Clinical trial NCT05307250: M-Suubi: a Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: AIDS PREVENTION
ADOLESCENT
ADHERENCE
AIDS/HIV PROBLEM
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-04-01
Enrollment: 840
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change HIV viral suppression
timeFrame: Baseline 12, 24 and 36 month follow-up
Secondary outcomes:
measure: Change in Adherence and retention in care
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: HIV Stigma Measure for Children
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: The Shame Questionnaire for Children
timeFrame: Baseline 12, 24 and 36 month follow-up
Other outcomes:
measure: Child Depression Inventory (CDI)
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Post-Traumatic Stress Disorder (PTSD)
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Tennessee Self-Concept Scale (TSCS)
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Beck Hopelessness Scale (BHS)
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: HIV Adherence Self-Efficacy Scale
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Family relations
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Social Support Behaviors Scale
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Rosenberg Self-Esteem Scale
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Savings Deposits
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Financial Literacy
timeFrame: Baseline 12, 24 and 36 month follow-up
measure: Caregiver mental health
timeFrame: Baseline 12, 24 and 36 month follow-up
Locations:
city: Masaka
country: Uganda
facility: International Center for Child Health and Development Field Office
Study officials:
References:
citation: 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.