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

September 11, 2022 updated by: Moi University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
    • RIFT Valley
      • Eldoret, RIFT Valley, Kenya, 30100
        • Florence Jaguga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 24 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention arm
Youth aged 15-24 years Intervention: screening and brief intervention for substance use
Behavioral: Screening and brief intervention for substance use
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.

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)
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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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)
baseline
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.
during the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moi University

Collaborators

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

Investigators

  • Principal Investigator: FLORENCE JAGUGA, MMED, MOI TEACHING & REFERRAL HOSPITAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2021

Primary Completion (ACTUAL)

March 30, 2022

Study Completion (ACTUAL)

June 30, 2022

Study Registration Dates

First Submitted

June 26, 2021

First Submitted That Met QC Criteria

August 1, 2021

First Posted (ACTUAL)

August 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 11, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MoiU5
  • D43TW009345 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD collected during the study after de-identification

IPD Sharing Time Frame

immediately following publication no end date

IPD Sharing Access Criteria

researchers whose proposed use of the data has been reviewed and approved by an IRB.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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