ComBaCaL HIV Prevention TwiCs (CoPrev)
Community-based, Village Health Worker-led, eHealth-supported, Integrated HIV Prevention for People at Substantial Risk of HIV Acquisition in Rural Lesotho: Protocol for a Cluster-randomized Hybrid Type 1 effectiveness-implementation Trial Within the ComBaCaL Cohort Study
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay chronic care village health workers (CC-VHWs).
This study is to evaluate the effectiveness and safety of the CoPrev model in regard to biomedical HIV prevention utilization compared with an enhanced standard of care, in which VHWs assisted by a tablet-based CDS application, perform the same activities except for the prescription and/or delivery of PEP, oral PrEP, COC and self-injectable contraception. Additionally, this study aims to assess the outcomes and processes related to the implementation of such a model.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Approximately 1.3 million new HIV infections were reported worldwide in 2024. Eastern and Southern Africa continue to bear the largest share of the HIV-related burden. To prevent lingering epidemics in these low-resource, high-prevalence regions, it is essential to intensify HIV prevention efforts, including the scale-up of effective biomedical HIV prevention, such as Pre-Exposure (PrEP) and Post- Exposure Prophylaxis (PEP). However, uptake, persistent use and adherence to biomedical HIV prevention remains low among individuals at substantial risk of HIV acquisition, especially in rural areas. Thus, there is an urgent need for scalable, integrated, cost-effective, and context-specific service delivery models that increase the utilization of biomedical HIV prevention among populations at increased risk in Southern Africa.
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay chronic care village health workers (CC-VHWs).
The ComBaCaL HIV Preven7on (CoPrev) model is a differen7ated, community-based preven7on model, that provides eligible individuals with an alterna7ve to facility-based HIV preven7on and contracep7on. It builds on the broader ComBaCaL model of care, which extends the role of VHWs beyond educa7on, counselling, screening, and referral, to include ac7ve management of preven7on and care services for selected condi7ons. This is enabled through a tablet-based CDS applica7on, allowing VHWs to independently prescribe and deliver selected medica7ons at community level.
Within the CoPrev model, VHWs, assisted by the CDS application, deliver an integrated HIV prevention package comprising HIV prevention education and counselling; HIV and HIV risk screening; condom provision; referral to health facilities, and the prescription and delivery of PEP (TDF/3TC/DTG) and oral PrEP (TDF/3TC) to those eligible. In addition, VHWs provide contraceptive services, including family planning education and counselling; pregnancy screening; referral to health facilities; and the delivery of refills of combined oral contraception (COC) and self-injectable contraception to those eligible.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participant of the ComBaCaL cohort study (signed informed consent available)
- Weight ≥ 35 kg
- Negative HIV screening test
- No potential exposure to HIV more than 72 hours ago (PEP eligibility window period) and less than 4 weeks ago (window period HIV test)
At substantial risk of HIV acquisition as per behavioural risk factors in the Lesotho's national HIV prevention and treatment guidelines:
- Report of serodiscordant partner who are not virally suppressed or have an unknown viral suppression status (either not on ART, initiated ART within the last 6 months, known virally unsuppressed or unknown virally suppression status but believed not to be taking treatment regularly)
- Report of sexual partner with unknown HIV status
- Report of unprotected sex with more than one partner in the last 6 months
- Report of STI by lab-testing or self-report of STI syndromic management in the last 6 months
- Report of exchanging money/goods for sex in the last 6 months (as recipient and vice versa)
- Report of intravenous drug use with shared equipment in the last 6 months
- Request for biomedical HIV prevention
Exclusion Criteria:
- Known allergies to PEP/oral PrEP
- Known glomerular filtration rate (GFR) < 60 ml/min or diagnosis of moderate/severe kidney disease or kidney failure
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Intervention villages
In the intervention villages, VHWs will follow the standard service protocol of the ComBaCaL cohort study, but in line with the CoPrev model, will also be able to additionally prescribe and deliver drugs for biomedical HIV prevention (PEP (TDF/3TC/DTG 300mg/300mg/50mg) or oral PrEP (TDF/3TC 300mg/300mg)) and offer refills for contraception (EE/LNG 30mcg/15mcg or 50mcg/15mcg) or self-injectable contraception (s.c.
104mg/0.65ml
medroxypregosteronacetate).
VHWs will provide monitoring for all dispensed drug regimens, thereby ensuring comprehensive and integrated sexual and reproductive health services within their communities.
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Comparador activo: Control villages
In the control villages, VHWs will follow the standard service protocol of the ComBaCaL cohort study.
Using the tablet-based CDS application, they will be trained and supervised to educate participants on HIV prevention, screen for HIV offering oral HIV self-tests, assess HIV risk behaviour, provide risk reduction counselling and condoms, and refer participants eligible for biomedical HIV prevention to the nearest health facility.
Furthermore, they will offer family planning education, pregnancy screening, and refer participants for contraception.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Monthly biomedical HIV prevention coverage over 6 months after enrolment
Periodo de tiempo: Single assessment visit scheduled approximately six months after enrolment (180 days)
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Biomedical HIV prevention coverage is defined at the person- month level as a binary indicator of whether a participant was covered by a biomedical HIV prevention method (PEP (TDF/3TC/DTG), oral PrEP (TDF/3TC), or injectable PrEP) during a given 30-day month within the six-month observation period following enrolment in the ComBaCaL HIV prevention TwiCs .
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Single assessment visit scheduled approximately six months after enrolment (180 days)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Niklaus Labhardt, Division of Clinical Epidemiology, University Hospital Basel
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Palabras clave
- Profilaxis posterior a la exposición (PEP)
- Trabajador de salud comunitario (CHW)
- Levonorgestrel (GNL)
- Profilaxis previa a la exposición (PrEP)
- Apoyo a la decisión clínica (CDS)
- Terapia antirretroviral (TAR)
- Dolutegravir (DTG)
- Estudio de cohorte de atención de enfermedades crónicas basadas en la comunidad de Lesotho (ComBaCaL)
- Etinilestradiol (EE)
- Lamivudina (3TC)
- Pruebas dentro de cohortes (TWICS)
- Países de ingresos bajos y medianos (LMIC)
- Adolescent girls and young women (AGYW)
- Village health worker (VHW)
- Tenofovir Disoproxil Fumarate (TDF)
- Combined oral contraception (COC)
- Sexually transmitted infection (STI)
Términos MeSH relevantes adicionales
- Infecciones transmitidas por la sangre
- Enfermedades urogenitales
- Enfermedades Genitales
- Procesos Patológicos
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades de virus lentos
- Infecciones por VIH
- Condiciones Patológicas, Signos y Síntomas
- Síndrome de inmunodeficiencia adquirida
- Enfermedades de transmisión sexual
Otros números de identificación del estudio
- ub26Labhardt2
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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