Adolescent Drinking, Drug Use, HIV/AIDS
Conditions
Brief 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.
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.
Interventions
BEHAVIORALEconomic Empowerment Intervention
Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts
BEHAVIORALAlcohol 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Completing the Study at 6 Months | Baseline and 6 months | Percentage of participants completing the study at 6 months |
| Number of Participants Enrolling in the Study at Baseline | Baseline | Number of participants enrolling in the study at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optimism Scale Total Score at Baseline | 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. |
| Optimism Scale Total Score at 6 Months | 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. |
| Beck Hopelessness Scale Total Score at Baseline | 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. |
| Beck Hopelessness Scale Total Score at 6 Months | 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. |
| Depressive Symptoms Total Score at Baseline | baseline | Center for Epidemiological Studies Depression Scale (CES-D). Total score range from 0-60. Higher scores indicate greater severity of depressive symptoms. |
| Depressive Symptom Total Score at 6 Months | 6 months | Center for Epidemiological Studies Depression Scale (CES-D). Total score range from 0-60. Higher scores indicate greater severity of depressive symptoms. |
| Percentage of Participants That Self-reported Use of Any Drug in Last 12 Months at the Baseline Assessment | 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. |
| Percentage of Participants That Self-reported Use of Any Drug in the Last 3 Months at the Baseline Assessment | 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. |
| Percentage of Participants That Self-reported Use of Alcohol in Last 12 Months at Baseline | baseline | Percentage of participants that self-reported use of alcohol in the last 12 months at the baseline assessment. |
| Percentage of Participants That Self-reported Use of Alcohol in Last 12 Months at the 6-month Assessment | 6-month follow-up | Percentage of participants that self-reported use of alcohol in the last 12 months at the 6-month assessment. |
| Percentage of Participants With a Positive Urine Test for Any Drug at Baseline | baseline | Percentage of participants with a positive urine test for any drug at the baseline 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 any drug at the 6-month 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 baseline assessment |
| Percentage of Participants With a Positive Urine Test for Alcohol at the 6-month Assessment | 6 months | Percentage of participants with a positive urine test for alcohol at the 6-month assessment |
| Percentage of Participants That Self-reported Use of Any Drug in Last 12 Months at 6 Month Assessment | 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. |
| Percentage of Participants That Self-reported Use of Any Drug in Last 3 Months at the 6-month Assessment | 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. |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alcohol and Drug Use Risk Reduction Arm Participants in the ADURR condition participated in four Alcohol and drug use risk reduction (ADURR) sessions focused on identifying and making decisions that align with values, managing individual risk-taking behaviors and peer pressure, strengthening interpersonal relationships, and goal setting. | 46 |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm In addition to the adapted ADU training module that the ADURR-only group will receive, AYLHIV in the intervention arm will receive four (4) Financial Literacy Training (FLT) sessions and a Youth Development Savings account (YDA) for long-term savings. For the proposed study, the EE intervention will be in the form of a YDA, where savings are housed at a local bank and deposits made by the adolescent are matched by the intervention to encourage savings. Each AYLHIV in the EE intervention will receive a YDA held in their own name in a bank registered by the Central Bank (Bank of Uganda). We will form partnerships with national banks operating in the study area. The account will then be matched with money from the program. The maximum adolescent's contribution to be matched by the program will be an equivalent of US $20 per month per adolescent or US $120 for the 6-month intervention period. | 49 |
| Total | 95 |
Baseline characteristics
| Characteristic | Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Total | Alcohol and Drug Use Risk Reduction Arm |
|---|---|---|---|
| Age, Continuous | 22.0 years STANDARD_DEVIATION 1.9 | 21.9 years STANDARD_DEVIATION 2 | 21.8 years STANDARD_DEVIATION 2.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 95 Participants | 46 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 31 Participants | 63 Participants | 32 Participants |
| Sex: Female, Male Male | 18 Participants | 32 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 49 |
| other Total, other adverse events | 0 / 46 | 0 / 49 |
| serious Total, serious adverse events | 0 / 46 | 0 / 49 |
Outcome results
Primary
Number of Participants Enrolling in the Study at Baseline
Number of participants enrolling in the study at baseline
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Number of Participants Enrolling in the Study at Baseline | 44 Participants |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Number of Participants Enrolling in the Study at Baseline | 46 Participants |
Primary
Percentage of Participants Completing the Study at 6 Months
Percentage of participants completing the study at 6 months
Time frame: Baseline and 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants Completing the Study at 6 Months | 44 Participants |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Percentage of Participants Completing the Study at 6 Months | 46 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Beck Hopelessness Scale Total Score at 6 Months | 5.2 score | Standard Deviation 3 |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Beck Hopelessness Scale Total Score at 6 Months | 4.4 score | Standard Deviation 2.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Beck Hopelessness Scale Total Score at Baseline | 4.6 score | Standard Deviation 2.2 |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Beck Hopelessness Scale Total Score at Baseline | 5.2 score | Standard Deviation 3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Depressive Symptoms Total Score at Baseline | 38.1 score | Standard Deviation 10.8 |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Depressive Symptoms Total Score at Baseline | 37.6 score | Standard Deviation 9.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Depressive Symptom Total Score at 6 Months | 37.6 score | Standard Deviation 9.2 |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Depressive Symptom Total Score at 6 Months | 37.1 score | Standard Deviation 9.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Optimism Scale Total Score at 6 Months | 39.5 score | Standard Deviation 4.4 |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Optimism Scale Total Score at 6 Months | 39.3 score | Standard Deviation 4.8 |
Secondary
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
Population: Score from Optimism scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Optimism Scale Total Score at Baseline | 38.5 score | Standard Deviation 5.7 |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Optimism Scale Total Score at Baseline | 38.8 score | Standard Deviation 5.4 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants That Self-reported Use of Alcohol in Last 12 Months at Baseline | 31 Participants |
| 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 | 35 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants That Self-reported Use of Alcohol in Last 12 Months at the 6-month Assessment | 29 Participants |
| 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 | 26 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants That Self-reported Use of Any Drug in Last 12 Months at 6 Month Assessment | 32 Participants |
| 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 | 28 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants That Self-reported Use of Any Drug in Last 12 Months at the Baseline Assessment | 34 Participants |
| 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 | 39 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants That Self-reported Use of Any Drug in Last 3 Months at the 6-month Assessment | 21 Participants |
| 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 | 24 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants That Self-reported Use of Any Drug in the Last 3 Months at the Baseline Assessment | 25 Participants |
| 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 | 31 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants With a Positive Urine Test for Alcohol at the 6-month Assessment | 8 Participants |
| 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 | 12 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants With a Positive Urine Test for Alcohol at the Baseline Assessment | 8 Participants |
| 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 | 20 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants With a Positive Urine Test for Any Drug at Baseline | 15 Participants |
| Alcohol and Drug Use Risk Reduction + Economic Empowerment (ADURR+EE) Arm | Percentage of Participants With a Positive Urine Test for Any Drug at Baseline | 24 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol and Drug Use Risk Reduction Arm | Percentage of Participants With a Positive Urine Test for Any Drug at the 6-month Assessment | 11 Participants |
| 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 | 15 Participants |