scholarly journals The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial

10.2196/10791 ◽  
2019 ◽  
Vol 8 (2) ◽  
pp. e10791 ◽  
Author(s):  
Elizabeth Mayfield Arnold ◽  
Dallas Swendeman ◽  
Danielle Harris ◽  
Jasmine Fournier ◽  
Leslie Kozina ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Load ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Youth Living With Hiv ◽  
Living With Hiv

scholarly journals The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Elizabeth Mayfield Arnold ◽  
Dallas Swendeman ◽  
Danielle Harris ◽  
Jasmine Fournier ◽  
Leslie Kozina ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Youth Living With Hiv ◽  
Living With Hiv

BACKGROUND Among youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life. OBJECTIVE This randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected). METHODS YLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will “step up” to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms. RESULTS Recruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020. CONCLUSIONS This is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life. CLINICALTRIAL ClinicalTrials.gov NCT03109431; https://clinicaltrials.gov/ct2/show/NCT03109431 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10791

Evaluation of a telephone-based stepped care intervention for alcohol-related disorders: A randomized controlled trial

2008 ◽  
Vol 93 (3) ◽  
pp. 244-251 ◽  
Author(s):  
Gallus Bischof ◽  
Janina M. Grothues ◽  
Susa Reinhardt ◽  
Christian Meyer ◽  
Ulrich John ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention

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).

scholarly journals Experiences with a violence and mental health safety protocol for a randomized controlled trial to support youth living with HIV

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Katherine G. Merrill ◽  
Jonathan K. Mwansa ◽  
Sam Miti ◽  
Virginia M. Burke ◽  
Elizabeth A. Abrams ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Resource Constraints ◽  
Controlled Trial ◽  
Sub Saharan Africa ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Adherence Support ◽  
Youth Living With Hiv ◽  
Living With Hiv

Abstract Background Safety protocols are an essential component of studies addressing violence and mental health but are rarely described in the published literature from Sub-Saharan Africa. We designed and implemented a safety protocol within Project YES! (Youth Engaging for Success), which enrolled 276 youth living with HIV (ages 15–24 years) in a randomized controlled trial of a peer-mentoring intervention across four HIV clinics in Ndola, Zambia. Methods Youth who reported severe violence and/or suicidal thoughts on research surveys or during meetings with youth peer mentors (YPM) were referred to designated healthcare providers (HCP). We explored experiences with the safety protocol using: a) monitoring data of referrals, and b) in-depth interviews with youth (n = 82), HCP (n = 10), YPM (n = 8), and staff (n = 6). Descriptive statistics were generated and thematic analysis of coded transcripts and written memos performed. Results Nearly half of youth enrolled (48% of females, 41% of males) were referred to a HCP at least once. The first referral was most often for sexual violence (35%) and/or suicidal ideation/depression (29%). All referred youth aged 15–17 years and over 80% of referred youth aged 18 + agreed to see a HCP. HCP referred 15% for additional services outside the clinic. Twenty-nine youth, all HCP, all YPM, and all staff interviewed discussed the safety protocol. Most youth felt “encouraged,” “helped,” “unburdened,” and “relieved” by their meetings with HCP; some expressed concerns about meeting with HCP. The safety protocol helped HCP recognize the need to integrate care for violence and mental health with medication adherence support. HCP, YPM, and study staff raised implementation challenges, including youth choosing not to open up to HCP, time and resource constraints, deficiencies in HCP training, and stigma and cultural norms inhibiting referrals outside the clinic for emotional trauma and mental health. Conclusions Implementing a safety protocol within an HIV clinic-based research study is possible and beneficial for youth and HCP alike. Implementation challenges underscore that HCP in Zambia work in over-stretched healthcare systems. Innovative strategies must address deficiencies in training and resources within HIV clinics and gaps in coordination across services to meet the overwhelming need for violence and mental health services among youth living with HIV.

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