Clinical trial NCT04998045: Feasibility and Acceptability of a Substance Use Screening and Brief Intervention for Youth Living With HIV in Kenya
Official title: Feasibility and Acceptability of a Peer-delivered Substance Use Screening and Brief Intervention for Youth Attending Rafiki Clinic in Eldoret, Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Substance Use Disorders
Lead sponsor: Moi University
Sponsor class: OTHER
Collaborators: name: Indiana University
name: Duke University
name: Moi Teaching and Referral Hospital
name: Fogarty International Center of the National Institute of Health
First posted: 2021-08-10
Enrollment: 106
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Substance use assessed by the alcohol, smoking and substance involvement screening test (ASSIST)
timeFrame: baseline
Secondary outcomes:
measure: level of depressive symptoms using the patient health questionnaire 9
timeFrame: baseline
measure: level of generalised anxiety using the 7 item generalised anxiety disorder scale
timeFrame: baseline
measure: Fidelity to the intervention assessed using a researcher designed rating scale
timeFrame: during the intervention
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Florence Jaguga
state: RIFT Valley
Study officials:
affiliation: MOI TEACHING & REFERRAL HOSPITAL
name: FLORENCE JAGUGA, MMED
role: PRINCIPAL_INVESTIGATOR
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