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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04998045
• Other study ID #: MoiU5
• Secondary ID: D43TW009345
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2022
• Source: Moi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Kenya	Florence Jaguga	Eldoret	RIFT Valley

Sponsors (5)

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

Country where clinical trial is conducted

Kenya, 

References & Publications (12)

Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50. — View Citation

Gaitho D, Kumar M, Wamalwa D, Wambua GN, Nduati R. Understanding mental health difficulties and associated psychosocial outcomes in adolescents in the HIV clinic at Kenyatta National Hospital, Kenya. Ann Gen Psychiatry. 2018 Jul 10;17:29. doi: 10.1186/s12991-018-0200-8. eCollection 2018. — View Citation

Gamarel KE, Brown L, Kahler CW, Fernandez MI, Bruce D, Nichols S; Adolescent Medicine Trials Network for HIV/AIDS Intervention. Prevalence and correlates of substance use among youth living with HIV in clinical settings. Drug Alcohol Depend. 2016 Dec 1;169:11-18. doi: 10.1016/j.drugalcdep.2016.10.002. Epub 2016 Oct 11. — View Citation

Humeniuk R, Ali R, Babor TF, Farrell M, Formigoni ML, Jittiwutikarn J, de Lacerda RB, Ling W, Marsden J, Monteiro M, Nhiwatiwa S, Pal H, Poznyak V, Simon S. Validation of the Alcohol, Smoking And Substance Involvement Screening Test (ASSIST). Addiction. 2008 Jun;103(6):1039-47. doi: 10.1111/j.1360-0443.2007.02114.x. Epub 2008 Mar 28. — View Citation

Kohrt BA, Ramaiya MK, Rai S, Bhardwaj A, Jordans MJD. Development of a scoring system for non-specialist ratings of clinical competence in global mental health: a qualitative process evaluation of the Enhancing Assessment of Common Therapeutic Factors (ENACT) scale. Glob Ment Health (Camb). 2015;2. pii: e23. doi: 10.1017/gmh.2015.21. Epub 2015 Dec 9. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

Mark D, Hrapcak S, Ameyan W, Lovich R, Ronan A, Schmitz K, Hatane L. Peer Support for Adolescents and Young People Living with HIV in sub-Saharan Africa: Emerging Insights and a Methodological Agenda. Curr HIV/AIDS Rep. 2019 Dec;16(6):467-474. doi: 10.1007/s11904-019-00470-5. Review. — View Citation

Musyoka CM, Mbwayo A, Donovan D, Mathai M. Alcohol and substance use among first-year students at the University of Nairobi, Kenya: Prevalence and patterns. PLoS One. 2020 Aug 28;15(8):e0238170. doi: 10.1371/journal.pone.0238170. eCollection 2020. — View Citation

Parcesepe AM, Lancaster K, Edelman EJ, DeBoni R, Ross J, Atwoli L, Tlali M, Althoff K, Tine J, Duda SN, Wester CW, Nash D; IeDEA Consortium. Substance use service availability in HIV treatment programs: Data from the global IeDEA consortium, 2014-2015 and 2017. PLoS One. 2020 Aug 27;15(8):e0237772. doi: 10.1371/journal.pone.0237772. eCollection 2020. — View Citation

Peltzer K, Matseke G, Azwihangwisi M. Evaluation of alcohol screening and brief intervention in routine practice of primary care nurses in Vhembe district, South Africa. Croat Med J. 2008 Jun;49(3):392-401. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Winn LAP, Paquette KL, Donegan LRW, Wilkey CM, Ferreira KN. Enhancing adolescent SBIRT with a peer-delivered intervention: An implementation study. J Subst Abuse Treat. 2019 Aug;103:14-22. doi: 10.1016/j.jsat.2019.05.009. Epub 2019 May 14. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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