Project YES! Youth Engaging for Success
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

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.
    

Intervention name(s): Project YES! Youth Engaging for Success
Intervention type(s): Behavioral
Intervention description(s): Participants in the intervention were offered once a month one-on-one meetings and group meetings with their assigned youth peer mentors over approximately six months. The participant's caregiver could also attend up to 3 caregiver support groups held at the clinic (every other month). In addition, intervention participants in the children's hospital were assessed (clinical and psycho social factors) for physical transition to an adult clinic. After midline data collection, the intervention arm went into a maintenance phase, meeting with the youth peer mentor every other month (3 times). Participants in the comparison arm after midline started the Project YES! intervention as described above. Primary analysis was conducted using midline data.
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Adolescents; Young Adults; Antiretroviral Therapy; Caregivers; Support Groups