NCT05597865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

October 12, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 2, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

October 20, 2022

Results QC Date

September 29, 2025

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (16)

  • 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 6-month Assessment

    6 month follow-up

  • Optimism Scale Total Score at Baseline

    Baseline

  • Optimism Scale Total Score at 6 Months

    6 months

  • Beck Hopelessness Scale Total Score at Baseline

    Baseline

  • +11 more secondary outcomes

Study Arms (2)

Control Arm

OTHER

Control arm will received Alcohol and Drug Use Risk Reduction Sessions

Behavioral: 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.

Behavioral: Economic Empowerment InterventionBehavioral: Alcohol and Drug Use Risk Reduction Sessions

Interventions

Economic Empowerment Intervention comprising Financial Literacy Sessions and Youth Development Accounts

Intervention

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.

Control ArmIntervention

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Center for Child Health and Development Field Office

Masaka, Uganda

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Underage DrinkingAcquired Immunodeficiency Syndrome

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorAlcohol DrinkingDrinking BehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Rachel Brathwaite
Organization
Washington University in St. Louis

Study Officials

  • Rachel Brathwaite, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 28, 2022

Study Start

October 12, 2023

Primary Completion

June 6, 2024

Study Completion

June 6, 2024

Last Updated

December 2, 2025

Results First Posted

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
These data will be available within 24 months after completing the study, and access will be maintained for 10 years.

Locations