reverse this process. The purpose of this paper is to investigate the safety and efficacy of probiotics on CD4 counts among Iranian PLWH. Design/methodology/approach In total, 50 PLWH with CD4 counts above 350 cells/mm3 did not receive ART participated in a randomized, double-blind trial and underwent 24 weeks of treatment with either LactoCare® or placebo twice daily. CD4 counts of the patients were measured at baseline, 12 weeks and 24 later in the two groups. Side effects were measured monthly using a specific checklist. Findings The mean CD4 count of the patients showed a significant difference between the two groups after six months. Through six months follow up, the mean CD4 count of the patients showed a significant reduction as compared to the baseline in the placebo group; however, it did not show a significant difference in the probiotic group. Repeated Measures Anova test showed a significant effect for time × treatment interaction on the CD4 count during the trial course. No significant difference between the two groups concerning adverse events was reported. Originality/value It seems the use of probiotics in PLWH with a CD4 count above 350 cells/mm3 who are not receiving antiretroviral drugs is safe and can reduce the devastating process of CD4+ T cells in these patients.

scholarly journals Mechanisms and Effects of a WeChat-Based Intervention on Suicide Among People Living With HIV and Depression: Path Model Analysis of a Randomized Controlled Trial

10.2196/14729 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e14729 ◽  
Author(s):  
Yiran Li ◽  
Yan Guo ◽  
Y Alicia Hong ◽  
Mengting Zhu ◽  
Chengbo Zeng ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Suicide Prevention ◽  
Perceived Stress ◽  
Mediating Effect ◽  
Path Model ◽  
Control Group ◽  
People Living With Hiv ◽  
Mhealth Intervention ◽  
Living With Hiv

Background People living with HIV and depression have high rates of suicide. Studies of mobile health (mHealth) interventions have shown feasibility, acceptability, and efficacy in improving mental health in people living with HIV and depression. However, few studies have examined the mechanisms and effects of mHealth interventions on suicide. Objective This study was designed to examine the mechanisms and effects of a WeChat-based intervention, Run4Love, on suicide among people living with HIV and depression in China, while considering perceived stress and depressive symptoms as mediators. Methods A sample of 300 People living with HIV and depression was recruited from the outpatient clinic of a large HIV or AIDS treatment hospital and was randomized to the Run4Love group or a control group. Data were collected at baseline, 3-, 6-, and 9-month follow-ups. Path analysis modeling, with longitudinal data, was used in data analyses. Results The Run4Love mHealth intervention had a direct effect on reducing suicide rate at the 6-month follow-up (beta=−.18, P=.02) and indirect effect through reducing perceived stress and depressive symptoms at the 3-month follow-up (beta=−.09, P=.001). A partial mediating effect between perceived stress and depressive symptoms accounted for 33% (–0.09/–0.27) of the total effect. Conclusions Through path analyses, we understood the mechanisms and effects of an mHealth intervention on suicide prevention. The findings underscored the importance of stress reduction and depression treatment in such a program. We call for more effective suicide prevention, especially mHealth interventions targeting the vulnerable population of people living with HIV and depression. Trial Registration Chinese Clinical Trial Registry ChiCTR-IPR-17012606; http://www.chictr.org.cn/showprojen.aspx?proj=21019

scholarly journals 1259. Household Income and Its Relationship with Patient-Reported Outcomes Among Older People Living with HIV

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S453-S454
Author(s):  
Peter Mazonson ◽  
Jeff Berko ◽  
Theoren Loo ◽  
Lynsay MacLaren ◽  
Erik S Lowman
Keyword(s):  
Health Outcomes ◽  
Household Income ◽  
Patient Reported Outcomes ◽  
Income Group ◽  
People Living With Hiv ◽  
Annual Household Income ◽  
Patient Reported ◽  
Part Time ◽  
Living With Hiv ◽  
The Relationship

Abstract Background Socioeconomic factors have been identified as a root cause of a wide range of health outcomes. However, there are no studies that describe the impact of these factors on patient-reported outcomes (PROs) among older (age 50+) people living with HIV (PLWH). This study examines the relationship between annual household income, sociodemographic factors, and several PROs among older PLWH. Methods A cross-sectional analysis examined the relationships between self-reported annual household income, sociodemographic information, and validated PROs. Statistical differences within sociodemographic groups were determined using chi-squared tests, and within PROs using bivariate risk ratios. Results Of 922 participants, the median age was 58 years (range: 50–88). The majority of participants were male (89%), gay (79%), and white (70%). Fifty-five percent reported an annual household income of less than $50,000 per year and 45% reported a household income of $50,000 or greater. Among people in the lower-income group, 33% were working full or part time, 24% were retired, and 43% were disabled, whereas among people in the higher income group, 76% were working full or part time, 19% were retired, and 5% were disabled (Table 1). Bivariate analysis showed that while there was not a significant relationship between age and income, income was significantly associated with work status, race, gender, education, relationship status, sexual orientation, and having enough money to meet basic needs. People with lower household income were significantly more likely to be depressed, anxious, and lonely, and to have 4 or more comorbid conditions (Table 2). They were also less likely to have high resilience, high social well-being, and high quality of life. Conclusion To the best of our knowledge, this is the first examination of the relationship between self-reported annual household income and PROs among older PLWH. In these bivariate analyses, income was positively associated with desirable PROs, and negatively associated with undesirable PROs. To be successful, programs designed to improve health outcomes for older PLWH must take into account the economic challenges faced by many in this group. Disclosures All authors: No reported disclosures.

scholarly journals Drug Use Mediates the Relationship Between Depressive Symptoms and Adherence to ART Among Recently Incarcerated People Living with HIV

2018 ◽  
Vol 23 (8) ◽  
pp. 2037-2047 ◽  
Author(s):  
Lauren M. Hill ◽  
Carol E. Golin ◽  
Nisha C. Gottfredson ◽  
Brian W. Pence ◽  
Bethany DiPrete ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Drug Use ◽  
People Living With Hiv ◽  
Living With Hiv ◽  
The Relationship

scholarly journals Protocol of a randomized controlled trial to test the effects of client-centered Representative Payee Services on antiretroviral therapy adherence among marginalized people living with HIV

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Abisola Olaniyan ◽  
Stephanie L. Creasy ◽  
D. Scott Batey ◽  
Maria Mori Brooks ◽  
Catherine Maulsby ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Load ◽  
Antiretroviral Therapy ◽  
Health Outcomes ◽  
Controlled Trial ◽  
People Living With Hiv ◽  
Randomized Controlled ◽  
Antiretroviral Therapy Adherence ◽  
Living With Hiv ◽  
Representative Payee

Abstract Background Client-Centered Representative Payee (CCRP) is an intervention modifying implementation of a current policy of the US Social Security Administration, which appoints organizations to serve as financial payees on behalf of vulnerable individuals receiving Social Security benefits. By ensuring beneficiaries’ bills are paid while supporting their self-determination, this structural intervention may mitigate the effects of economic disadvantage to improve housing and financial stability, enabling self-efficacy for health outcomes and improved antiretroviral therapy adherence. This randomized controlled trial will test the impact of CCRP on marginalized people living with HIV (PLWH). We hypothesize that helping participants to pay their rent and other bills on time will improve housing stability and decrease financial stress. Methods PLWH (n = 160) receiving services at community-based organizations will be randomly assigned to the CCRP intervention or the standard of care for 12 months. Fifty additional participants will be enrolled into a non-randomized (“choice”) study allowing participant selection of the CCRP intervention or control. The primary outcome is HIV medication adherence, assessed via the CASE adherence index, viral load, and CD4 counts. Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months. Viral load, CD4, and appointment adherence data will be collected at baseline, 6, 12, 18, and 24 months from medical records. Outcomes will be compared by treatment group in the randomized trial, in the non-randomized cohort, and in the combined cohort. Qualitative data will be collected from study participants, eligible non-participants, and providers to explore underlying mechanisms of adherence, subjective responses to the intervention, and implementation barriers and facilitators. Discussion The aim of this study is to determine if CCRP improves health outcomes for vulnerable PLWH. Study outcomes may provide information about supports needed to help economically fragile PLWH improve health outcomes and ultimately improve HIV health disparities. In addition, findings may help to refine service delivery including the provision of representative payee to this often-marginalized population. This protocol was prospectively registered on May 22, 2018 with ClinicalTrials.gov (NCT03561103).

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