IGHID 12230 - HIV 予防のための経験的な簡単なアルコール介入の実施試験 (EBAI)

アクティブコンパレータ：ファシリテーションのみ (FAC)

FAC 部門にランダムに割り当てられたクリニックは、促進のみのアプローチを使用して PWH への BAI の提供を実施します。

他の：ファシリテーション (FAC)

促進アプローチでは、クリニックがカウンセラーのスキル、競合する優先事項、リソース不足などの共通の障壁に対処できるようにする柔軟なクリニック レベルの実装戦略が使用されます。

実験的：促進と経験的な簡単なアルコール介入 (EBAI+FAC)

EBAI+FAC 部門にランダムに割り当てられたクリニックは、促進アプローチを使用して PWH 参加者に BAI を実施します。 さらに、クリニックのスタッフは、自身のアルコール使用に関係なく、BAI を提供する前に自ら BAI を提供されます。

他の：ファシリテーション (FAC)

促進アプローチでは、クリニックがカウンセラーのスキル、競合する優先事項、リソース不足などの共通の障壁に対処できるようにする柔軟なクリニック レベルの実装戦略が使用されます。

行動：体験的簡易アルコール介入 (EBAI)

クリニックのスタッフには、導入前に体験型 BAI が提供されます。 BAI は 2 回の対面セッションと 2 回のブースター電話セッションで構成されます。 PWH参加者へのBAIの提供を担当するクリニックのスタッフには、BAIを受けた経験とBAIの提供を統合するための追加の3回の統合セッションが提供されます。

Fidelity Score

Fidelity is a clinic-level measure assessed as a composite of the recipients of the BAI. The timeframe of 15 months reflects individual recruitment over 12 months plus 3 months for completion of the BAI.

The score comprises successful completion of the 4 protocol-specified BAI sessions (2 in-person, 2 by phone) within 7 weeks of the initial session weighted by the central fidelity rater's quality rating of the in-person sessions. Fidelity will be assessed using a tailored selection of fidelity measures including the BAI Core Components Checklist. The clinic fidelity score ranges from 0-100. The score will be the percentage of counseling sessions completed, multiplied (weighted) by the combined average quality rating of counseling sessions. Higher scores indicate higher fidelity.

Viral Suppression

Viral suppression is defined as a viral load <1000 copies/mL on a dried blood spot (DBS) sample collected 12 months after enrollment of a participant.

BAI Acceptability Score - Clinic Staff: Acceptability of Intervention Measure (AIM) scale

Acceptability is the perception that the BAI intervention is agreeable, palatable, or satisfactory to clinic staff.

Acceptability among clinic staff will be assessed using the Acceptability of Intervention Measure (AIM), which consists of 4 items containing responses on a 5-point Likert scale, ranging from 1-4.

The AIM score will be the mean of the 4 item responses (range: 1-5). Higher AIM scores indicate higher acceptability.

BAI Acceptability score Counselors: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Providers

Acceptability is the perception that the BAI intervention is agreeable, palatable, or satisfactory to counselors delivering the BAI to patients.

Acceptability among counselor participants will be assessed using the Mental Health Implementation Science Tools (mhIST) Acceptability Scale for providers, which consists of 13 items containing responses on a 4-point Likert scale, ranging from 0-3. The mhIST score is calculated as the mean score of all responses (range: 0-39). Higher mhIST scores indicate higher acceptability.

BAI Acceptability PWH: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Consumers

Acceptability is the perception that the BAI intervention is agreeable, palatable, or satisfactory to PWH.

Acceptability among PWH participants will be assessed using the Mental Health Implementation Science Tools (mhIST) Acceptability Scale for consumers, which consists of 15 items containing responses on a 4-point Likert scale ranging from 0-3. The mhIST score is calculated as the mean score of all responses (range: 0-45). Higher mhIST scores indicate higher acceptability.

Penetration- Proportion of PWH Screened with the AUDIT-C

The first penetration metric will be the: proportion of PWH initiating or on ART who are screened with the AUDIT-C.

Penetration - Proportion of PWH who screen positive who receive at least one counseling session

The second penetration metric will be the proportion of PWH that screen positive who receive at least one BAI counseling session.

Costs

Investigators will use an "ingredients" or bottom-up approach, with comparison to "top-down" costing. The cost estimates will follow the investigators published conceptual framework for assessing implementation costs and cost analysis of health services. Investigators will include all types of measurable costs (e.g., staff, equipment, consumables, overheads, etc.) associated with key steps and component of the respective implementation strategy and BAI service delivery. Investigators will follow international conventions for all procedures including economic costing, discounting, and reporting.

Sustainability Score: Provider Support of Sustainment Scale (PRESS)

Sustainability will be measured among clinic staff, including directors, using the provider support of sustainment scale (PRESS), a brief, 3-item measure of sustainment that is pragmatic and useable across different evidence-based intervention (EBIs), provider types, and settings. Responses are recorded on a 5-point scale ranging from 0 (not at all) to 4 (to a very great extent) and the score is calculated as the mean of the 3 responses with higher scores indicating higher sustainability. The PRESS captures frontline staff's report of their clinic's continued use of an EBI.

AUDIT (total score) - Clinic staff

Investigators will assess the total Alcohol Use Disorders Identification Test (AUDIT) score. The AUDIT is a 10-item scale with summed responses ranging from 0-40; higher scores indicating more harmful alcohol consumption.

AUDIT (total score) - PWH

Investigators will assess the total Alcohol Use Disorders Identification Test (AUDIT) score. The AUDIT is a 10-item scale with summed responses ranging from 0-40; higher scores indicating more harmful alcohol consumption.

Fidelity (Extended Window)

Fidelity is a clinic-level measure assessed as a composite of the recipients of the BAI. The timeframe of 17 months reflects individual recruitment over 12 months plus 5 months for completion of the BAI.

The score comprises successful completion of the 4 protocol-specified BAI sessions (2 in-person, 2 by phone) within 4 months of the initial session weighted by the central fidelity rater's quality rating of the in-person sessions. Fidelity will be assessed using a tailored selection of fidelity measures including the BAI Core Components Checklist. The clinic fidelity score ranges from 0-100. The score will be the percentage of counseling sessions completed, multiplied (weighted) by the combined average quality rating of counseling sessions. Higher scores indicate higher fidelity.