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NCT05073705Completed

Self-management of HIV Among Adolescents

Self Management Among Adolescents Living With HIV in Uganda

Source: ClinicalTrials.gov · Last updated 30 Apr 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
80 (actual)
First submitted
22 Sept 2021
Start date
19 Aug 2023
Primary completion date
25 Mar 2024
Lead sponsor
Mbarara University of Science and Technology
Diseases
HIV
NCT number
NCT05073705

What you commit to

  • Study type: Interventional
  • Participants enrolled: 80
  • From 19 Aug 2023 to the primary completion date, 25 Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Not physically strong enough (due to physical illness) to remain present for the duration of the interview

Other

  • Has not been fully disclosed to them
  • Have difficulty fully understanding the interview questions due to cognitive impairments

Who the study is looking for

  • Should be aged15-24 years
  • Fully disclosed of their HIV status
  • live within 60 km of the clinic
  • be able to provide assent or informed consent.

Age in the registry: 15 years to 24 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mbarara Regional Referral Hospital
Coordinator of this site? Confirm its status
MbararaUgandaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.