- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01917994
Text Messaging Intervention to Improve Retention in Care and Virologic Suppression in an Urban HIV-Infected Population (Connect4Care)
Seek Test Treat Retain Strategies Leveraging Mobile Health Technologies
Retention in care and virologic suppression are the key final steps of the HIV treatment cascade. Poor or intermittent retention has been associated with later initiation of antiretroviral therapy, virologic failure, and death. Regular HIV care has also been associated with a decrease in HIV transmission risk behavior. Despite the proven health and prevention benefits of consistent HIV care, only 40-50% of those infected with HIV in the United States are estimated to meet current retention in care standards and even fewer - only about 25% - are estimated to be virologically suppressed.
The Behavioral Model for Vulnerable Populations provides a useful framework for understanding broad areas that may impact adherence to care and treatment. Individual-level domains include vulnerable (e.g., depression, stigma), enabling (e.g., social support, positive affect), and need (e.g., co-morbidities) factors, and structural domains include, for example, features or the clinic and the provider-patient relationship.
Short message service (SMS) technology represents a new and exciting tool to help retain HIV-infected patients in care and treatment. SMS interventions have been deployed successfully in support of antiretroviral adherence and virologic suppression in sub-Saharan Africa, where two randomized trials have showed clear benefits. A pilot study conducted in our clinic suggests that use of SMS messages to promote adherence to care and treatment in the urban HIV-infected poor is both feasible and acceptable.
The investigators believe that combining SMS technology with content-specific messages designed to impact factors highlighted in the Behavioral Model for Vulnerable Populations can improve retention in care and virologic suppression for an urban public hospital population living with HIV, thus the investigators propose the following specific aims.
Specific Aim 1: Determine whether a behavioral theory-based SMS intervention improves virologic suppression [primary outcome] and retention in care [secondary outcome] for a vulnerable urban HIV-infected population through a randomized trial of this technology compared to SMS appointment reminders alone. Retention in care will also be analyzed as a mediator of virologic suppression. Exploratory outcomes include time to virologic suppression, sustained virologic suppression, emergency department utilization and antiretroviral adherence, as well as levels of depression, positive affect, social support and empowerment.
Specific Aim 2: Examine patient experiences with the SMS intervention, focusing specifically on: 1) satisfaction with this technology; 2) identifying barriers to and facilitators of patient use of this technology, and; 3) the preferred frequency and content of intervention messages.
Specific Aim 3: Conduct cost and cost-effectiveness analyses of the SMS intervention.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
-
San Francisco, California, Stati Uniti, 94110
- San Francisco General Hospital Positive Health Program
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- HIV-infected
- Age 18 or over
- English-speaking
- Able to give informed consent
- Have a cell phone and willing to send/receive up to 25 text messages/month
- Detectable viral load plus either 1) new to clinic (no more than 2 primary care visits) or 2) history of poor retention (one missed visit or lack of six-month visit constancy in the past year)
Exclusion Criteria:
- HIV-uninfected
- Under age 18
- Monolingual speaker of a language other than English
- Unable to give informed consent
- Undetectable viral load
- Perfect appointment adherence
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Text Messages + Appointment Reminders
Participants in the intervention arm will receive supportive, informational, or motivational text messages three times a week for one year in addition to text message reminders about HIV primary care appointments.
|
The intervention consists of supportive, informational, and motivational text messages three times a week targeting the following domains: promoting a sense of connectedness to the clinic, fostering social support, building empowerment, ameliorating negative affect, cultivating positive affect, and promoting healthy behaviors and adherence to antiretroviral medication.
|
|
Comparatore attivo: Appointment Reminders
Participants in the control arm will receive text messages reminding them of HIV primary care appointments 48 hours before the scheduled appointment.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Viral Load
Lasso di tempo: 12 month
|
12 month
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Missed Visit Proportion
Lasso di tempo: 12 month
|
Number of missed or "no show" visits divided by number of scheduled appointments
|
12 month
|
|
Appointment Adherence
Lasso di tempo: 12 month
|
Each participant's proportion of kept appts divided by scheduled appts (mean of the proportions)
|
12 month
|
|
Visit Constancy
Lasso di tempo: 12 month
|
At least one kept visit in each six-month period
|
12 month
|
|
Attended All Scheduled Visits
Lasso di tempo: 12 month
|
Attended all scheduled visits
|
12 month
|
Altre misure di risultato
Misura del risultato |
Lasso di tempo |
|---|---|
|
Time to Virologic Suppression
Lasso di tempo: 12 month
|
12 month
|
|
Sustained virologic suppression
Lasso di tempo: 12 month
|
12 month
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Katerina Christopoulos, MD, University of California, San Francisco
Pubblicazioni e link utili
Pubblicazioni generali
- Christopoulos KA, Riley ED, Tulsky J, Carrico AW, Moskowitz JT, Wilson L, Coffin LS, Falahati V, Akerley J, Hilton JF. A text messaging intervention to improve retention in care and virologic suppression in a U.S. urban safety-net HIV clinic: study protocol for the Connect4Care (C4C) randomized controlled trial. BMC Infect Dis. 2014 Dec 31;14:718. doi: 10.1186/s12879-014-0718-6.
- Christopoulos KA, Riley ED, Carrico AW, Tulsky J, Moskowitz JT, Dilworth S, Coffin LS, Wilson L, Peretz JJ, Hilton JF. A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial. Clin Infect Dis. 2018 Aug 16;67(5):751-759. doi: 10.1093/cid/ciy156.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- R01DA032057 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su HIV
-
Federal University of São PauloGilead SciencesCompletato
-
University of MinnesotaRitiratoInfezioni da HIV | HIV/AIDS | HIV | AIDS | Problema di Aids/Hiv | AIDS e infezioniStati Uniti
-
National Institute of Allergy and Infectious Diseases...Duke University; Department of Health and Human Services (HHS)Non ancora reclutamento
-
Jecho Biopharmaceuticals Co., Ltd.Non ancora reclutamento
-
Boston UniversityBill and Melinda Gates Foundation; HE2RO, University of the WitwatersrandReclutamento
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH); Department of Health and Human ServicesReclutamento
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Partners in Hope, Inc.Reclutamento
-
Kelley-Ross & Associates, Inc.Gilead SciencesAttivo, non reclutante
-
Center for Innovative Public Health ResearchNational Institute of Mental Health (NIMH); Makerere University; Internet Solutions...Non ancora reclutamento
Prove cliniche su Text Messages
-
Fundació d'investigació Sanitària de les Illes...CompletatoDiabete mellito, tipo 2Spagna
-
The University of Hong KongNon ancora reclutamentoIntervento | ControlloHong Kong
-
Fundació d'investigació Sanitària de les Illes...CompletatoStato prediabeticoSpagna
-
Washington University School of MedicineNovartis; National Comprehensive Cancer NetworkNon ancora reclutamentoCancro al seno | Cancro al senoStati Uniti
-
Taipei Medical UniversityCompletato
-
Fundació d'investigació Sanitària de les Illes...CompletatoDiabete mellito, tipo 2Spagna
-
Scripps Whittier Diabetes InstituteReclutamentoDiabete di tipo 2Stati Uniti
-
Yale UniversityCompletatoCancro al seno | Aderenza, Farmaco | Effetto collateraleStati Uniti
-
Boston UniversityNational Cancer Institute (NCI); Brown University; National Institutes of Health... e altri collaboratoriCompletato
-
Stanford UniversityNational Institute of Mental Health (NIMH); University of Pennsylvania; The University... e altri collaboratoriAttivo, non reclutanteDisturbo post traumatico da stressStati Uniti