An interventional study of Economic Empowerment Intervention and Alcohol and Drug Use Risk Reduction Sessions in Adolescent Drinking, HIV/AIDS and Drug Use, sponsored by Washington University School of Medicine. Completed at 1 site in Uganda. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention
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.
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.
44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.
This study's enrollment of 95 is below the median of 360 across 43 interventional studies indexed under Underage Drinking.
Browse Underage Drinking studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control arm will received Alcohol and Drug Use Risk Reduction Sessions
Behavioral: Alcohol and Drug Use Risk Reduction Sessions
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 · Behavioral: Alcohol and Drug Use Risk Reduction Sessions
Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts
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.
Percentage of Participants Completing the Study at 6 Months
Percentage of participants completing the study at 6 months
Time frame: Baseline and 6 months
Number of Participants Enrolling in the Study at Baseline
Number of participants enrolling in the study at baseline
Time frame: Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
| Milestone | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Started | 46 | 49 |
| Completed | 44 | 46 |
| Not completed | 2 | 3 |
Percentage of participants completing the study at 6 months
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants Completing the Study at 6 Months | 44 | 46 |
Number of participants enrolling in the study at baseline
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Number of Participants Enrolling in the Study at Baseline | 44 | 46 |
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.
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants That Self-reported Use of Any Drug in the Last 3 Months at the Baseline Assessment | 25 | 31 |
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.
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants That Self-reported Use of Any Drug in Last 3 Months at the 6-month Assessment | 21 | 24 |
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.
| score | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Optimism Scale Total Score at Baseline | 38.5 ± 5.7 | 38.8 ± 5.4 |
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.
| score | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Optimism Scale Total Score at 6 Months | 39.5 ± 4.4 | 39.3 ± 4.8 |
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.
| score | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Beck Hopelessness Scale Total Score at Baseline | 4.6 ± 2.2 | 5.2 ± 3.0 |
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.
| score | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Beck Hopelessness Scale Total Score at 6 Months | 5.2 ± 3.0 | 4.4 ± 2.4 |
Center for Epidemiological Studies Depression Scale (CES-D). Total score range from 0-60. Higher scores indicate greater severity of depressive symptoms.
| score | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Depressive Symptoms Total Score at Baseline | 38.1 ± 10.8 | 37.6 ± 9.5 |
Center for Epidemiological Studies Depression Scale (CES-D). Total score range from 0-60. Higher scores indicate greater severity of depressive symptoms.
| score | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Depressive Symptom Total Score at 6 Months | 37.6 ± 9.2 | 37.1 ± 9.1 |
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.
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants That Self-reported Use of Any Drug in Last 12 Months at the Baseline Assessment | 34 | 39 |
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.
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants That Self-reported Use of Any Drug in Last 12 Months at 6 Month Assessment | 32 | 28 |
Percentage of participants that self-reported use of alcohol in the last 12 months at the baseline assessment.
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants That Self-reported Use of Alcohol in Last 12 Months at Baseline | 31 | 35 |
Percentage of participants that self-reported use of alcohol in the last 12 months at the 6-month assessment.
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants That Self-reported Use of Alcohol in Last 12 Months at the 6-month Assessment | 29 | 26 |
Percentage of participants with a positive urine test for any drug at the baseline assessment
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants With a Positive Urine Test for Any Drug at Baseline | 15 | 24 |
Percentage of participants with a positive urine test for any drug at the 6-month assessment
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants With a Positive Urine Test for Any Drug at the 6-month Assessment | 11 | 15 |
Percentage of participants with a positive urine test for alcohol at the baseline assessment
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants With a Positive Urine Test for Alcohol at the Baseline Assessment | 8 | 20 |
Percentage of participants with a positive urine test for alcohol at the 6-month assessment
| Participants | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm |
|---|---|---|
| Percentage of Participants With a Positive Urine Test for Alcohol at the 6-month Assessment | 8 | 12 |
Collected over baseline to 6 months follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Age, Continuous(years) | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Total |
|---|---|---|---|
| Mean | 21.8 ± 2.21 | 22.0 ± 1.90 | 21.9 ± 2.0 |
| Sex: Female, Male(Participants) | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Total |
|---|---|---|---|
| Female | 32 | 31 | 63 |
| Male | 14 | 18 | 32 |
| Race (NIH/OMB)(Participants) | Alcohol and Drug Use Risk Reduction Arm | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 46 | 49 | 95 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol
Time frame: These data will be available within 24 months after completing the study, and access will be maintained for 10 years.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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