Self-management of HIV Among Adolescents

NCT05073705 | Completed

• 1 other identifier: MUST-2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

HIV

Keywords

Transition readiness; self-management; retention in care; ART adherence; Adolescents

Outcome Measures

Primary Outcomes (1)

• Mean adherence

  Treatment adherence based on unannounced pill counts. Pill count adherence will be calculated as (the number of pills dispensed) minus (number of pills counted) divided by (the number of pills expected to be taken) in the previous month.

  6 months

Secondary Outcomes (1)

• Mean transition readiness score

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

Control condition: The control condition will be standard of care. This will include regular review in the clinic for medical refills and adherence counseling that will be given in the clinic as required and determined by the attending clinicians and the counselors in the HIV clinic. The clinic visits will be guided by the clinical status, availability of school programs, distance from the clinic, and ability to afford transport fare to the clinic.

Empowerment and personal transformation intervention

EXPERIMENTAL

Intervention/Treatment: 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.

Behavioral: Empowerment and personal transformation intervention

Interventions

Empowerment and personal transformation intervention BEHAVIORAL

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.

Empowerment and personal transformation intervention

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Has not been fully disclosed to them
• Not physically strong enough (due to physical illness) to remain present for the duration of the interview
• Have difficulty fully understanding the interview questions due to cognitive impairments

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

Study Officials

• Scholastic Ashaba, MD, PhD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention condition. The empowerment and personal transformation (EPT) intervention Control condition. The control condition will be standard of care. At the MRRH HIV clinic, ALHIV are identified for the transition to adult HIV care after careful consideration of factors that are individual specific. Under current standard of care, clinic visits are guided by a number of factors including the patient's age, clinical status, availability of school programs, distance from the clinic, and ability to afford transport fare to the clinic. Randomization. Experimental procedures will be registered with ClinicalTrials.gov. Participants will be allocated to the treatment vs. control conditions in equal proportions in a parallel group design in which treatment assignment will be determined centrally using a computerized random number generator. Randomization will be stratified by age (15-19 vs 20-24 years) and gender (male vs female).

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 11, 2021
• Study Start: August 19, 2023
• Primary Completion: March 25, 2024
• Study Completion: April 10, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

UG (1)