- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02556957
CHWs, mHealth, and Combination HIV Prevention (mLAKE)
CHWs, mHealth, and Combination HIV Prevention: An Implementation Science Cluster-Randomized Trial (mLAKE)
Kasensero, a fishing community on Lake Victoria in Uganda, is a representative HIV "hotspot" with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations, compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have recognized the urgent need to target hotspots with enhanced HIV treatment and prevention efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies for hotspots is limited and is thus a priority need for the field.
The investigators propose an implementation science, cluster-randomized, controlled trial in Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting combination HIV prevention (CHP) services supported by mobile health technologies (mHealth). CHP is the implementation of multiple, evidence-based HIV prevention services (HIV testing and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to maximize population-level impact on HIV incidence. For CHP to substantively decrease HIV incidence, most community members must be assessed for risk factors and current CHP utilization, then triaged, motivated, linked, and, if HIV-infected, retained in care. The proposed intervention will use low-cost CHWs leveraging mHealth decision support and counseling tools to promote CHP along this entire continuum of HIV service utilization. The hypotheses for this implementation science research are that residents in clusters receiving the implementation intervention will have improved CHP service uptake and decreased Population Prevalence of Viremia (PPDV) compared to controls receiving standard of care.
The intervention will be evaluated through a pragmatic, cluster-randomized trial nested within a large, ongoing population-based cohort study of HIV, the Rakai Community Cohort Study (RCCS). Intervention arm participants will be visited in their place of residence by CHWs trained to evaluate and triage participants into risk categories, provide tailored CHP health counseling, linkage, and adherence support, all supported by a mHealth decision support tool. The primary outcomes will be CHP service coverage and PPDV. Other outcomes will be HIV incidence, population viral load, implementation measures, retention, virologic suppression, and sexual behaviors.
Complimentary mixed methods (quantitative, qualitative, and cost) evaluations of the trial will be conducted to evaluate implementation processes, facilitators, and barriers to inform study results and future program uptake. Focus groups and in-depth interviews will be conducted during and after the follow-up period and synthesized with quantitative data. Intervention costs will be prospectively measured to provide information on program affordability.
Through this study, a novel, low-cost, and scalable implementation intervention to improve CHP uptake will be evaluated in an HIV "hotspot" critical to controlling the HIV epidemic. The study design ensures rigorous evidence of immediate relevance to many stakeholders.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Entebee, Uganda
- Rakai Health Sciences Program
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Resident of Kasensero
Exclusion Criteria:
-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: HealthScouts Intervention
HealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application.
|
|
Comparador activo: Standard of Care
Referral by RCCS to HIV services.
Free HIV clinic available in the community.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Population Prevalence of Detectable Viremia
Periodo de tiempo: 4 Years
|
Proportion of the entire population who have detectable HIV viremia
|
4 Years
|
ART Coverage (self-report)
Periodo de tiempo: 4 Years
|
Proportion of HIV+ persons who are on ART
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4 Years
|
HIV Care Coverage (self-report)
Periodo de tiempo: 4 years
|
Proportion of HIV+ persons who are in HIV care
|
4 years
|
Medical Male Circumcision Coverage (self-report)
Periodo de tiempo: 4 years.
|
Proportion of men who are circumcised
|
4 years.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
HIV Incidence
Periodo de tiempo: 4 years.
|
4 years.
|
|
Sexual Behaviors (self-report)
Periodo de tiempo: 4 years
|
Proportion of the population which has multiple partners and/or inconsistent or no condom use
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4 years
|
Population HIV Viral Load
Periodo de tiempo: 4 years
|
The mean viral load of HIV+ persons
|
4 years
|
HIV Counseling and Testing Coverage (self-report)
Periodo de tiempo: 4 years
|
Proportion of the entire population who have received HIV Counseling and Testing
|
4 years
|
HIV Prevalence
Periodo de tiempo: 4 years
|
The prevalence of HIV in the entire population
|
4 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Larry W Chang, Johns Hopkins School of Medicine
Publicaciones y enlaces útiles
Publicaciones Generales
- Chang LW, Mbabali I, Hutton H, Amico KR, Kong X, Mulamba J, Anok A, Ssekasanvu J, Long A, Thomas AG, Thomas K, Bugos E, Pollard R, van Wickle K, Kennedy CE, Nalugoda F, Serwadda D, Bollinger RC, Quinn TC, Reynolds SJ, Gray RH, Wawer MJ, Nakigozi G. Novel community health worker strategy for HIV service engagement in a hyperendemic community in Rakai, Uganda: A pragmatic, cluster-randomized trial. PLoS Med. 2021 Jan 6;18(1):e1003475. doi: 10.1371/journal.pmed.1003475. eCollection 2021 Jan.
- Chang LW, Mbabali I, Kong X, Hutton H, Amico KR, Kennedy CE, Nalugoda F, Serwadda D, Bollinger RC, Quinn TC, Reynolds SJ, Gray R, Wawer M, Nakigozi G. Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial. Trials. 2017 Oct 23;18(1):494. doi: 10.1186/s13063-017-2243-6.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IRB00062089
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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