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Preventing Harmful Alcohol Use Among Trauma Patients in Cameroon

2026年6月27日 更新者:Serge Ngekeng、University of Buea

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.

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.

調査の概要

詳細な説明

**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.

研究の種類

介入

入学 (推定)

690

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Serge Ngekeng, PhD in Public Health
  • 電話番号:+237675652562
  • メール:sergengekeng@gmail.com

研究場所

    • South-West Region
      • Limbe、South-West Region、カメルーン、00237
        • Limbe Regional Hospital
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Immediate SBIRT
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.
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.
アクティブコンパレータ:Waitlist Control
Participants receive usual care during the follow-up period and are offered the SBIRT intervention after completion of the six-month follow-up assessment.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Alcohol Use at 6 Months
時間枠:Baseline and 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).
Baseline and 6 months
Change in Phosphatidylethanol (PEth) Levels
時間枠:Baseline and 6 months
Change in alcohol consumption measured using phosphatidylethanol (PEth), a biomarker of recent alcohol use, from baseline to 6 months.
Baseline and 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Alcohol Use at 1 Month
時間枠: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.
1 month
Alcohol Use at 3 Months
時間枠: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.
3 Months
PEth Levels at 1 Month
時間枠:1 Month
PEth concentration at 1 month following enrollment.
1 Month
PEth Levels at 3 months
時間枠:3 month
PEth concentration at 3 month following enrollment.
3 month
Referral Uptake
時間枠:Within 6 months
Proportion of participants referred for additional alcohol treatment services who attend at least one referral appointment.
Within 6 months
Depressive Symptoms
時間枠:Baseline, 1 month, 3 months, and 6 months
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
Baseline, 1 month, 3 months, and 6 months
SBIRT Delivery Rate
時間枠:Through study completion, an average of 36 months.
Proportion of eligible participants who receive all components of the SBIRT intervention.
Through study completion, an average of 36 months.
Intervention Fidelity
時間枠:Through study completion, an average of 36 months.
Adherence of healthcare workers to SBIRT delivery protocols assessed using structured fidelity checklists.
Through study completion, an average of 36 months.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Serge Ngekeng, PhD in Public Health、University of Buea

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年3月1日

一次修了 (推定)

2030年8月1日

研究の完了 (推定)

2030年8月1日

試験登録日

最初に提出

2026年6月19日

QC基準を満たした最初の提出物

2026年6月27日

最初の投稿 (実際)

2026年6月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月30日

QC基準を満たした最後の更新が送信されました

2026年6月27日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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