Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents
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ClinicalTrials.gov Identifier: NCT05597865 |
Recruitment Status :
Recruiting
First Posted : October 28, 2022
Last Update Posted : December 12, 2023
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Condition or disease | Intervention/treatment | Phase |
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Adolescent Drinking HIV/AIDS Drug Use | Behavioral: Economic Empowerment Intervention Behavioral: Alcohol and Drug Use Risk Reduction Sessions | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents |
Actual Study Start Date : | October 12, 2023 |
Estimated Primary Completion Date : | May 2024 |
Estimated Study Completion Date : | May 2024 |
Arm | Intervention/treatment |
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Control Arm
Control arm will received Alcohol and Drug Use Risk Reduction Sessions
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Behavioral: Alcohol 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. |
Experimental: Intervention
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.
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Behavioral: Economic Empowerment Intervention
Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts Behavioral: Alcohol 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. |
- Feasibility of the intervention [ Time Frame: Change from Baseline to 6 months ]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 [ Time Frame: Change from Baseline to 6 months ]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
- Alcohol/drug expectancies [ Time Frame: Change from Baseline to 6 months ]Alcohol expectancy scale
- Change in Frequency and quantity of substance use [ Time Frame: Change from Baseline to 6 months ]SUBSTANCE USE assessed using NIDA-Modified ASSIST Urine tests for alcohol and drug use
- Change in anti-retroviral treatment adherence [ Time Frame: Change from Baseline to 6 months ]Self-reported adherence
- Change in Optimism [ Time Frame: Change from baseline to 6 months ]Optimism scale
- Change in Hopelessness [ Time Frame: Change from baseline to 6 months ]Beck's Hopelessness Scale
- Change in Depressive symptoms [ Time Frame: Change from baseline to 6 months ]Center For Epidemiologic Studies Depression Scale
- Change in Self-efficacy in HIV treatment adherence [ Time Frame: Change from baseline to 6 months ]Self-efficacy in HIV treatment adherence scale
- Change in Savings [ Time Frame: Change from baseline to 6 months ]We will utilize bank statements and financial diaries to monitor savings
- Change in Self-concept [ Time Frame: Change from baseline to 6 months ]TENNESSEE SELF-CONCEPT SCALE
- Change in PERECEIVED STRESS [ Time Frame: Change from baseline to 6 months ]PERECEIVED STRESS SCALE
- Change in LONELINESS [ Time Frame: Change from baseline to 6 months ]UCLA LONELINESS SCALE
- Change in Sexual risk-taking [ Time Frame: Change from baseline to 6 months ]self-reported questions on sexual risk-taking
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Ages Eligible for Study: | 18 Years to 24 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05597865
Contact: Rachel Brathwaite, PhD | 3149351775 | rachel.brathwaite@yahoo.com |
Uganda | |
International Center for Child Health and Development Field Office | Recruiting |
Masaka, Uganda | |
Contact: Ritah Barungi rbarungi@gmail.com |
Principal Investigator: | Rachel Brathwaite, PhD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT05597865 |
Other Study ID Numbers: |
1R21AA030225-01 ( U.S. NIH Grant/Contract ) 1R21AA030225-01 ( U.S. NIH Grant/Contract ) |
First Posted: | October 28, 2022 Key Record Dates |
Last Update Posted: | December 12, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Supporting Materials: |
Study Protocol |
Time Frame: | These data will be available within 24 months after completing the study, and access will be maintained for 10 years. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Substance-Related Disorders Underage Drinking Chemically-Induced Disorders |
Mental Disorders Alcohol Drinking Drinking Behavior |