M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma

NCT05307250 | Active Not Recruiting DMC

• 1 other identifier: R01MH126892
• Study Type: interventional
• Target: 1,851
• Locations: 1 country
• Sites: 1

Brief Summary

M-Suubi, a three arm cluster randomized study will examine the effects and cost-effectiveness of a multi-level intervention on HIV viral suppression among 840 adolescents living with HIV (ALHIV) enrolled in 42 secondary schools with a boarding section. The investigators will test the effects of a group-based HIV stigma reduction intervention for educators (GED-HIVSR), over and above the effects of multiple family groups with HIV stigma reduction combined with family economic empowerment (MFG-HIVSR plus FEE), relative to Bolstered Standard of Care (BSOC). ALHIV will be randomized at the school level to one of three study arms

Conditions

HIV/AIDS

Keywords

AIDS PREVENTION; ADOLESCENT; ADHERENCE; AIDS/HIV PROBLEM

Outcome Measures

Primary Outcomes (1)

• Change HIV viral suppression

  Change in viral suppression will be assessed using viral load (VL) data collected from health clinic records. VL will be dichotomized between undetectable /suppression (VL\< 40 copies/ml) and detectable/failed viral suppression (VL \> =40 copies/ml) levels at each assessment time.

  Baseline 12, 24 and 36 month follow-up

Secondary Outcomes (3)

• Change in Adherence and retention in care

  Baseline 12, 24 and 36 month follow-up

• HIV Stigma Measure for Children

  Baseline 12, 24 and 36 month follow-up

• The Shame Questionnaire for Children

  Baseline 12, 24 and 36 month follow-up

Other Outcomes (11)

• Child Depression Inventory (CDI)

  Baseline 12, 24 and 36 month follow-up

• Post-Traumatic Stress Disorder (PTSD)

  Baseline 12, 24 and 36 month follow-up

• Tennessee Self-Concept Scale (TSCS)

  Baseline 12, 24 and 36 month follow-up

Study Arms (3)

Treatment Arm 1

EXPERIMENTAL

Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE

Behavioral: Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE; Other: Bolstered Standard of Care (BSOC)

Treatment Arm 2

EXPERIMENTAL

Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR)

Behavioral: Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR).; Other: Bolstered Standard of Care (BSOC)

Control Arm

OTHER

Bolstered Standard of Care (BSOC)

Other: Bolstered Standard of Care (BSOC)

Interventions

Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE BEHAVIORAL

In addition to the BSOC, ALHIV and their caregivers will participate in a family strengthening intervention plus a family economic empowerment intervention. MFG is an evidence-based family-centered, group-delivered, evidence-informed, strength-based 10-session (weekly) intervention for children whose families struggle with poverty. Six additional sessions covering HIV stigma stigma-related issues will be added. ALHIV will receive a YDA with a 1:1 matched savings program at a financial institution accredited by the Bank of Uganda. Each YDA will be opened in the name of the adolescent, with their primary caregiver as a co-signer, until the adolescent turns 18 years. The account will then be matched with money from the program on 1:1 rate.

Treatment Arm 1

Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR). BEHAVIORAL

In addition to BSOC and MFG-HIVSR+FEE, ALHIV in this arm will receive the school-level HIV stigma reduction intervention targeting teachers, school nurses, matrons, and administrators (headteachers, director of studies) in their schools. GED-HIVSR seeks to impart educators in the intervention schools with HIV related knowledge, provide a safe space for educators to explore their personal values and bias that may promote or hinder their role of supportive individuals and systems for ALHIV, and empower them with knowledge and skills to act as change agents within their schools.

Treatment Arm 2

Bolstered Standard of Care (BSOC) OTHER

All participants (in control and treatment arms) will receive medical and psychosocial support as part of the BSOC. 1) Medical SOC: All public clinics, including our study sites, follow procedures for pediatric ART initiation and monitoring, as outlined in the National Department of Health Guidelines for pediatric HIV care in Uganda. Specifically, immediately after initiation, or if clinically unstable, ALHIV are seen more frequently (weekly to monthly). Laboratory data (VL and CD4 counts) are collected every six months until the patient is stabilized and then annually, using the National Health Laboratory Service standardized protocol. A

Control Arm; Treatment Arm 1; Treatment Arm 2

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• HIV-positive adolescents confirmed by medical report
• Prescribed antiretroviral therapy
• Enrolled in primary and secondary schools in a boarding section
• Caregivers of ALHIV who agree to participate in the study
• Teachers, school nurses, and administrators in the target schools who agree to participate in the study

You may not qualify if:

• \- A significant cognitive impairment that interferes with the participant's understanding of the informed consent process, or inability/unwillingness to commit to completing the study

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

International Center for Child Health and Development Field Office

Masaka, Uganda

Location

Related Publications (2)

• Mutumba M, Ssewamala FM, Nabunya P, Nattabi J, Namirembe R, Matovu F, Namatovu P, Mwebembezi A. HIV-related stigma and academic outcomes: the mediating role of mental health among adolescents living with HIV in Uganda. AIDS Care. 2025 Dec 29:1-12. doi: 10.1080/09540121.2025.2606202. Online ahead of print.

  PMID: 41457981 DERIVED

• Mutumba M, Ssewamala F, Namirembe R, Sensoy Bahar O, Nabunya P, Neilands T, Tozan Y, Namuwonge F, Nattabi J, Acayo Laker P, Mukasa B, Mwebembezi A. A Multilevel Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes Among Adolescents Living With HIV in Uganda: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 5;11(10):e40101. doi: 10.2196/40101.

  PMID: 36197706 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: April 1, 2022
• Study Start: March 15, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

UG (1)