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Completed

NCT Number: NCT05597865

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Economic Empowerment Intervention

Behavioral

Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts

Alcohol and Drug Use Risk Reduction Sessions

Behavioral

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.

Primary outcomes

  1. Percentage of Participants Completing the Study at 6 Months

    Time frame: Baseline and 6 months

    Percentage of participants completing the study at 6 months

  2. Number of Participants Enrolling in the Study at Baseline

    Time frame: Baseline

    Number of participants enrolling in the study at baseline

Secondary outcomes

  1. 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 baseline assessment . Any of the drugs in the list of substances specified in the NIDA-Modified ASSIST questionnaire.

  2. 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

    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.

  3. Optimism Scale Total Score at Baseline

    Time frame: 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.

  4. Optimism Scale Total Score at 6 Months

    Time frame: 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.

  5. Beck Hopelessness Scale Total Score at Baseline

    Time frame: 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.

  6. Beck Hopelessness Scale Total Score at 6 Months

    Time frame: 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.

  7. Depressive Symptoms Total Score at Baseline

    Time frame: baseline

    Center for Epidemiological Studies Depression Scale (CES-D). Total score range from 0-60. Higher scores indicate greater severity of depressive symptoms.

  8. Depressive Symptom Total Score at 6 Months

    Time frame: 6 months

    Center for Epidemiological Studies Depression Scale (CES-D). Total score range from 0-60. Higher scores indicate greater severity of depressive symptoms.

  9. 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 the baseline assessment. Any of the drugs in the list of substances specified in the NIDA-Modified ASSIST questionnaire.

  10. 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 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.

  11. 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 the last 12 months at the baseline assessment.

  12. 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 that self-reported use of alcohol in the last 12 months at the 6-month assessment.

  13. 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 baseline assessment

  14. 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 any drug at the 6-month assessment

  15. 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 baseline assessment

  16. Percentage of Participants With a Positive Urine Test for Alcohol at the 6-month Assessment

    Time frame: 6 months

    Percentage of participants with a positive urine test for alcohol at the 6-month assessment

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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