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Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa

16 мая 2022 г. обновлено: 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).

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

66

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 65 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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:

    1. Not attained viral suppression from first line ART (VL>400 copies/mL)
    2. On second-line ART treatment
    3. Reinitiated first-line treatment within the past three months
    4. 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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: Project Khanya
This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
Без вмешательства: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Changes in HIV Medication Adherence Throughout Intervention Phase
Временное ограничение: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device
Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Biological Measure of Substance Use
Временное ограничение: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Substance use measured with urinalysis.
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Biological Measure of Substance Use
Временное ограничение: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention 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 the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Changes in Self-reported Substance Use
Временное ограничение: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention 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 the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Biological Measure of Substance Use
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Intervention Acceptability
Временное ограничение: 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)
Intervention Feasibility
Временное ограничение: 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)
Intervention Fidelity
Временное ограничение: 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)
Intervention Uptake
Временное ограничение: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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)

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
HIV Viral Load
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Maryland, College Park

Соавторы

National Institute on Drug Abuse (NIDA)
University of Cape Town

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

30 июля 2018 г.

Первичное завершение (Действительный)

12 февраля 2020 г.

Завершение исследования (Действительный)

7 апреля 2020 г.

Даты регистрации исследования

Первый отправленный

7 мая 2018 г.

Впервые представлено, что соответствует критериям контроля качества

17 мая 2018 г.

Первый опубликованный (Действительный)

18 мая 2018 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 мая 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

16 мая 2022 г.

Последняя проверка

1 мая 2022 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 187/2018
  • K23DA041901 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

Да

Описание плана IPD

After all primary analyses are complete, de-identified data will be available per request of outside individual.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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