IGHID 12230 - HIV 예방을 위한 경험적 간략 알코올 중재 구현 시험 (EBAI)

활성 비교기: 촉진 전용(FAC)

FAC 부서에 무작위로 배정된 클리닉은 촉진 전용 접근 방식을 사용하여 PWH에 BAI 전달을 구현합니다.

다른: 촉진 (FAC)

촉진 접근 방식은 클리닉이 상담사 기술, 경쟁 우선 순위 및 자원 부족과 같은 일반적인 장벽을 해결하는 데 도움이 되는 유연한 클리닉 수준 구현 전략을 사용합니다.

실험적: 촉진 및 경험적 간략한 알코올 중재(EBAI+FAC)

EBAI+FAC 부문에 무작위로 배정된 클리닉은 촉진 접근 방식을 사용하여 PWH 참가자에게 BAI 제공을 구현합니다. 또한, 자신의 알코올 사용 여부와 상관없이 진료소 직원은 BAI를 전달하기 전에 BAI를 직접 제공받게 됩니다.

다른: 촉진 (FAC)

촉진 접근 방식은 클리닉이 상담사 기술, 경쟁 우선 순위 및 자원 부족과 같은 일반적인 장벽을 해결하는 데 도움이 되는 유연한 클리닉 수준 구현 전략을 사용합니다.

행동: 경험적 간략한 알코올 중재(EBAI)

임상 직원에게는 구현에 앞서 체험형 BAI가 제공됩니다. BAI는 2회의 대면 세션과 2회의 추가 전화 세션으로 구성됩니다. PWH 참가자에게 BAI를 전달하는 책임을 맡은 클리닉 직원에게는 BAI를 받은 경험과 BAI 전달을 통합하기 위한 3회의 추가 통합 세션이 제공됩니다.

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.