NCT04946071

Brief Summary

Over 2.6 million children aged 0-15 years are living with HIV globally, with the majority living in low and middle income countries in sub-Saharan Africa. Addressing stigma associated with HIV is key given the significant harm that may be experienced in the form of negative health and social outcomes, reduced access to HIV prevention services, and increased vulnerability to infection. This stepped-wedge, cluster randomized trial with assess the impact of an arts-based HIV stigma intervention on knowledge and attitudes towards children who are HIV+ and - affected; enacted, internalized, anticipated, courtesy, and perceived stigma (primary outcomes); HIV testing frequency among sexually active participants; linkage to care, antiretroviral therapy (ART) initiation and adherence among HIV+ participants; and viral suppression among HIV+ participants (secondary outcomes) of children aged 10+ years in Omoro District, Uganda, post-intervention and 5-months post-intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

2.6 years

First QC Date

May 28, 2021

Last Update Submit

November 19, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change from baseline and between time points in enacted, anticipated and internalized stigma towards HIV+ students

    measured using the Adolescents Living with HIV - Stigma Scale. The scale comprises of 10 items and will be administered by a member of the research team.

    post-intervention (8 weeks), post-intervention (16 weeks), post-intervention (24 weeks), 5 months post-intervention.

  • Change from baseline and between time points in courtesy stigma towards HIV+ students

    measured using the Brief Stigma by Association Scale in HIV-affected students. The scale comprises of 10 items and will be administered by a member of the research team.

    post-intervention (8 weeks), post-intervention (16 weeks), post-intervention (24 weeks), 5 months post-intervention.

  • Change from baseline and between time points in perceived stigma

    measured using the Stewart's 10-item subscale on felt-normative stigma towards people living with HIV. The scale will be administered by a member of the research team.

    Baseline (0 weeks), post-intervention (8 weeks), post-intervention (16 weeks), post-intervention (24 weeks), 5 months post-intervention.

  • Change from baseline and between time points in HIV knowledge

    measured using questionnaire on HIV knowledge. Questionnaire will be administered by a member of the research team.

    Baseline (0 weeks), post-intervention (8 weeks), post-intervention (16 weeks), post-intervention (24 weeks), 5 months post-intervention.

  • Change from baseline and between time points for fear of HIV transmission and disease

    measured using questionnaire on fear of HIV transmission and disease. Questionnaire will be administered by a member of the research team.

    Baseline (0 weeks), post-intervention (8 weeks), post-intervention (16 weeks), post-intervention (24 weeks), 5 months post-intervention.

Secondary Outcomes (5)

  • HIV testing frequency among sexually active participants

    Baseline (0 weeks), post-intervention (8 weeks), post-intervention (16 weeks), post-intervention (24 weeks), 5 months post-intervention.

  • Initiation of linkage to care among HIV+ participants

    Baseline (0 weeks), post-intervention (8 weeks), post-intervention (16 weeks), post-intervention (24 weeks), 5 months post-intervention.

  • ART initiation among HIV+ participants

    Baseline (0 weeks), post-intervention (8 weeks), post-intervention (16 weeks), post-intervention (24 weeks), 5 months post-intervention.

  • Change from baseline and between time points in viral suppression among HIV+ participants

    post-intervention (8 weeks), post-intervention (16 weeks), post-intervention (24 weeks), 5 months post-intervention.

  • Change from baseline and between time points in ART adherence

    post-intervention (8 weeks), post-intervention (16 weeks), post-intervention (24 weeks), 5 months post-intervention.

Study Arms (4)

Control

NO INTERVENTION

Period in which each group will not receive the arts-based HIV stigma intervention.

Group 1

EXPERIMENTAL

Arts-based HIV stigma intervention for three 8-week periods (24 weeks). The intervention will begin with 5 weeks of two 2 interrelated activities: 1) Transformative educational activities that will engage learners in problem-based discussions; 2) Arts-based activities that will focus on addressing the "problem" through finding "solutions" and encouraging action will be accomplished by learning traditional Ugandan songs, dance, told and acted stories, proverbs and sayings that incorporate empowering messages and moral teachings connected with self and community, respect for self, peers and authority, and responsibility for others. These activities will be followed by 3 weeks of a participatory theatre intervention (PTI) developed by students that will summarize the learnings and cultural traditions from the weekly sessions.

Behavioral: Arts-based HIV stigma intervention

Group 2

EXPERIMENTAL

Arts-based HIV stigma intervention for two 8-week periods (16 weeks). Each intervention period will begin with 5 weeks of two 2 interrelated activities: 1) Transformative educational activities that will engage learners in problem-based discussions; 2) Arts-based activities that will focus on addressing the "problem" through finding "solutions" and encouraging action will be accomplished by learning traditional Ugandan songs, dance, told and acted stories, proverbs and sayings that incorporate empowering messages and moral teachings connected with self and community, respect for self, peers and authority, and responsibility for others. These activities will be followed by 3 weeks of a participatory theatre intervention (PTI) developed by students that will summarize the learnings and cultural traditions from the weekly sessions.

Behavioral: Arts-based HIV stigma intervention

Group 3

EXPERIMENTAL

Arts-based HIV stigma intervention for one 8-week period. The intervention period will begin with 5 weeks of two 2 interrelated activities: 1) Transformative educational activities that will engage learners in problem-based discussions; 2) Arts-based activities that will focus on addressing the "problem" through finding "solutions" and encouraging action will be accomplished by learning traditional Ugandan songs, dance, told and acted stories, proverbs and sayings that incorporate empowering messages and moral teachings connected with self and community, respect for self, peers and authority, and responsibility for others. These activities will be followed by 3 weeks of a participatory theatre intervention (PTI) developed by students that will summarize the learnings and cultural traditions from the weekly sessions.

Behavioral: Arts-based HIV stigma intervention

Interventions

The intervention will consist of 2-hour weekly sessions offered to students in participating schools. HIV-related stigma will be addressed by providing key information related to HIV and stigma, facilitating the acquisition of coping skills, and utilizing local cultural practices facilitated by Elders using creative methods to shift existing social and cultural norms that produce and perpetuate stigmatization. Specific intervention activities will include three interrelated activities. The core 2-hour weekly session will cover (1) transformative educational activities; (2) arts-based activities; (3) a summative activity consisting of (3) participatory theatre activites.

Group 1Group 2Group 3

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children (age ≥10 years) in Omoro District, Northern Uganda
  • Attending a government-funded primary and/or secondary school in the Omoro District
  • Enrolled in primary grades 4-6 and secondary grades 1-3

You may not qualify if:

  • Those attending the following government-funded schools due to distance: Awere secondary school, Awere primary school, Dino primary school, Odek primary school, Agweno primary school, Jing Komi primary school, Acet primary school, Awali primary school, Aromo Wanglobo primary school, Binya primary school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omoro District

Palenga, Uganda

Location

Related Publications (1)

  • Mendelsohn JB, Fournier B, Caron-Roy S, Maina G, Strudwick G, Ojok S, Lim HJ, Sanches M, Logie CH, Sommerfeldt S, Nykiforuk C, Harrowing J, Adyanga FA, Hakiigaba JO, Bilash O. Reducing HIV-related stigma among young people attending school in Northern Uganda: study protocol for a participatory arts-based population health intervention and stepped-wedge cluster-randomized trial. Trials. 2022 Dec 23;23(1):1043. doi: 10.1186/s13063-022-06643-9.

MeSH Terms

Conditions

Health Risk BehaviorsBehavior

Condition Hierarchy (Ancestors)

Health Behavior

Study Officials

  • Bonnie Fournier, PhD RN

    Thompson Rivers University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The study will employ a stepped-wedge, cluster randomized design involving crossover of clusters from the control to the intervention arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 30, 2021

Study Start

May 5, 2021

Primary Completion

November 24, 2023

Study Completion

January 6, 2024

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations