Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05073705 |
| Other study ID # |
MUST-2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 19, 2023 |
| Est. completion date |
April 10, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Mbarara University of Science and Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There are over 73,000 adolescents living with HIV (ALHIV) in Uganda constituting 4% of the
worldwide population of ALHIV. HIV remains a leading cause of death among adolescents despite
widespread availability of antiretroviral medication. Generally, ALHIV have poor outcomes
with higher rates of loss to follow up compared with other age groups. Mortality rates and
loss to follow up are highest during the transition period. Transition success may be
maximized for ALHIV who are better prepared to negotiate care in adult HIV clinic settings.
This study proposes to develop a self-management intervention for ALHIV transitioning to
adult HIV care and test the impacts of the intervention on HIV outcomes. Conducting the
proposed studies in this application will complement my prior training in psychiatry while
filling key gaps in three areas: (a) behavioral science theories and their application to
behavioral interventions, (b) adaptation and design of behavioral interventions, and (c)
testing of behavioral interventions through randomized trials. To fill these gaps, the
investigators will conduct qualitative research to elaborate a conceptual framework of the
barriers faced by ALHIV transitioning to adult HIV care in Uganda (Aim 1), develop a
self-management intervention that will enable ALHIV to successfully transition to adult HIV
care (Aim 2), and assess feasibility, acceptability, and preliminary effects of the
self-management intervention on HIV outcomes for ALHIV transitioning to adult HIV care (Aim
3). This study will be the first to develop a self-management intervention targeting the
critical transition period from pediatric to adult HIV care in sub-Saharan Africa and the
first to use a randomized design to test the effect of a self-management intervention on
health outcomes among ALHIV in Uganda who are transitioning to adult HIV care. These findings
will have significant public health impact by optimizing health outcomes for a key population
in the global HIV epidemic. The proposed research will serve as the basis for a competitive
R01 grant proposal, submitted in year 4, to conduct a fully-powered, randomized controlled
trial to evaluate the effectiveness of a behavioral intervention to improve retention in care
and viral suppression among ALHIV in Uganda who are navigating the critical period of
transition to adult HIV care.
Description:
HIV is a leading cause of mortality among adolescents living with HIV (ALHIV) in sub-Saharan
Africa. Mortality among ALHIV is attributed to disengagement from care and poor adherence to
HIV medications . Rates of retention in care and adherence to ART are lowest among ALHIV
compared to other age groups. The risks of disengagement from care, being lost to follow up,
and mortality rates are highest during the transition from pediatric to adult HIV care.
2. Upon reaching adulthood, ALHIV should be transitioned to adult HIV care for age- and
developmentally-appropriate medical care to maximize long term functioning . Perinatally
infected ALHIV are dependent on pediatric HIV care providers and oftentimes family members,
but will need to become self-reliant and manage their own health as they get older. However,
ALHIV are often reluctant to transition to adult HIV care due to anticipated stigma, fear of
disclosure, and/or lack of self-efficacy to assume responsibility for their own HIV care. Due
to the challenges faced by ALHIV they need assistance with social and psychological skills to
enable them to assume responsibilities related to their HIV care.
3. ALHIV lack the necessary skills to negotiate care in adult HIV care settings. The majority
of adolescents and young adults with chronic conditions do not have the necessary skills to
negotiate their own care by the time they are transitioned to adult care. Myriad physical,
psychological and social challenges that are characteristic of adolescence compounded by the
need for peer acceptance and HIV stigma further complicate the adolescents' ability to cope
with and manage HIV illness, thereby threatening their ability to advocate for themselves and
seek care. In general, adolescents facing the transition to adult care may attain better
health outcomes if they are prepared to negotiate care in adult clinic settings . Thus, there
is need for developmentally tailored interventions to help ALHIV obtain the skills they need
to successfully transition to adult HIV care.
4. Self-management interventions have potential to facilitate successful transition to adult
HIV care and also improve HIV outcomes. Self-management refers to the context and processes
through which individuals and families use condition-specific knowledge, beliefs, and skills
to achieve optimal health outcomes and health related quality of life. Self-management
interventions are aimed at helping adolescents develop the skills and behaviors they need to
transition to adulthood and independent living despite their chronic condition. Through
self-management programs individuals gain information and skills related to their disease to
increase self-efficacy and enable them to function independent of their parents and health
care providers. Successful implementation of self-management programs has been linked to
improved health outcomes while lack of self-management among individuals with chronic illness
has been associated with increased mortality and decreased quality of life. Self-management
interventions for HIV have been reported to have a positive impact on different aspects of
HIV treatment outcomes including physical, psychological, and behavioral health outcomes .
However, currently majority of the available self-management interventions were developed in
high-income countries for other chronic conditions like spina bifida and diabetes and may not
be appropriate for use among ALHIV. The few self-management interventions specific to HIV
were developed for HIV-positive adults and may not be developmentally suited for ALHIV.
Moreover, most HIV clinics in sub-Saharan Africa focus primarily on provision of medical
services, with minimal or no attention paid to the social and psychological challenges of
managing HIV as a chronic illness.
The study proposes to achieve the following aims:
Aim 1: Use qualitative research to develop a conceptual framework of the barriers faced by
ALHIV transitioning to adult HIV care in Uganda. The investigators will conduct in-depth
qualitative interviews with a purposive sample of ALHIV before adult HIV care transition
(n=15) and after transition (including both those lost to follow-up and those successfully
retained in care; n=15), caregivers (n=20), and healthcare providers (n=10). Interviews will
focus on barriers to successful transition and potential facilitators and interventions.
Aim 2: Develop a self-management intervention that will enable ALHIV to successfully
transition to adult HIV care. The initial content of the intervention will be based on the
qualitative data from Aim 1. Based on my preliminary data and existing research, the
investigators anticipate that the intervention will include 6 weekly sessions and involve
elements of psychoeducation, cognitive behavioral strategies, self-efficacy training, problem
solving, and resilience strengthening. Final intervention content will be refined in focus
group discussions with ALHIV (n=10), caregivers (n=10), and health care providers (n=10).
Aim 3: Assess feasibility, acceptability, and preliminary effects of the self-management
intervention on HIV outcomes for ALHIV transitioning to adult HIV care. The investigators
will conduct a pilot randomized controlled trial with 80 ALHIV who will have been identified
by their pediatric providers for transition to adult HIV care; 40 will be randomly assigned
to the self-management intervention and 40 will be assigned to standard of care. Outcomes
will be assessed at pre-intervention baseline, at 6 weeks (immediately post-intervention),
and at 6 months post-intervention follow-up. The primary outcomes will be treatment adherence
(based on pharmacy refill, pill count, and self-report), engagement in care, and adherence
self-efficacy. Secondary outcomes will include acceptability and feasibility of the
intervention, internalized/anticipated HIV stigma, depression, problem solving skills,
quality of life, viral load suppression, and retention in care.
