Clinical trial NCT05597865: Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents
Official title: Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Drinking
HIV/AIDS
Drug Use
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-10-28
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study will test the impact of an economic empowerment intervention on reducing alcohol and drug use (ADU) among adolescents and youth living with HIV (AYLHIV) in poverty-impacted communities in Uganda. It focuses on improving understanding of multi-level context- specific risk and protective factors for ADU among AYLHIV.

Detailed description: Adolescent alcohol and drug use (ADU) is a significant public health challenge in sub-Saharan Africa (SSA). About 41.6% of adolescents in SSA reported using at least one psychoactive agent, with alcohol being the most commonly used drug. Uganda, one of the poorest countries in SSA, has the second highest rate of per capita alcohol consumption in SSA (15.1 liters of pure alcohol vs regional average of 6.2 liters of pure alcohol) and one third of Ugandan adolescents have used alcohol in their lifetime, 22.5 million are current drinkers, and over 50% engage in heavy episodic drinking. These estimates reach even greater magnitudes in the country's fishing villages - a key vulnerable population- where ADU is normative. A few studies have assessed ADU among AYLHIV, yet AYLHIV are at higher risk for ADU, and ADU impedes adherence to antiretroviral therapy (ART) retention in care, and viral suppression. Several studies have examined the risk and resilience factors for ADU but few interventions targeting ADU have been tested in SSA. . The majority of ADU interventions have been implemented in school settings, which may exclude adolescents in fishing communities that have high rates of school dropout. Moreover, none has targeted risk factors such as poverty and mental health, which are rampant among AYLHIV and their families, undermine AYLHIV's coping skills and resources, and have been associated with increased risk for ADU among adolescents. Economic empowerment (EE) interventions have the potential to prevent ADU among AYLHIV by reducing poverty and its associated mental health impacts, and also bolstering AYLHIV and their families' resources to overcome the challenges associated with HIV. Given the lack of evidence-based culturally tailored interventions to prevent ADU in AYLHIV in low-income settings such as Uganda, this study proposes to: Aim 1a. Examine the prevalence and consequences of ADU in a sample of 200 AYLHIV (ages 18-24) seen at six (6) HIV clinics located in the fishing communities of southwestern Uganda. ADU will be measured using self-report and biological data (i.e. urine). Aim 1b. Using a mixed methods approach, identify the multi-level (individual, interpersonal, community and structural) factors associated with ADU among AYLHIV. Aim 2: Using a subset of the sample, explore the feasibility and short-term effects of a EE intervention on ADU among AYLHIV. Our intervention focuses on older adolescents and young adults in a high-risk environment (i.e. fishing communities) to elucidate the contextually relevant risk and resilience factors for ADU among AYLHIV undergoing social transitions. Additionally we innovatively target the most commonly occurring risk and resilience factors for ADU (i.e. poverty and mental health problems) through the EE that includes provision of youth development savings accounts, financial literacy sessions and ADU risk reduction sessions.

Eligibility criteria: Inclusion Criteria for AYLHIV:

1. male or female AYLHIV aged 15-24 years;
2. medically diagnosed with HIV and aware of their HIV status;
3. enrolled in care at one of the selected HIV clinics.
4. positive self-report or urine test for alcohol or drug use

Exclusion Criteria:

1. any AYLHIV with negative urine alcohol or drug use test and negative self-report for alcohol and drug use
2. anyone with a significant cognitive impairment that interferes with their understanding of the informed consent process, or is unable/unwilling to consent.

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Change from Baseline to 6 months
measure: Acceptability of the intervention
timeFrame: Change from Baseline to 6 months
Secondary outcomes:
measure: Alcohol/drug expectancies
timeFrame: Change from Baseline to 6 months
measure: Change in Frequency and quantity of substance use
timeFrame: Change from Baseline to 6 months
measure: Change in anti-retroviral treatment adherence
timeFrame: Change from Baseline to 6 months
measure: Change in Optimism
timeFrame: Change from baseline to 6 months
measure: Change in Hopelessness
timeFrame: Change from baseline to 6 months
measure: Change in Depressive symptoms
timeFrame: Change from baseline to 6 months
measure: Change in Self-efficacy in HIV treatment adherence
timeFrame: Change from baseline to 6 months
measure: Change in Savings
timeFrame: Change from baseline to 6 months
measure: Change in Self-concept
timeFrame: Change from baseline to 6 months
measure: Change in PERECEIVED STRESS
timeFrame: Change from baseline to 6 months
measure: Change in LONELINESS
timeFrame: Change from baseline to 6 months
measure: Change in Sexual risk-taking
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Masaka
country: Uganda
facility: International Center for Child Health and Development Field Office
Study officials:
affiliation: Washington University School of Medicine
name: Rachel Brathwaite, PhD
role: PRINCIPAL_INVESTIGATOR
References: