Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
2022年5月16日 更新者：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).
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
66
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。
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
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
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 |
|---|---|
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実験的：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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介入なし：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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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 |
|---|---|---|
|
Changes in HIV Medication Adherence Throughout Intervention Phase
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Biological Measure of Substance Use
時間枠：Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
Substance use measured with urinalysis.
|
Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
|
Biological Measure of Substance Use
時間枠：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
時間枠：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
時間枠：Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
|
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
時間枠：Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
|
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
時間枠：Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
|
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).
|
Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
|
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Intervention Uptake
時間枠：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)
|
Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HIV Viral Load
時間枠：Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
Percentage of patients with a suppressed viral load (<400 copies/ml)
|
Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
|
Changes in Self-reported Substance Use
時間枠：Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
Changes in percent days used any substance measured by timeline follow-back
|
Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
|
|
Changes in Self-reported Substance Use
時間枠：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)
|
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。
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。
一般刊行物
- 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.
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 (実際)
2018年7月30日
一次修了 (実際)
2020年2月12日
研究の完了 (実際)
2020年4月7日
試験登録日
最初に提出
2018年5月7日
QC基準を満たした最初の提出物
2018年5月17日
最初の投稿 (実際)
2018年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2022年5月18日
QC基準を満たした最後の更新が送信されました
2022年5月16日
最終確認日
2022年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 187/2018
- K23DA041901 (米国 NIH グラント/契約)
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?
はい
IPD プランの説明
After all primary analyses are complete, de-identified data will be available per request of outside individual.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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