Self-management of HIV Among Adolescents

NCT05073705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-04-30

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Empowerment and personal transformation intervention

The intervention to be delivered is the Empowerment and Personal Transformation (EPT) intervention. The EPT intervention is 6-session weekly intervention that will be given in groups. A closed group format of at least 8 participants will be used to maximize confidentiality and group cohesion. It involves elements of communication skills, empowerment and mindfulness, values and beliefs, trauma and healing, addresses issues of dependence and independence, and experiential therapy which addresses issues of emotional processing, resolution of conflicts from the past, and creative expression. The EPT intervention is 6-session weekly intervention that will be given in groups. Intervention content will be delivered by a degree level trained counselor at the MRRH HIV clinic following a manual.

Sponsors & Collaborators

  • Mbarara University of Science and Technology

    lead OTHER

Principal Investigators

  • Scholastic Ashaba, MD, PhD · Mbarara University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-19
Primary Completion
2024-03-25
Completion
2024-04-10

Countries

  • Uganda

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05073705 on ClinicalTrials.gov