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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597865
• Other study ID #: 1R21AA030225-01
• Secondary ID: 1R21AA030225-01
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2023
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: Rachel Brathwaite, PhD
• Phone: 3149351775
• Email: rachel.brathwaite[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Drinking
• Drug Use
• HIV/AIDS
• Substance-Related Disorders
• Underage Drinking

Intervention

Behavioral:
• Economic Empowerment Intervention
Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts
• Alcohol and Drug Use Risk Reduction Sessions
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.

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 on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Alcohol/drug expectancies	Alcohol expectancy scale	Change from Baseline to 6 months
Secondary	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
Secondary	Change in anti-retroviral treatment adherence	Self-reported adherence	Change from Baseline to 6 months
Secondary	Change in Optimism	Optimism scale	Change from baseline to 6 months
Secondary	Change in Hopelessness	Beck's Hopelessness Scale	Change from baseline to 6 months
Secondary	Change in Depressive symptoms	Center For Epidemiologic Studies Depression Scale	Change from baseline to 6 months
Secondary	Change in Self-efficacy in HIV treatment adherence	Self-efficacy in HIV treatment adherence scale	Change from baseline to 6 months
Secondary	Change in Savings	We will utilize bank statements and financial diaries to monitor savings	Change from baseline to 6 months
Secondary	Change in Self-concept	TENNESSEE SELF-CONCEPT SCALE	Change from baseline to 6 months
Secondary	Change in PERECEIVED STRESS	PERECEIVED STRESS SCALE	Change from baseline to 6 months
Secondary	Change in LONELINESS	UCLA LONELINESS SCALE	Change from baseline to 6 months
Secondary	Change in Sexual risk-taking	self-reported questions on sexual risk-taking	Change from baseline to 6 months