Alcohol Use DisorderNCT07677449
Preventing Harmful Alcohol Use Among Trauma Patients in Cameroon
A study testing Cameroon-Adapted SBIRT in people with Alcohol Use Disorder and Alcohol-Related Injury, run by University of Buea at 1 site in Cameroon.
Trial summary
Brief Summary Alcohol use is a major contributor to injury burden in Cameroon, particularly among trauma patients presenting to emergency departments. Despite the strong association between alcohol use and injury, structured alcohol screening and intervention programs are not routinely integrated into trauma care in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol-Related Injury, Trauma
- What is being tested?
- Cameroon-Adapted SBIRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 1 siteCameroon
- Study dates
- Mar 2027to Aug 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult trauma patients aged 18 years and older presenting to the Emergency Department of Limbe Regional Hospital.
- Positive alcohol screening based on the Single Alcohol Screening Question (SASQ).
- AUDIT-C score ≥4 for men or ≥3 for women.
- Able to provide informed consent.
- Resident within the study catchment area and available for follow-up.
- Access to a telephone or another reliable means of contact for follow-up assessments.
Who cannot join
- Severe cognitive impairment preventing participation in study procedures or - provision of informed consent.
- Severe traumatic brain injury or other medical condition requiring immediate life-saving intervention that precludes participation.
- Current psychosis or severe psychiatric illness preventing meaningful participation in the intervention.
- In police custody or other circumstances limiting ability to participate in follow-up.
- Planned relocation outside the study catchment area during the study follow-up period.
- Previously enrolled in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cameroon1 site
Limbe Regional Hospital
Limbe, South-West Region, 00237
Serge Ngekeng, PhD in public Health, 675652562, sergengekeng@gmail.com
About this study
Official title: Implementation of a Culturally Adapted Alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) Program in Cameroon
Brief Summary
Alcohol use is a major contributor to injury burden in Cameroon, particularly among trauma patients presenting to emergency departments. Despite the strong association between alcohol use and injury, structured alcohol screening and intervention programs are not routinely integrated into trauma care in Cameroon. This study aims to evaluate a Cameroon-adapted Screening, Brief Intervention, and Referral to Treatment (SBIRT) program for trauma patients at the Limbe Regional Hospital.
Read more
The study will be conducted in three phases: (1) training emergency department healthcare providers on a culturally adapted SBIRT program; (2) evaluating the feasibility, acceptability, and fidelity of SBIRT implementation in routine emergency care; and (3) assessing the effectiveness of SBIRT in reducing harmful alcohol use among trauma patients. Healthcare workers will be trained to deliver SBIRT, and eligible trauma patients screening positive for risky alcohol use will be enrolled in a randomized waitlist-controlled trial. Participants will undergo alcohol screening using validated tools and will be followed for six months. Outcomes will include alcohol use measured by the Alcohol Use Disorders Identification Test (AUDIT), phosphatidylethanol (PEth) biomarker levels, referral uptake, implementation outcomes, and patient well-being measures.
The study is expected to generate evidence on the feasibility and effectiveness of integrating alcohol interventions into trauma care in a low-resource setting and inform future scale-up of SBIRT programs in Cameroon and similar settings.
Read the detailed description
Detailed Description
Alcohol use is a major contributor to the burden of injury in Cameroon and other low- and middle-income countries (LMICs). Studies conducted in Cameroon have demonstrated high levels of alcohol use among road users and trauma patients, with substantial proportions of injured patients reporting recent alcohol consumption or testing positive for alcohol at the time of injury. Harmful alcohol use is associated with increased risk of injury, injury recurrence, disability, and mortality. Despite this burden, systematic alcohol screening and intervention services are not routinely integrated into trauma care in Cameroon.
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based approach designed to identify individuals with risky alcohol use, provide brief counseling to promote behavior change, and facilitate referral to treatment when indicated. SBIRT has been successfully implemented in emergency departments and trauma centers in high-income countries and has demonstrated effectiveness in reducing harmful alcohol use and alcohol-related consequences. However, little is known about the feasibility, acceptability, and effectiveness of SBIRT in resource-constrained emergency care settings in sub-Saharan Africa.
The purpose of this study is to evaluate a Cameroon-adapted SBIRT program implemented within the Emergency Department of the Limbe Regional Hospital. The intervention was developed through a participatory adaptation process involving emergency department clinicians, mental health providers, trauma researchers, implementation scientists, and other stakeholders to ensure cultural appropriateness and operational feasibility within the Cameroonian healthcare context.
The study has three primary objectives: (1) to train emergency department healthcare providers in delivery of a Cameroon-adapted SBIRT program; (2) to evaluate the feasibility, acceptability, adoption, and fidelity of SBIRT implementation in routine emergency care; and (3) to evaluate the effectiveness of SBIRT in reducing harmful alcohol use among trauma patients.
The study will be conducted in phases. During the preparatory phase, stakeholders will be engaged to refine implementation procedures and pretest the training curriculum. Emergency department healthcare workers, including physicians, nurses, and mental health nurses, will then undergo structured training on alcohol screening, motivational interviewing, brief intervention delivery, and referral procedures. Following training, a transition period will be used to integrate SBIRT into routine emergency department operations and optimize implementation workflows before initiation of full study enrollment.
All eligible adult trauma patients presenting to the Emergency Department will be screened for alcohol use using the Single Alcohol Screening Question (SASQ). Patients reporting alcohol use will complete the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C). Men with AUDIT-C scores of 4 or greater and women with AUDIT-C scores of 3 or greater will be considered positive for risky alcohol use and eligible for study enrollment. Participants will subsequently complete the full Alcohol Use Disorders Identification Test (AUDIT) for characterization of alcohol use severity. Individuals with AUDIT scores of 8 or greater will be referred for additional evaluation and treatment according to the study referral protocol.
Eligible participants will be randomized to either an intervention arm or a waitlist-control arm. Participants assigned to the intervention arm will receive the Cameroon-adapted SBIRT program delivered by trained healthcare workers during their emergency department visit. The intervention consists of alcohol risk screening, personalized feedback regarding alcohol use, a brief motivational interviewing-based counseling session, and referral to treatment when indicated. Participants assigned to the waitlist-control arm will receive usual care during the study period and will be offered the intervention following completion of study follow-up.
Participants will be followed for six months following enrollment. Follow-up assessments will occur at one month, three months, and six months after enrollment. Alcohol use outcomes will be assessed using both self-reported and biological measures. Self-reported alcohol use will be measured using the AUDIT instrument. Biological alcohol use will be assessed using phosphatidylethanol (PEth), a validated biomarker of recent alcohol consumption. Additional outcomes will include referral uptake, treatment engagement, depression symptoms measured using the Patient Health Questionnaire-9 (PHQ-9), and injury-related outcomes.
Implementation outcomes will be evaluated using implementation science frameworks including the Consolidated Framework for Implementation Research (CFIR), Proctor's Implementation Outcomes Framework, and the FRAMES model. Feasibility, acceptability, fidelity, adoption, and implementation determinants will be assessed through implementation monitoring, provider surveys, direct observation of intervention delivery, and qualitative interviews with healthcare workers and patients.
The primary hypothesis is that the Cameroon-adapted SBIRT program can be feasibly integrated into routine emergency department care and that participants receiving the intervention will demonstrate greater reductions in harmful alcohol use over six months compared with participants receiving usual care. The study will generate evidence regarding implementation strategies, intervention effectiveness, and scalability of alcohol interventions in trauma care settings within LMICs.
Results from this study are expected to inform future implementation and scale-up of SBIRT programs in Cameroon and other resource-limited settings. The findings may also provide implementation insights relevant to underserved trauma systems and emergency care settings globally where access to behavioral health and substance use services remains limited.
- Conditions
- Alcohol Use Disorder, Alcohol-Related Injury, Trauma
- Being tested
- Cameroon-Adapted SBIRT, Usual Care
- Keywords
- Alcohol Use Disorder (AUD), Alcohol Screening, Alcohol-Related Injury, Screening, Brief Intervention, and Referral to Treatment (SBIRT), Brief Intervention, Emergency Department, Trauma Care, AUDIT-C, Referral to Treatment, Substance Use Intervention, Emergency Medicine, Implementation Science, Injury Prevention, Road Traffic Injury, Trauma Patients
- Medical subject headings
- Alcoholism, Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cameroon-Adapted SBIRTBehavioural
A culturally adapted Screening, Brief Intervention, and Referral to Treatment (SBIRT) program delivered by trained emergency department healthcare workers. The intervention includes alcohol risk screening, brief motivational interviewing-based counseling, and referral to treatment when appropriate.
Usual CareOther
Standard emergency department care without structured SBIRT delivery during the study follow-up period. Participants are offered SBIRT after completing six months of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Immediate SBIRT | Experimental | Participants receive the Cameroon-adapted Screening, Brief Intervention, and Referral to Treatment (SBIRT) program during their emergency department visit. The intervention includes alcohol screening, personalized feedback, a brief motivational interviewing-based counseling session, and referral to treatment when indicated. Receives: Behavioral: Cameroon-Adapted SBIRT |
| Waitlist Control | Active comparator | Participants receive usual care during the follow-up period and are offered the SBIRT intervention after completion of the six-month follow-up assessment. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use at 6 Months
Change in harmful alcohol use from baseline to 6 months following enrollment, measured using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C).
Measured: Baseline and 6 months
Change in Phosphatidylethanol (PEth) Levels
Change in alcohol consumption measured using phosphatidylethanol (PEth), a biomarker of recent alcohol use, from baseline to 6 months.
Measured: Baseline and 6 months
Secondary outcomes (8)
Alcohol Use at 1 Month
Change in Alcohol Use Measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score at 1 month following enrollment. The total score ranges from 0 to 12, with higher scores indicating greater alcohol consumption and increased risk of hazardous or harmful drinking.
Measured: 1 month
Alcohol Use at 3 Months
Change in Alcohol Use Measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score at 3 month following enrollment. The total score ranges from 0 to 12, with higher scores indicating greater alcohol consumption and increased risk of hazardous or harmful drinking.
Measured: 3 Months
PEth Levels at 1 Month
PEth concentration at 1 month following enrollment.
Measured: 1 Month
PEth Levels at 3 months
PEth concentration at 3 month following enrollment.
Measured: 3 month
Referral Uptake
Proportion of participants referred for additional alcohol treatment services who attend at least one referral appointment.
Measured: Within 6 months
Depressive Symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated nine-item self-report questionnaire that measures the severity of depressive symptoms over the preceding two weeks. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms
Measured: Baseline, 1 month, 3 months, and 6 months
SBIRT Delivery Rate
Proportion of eligible participants who receive all components of the SBIRT intervention.
Measured: Through study completion, an average of 36 months.
Intervention Fidelity
Adherence of healthcare workers to SBIRT delivery protocols assessed using structured fidelity checklists.
Measured: Through study completion, an average of 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startMar 2027 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who screen positive for risky alcohol use based on AUDIT-C criteria will be randomly assigned in a 1:1 ratio to either an immediate intervention group or a waitlist-control group. Participants in the immediate intervention group will receive the Cameroon-adapted Screening, Brief Intervention, and Referral to Treatment (SBIRT) program during their emergency department visit. Participants in the waitlist-control group will receive usual care during the study follow-up period and will be offered the SBIRT intervention after completion of the six-month follow-up assessment. All participants will undergo baseline assessment and follow-up evaluations at 1, 3, and 6 months. Outcomes will be compared between groups to evaluate the effectiveness of the intervention.
- Masking
- None (open label)
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Buea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serge Ngekeng, University of Buea
- Investigators
- Serge Ngekeng, PhD in Public Health, Principal investigator, University of Buea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677449
- Sponsor's protocol ID
- SBIRT_UB
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available at this time. The study collects sensitive clinical, behavioral, and biomarker data, and participant confidentiality must be protected. Future sharing of de-identified data may be considered upon reasonable request and subject to applicable ethical, institutional, and regulatory approvals.
Publications
Ngekeng S, Kibu O, Oke R, Bassah N, Touko DA, Yost MT, Dissak-Delon F, Tendongfor N, Nguefack-Tsague G, Hubbard A, McCoy SI, Christie SA, Chichom-Mefire A, Juillard C. Prehospital factors associated with mortality among road traffic injury patients: analysis of Cameroon trauma registry data. BMC Emerg Med. 2024 Oct 16;24(1):194. doi: 10.1186/s12873-024-01113-8.
PubMed 39415156Ngekeng S, Oke R, Yost M, Dissak-Delon F, Hubbard A, McCoy SI, Christie A, Shoptaw S, Chichom-Mefire A, Juillard C. Prevalence and Factors Associated With Alcohol-Related Road Traffic Injuries in Cameroon. J Surg Res. 2024 Oct;302:116-124. doi: 10.1016/j.jss.2024.07.050. Epub 2024 Aug 2.
PubMed 39096740Babor TF, Del Boca F, Bray JW. Screening, Brief Intervention and Referral to Treatment: implications of SAMHSA's SBIRT initiative for substance abuse policy and practice. Addiction. 2017 Feb;112 Suppl 2:110-117. doi: 10.1111/add.13675.
PubMed 28074569Babor TF, McRee BG, Kassebaum PA, Grimaldi PL, Ahmed K, Bray J. Screening, Brief Intervention, and Referral to Treatment (SBIRT): toward a public health approach to the management of substance abuse. Subst Abus. 2007;28(3):7-30. doi: 10.1300/J465v28n03_03.
PubMed 18077300