- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03529409
Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Cape Town, Afrique du Sud, 7700
- University of Cape Town
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Maryland
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College Park, Maryland, États-Unis, 20742
- University of Maryland
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Changes in HIV Medication Adherence Throughout Intervention Phase
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Biological Measure of Substance Use
Délai: 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)
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Biological Measure of Substance Use
Délai: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up 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 follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Changes in Self-reported Substance Use
Délai: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up 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 follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Intervention Acceptability
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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HIV Viral Load
Délai: 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
Délai: 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
Délai: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Changes in number of drinks 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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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles induits chimiquement
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Maladies du système immunitaire
- Maladies à virus lents
- Troubles liés à une substance
- Infections à VIH
- Syndrome immunodéficitaire acquis
- Syndromes d'immunodéficience
- Troubles liés à l'alcool
Autres numéros d'identification d'étude
- 187/2018
- K23DA041901 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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Essais cliniques sur Project Khanya
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VA Office of Research and DevelopmentComplété
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Northwestern UniversityRetiré
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Florida State UniversityComplétéTrouble de l'alimentationÉtats-Unis
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Chulalongkorn UniversityThai Red Cross AIDS Research Centre; International AIDS SocietyComplétéPrévention du VIH | Adhésion, Médicaments | Comportement des adolescents | Santé mobile | Santé sexuelleThaïlande
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Western Washington UniversityComplétéL'image corporelle | Symptôme de trouble de l'alimentation | Biais de poidsÉtats-Unis
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Virginia Commonwealth UniversityHenrico County Public Schools; Virginia Department of Aging and Rehabilitative... et autres collaborateursComplété
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University of Maryland, College ParkNational Institute on Drug Abuse (NIDA); University of Miami; Weill Medical... et autres collaborateursRecrutementTroubles liés à l'alcool | Consommation de substances | L'usage de drogues | Virus de l'immunodéficience humaineAfrique du Sud
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Virginia Commonwealth UniversityNational Institute on Disability, Independent Living, and Rehabilitation...ComplétéTroubles du spectre autistique | Autisme | Syndrome d'Asperger | Trouble envahissant du développement | Développement de l'adolescence
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University of SheffieldPrincess Nourah Bint Abdulrahman UniversityComplétéSymptôme de trouble de l'alimentation et insatisfaction liée à l'image corporelleArabie Saoudite
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Johns Hopkins UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)ComplétéInfections à VIH | AlcoolismeÉtats-Unis