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

HIV/AIDS Clinical Trial

Official title:

M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes Among Adolescents Living With HIV in Uganda

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307250
• Other study ID #: R01MH126892
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: July 2023
• Source: Washington University School of Medicine
• Contact: Fred M Ssewamala, PhD
• Phone: 3149358521
• Email: fms1[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

HIV stigma remains a formidable barrier to HIV treatment adherence among adolescents in Uganda, contributing to low rates of medication adherence and viral suppression (less than 50%) and high attrition from HIV treatment services. ALHIV experience HIV stigma (internalized, anticipated and enacted) in various settings, including families and schools, the most important developmental contexts that should otherwise be supportive of their development and wellbeing. One of the unique features about education in Uganda and other countries in Sub-Saharan Africa is the high proportion (over 60%) of school-going adolescents enrolled in boarding secondary schools - which represent a form of parental opt-in institutionalized care. ALHIV in schools are more disadvantaged and have lower levels of HIV treatment adherence due to high levels of HIV stigma within schools, rigid school structures and routines, lack of adherence support and food insecurity. Within families, HIV stigma is perpetuated in various forms including discrimination and violence, often due to unfounded fears of infection-hence undermining the quality of family relations and supports for ALHIV. Building on our research and current evidence on HIV stigma reduction, the investigators propose a multi-level three-arm cluster randomized study (M-Suubi) with the following specific aims: Aim 1: Examine the impact of M-Suubi on HIV viral suppression (primary outcome); and adherence to HIV treatment (keeping appointments, pharmacy refills, pill counts), and retention in care (secondary outcome); Aim 2: Examine the effect of M-Suubi on HIV stigma (internalized, anticipated and enacted), with secondary analyses to explore hypothesized mechanisms of change (e.g. depression) and intervention mediation; Aim 3: Assess the cost and cost-effectiveness of each intervention condition; and Aim 4: Qualitatively examine: a) participants' experiences with HIV stigma, HIV treatment adherence, and the intervention; and 2) educators' attitudes towards ALHIV, experiences with GED-HIVSR, and program/policy implementation post-training. The study will enroll 840 ALHIV recruited from 42 schools located within the greater Masaka region, heavily affected by HIV (prevalence 12% vs 7.3% national average). M-Suubi will be provided for 20 months, with assessments at baseline, 12, 24 and 36 months. Findings may inform combination intervention efforts to optimize HIV treatment outcomes and engagements in care among ALHIV.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.
• 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

Locations

Country	Name	City	State
Uganda	International Center for Child Health and Development Field Office	Masaka

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Depression Inventory (CDI)	Depressive Symptoms will be measured using the Child Depression Inventory (CDI) scale. We will measure the mean score on the CDI scale over time. The total score range between 0 and 28 with a high score indicating higher levels of depressive symptoms.	Baseline 12, 24 and 36 month follow-up
Other	Post-Traumatic Stress Disorder (PTSD)	Post-Traumatic Stress Disorder (PTSD) will be measured using the Child PTSD Reaction Scale. We will measure the mean score on the Child PTSD Reaction Scale over time. The total score range between 0 and 120, with a high score indicating higher levels of PTSD.	Baseline 12, 24 and 36 month follow-up
Other	Tennessee Self-Concept Scale (TSCS)	Self concept will be measured using the Tennessee Self-Concept Scale (TSCS). We will measure the mean score on the TSCS over time. The total score range between 20 and 100 with a high score indicating higher levels of self-concept.	Baseline 12, 24 and 36 month follow-up
Other	Beck Hopelessness Scale (BHS)	Hopelessness will be measured using the Beck Hopelessness Scale (BHS). We will measure the mean score on the BHS over time. The total score range between 0 and 20 with a high score indicating higher levels of hopelessness.	Baseline 12, 24 and 36 month follow-up
Other	HIV Adherence Self-Efficacy Scale	Self reported medication adherence will be measured by the number of times a child missed taking medication in the past 30 days, and number of days took medication the way they were supposed to.; HIV Adherence Self-Efficacy Scale (HIV-ASES)	Baseline 12, 24 and 36 month follow-up
Other	Family relations	Change in family relations will be measured by Family Environment Scale	Baseline 12, 24 and 36 month follow-up
Other	Social Support Behaviors Scale	Social support from family members and friends will be measured using the Social Support Behaviors Scale (SSBS). We will measure the mean score on the SSBS over time. The total score ranges between 45-225, with higher score indicating higher levels of social support.	Baseline 12, 24 and 36 month follow-up
Other	Rosenberg Self-Esteem Scale	Self- Esteem will be measured using the Rosenberg Self-Esteem Scale. The total score range 0-30 where a score less than 15 may indicate a problematic low self esteem.	Baseline 12, 24 and 36 month follow-up
Other	Savings Deposits	Change in savings will be measured by Bank statements and financial diaries. Minimum savings will be 0.	Baseline 12, 24 and 36 month follow-up
Other	Financial Literacy	Change in Financial Literacy knowledge	Baseline 12, 24 and 36 month follow-up
Other	Caregiver mental health	Hopkins Symptom Checklists will be used to measure symptoms of anxiety and depression. We will measure the mean score of the Hopkins Symptoms Checklists over time. High score indicates severe levels of anxiety and depression.	Baseline 12, 24 and 36 month follow-up
Primary	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	Change in Adherence and retention in care	Change in adolescent Self reported medication adherence. This will be measured using the Adherence and retention in care questionnaire focusing on the pharmacy refills, pill counts and missed appointments at each assessment time.	Baseline 12, 24 and 36 month follow-up
Secondary	HIV Stigma Measure for Children	HIV-associated stigma for children will be measured using the HIV Stigma Measure. We will measure the mean score over time. The total score range between 40- 160 with a high score indicating higher levels of perceived HIV-associated stigma.	Baseline 12, 24 and 36 month follow-up
Secondary	The Shame Questionnaire for Children	Shame related to living with HIV will be measured using the Shame Questionnaire. We will measure the mean score over time. The total score range between 0 and 16 with a higher score indicating higher levels of HIV-associated shame.	Baseline 12, 24 and 36 month follow-up