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Completed

NCT Number: NCT04998045

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

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.

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Key information

Conditions

Substance Use Chemically-Induced Disorders Mental Disorders Substance Use Disorders Substance-Related Disorders

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florence Jaguga

Eldoret, RIFT Valley, 30100, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Screening and brief intervention for substance use

Behavioral

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.

Primary outcomes

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

    Time frame: baseline

    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

Secondary outcomes

  1. level of depressive symptoms using the patient health questionnaire 9

    Time frame: baseline

    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.

  2. level of generalised anxiety using the 7 item generalised anxiety disorder scale

    Time frame: baseline

    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)

  3. Fidelity to the intervention assessed using a researcher designed rating scale

    Time frame: during the intervention

    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.

Sponsors and collaborators

Lead sponsor

Moi University

Other

Collaborators

  • Duke University
  • Fogarty International Center of the National Institute of Health
  • Indiana University
  • Moi Teaching and Referral Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2021
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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