Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents

Conditions
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Adolescent Drinking, HIV/AIDS, Drug Use

Intervention / Treatment
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* Behavioral: Economic Empowerment Intervention
* Behavioral: Alcohol and Drug Use Risk Reduction Sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for AYLHIV: male or female AYLHIV aged 15-24 years; medically diagnosed with HIV and aware of their HIV status; enrolled in care at one of the selected HIV clinics. positive self-report or urine test for alcohol or drug use Exclusion Criteria: any AYLHIV with negative urine alcohol or drug use test and negative self-report for alcohol and drug use anyone with a significant cognitive impairment that interferes with their understanding of the informed consent process, or is unable/unwilling to consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Arm<br>Control arm will received Alcohol and Drug Use Risk Reduction Sessions | Behavioral: Alcohol and Drug Use Risk Reduction Sessions<br>* All participants in the control and treatment arm will receive Alcohol and Drug Use Risk Reduction sessions tailored for Adolescents and Youths Living with HIV.<br>|
| Experimental: Intervention<br>Participants in the intervention arm will receive four (4) Financial Literacy (FL) training sessions and receive a Youth Development Savings account (YDA) at a financial institution accredited by the Bank of Uganda for long-term savings. Each YDA account will be opened in the name of the participant. Savings will be matched at a 1:1 rate with money from the program. | Behavioral: Economic Empowerment Intervention<br>* Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts<br>Behavioral: Alcohol and Drug Use Risk Reduction Sessions<br>* All participants in the control and treatment arm will receive Alcohol and Drug Use Risk Reduction sessions tailored for Adolescents and Youths Living with HIV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention | Proportion of participants enrolled Proportion of participants refused Willingness of local partners to assist with recruitment Reasons for refusal or ineligibility Reasons for enrolment in intervention | Change from Baseline to 6 months | 
| Acceptability of the intervention | Retention and follow-up rates Proportion that adhered to study study procedures, intervention attendance and engagement Level of safety of the procedures in the intervention How the intervention fits with the daily life activities of study participants Where the intervention involves a reasonable amount of time, or it creates a burden for participants Extent to which intervention is acceptable and appealing to study participants | Change from Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol/drug expectancies | Alcohol expectancy scale | Change from Baseline to 6 months | 
| Change in Frequency and quantity of substance use | SUBSTANCE USE assessed using NIDA-Modified ASSIST Urine tests for alcohol and drug use | Change from Baseline to 6 months | 
| Change in anti-retroviral treatment adherence | Self-reported adherence | Change from Baseline to 6 months | 
| Change in Optimism | Optimism scale | Change from baseline to 6 months | 
| Change in Hopelessness | Beck's Hopelessness Scale | Change from baseline to 6 months | 
| Change in Depressive symptoms | Center For Epidemiologic Studies Depression Scale | Change from baseline to 6 months | 
| Change in Self-efficacy in HIV treatment adherence | Self-efficacy in HIV treatment adherence scale | Change from baseline to 6 months | 
| Change in Savings | We will utilize bank statements and financial diaries to monitor savings | Change from baseline to 6 months | 
| Change in Self-concept | TENNESSEE SELF-CONCEPT SCALE | Change from baseline to 6 months | 
| Change in PERECEIVED STRESS | PERECEIVED STRESS SCALE | Change from baseline to 6 months | 
| Change in LONELINESS | UCLA LONELINESS SCALE | Change from baseline to 6 months | 
| Change in Sexual risk-taking | self-reported questions on sexual risk-taking | Change from baseline to 6 months |