Clinical trial NCT04115813: Project YES! Youth Engaging for Success
Official title: Transitioning Adolescents to HIV Self-Management in Zambia (Known as: Project YES: Youth Engaging for Success)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Adolescents
Young Adults
Antiretroviral Therapy
Caregivers
Support Groups
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Population Council
name: Arthur Davison Children's Hospital
First posted: 2019-10-04
Enrollment: 276
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After about 6 months and the completion of the initial intervention the intervention arm went into a less intensive maintenance phase and the comparison arm started to receive the intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Youth-led strategies remain untested in clinic-based programs to achieve viral suppression (VS) and reduce self-stigma (feelings of worthlessness/shame) among adolescents and young adults (AYA) living with HIV in sub-Saharan Africa. In response, Project YES! will conduct a randomized controlled trial to test the impact of a theory-based intervention that places trained and paid HIV-positive youth peer mentors (YPMs) in four HIV clinics in Ndola, Zambia. AYA, ages 15 to 24 years, will be randomly assigned to either an intervention arm, consisting of monthly one-on-one and small group sessions with a YPM and optional caregiver support groups, or a usual care arm. Survey data and blood samples will be collected and analyzed to test the hypothesis that youth who are in the intervention group will experience more viral suppression than youth in the comparison group.

Detailed description: BACKGROUND/INTRODUCTION While the literature on pediatric chronic illnesses often emphasizes the needs of adolescents transitioning from pediatric to adult care, there is no published literature on interventions to support HIV-positive adolescents transitioning to adult care and/or HIV self-management in sub-Saharan Africa (SSA). Similarly, there is virtually no data on how to best engage families and peers to support youth (YLHIV) with their care needs in SSA, despite the known impact families and peers have on adolescent health. For example, a 2015 review found only 14 studies on adolescents living with HIV (ALHIV) transitioning to adult care, all of which were conducted in the US or UK and the majority of which were qualitative studies with sample sizes of 50 participants or fewer. A 2016 systematic review examined the literature to assess the effectiveness of self-management interventions for young people across chronic illnesses. Out of 42 randomized controlled trials included in the review, none were conducted in SSA. The authors note that most interventions focused on the medical aspects of self-management rather than psycho-social issues. The authors also discuss the potential role for online peer support. These findings correspond with other articles that define three specific aspects of self-management: medical management (e.g., treatment adherence), role management (e.g., social participation), and emotional or identity management (e.g., feelings, stigma).

Despite this lack of evidence on how to support youth, the need remains great. Preliminary analysis of routine viral load (VL) testing conducted among ALHIV clinic attendees at the Arthur Davison Children's Hospital (ADCH) in Ndola, Zambia revealed that around 50% of ALHIV have viral failure defined as 1000 copies/ml or higher. This staggering percentage underscores the urgent need for assistance with care for this population.

This study will address this gap by testing a peer-mentoring program to implement the AIDS Support \& Technical Assistance Resources (AIDSTAR-One) toolkit for transition (https://aidsfree.usaid.gov/sites/default/files/final_alhivtoolkit_web.pdf). AIDSTAR-One developed this toolkit as a resource for health care providers to support youth transitioning to HIV self-management as well as their caregivers. The current version, released in 2014, includes a transition readiness checklist designed for health care providers to monitor an adolescent's ability to self-manage his/her HIV. The toolkit also has corresponding modules that cover 10 subject areas deemed critical for youth's successful HIV self-management, including psychosocial development, mental health, sexual and reproductive health, alcohol and substance abuse, beneficial disclosure and clinical considerations.

While there have been no large scale implementations of this toolkit, the initial version was piloted in Kenya in 2012 "to inform final adaptations prior to dissemination" A survey conducted among 17 health care and community care providers in Kenya who were trained on the AIDSTAR-One toolkit, found that a majority were satisfied with the kit. A key concern expressed, however, was the time needed to implement the toolkit approach in settings where providers are overburdened. A subsequent key recommendation made by providers during this pilot evaluation was to expand the use of the toolkit to community-based providers, including specifically peer counselors or mentors. Peer mentors, especially those who are trained well and given paid positions, have been effective in other settings, such as the Mothers to Mothers program in South Africa r the Restless Development program in Zambia. In South Africa, paid mentors who are mothers themselves and had undergone prevention of mother to child HIV transmission (PMTCT) learned concrete employable skills and were integrated into the health care system to mentor women undergoing PMTCT. In Zambia, a youth intervention was conducted that placed young adults (18 to 24 years) in government schools to teach a Ministry of Education life skills course. Again, these youth mentors were paid, well trained, and given a position within the system. Results from an evaluation found that students in the schools with youth mentors had more HIV and reproductive health knowledge, and lower levels of stigma and sexual risk-taking behaviors, than their peers in schools without youth mentors. In this study, peer mentors will be integrated into the health care system to implement the toolkit.

This study will further explore the potential integration of violence-related content into the intervention. Despite limited existing literature on violence victimization among HIV-positive youth in SSA, studies among adults in SSA and elsewhere have documented negative impacts of violence victimization on HIV disclosure, linkage to care, and engagement and retention in care. A deeper understanding is needed of the types of violence experienced by youth, the influence of such violence on youth's HIV care and treatment, and the potential role of the adapted AIDSTAR-One toolkit for transition in addressing such violence.

STUDY GOAL AND AIMS

The overall goal of this study is to test a peer-mentoring approach to implementing the AIDSTAR-One toolkit to improve HIV-related outcomes, including viral suppression, among youth as they transition to, and engage in, self-management and adult HIV care and treatment. The specific aims of the study are to:

AIM 1) Assess the impact of a peer mentoring approach to implementing the AIDSTAR-One toolkit on viral suppression and other HIV-related outcomes such as retention in care and adherence to combination antiretroviral therapy (cART), among transitioning youth in different care facility settings (e.g., pediatric hospital, adult hospital, and primary care facilities). Hypothesis: Youth in the intervention arm will experience greater HIV viral suppression at the end of six months of the intervention than youth in the comparison arm.

AIM 1a) Conduct a stratified analysis to examine the impact of a peer mentoring approach separately among: a) the 144 youth participants (15-24) transitioning out of an adolescent clinic into an adult clinic; and b) among 144 youth participants (15-24) who are already attending adult care. This will be a sub-analysis of the larger study to determine the effects of the intervention among these two distinct groups of adolescents and youth.

AIM 2) Examine the experiences of youth and their families, health care providers, peer mentors, and study staff with the peer-mentoring/toolkit program: This objective will be achieved by conducting about 80 qualitative in-depth interviews (IDIs) with the youth participants, as well as about 30 IDIs with their family caregivers. The study team will also interview the health care providers and peer mentors involved in implementing the program, estimated to be around 10 and 12 people respectively. The interviewers will further interview study staff involved in implementing the referral process established for the study (see Section 7.4), estimated to be around 6 people. Out of the 80 youth who will be interviewed, half will be sampled on viral load (VL) test results (e.g. have VL failure at baseline and suppression at midline) and half will be sampled based on VL test results and varying experiences of violence. Interviews with the youth, caregivers, healthcare providers, and peer mentors will provide data on the positive and negative experiences these four groups had with the intervention and the mechanisms believed to support or hinder adolescents' viral suppression. By sampling half of the youth specifically on violence experiences, the study team will also investigate how youth's experiences of violence victimization may relate to their HIV self-management and how the intervention has helped youth deal with these violent experiences, including through the referral procedures established for the study. Interviews with the study staff will offer additional insight into the effectiveness of the referral procedures put in place to support youth with experiences of violence victimization, mental health issues, and other concerns about their wellbeing. These data will contextualize the quantitative data findings and ultimately inform and strengthen the intervention approach.

STUDY DESIGN The study is a randomized controlled trial (RCT) at the individual level. The study team will test a six-month peer-mentoring program among 144 YLHIV in an intervention arm compared to 144 YLHIV in a comparison arm. Participants for the RCT will be consecutively selected from two hospitals -- Arthur Davison Children's Hospital (ADCH) and Ndola Teaching Hospital (NTH) - and two primary care clinics (PCCs) - Twapia Clinic and Lubuto Clinic. The participating facilities were purposively selected because they represent different models of care. ADCH is a hospital for children and serves older youth who should ultimately transition to adult care. In contrast, NTH and the two primary care clinics are essentially adult HIV care settings. While they were not designed to initially serve HIV positive adolescents, they continue to experience a growth in the number of enrolled adolescents. The PCCs were purposively selected based on their high ALHIV patient populations, designated ART center status, and proximity to other study sites.

After the completion of the initial 6-month intervention and the subsequent 6-month follow-up assessment among participants in both arms, the primary intervention group will enter a maintenance phase and the comparison group will receive the intervention for six months. Assessments, including a survey and a blood draw for VL testing, will occur at baseline, at the end of the first six months, and at the end of 12 months. Resistance testing will also be conducted at baseline for those participants who have a VL failure, defined as 1000 copies/ml or higher. Resistance testing is critical for this study as the primary outcome is viral suppression, something that will not occur if a participant has a resistant strain and is not on the correct treatment, no matter how adherent s/he may be. Routine VL results from among ADCH patients reveals that approximately 50% of adolescents have VL failure. Based on that data, it was estimated that 50% of the 288 participants in this research (n=144) will have VL failure and need resistance testing.

At the end of the initial 6-month intervention, study team members will begin conducting qualitative in-depth interviews with participants, their caregivers when possible, and the health care providers, peer mentors, and study staff involved in delivering the program. These data will provide contextual details and experiences to help interpret the study findings and determine what aspects of the intervention were valued.

Eligibility criteria: Inclusion Criteria:

* In the age range of 15-24 years
* Aware of her/his HIV status
* On cART for at least six months
* Speaks Bemba or English
* Not planning to move out of the district in the next 18 months
* Planning to be available to attend study activities over the next 18-months, as needed

Exclusion Criteria:

* Being too sick to participate
* Attending boarding school
* Having a sibling already enrolled in the study (one youth per household)
* Having participated in the recent NIH-funded R34 Positive Connections intervention

Primary outcomes:
measure: Proportion of Participants with Viral Suppression (<1000 copies/mL) at Baseline and Midline
timeFrame: ~ 6 months (from baseline to midline)
Secondary outcomes:
measure: Proportion of Participants with Internalized Stigma (binary, yes to two out of three questions) at baseline and midline.
timeFrame: ~ 6 months (from baseline to midline)
measure: Proportion of Participants with Antiretroviral Adherence Treatment Gap at baseline and midline
timeFrame: ~ 6 months (from baseline to midline)
Other outcomes:
Locations:
city: Ndola
country: Zambia
facility: Arthur Davison Children's Hospital
state: Copperbelt Province
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Julie A Denison, PhD
role: PRINCIPAL_INVESTIGATOR
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