Clinical trial NCT05545904: Feasibility of Peer-mentor Delivered Substance Use Brief Intervention for Adolescents in Kenya
Official title: A Pilot Study to Evaluate the Feasibility & Acceptability of a Peer-mentor Delivered Substance Use Screening and Brief Intervention for Adolescents in Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use
Lead sponsor: Moi University
Sponsor class: OTHER
Collaborators: name: Indiana University
First posted: 2022-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following enrollment and baseline assessment, participants will be randomized to one of the two study groups (allocation ratio: 1:1) - SBI intervention or the control condition (an education session on harms of substance use.
Primary purpose: PREVENTION

Brief summary: Adolescent substance use is prevalent in Kenya and in the US, and is associated with significant negative health and social outcomes. Unfortunately adolescents in both regions have limited access to substance use treatment because services are costly and scarce. The aim of this study is to pilot study procedures and obtain data on intervention acceptability, fidelity and preliminary efficacy, to determine the feasibility of a definitive randomized controlled trial (RCT) of the efficacy of a peer-delivered substance use brief intervention among adolescents attending an out-patient clinic in Kenya.

Detailed description: Background: Adolescent substance use is prevalent in Kenya and in the US, and is associated with significant negative health and social outcomes. Unfortunately adolescents in both regions have limited access to substance use treatment because services are costly and scarce. Substance use screening and brief Intervention (SBI) delivered in primary health care by peer-mentors, represents a promising strategy for overcoming these barriers to substance use treatment for adolescents.

Objective: The aim of this study is to pilot study procedures and obtain data on intervention acceptability, fidelity and preliminary efficacy, to determine the feasibility of a definitive randomized controlled trial (RCT) of the efficacy of a peer-delivered substance use SBI among adolescents attending an out-patient clinic in Kenya.

Design: The study will use both qualitative and quantitative methods to meet its objectives

Intervention: SBI includes a single session of screening using the Alcohol, Smoking \& Substance Use Involvement Screening Test for Youth questionnaire (ASSIST-Y), followed by a brief intervention (20-30 minutes of motivational interviewing) for those with moderate and high risk substance use. Three peers will be trained for five days on how to deliver the SBI. The peer-mentors will receive regular supervision throughout the study implementation process.

Outcomes: SBI feasibility will be defined by the extent to which fidelity to the SBI is maintained and the preliminary effects of the SBI on substance use and quality of life outcomes. SBI acceptability will be evaluated from the perspective of the adolescents using qualitative interviews guided by Sekhon's theoretical framework of acceptability. Feasibility of conducting a future full-scale RCT will be explored by measuring outcomes such as study participation rate, willingness to be randomized, study completion rates and ability to measure effectiveness outcomes.

Investigating team and future plans: This study will be conducted by a team including faculty from Moi Teaching and Referral Hospital, faculty from Indiana University, and a team from the National Authority for Campaign Against Alcohol and drug abuse (NACADA). Our team has experience implementing and scaling peer-led substance use SBIs for adolescent populations. If the SBI and its delivery are found to be feasible and acceptable the plan is to partner with the government to conduct a full-scale multi-site RCT in Kenya and Indiana.

Eligibility criteria: Inclusion Criteria:

* Participants will be adolescents attending the Rafiki clinic, aged 15-24 years and who have moderate or high risk substance use as defined by the Alcohol, Smoking \& Substance Use Involvement Screening Test for Youth questionnaire (ASSIST-Y) scores

Exclusion Criteria:

* The following youth will be excluded: (i) those ill during the appointment (ii) those who decline to assent/consent (iii) those already enrolled in the Fogarty project.

Primary outcomes:
measure: Change in substance use scores (measured using ASSIST-Y)
timeFrame: Change from baseline to 3 months post-intervention.
Secondary outcomes:
measure: Change in quality of life scores (measured using the Brief Version WHO-Quality of life tool)
timeFrame: Change from baseline to 3 months post-intervention.
measure: Fidelity to the intervention assessed using a researcher designed rating scale
timeFrame: until completion of participant recruitment and follow-up, an average of 3 months
measure: Study Participation Rate
timeFrame: until completion of participant recruitment and follow-up, an average of 3 months
measure: Proportion of participants meeting inclusion criteria who get excluded
timeFrame: until completion of participant recruitment and follow-up, an average of 3 months
measure: Proportion of participants willing to be randomized
timeFrame: until completion of participant recruitment and follow-up, an average of 3 months
measure: Study Completion Rate
timeFrame: Baseline, month 3
measure: Participant Burden
timeFrame: Baseline, month 3
measure: Data Completeness
timeFrame: Baseline, month 3
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Florence Jaguga
state: RIFT Valley
Study officials:
affiliation: MOI TEACHING & REFERRAL HOSPITAL
name: FLORENCE M, JAGUGA, MMED
role: PRINCIPAL_INVESTIGATOR
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