Feasibility and Acceptability of a Substance Use Screening and Brief Intervention for Youth Living With HIV in Kenya

Study Overview
=================
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.

Detailed Description
-----------------
Globally, youth are disproportionately affected by substance use. In sub-Saharan Africa (SSA), an estimated 41% of youth have used at least one substance in their lifetime. Youth Living with HIV (YLH) have not been spared. In a study conducted in Kenya, 33% and 46% of youth attending a HIV clinic reported harmful patterns of alcohol and illicit substance use respectively. Substance use among YLH has been associated with negative outcomes including antiretroviral therapy (ART) non-adherence, neurocognitive deficits, poor virologic control and depression. Unfortunately, YLH in SSA lack access to substance use interventions. A study conducted by Parcesepe et al reported that only 37% of HIV adolescent sites in select LMICs offered any substance use screening and interventions. The World Health Organization (WHO) recommends screening and brief intervention (SBI) in primary healthcare for identification and early intervention for substance use. Primary healthcare workers in LMICs are however often unable to implement SBI due to heavy workload. Peers represent a potential means through which SBI may be delivered in adolescent HIV settings and presents a number of advantages. First, peer support systems are well established in many adolescent HIV clinics in sub-Saharan Africa. Secondly, by drawing upon their shared experiences as youth living with HIV, the peers can provide empathic support to the adolescents. Few studies have evaluated implementation of peer-delivered SBI for adolescents. Available studies have been conducted in high-income countries. To our knowledge, no study has evaluated implementation of peer-delivered SBI among YLH. Our project seeks to fill this gap by evaluating the feasibility and acceptability of a peer-delivered SBI for YLH in Kenya. This project is in line with: (i) Kenyan Ministry of Health guidelines for delivery of adolescent and youth friendly services which lists substance use counseling as an essential service, and (ii) United Nations Programme on HIV/AIDS (UNAIDS) Fast-track target 95-95-95, which requires that by 2030, 95% of people on ART be virally suppressed (12) as well as target 3.5 of the Sustainable Development Goals (SDGs) which requires that governments strengthen the treatment and prevention of substance abuse. Data from this study will set the stage for full-efficacy trials and ultimately to scale-up efforts to other LMICs.

Official Title
-----------------
Feasibility and Acceptability of a Peer-delivered Substance Use Screening and Brief Intervention for Youth Attending Rafiki Clinic in Eldoret, Kenya

Conditions
-----------------
Substance Use, Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Screening and brief intervention for substance use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: • Youth aged 15-24 years Exclusion criteria those ill during the appointment those who decline to assent/consent youth unable to speak fluently in English.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Youth aged 15-24 years Intervention: screening and brief intervention for substance use | Behavioral: Screening and brief intervention for substance use<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of depressive symptoms using the patient health questionnaire 9 | It is a 9 item tool that examines for symptoms over the past two week period. Each of the 9 items is rated as follows: 0 - not at all, 1 - Several days, 2 - More than half the days, 3 - Nearly every day. Scoring: 0-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. | baseline | 
| level of generalised anxiety using the 7 item generalised anxiety disorder scale | It is a 7 item tool that examines for symptoms over the past two week period. Scoring: mild anxiety (5-9), moderate range (10-14), and severe range (15-21) | baseline | 
| Fidelity to the intervention assessed using a researcher designed rating scale | Fidelity checklists will be developed based on key elements of the intervention. Items will be rated by the SBI trainers on a 3-point scale. | during the intervention |