Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents
Primary Purpose
Adolescent Drinking, HIV/AIDS, Drug Use
Status
Not yet recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Economic Empowerment Intervention
Alcohol and Drug Use Risk Reduction Sessions
Sponsored by
About this trial
This is an interventional prevention trial for Adolescent Drinking
Eligibility Criteria
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.
Sites / Locations
- International Center for Child Health and Development Field Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control Arm
Intervention
Arm Description
Control arm will received 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.
Outcomes
Primary Outcome Measures
Feasibility of the intervention
Proportion of participants enrolled Proportion of participants refused Willingness of local partners to assist with recruitment Reasons for refusal or ineligibility Reasons for enrolment in intervention
Acceptability of the intervention
Retention and follow-up rates Proportion that adhered to study study procedures, intervention attendance and engagement Level of safety of the procedures in the intervention How the intervention fits with the daily life activities of study participants Where the intervention involves a reasonable amount of time, or it creates a burden for participants Extent to which intervention is acceptable and appealing to study participants
Secondary Outcome Measures
Alcohol/drug expectancies
Alcohol expectancy scale
Change in Frequency and quantity of substance use
SUBSTANCE USE assessed using NIDA-Modified ASSIST Urine tests for alcohol and drug use
Change in anti-retroviral treatment adherence
Self-reported adherence
Change in Optimism
Optimism scale
Change in Hopelessness
Beck's Hopelessness Scale
Change in Depressive symptoms
Center For Epidemiologic Studies Depression Scale
Change in Self-efficacy in HIV treatment adherence
Self-efficacy in HIV treatment adherence scale
Change in Savings
We will utilize bank statements and financial diaries to monitor savings
Change in Self-concept
TENNESSEE SELF-CONCEPT SCALE
Change in PERECEIVED STRESS
PERECEIVED STRESS SCALE
Change in LONELINESS
UCLA LONELINESS SCALE
Change in Sexual risk-taking
self-reported questions on sexual risk-taking
Full Information
NCT ID
NCT05597865
First Posted
October 20, 2022
Last Updated
October 25, 2022
Sponsor
Washington University School of Medicine
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05597865
Brief Title
Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents
Official Title
Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Drinking, HIV/AIDS, Drug Use
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
Other
Arm Description
Control arm will received Alcohol and Drug Use Risk Reduction Sessions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Economic Empowerment Intervention
Intervention Description
Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts
Intervention Type
Behavioral
Intervention Name(s)
Alcohol and Drug Use Risk Reduction Sessions
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of the intervention
Description
Proportion of participants enrolled Proportion of participants refused Willingness of local partners to assist with recruitment Reasons for refusal or ineligibility Reasons for enrolment in intervention
Time Frame
Change from Baseline to 6 months
Title
Acceptability of the intervention
Description
Retention and follow-up rates Proportion that adhered to study study procedures, intervention attendance and engagement Level of safety of the procedures in the intervention How the intervention fits with the daily life activities of study participants Where the intervention involves a reasonable amount of time, or it creates a burden for participants Extent to which intervention is acceptable and appealing to study participants
Time Frame
Change from Baseline to 6 months
Secondary Outcome Measure Information:
Title
Alcohol/drug expectancies
Description
Alcohol expectancy scale
Time Frame
Change from Baseline to 6 months
Title
Change in Frequency and quantity of substance use
Description
SUBSTANCE USE assessed using NIDA-Modified ASSIST Urine tests for alcohol and drug use
Time Frame
Change from Baseline to 6 months
Title
Change in anti-retroviral treatment adherence
Description
Self-reported adherence
Time Frame
Change from Baseline to 6 months
Title
Change in Optimism
Description
Optimism scale
Time Frame
Change from baseline to 6 months
Title
Change in Hopelessness
Description
Beck's Hopelessness Scale
Time Frame
Change from baseline to 6 months
Title
Change in Depressive symptoms
Description
Center For Epidemiologic Studies Depression Scale
Time Frame
Change from baseline to 6 months
Title
Change in Self-efficacy in HIV treatment adherence
Description
Self-efficacy in HIV treatment adherence scale
Time Frame
Change from baseline to 6 months
Title
Change in Savings
Description
We will utilize bank statements and financial diaries to monitor savings
Time Frame
Change from baseline to 6 months
Title
Change in Self-concept
Description
TENNESSEE SELF-CONCEPT SCALE
Time Frame
Change from baseline to 6 months
Title
Change in PERECEIVED STRESS
Description
PERECEIVED STRESS SCALE
Time Frame
Change from baseline to 6 months
Title
Change in LONELINESS
Description
UCLA LONELINESS SCALE
Time Frame
Change from baseline to 6 months
Title
Change in Sexual risk-taking
Description
self-reported questions on sexual risk-taking
Time Frame
Change from baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Brathwaite, PhD
Phone
3149351775
Email
rachel.brathwaite@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Brathwaite, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Center for Child Health and Development Field Office
City
Masaka
Country
Uganda
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ritah Barungi
Email
rbarungi@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
These data will be available within 24 months after completing the study, and access will be maintained for 10 years.
Learn more about this trial
Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents
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