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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Drug Use; Adolescent Drinking
• Intervention / Treatment: Behavioral: Alcohol and Drug Use Risk Reduction Sessions; Behavioral: Economic Empowerment Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Masaka, Uganda
    • International Center for Child Health and Development Field Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 20 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Arm; Control arm will received Alcohol and Drug Use Risk Reduction Sessions	Behavioral: 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.
Experimental: Intervention; 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: 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.; Behavioral: Economic Empowerment Intervention; Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Completing the Study at 6 Months	Percentage of participants completing the study at 6 months	Baseline and 6 months
Number of Participants Enrolling in the Study at Baseline	Number of participants enrolling in the study at baseline	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants That Self-reported Use of Any Drug in the Last 3 Months at the Baseline Assessment	Percentage of participants that self-reported use of any drug in last 3 months at the baseline assessment . Any of the drugs in the list of substances specified in the NIDA-Modified ASSIST questionnaire.	baseline
Percentage of Participants That Self-reported Use of Any Drug in Last 3 Months at the 6-month Assessment	Percentage of participants that self-reported use of any drug in last 3 months at the 6-month assessment. Any of the drugs in the list of substances specified in the NIDA-Modified ASSIST questionnaire.	6 month follow-up
Optimism Scale Total Score at Baseline	Optimism scale measures hope that something good is going to happen in the future. Total score ranges from 9 to 45. Items were rated on a 5-item scale with higher scores are indicative of higher levels of optimism.	Baseline
Optimism Scale Total Score at 6 Months	Optimism scale measures hope that something good is going to happen in the future. Total score ranges from 9 to 45. Items were rated on a 5-item scale with higher scores are indicative of higher levels of optimism.	6 months
Beck Hopelessness Scale Total Score at Baseline	Beck Hopelessness Scale total score at baseline is a 20-item scale that assesses negative expectations about the future. The total score ranges from 0-20. Higher scores indicate greater levels of hopelessness (more negative expectations about the future, less motivation, more pessimism.	Baseline
Beck Hopelessness Scale Total Score at 6 Months	Beck Hopelessness Scale total score at baseline is a 20-item scale that assesses negative expectations about the future. The total score ranges from 0-20. Higher scores indicate greater levels of hopelessness (more negative expectations about the future, less motivation, more pessimism.	6 months
Depressive Symptoms Total Score at Baseline	Center for Epidemiological Studies Depression Scale (CES-D). Total score range from 0-60. Higher scores indicate greater severity of depressive symptoms.	baseline
Depressive Symptom Total Score at 6 Months	Center for Epidemiological Studies Depression Scale (CES-D). Total score range from 0-60. Higher scores indicate greater severity of depressive symptoms.	6 months
Percentage of Participants That Self-reported Use of Any Drug in Last 12 Months at the Baseline Assessment	Percentage of participants that self-reported use of any drug in last 12 months at the baseline assessment. Any of the drugs in the list of substances specified in the NIDA-Modified ASSIST questionnaire.	baseline
Percentage of Participants That Self-reported Use of Any Drug in Last 12 Months at 6 Month Assessment	Percentage of participants that self-reported use of any drug in last 12 months at the 6-month assessment. Any of the drugs in the list of substances specified in the NIDA-Modified ASSIST questionnaire.	6 month follow-up
Percentage of Participants That Self-reported Use of Alcohol in Last 12 Months at Baseline	Percentage of participants that self-reported use of alcohol in the last 12 months at the baseline assessment.	baseline
Percentage of Participants That Self-reported Use of Alcohol in Last 12 Months at the 6-month Assessment	Percentage of participants that self-reported use of alcohol in the last 12 months at the 6-month assessment.	6-month follow-up
Percentage of Participants With a Positive Urine Test for Any Drug at Baseline	Percentage of participants with a positive urine test for any drug at the baseline assessment	baseline
Percentage of Participants With a Positive Urine Test for Any Drug at the 6-month Assessment	Percentage of participants with a positive urine test for any drug at the 6-month assessment	6 month follow-up
Percentage of Participants With a Positive Urine Test for Alcohol at the Baseline Assessment	Percentage of participants with a positive urine test for alcohol at the baseline assessment	baseline
Percentage of Participants With a Positive Urine Test for Alcohol at the 6-month Assessment	Percentage of participants with a positive urine test for alcohol at the 6-month assessment	6 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Rachel Brathwaite, PhD, Washington University School of Medicine

Publications and helpful links

General Publications

• Brathwaite R, Mutumba M, Nanteza J, Filiatreau LM, Migadde H, Namatovu P, Nabisere B, Mugisha J, Mwebembezi A, Ssewamala FM. Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2023 Jun 14;12:e46486. doi: 10.2196/46486.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): June 6, 2024
• Study Completion (Actual): June 6, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Drinking Behavior; Slow Virus Diseases; HIV Infections; Alcohol Drinking; Behavior; Adolescent Behavior; Underage Drinking; Acquired Immunodeficiency Syndrome; Organic Chemicals; Alcohols; Ethanol
• Other Study ID Numbers: 1R21AA030225-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data will be made available to other researchers through the NIH central data repositories upon request from the researcher. The researcher will be required to provide a research question, hypothesis, and analysis plan and strategies for maintaining data integrity in order to access the data.
• IPD Sharing Time Frame: These data will be available within 24 months after completing the study, and access will be maintained for 10 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No