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

Not Applicable

Active, not recruiting

• Conditions: HIV/AIDS
• Interventions: Behavioral: Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE; 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)

• Registration Number: NCT05307250
• Lead Sponsor: Washington University School of Medicine

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-21
• Study Start: 2022-03-15
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-04-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm 1	Bolstered Standard of Care (BSOC)	Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE
Treatment Arm 1	Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE	Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE
Treatment Arm 2	Bolstered Standard of Care (BSOC)	Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR)
Treatment Arm 2	Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR).	Multiple Family Groups for HIV stigma reduction (MFG-HIVSR) plus FEE plus Group-based stigma reduction for educators (GED-HIVSR)
Control Arm	Bolstered Standard of Care (BSOC)	Bolstered Standard of Care (BSOC)

Primary Outcome Measures

Name	Time	Method
Change HIV viral suppression	Baseline 12, 24 and 36 month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
HIV Stigma Measure for Children	Baseline 12, 24 and 36 month follow-up	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.
Change in Adherence and retention in care	Baseline 12, 24 and 36 month follow-up	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.
The Shame Questionnaire for Children	Baseline 12, 24 and 36 month follow-up	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.

Trial Locations

Locations (1)

International Center for Child Health and Development Field Office; 🇺🇬 Masaka, Uganda