NCT04998045

Brief Summary

Youth living with HIV in Kenya frequently use substances and this negatively affects their mental health as well as viral suppression. The goal of this study is to evaluate the feasibility and acceptability of a peer-delivered substance use screening and brief intervention for these youth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

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

June 26, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

June 26, 2021

Last Update Submit

September 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Substance use assessed by the alcohol, smoking and substance involvement screening test (ASSIST)

    The ASSIST tool enquires about lifetime use of 9 substances (alcohol, tobacco, cannabis, cocaine, inhalants, amphetamines, opioids, hallucinogens and sedatives). Endorsement of lifetime use is followed by a series of questions enquiring about pattern of use in the past 3 months. Scoring for alcohol use is as follows: 0-10 Low; 11-26 Moderate; 27+ High. Scoring for all other substances is as follows: 0-3 Low; 4-26 Moderate; 27+ High

    baseline

Secondary Outcomes (3)

  • level of depressive symptoms using the patient health questionnaire 9

    baseline

  • level of generalised anxiety using the 7 item generalised anxiety disorder scale

    baseline

  • Fidelity to the intervention assessed using a researcher designed rating scale

    during the intervention

Study Arms (1)

Intervention arm

EXPERIMENTAL

Youth aged 15-24 years Intervention: screening and brief intervention for substance use

Behavioral: Screening and brief intervention for substance use

Interventions

Screening will be done using the WHO Alcohol Smoking and Substance Involvement Screening Test (ASSIST). The brief intervention will be delivered based on ASSIST risk scores: low risk - verbal positive reinforcement and brief advice on harmful consequences of substance use (ii) moderate risk - brief motivational interviewing (BMI) (iii) high risk - BMI and referral to child psychiatry out-patient clinic. The BMI will be delivered in a single session (approximately 15 minutes) using Feedback Listen Options model (15): (i) providing feedback on screening results (ii) exploring pros and cons of substance use, enquiring about importance of change (iii) exploring options for change.

Intervention arm

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Youth aged 15-24 years

You may not qualify if:

  • those ill during the appointment
  • those who decline to assent/consent
  • youth unable to speak fluently in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florence Jaguga

Eldoret, RIFT Valley, 30100, Kenya

Location

Related Publications (13)

  • Gamarel KE, Brown L, Kahler CW, Fernandez MI, Bruce D, Nichols S; Adolescent Medicine Trials Network for HIV/AIDS Intervention. Prevalence and correlates of substance use among youth living with HIV in clinical settings. Drug Alcohol Depend. 2016 Dec 1;169:11-18. doi: 10.1016/j.drugalcdep.2016.10.002. Epub 2016 Oct 11.

    PMID: 27750182BACKGROUND
  • Gaitho D, Kumar M, Wamalwa D, Wambua GN, Nduati R. Understanding mental health difficulties and associated psychosocial outcomes in adolescents in the HIV clinic at Kenyatta National Hospital, Kenya. Ann Gen Psychiatry. 2018 Jul 10;17:29. doi: 10.1186/s12991-018-0200-8. eCollection 2018.

    PMID: 30002721BACKGROUND
  • Parcesepe AM, Lancaster K, Edelman EJ, DeBoni R, Ross J, Atwoli L, Tlali M, Althoff K, Tine J, Duda SN, Wester CW, Nash D; IeDEA Consortium. Substance use service availability in HIV treatment programs: Data from the global IeDEA consortium, 2014-2015 and 2017. PLoS One. 2020 Aug 27;15(8):e0237772. doi: 10.1371/journal.pone.0237772. eCollection 2020.

    PMID: 32853246BACKGROUND
  • Peltzer K, Matseke G, Azwihangwisi M. Evaluation of alcohol screening and brief intervention in routine practice of primary care nurses in Vhembe district, South Africa. Croat Med J. 2008 Jun;49(3):392-401. doi: 10.3325/cmj.2008.3.392.

    PMID: 18581618BACKGROUND
  • Mark D, Hrapcak S, Ameyan W, Lovich R, Ronan A, Schmitz K, Hatane L. Peer Support for Adolescents and Young People Living with HIV in sub-Saharan Africa: Emerging Insights and a Methodological Agenda. Curr HIV/AIDS Rep. 2019 Dec;16(6):467-474. doi: 10.1007/s11904-019-00470-5.

    PMID: 31776974BACKGROUND
  • Winn LAP, Paquette KL, Donegan LRW, Wilkey CM, Ferreira KN. Enhancing adolescent SBIRT with a peer-delivered intervention: An implementation study. J Subst Abuse Treat. 2019 Aug;103:14-22. doi: 10.1016/j.jsat.2019.05.009. Epub 2019 May 14.

    PMID: 31229188BACKGROUND
  • Humeniuk R, Ali R, Babor TF, Farrell M, Formigoni ML, Jittiwutikarn J, de Lacerda RB, Ling W, Marsden J, Monteiro M, Nhiwatiwa S, Pal H, Poznyak V, Simon S. Validation of the Alcohol, Smoking And Substance Involvement Screening Test (ASSIST). Addiction. 2008 Jun;103(6):1039-47. doi: 10.1111/j.1360-0443.2007.02114.x. Epub 2008 Mar 28.

    PMID: 18373724BACKGROUND
  • Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

    PMID: 19664226BACKGROUND
  • Musyoka CM, Mbwayo A, Donovan D, Mathai M. Alcohol and substance use among first-year students at the University of Nairobi, Kenya: Prevalence and patterns. PLoS One. 2020 Aug 28;15(8):e0238170. doi: 10.1371/journal.pone.0238170. eCollection 2020.

    PMID: 32857791BACKGROUND
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Kohrt BA, Ramaiya MK, Rai S, Bhardwaj A, Jordans MJD. Development of a scoring system for non-specialist ratings of clinical competence in global mental health: a qualitative process evaluation of the Enhancing Assessment of Common Therapeutic Factors (ENACT) scale. Glob Ment Health (Camb). 2015;2:e23. doi: 10.1017/gmh.2015.21. Epub 2015 Dec 9.

    PMID: 28593049BACKGROUND
  • Jaguga F, Kwobah EK, Giusto A, Apondi E, Barasa J, Korir M, Rono W, Kosgei G, Puffer E, Ott M. Feasibility and acceptability of a peer provider delivered substance use screening and brief intervention program for youth in Kenya. BMC Public Health. 2023 Nov 16;23(1):2254. doi: 10.1186/s12889-023-17146-w.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Mass ScreeningCrisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health PracticePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • FLORENCE JAGUGA, MMED

    MOI TEACHING & REFERRAL HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All eligible youth will be screened for substance use and assigned to the intervention based on level of substance use risk. Immediately after the intervention they will rate the acceptability of the intervention. After enrollment is over, peers, clinic staff and youth will be asked to give feedback (qualitative and quantitative) on the feasibility and acceptability of the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2021

First Posted

August 10, 2021

Study Start

July 1, 2021

Primary Completion

March 30, 2022

Study Completion

June 30, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

All IPD collected during the study after de-identification

Shared Documents
STUDY PROTOCOL
Time Frame
immediately following publication no end date
Access Criteria
researchers whose proposed use of the data has been reviewed and approved by an IRB.

Locations