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

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

Interventions

BEHAVIORAL

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

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.

BEHAVIORAL

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

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.

OTHER

Bolstered Standard of Care (BSOC)

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Washington University School of Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-15

Primary Completion

2026-07-31

Completion

2026-07-31

Countries

• Uganda

Study Locations