Adolescent DrinkingNCT05597865
Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents
A study testing Economic Empowerment Intervention and Alcohol and Drug Use Risk Reduction Sessions in people with Adolescent Drinking and HIV/AIDS, run by Washington University School of Medicine at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Drinking, HIV/AIDS, Drug Use
- What is being tested?
- Economic Empowerment Intervention and Alcohol and Drug Use Risk Reduction Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUganda
- Study dates
- 12 Oct 2023to 6 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uganda1 site
International Center for Child Health and Development Field Office
Masaka
About this study
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.
Read the 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.
- Conditions
- Adolescent Drinking, HIV/AIDS, Drug Use
- Being tested
- Economic Empowerment Intervention, Alcohol and Drug Use Risk Reduction Sessions
- Medical subject headings
- Underage Drinking, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Economic Empowerment InterventionBehavioural
Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts
Alcohol and Drug Use Risk Reduction SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Other | Control arm will received Alcohol and Drug Use Risk Reduction Sessions Receives: Behavioral: Alcohol and Drug Use Risk Reduction Sessions |
| Intervention | Experimental | 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. Receives: Behavioral: Economic Empowerment Intervention; Behavioral: Alcohol and Drug Use Risk Reduction Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Completing the Study at 6 Months
Percentage of participants completing the study at 6 months
Measured: Baseline and 6 months
Number of Participants Enrolling in the Study at Baseline
Number of participants enrolling in the study at baseline
Measured: Baseline
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start12 Oct 2023
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent DrinkingStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Rachel Brathwaite, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597865
- Sponsor's protocol ID
- 1R21AA030225-01
- Other IDs
- 1R21AA030225-01
- Status last verified
- Nov 2025
- First submitted
- 20 Oct 2022
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 37314844
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents
- ClinicalTrials.gov ID
- NCT05597865
- Acronym / sponsor ID
- 1R21AA030225-01
- Conditions
- Adolescent Drinking, HIV/AIDS, Drug Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Other | Behavioral: Alcohol and Drug Use Risk Reduction SessionsControl arm will received Alcohol and Drug Use Risk Reduction Sessions |
| Intervention | Experimental | Behavioral: Economic Empowerment Intervention, Behavioral: Alcohol and Drug Use Risk Reduction SessionsParticipants 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Economic Empowerment InterventionEconomic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts | Behavioural | Intervention |
| Alcohol and Drug Use Risk Reduction SessionsAll participants in the control and treatment arm will receive Alcohol and Drug Use Risk Reduction sessions tailored for Adolescents and Youths Living with HIV. | Behavioural | Control Arm, Intervention |
Primary outcome
Percentage of Participants Completing the Study at 6 Months
Time frame: Baseline and 6 months
Percentage of participants completing the study at 6 months
Number of Participants Enrolling in the Study at Baseline
Time frame: Baseline
Number of participants enrolling in the study at baseline
16 secondary outcomes
Percentage of Participants That Self-reported Use of Any Drug in the Last 3 Months at the Baseline Assessment
Time frame: baseline
Percentage of Participants That Self-reported Use of Any Drug in Last 3 Months at the 6-month Assessment
Time frame: 6 month follow-up
Optimism Scale Total Score at Baseline
Time frame: Baseline
Optimism Scale Total Score at 6 Months
Time frame: 6 months
Beck Hopelessness Scale Total Score at Baseline
Time frame: Baseline
Beck Hopelessness Scale Total Score at 6 Months
Time frame: 6 months
Depressive Symptoms Total Score at Baseline
Time frame: baseline
Depressive Symptom Total Score at 6 Months
Time frame: 6 months
Percentage of Participants That Self-reported Use of Any Drug in Last 12 Months at the Baseline Assessment
Time frame: baseline
Percentage of Participants That Self-reported Use of Any Drug in Last 12 Months at 6 Month Assessment
Time frame: 6 month follow-up
Percentage of Participants That Self-reported Use of Alcohol in Last 12 Months at Baseline
Time frame: baseline
Percentage of Participants That Self-reported Use of Alcohol in 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
Time frame: baseline
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
Time frame: baseline
Percentage of Participants With a Positive Urine Test for Alcohol at the 6-month Assessment
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37314844Brathwaite 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Brathwaite, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Economic Empowerment Intervention and Alcohol and Drug Use Risk Reduction Sessions in people with Adolescent Drinking and HIV/AIDS, run by Washington University School of Medicine at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Completing the Study at 6 Months (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.