Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AA030225-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Other | Control arm will received 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Economic Empowerment Intervention | Behavioral | Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria for AYLHIV:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rachel Brathwaite, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Center for Child Health and Development Field Office | Masaka | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37314844 | Derived | 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. |
Not provided
Not provided
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.
These data will be available within 24 months after completing the study, and access will be maintained for 10 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Completing the Study at 6 Months | Percentage of participants completing the study at 6 months | Posted | Count of Participants | Participants | Baseline and 6 months |
|
baseline to 6 months follow-up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Brathwaite | Washington University in St. Louis | 3147282869 | rachel.brathwaite@yahoo.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2022 | Sep 24, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2025 | Sep 24, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000066608 | Underage Drinking |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D001519 | Behavior |
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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 |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants Enrolling in the Study at Baseline | Number of participants enrolling in the study at baseline | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 month follow-up |
|
|
|
| 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. | Score from Optimism scale | Posted | Mean | Standard Deviation | score | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score | baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score | 6 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 month follow-up |
|
|
|
| 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. | Posted | Count of Participants | Participants | baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6-month follow-up |
|
|
|
| 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 | Posted | Count of Participants | Participants | baseline |
|
|
|
| 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 | Posted | Count of Participants | Participants | 6 month follow-up |
|
|
|
| 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 | Posted | Count of Participants | Participants | baseline |
|
|
|
| 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 | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | 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. | 0 | 49 | 0 | 49 | 0 | 49 |
Not provided
Not provided
| D015658 |
| HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |