Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
2022년 5월 16일 업데이트: Jessica Magidson, University of Maryland, College Park
Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa
The purpose of this study is to test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa.
The intervention is specifically designed to be implemented by non-specialist counselors using a task sharing model in local HIV clinics.
The behavioral intervention will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as described in study endpoint section below).
연구 개요
상세 설명
The HIV epidemic in South Africa (SA) is among the highest in the world.
SA has a large antiretroviral therapy (ART) program, but some individuals exhibit poor ART adherence, which increases the likelihood of developing drug resistance and failing the only available first and second line ART regimens in SA.
ART nonadherence contributes to greater morbidity, mortality, and higher likelihood of sexual HIV transmission when virus is detectable.
At the same time, alcohol and other drug use is prevalent among HIV-infected individuals in SA and associated with worse ART adherence, lower rates of viral suppression, and HIV transmission risk behavior.
Yet, despite the impact of untreated substance use on poor HIV treatment outcomes and continued HIV transmission, there is little if any integration of substance use and HIV care services in SA, which creates a fragmented and incomplete system of care.
This study had three phases, first being formative, qualitative work which led to a systematic treatment adaptation phase.
This third phase, the clinical trial, is based on this formative work and other empirical support using behavioral interventions to improve ART adherence and reduce substance use in resource-limited settings, including SA.
This study is a Type 1 hybrid effectiveness-implementation trial of a lay counselor-delivered behavioral intervention for adherence and substance use integrated into the HIV primary care setting in SA.
To ensure that those who need this intervention most will receive it, participants will be patients with HIV who are struggling with adherence (as defined in the investigator's inclusion criteria) and who have an elevated substance use risk.
연구 유형
중재적
등록 (실제)
66
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- HIV positive and on ART
- 18-65 years of age
- Elevated substance use risk (ASSIST score greater than or equal to 4 for drugs or greater than or equal to 11 for alcohol)
Have at least one of the following:
- Not attained viral suppression from first line ART (VL>400 copies/mL)
- On second-line ART treatment
- Reinitiated first-line treatment within the past three months
- Had a pharmacy non-refill at least once in the past 3 months
Exclusion Criteria:
- Inability to provide informed consent or complete procedures in English or isiXhosa
- Severe risk/likely dependence for opiates (ASSIST score >26) because opiate substitution therapy may not be available
- Severe alcohol dependence symptoms that may warrant medical management of potential withdrawal symptoms
- Active, untreated, major mental illness (with untreated psychosis or mania) that would interfere with the paraprofessional adapted intervention
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Project Khanya
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic.
They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
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This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
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간섭 없음: ESOC
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic.
The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use.
We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral.
Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in HIV Medication Adherence Throughout Intervention Phase
기간: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device
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Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Biological Measure of Substance Use
기간: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Substance use measured with urinalysis.
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Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Biological Measure of Substance Use
기간: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption.
Minimum detection value is 8 ng/mL.
Higher PEth values indicate greater concentration of alcohol.
Values of ≥ 50 ng/mL indicate unhealthy drinking.
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Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Changes in Self-reported Substance Use
기간: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST).
It is a measure used to assess substance use risk for alcohol, cannabis, cocaine, opiates, and amphetamines, hallucinogens, and other drugs.
Standardized cutoff scores are used to categorize risk levels: low risk (0-3 for illicit drugs/0-10 for alcohol), moderate risk (4-26 for illicit drugs/11-26 for alcohol), or high risk (> 26) for substance use-related problems.
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Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Biological Measure of Substance Use
기간: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Substance use measured with urinalysis.
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Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
|
Biological Measure of Substance Use
기간: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption.
Minimum detection value is 8 ng/mL.
Higher PEth values indicate greater concentration of alcohol.
Values of ≥ 50 ng/mL indicate unhealthy drinking.
|
Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
|
Changes in Self-reported Substance Use
기간: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST).
It is a measure used to assess substance use risk for alcohol, cannabis, cocaine, opiates, and amphetamines, hallucinogens, and other drugs.
Standardized cutoff scores are used to categorize risk levels: low risk (0-3 for illicit drugs/0-10 for alcohol), moderate risk (4-26 for illicit drugs/11-26 for alcohol), or high risk (> 26) for substance use-related problems.
|
Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Intervention Acceptability
기간: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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15-item acceptability subscale of a pragmatic, quantitative assessment based on RE-AIM developed by the Applied Mental Health Research group (AMHR) at Johns Hopkins University. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater acceptability. Qualitative interviews will also be conducted with intervention participants at the end of the study to assess acceptability guided by RE-AIM and the Proctor model. |
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Intervention Feasibility
기간: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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14-item feasibility subscale of a pragmatic, quantitative assessment based on RE-AIM developed by the Applied Mental Health Research group (AMHR) at Johns Hopkins University. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater feasibility. Qualitative interviews will also be conducted with intervention participants at the end of the study to assess feasibility guided by RE-AIM and the Proctor model. |
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Intervention Fidelity
기간: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Independent fidelity ratings of a randomly selected subset (20%) of intervention sessions using a fidelity assessment developed for each session that includes 15-19 items that map onto each core intervention component, and factors unique to the peer delivery implementation strategy (i.e., appropriate self-disclosure, stigmatizing behaviors, common factors including warmth and non-judgment).
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Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Intervention Uptake
기간: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Intervention participant attendance and retention (i.e., the mean number of intervention sessions attended by intervention participants)
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Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
HIV Viral Load
기간: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Percentage of patients with a suppressed viral load (<400 copies/ml)
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Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Changes in Self-reported Substance Use
기간: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Changes in percent days used any substance measured by timeline follow-back
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Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
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Changes in Self-reported Substance Use
기간: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
Changes in number of drinks measured by timeline follow-back
|
Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Belus JM, Rose AL, Andersen LS, Ciya N, Joska JA, Myers B, Safren SA, Magidson JF. Adapting a Behavioral Intervention for Alcohol Use and HIV Medication Adherence for Lay Counselor Delivery in Cape Town, South Africa: A Case Series. Cogn Behav Pract. 2022 May;29(2):454-467. doi: 10.1016/j.cbpra.2020.10.003. Epub 2020 Nov 10.
- Belus JM, Joska JA, Bronsteyn Y, Rose AL, Andersen LS, Regenauer KS, Myers B, Hahn JA, Orrell C, Safren SA, Magidson JF. Gender Moderates Results of a Randomized Clinical Trial for the Khanya Intervention for Substance Use and ART Adherence in HIV Care in South Africa. AIDS Behav. 2022 Nov;26(11):3630-3641. doi: 10.1007/s10461-022-03765-8. Epub 2022 Jul 27.
- Magidson JF, Joska JA, Belus JM, Andersen LS, Regenauer KS, Rose AL, Myers B, Majokweni S, O'Cleirigh C, Safren SA. Project Khanya: results from a pilot randomized type 1 hybrid effectiveness-implementation trial of a peer-delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa. J Int AIDS Soc. 2021 Jun;24 Suppl 2:e25720. doi: 10.1002/jia2.25720.
- Magidson JF, Joska JA, Myers B, Belus JM, Regenauer KS, Andersen LS, Majokweni S, O'Cleirigh C, Safren SA. Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa. Implement Sci Commun. 2020;1:23. doi: 10.1186/s43058-020-00004-w. Epub 2020 Mar 4.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 7월 30일
기본 완료 (실제)
2020년 2월 12일
연구 완료 (실제)
2020년 4월 7일
연구 등록 날짜
최초 제출
2018년 5월 7일
QC 기준을 충족하는 최초 제출
2018년 5월 17일
처음 게시됨 (실제)
2018년 5월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 5월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 5월 16일
마지막으로 확인됨
2022년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 187/2018
- K23DA041901 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
After all primary analyses are complete, de-identified data will be available per request of outside individual.
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
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