Efficacy of SMS to Improve Early Retention in HIV Care for PLWH in Lima
1. mars 2019 oppdatert av: ROBINSON CABELLO, NGO Via Libre
Efficacy of an Intervention With Text Messaging to Improve Early Retention in HIV Care for People With HIV Who Receive Treatment at VIA LIBRE
Randomized controlled study that will evaluate the effect of a text message-based strategy to improve retention in HIV care.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a randomized controlled pilot study with a parallel 2-arm design.
It will evaluate the effect of a text message-based strategy to improve retention in HIV care at the study clinic, compared to the standard of care.
Trained counselors will deliver the text messages.
After a block randomization, the trained counselor (a nurse) will send the first welcoming message to participants in the intervention arm.
The nurse will send 2 tailored text messages per week.
In addition 2 to 4 days before an appointment, the nurse will send a message reminder.
In addition, the nurse will have bilateral communication with participants using text messages according to their needs.
The participants of the intervention arm will interact with the nurse during 3 months with a semi-structured strategy, that is, with template text messages (predesigned) and open messages (for which the nurse will be trained).
Three and six months after started the intervention the variables of interest will be assessed.
Studietype
Intervensjonell
Registrering (Forventet)
144
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Lima, Peru, Lima1
- Rekruttering
- Via Libre
-
Ta kontakt med:
- Robinson Cabello, MD
- Telefonnummer: 012039900
- E-post: rcabello@vialibre.org.pe
-
Ta kontakt med:
- Maria Romero, BSN
- Telefonnummer: 012039900
- E-post: mromero.vialibre@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Male 18 years old or older.
- Linked to HIV care at the study clinic.
- Have a cell phone.
- Diagnosed at the study clinic of referred from other center to start ART.
- Give consent to participate.
Exclusion Criteria:
- Enrolled in other HIV study using text messages.
- Have started ART.
- Enrolled in a clinical trial.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention
Participants will receive 2 tailored text messages weekly from a trained counselor during 3 months.
|
Trained counselors will deliver the text messages.
After a block randomization, the trained counselor (a nurse) will send the first welcoming message to participants in the intervention arm.
The nurse will send 2 tailored text messages per week.
In addition 2 to 4 days before an appointment, the nurse will send a message reminder.
In addition, the nurse will have bilateral communication with participants using text messages according to their needs.
The participants of the intervention arm will interact with the nurse during 3 months with a semi-structured strategy, that is, with template text messages (predesigned) and open messages (for which the nurse will be trained).
Three and six months after started the intervention the variables of interest will be assessed.
|
|
Ingen inngripen: Control
Participants will receive standard of care: pre and post counseling after being diagnosed with HIV
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Retention in timely monitoring of viral load (VL)
Tidsramme: 6 months
|
Rate of participants with a second lab result of VL available 6 months after initiation of ART, verified using lab records
|
6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Retention in HIV care
Tidsramme: 3 months
|
Rate of participants who attended the 2nd and 3rd appointments for HIV care at the study clinic, verified using medical records
|
3 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010 Nov 27;376(9755):1838-45. doi: 10.1016/S0140-6736(10)61997-6. Epub 2010 Nov 9.
- Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach. 2nd edition. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK374294/
- Mannheimer S, Friedland G, Matts J, Child C, Chesney M. The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials. Clin Infect Dis. 2002 Apr 15;34(8):1115-21. doi: 10.1086/339074. Epub 2002 Mar 11.
- Rana AI, van den Berg JJ, Lamy E, Beckwith CG. Using a Mobile Health Intervention to Support HIV Treatment Adherence and Retention Among Patients at Risk for Disengaging with Care. AIDS Patient Care STDS. 2016 Apr;30(4):178-84. doi: 10.1089/apc.2016.0025.
- Menacho L, Garcia PJ, Blas MM, Diaz G, Zunt JR. What Men Who Have Sex With Men in Peru Want in Internet-Based Sexual Health Information. J Homosex. 2018;65(7):934-946. doi: 10.1080/00918369.2017.1364939. Epub 2017 Sep 22.
- AIDS by the numbers. UNAIDS, 2016. Retrieved from: http://www.unaids.org/sites/default/files/media_asset/AIDS-by-the-numbers2016_en.pdf
- UNAIDS country Peru report, 2016. Retrieved from: http://www.unaids.org/en/regionscountries/countries/peru
- Chow JY, Konda KA, Borquez A, Caballero P, Silva-Santisteban A, Klausner JD, Caceres CF. Peru's HIV care continuum among men who have sex with men and transgender women: opportunities to optimize treatment and prevention. Int J STD AIDS. 2016 Oct;27(12):1039-1048. doi: 10.1177/0956462416645727. Epub 2016 Apr 20.
- Wolff MJ, Cortes CP, Mejia FA, Padgett D, Belaunzaran-Zamudio P, Grinsztejn B, Giganti MJ, McGowan CC, Rebeiro PF; Caribbean, Central and South America network for HIV epidemiology (CCASAnet). Evaluating the care cascade after antiretroviral therapy initiation in Latin America. Int J STD AIDS. 2018 Jan;29(1):4-12. doi: 10.1177/0956462417714094. Epub 2017 Jun 15.
- Prevention gap report. UNAIDS, 2016. Retrieved from: http://www.unaids.org/sites/default/files/media_asset/2016-prevention-gapreport_en.pdf
- Muessig KE, LeGrand S, Horvath KJ, Bauermeister JA, Hightow-Weidman LB. Recent mobile health interventions to support medication adherence among HIV-positive MSM. Curr Opin HIV AIDS. 2017 Sep;12(5):432-441. doi: 10.1097/COH.0000000000000401.
- Bayona E, Menacho L, Segura ER, Mburu G, Roman F, Tristan C, Bromley E, Cabello R. The Experiences of Newly Diagnosed Men Who Have Sex with Men Entering the HIV Care Cascade in Lima, Peru, 2015-2016: A Qualitative Analysis of Counselor-Participant Text Message Exchanges. Cyberpsychol Behav Soc Netw. 2017 Jun;20(6):389-396. doi: 10.1089/cyber.2016.0435.
- Yu Y, Luo D, Chen X, Huang Z, Wang M, Xiao S. Medication adherence to antiretroviral therapy among newly treated people living with HIV. BMC Public Health. 2018 Jul 4;18(1):825. doi: 10.1186/s12889-018-5731-z.
- Menacho LA, Blas MM, Alva IE, Roberto Orellana E. Short Text Messages to Motivate HIV Testing Among Men Who have Sex with Men: A Qualitative Study in Lima, Peru. Open AIDS J. 2013 Apr 5;7:1-6. doi: 10.2174/1874613601307010001. Print 2013.
- Young SD, Cumberland WG, Nianogo R, Menacho LA, Galea JT, Coates T. The HOPE social media intervention for global HIV prevention in Peru: a cluster randomised controlled trial. Lancet HIV. 2015 Jan;2(1):e27-32. doi: 10.1016/S2352-3018(14)00006-X.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. desember 2018
Primær fullføring (Forventet)
11. april 2019
Studiet fullført (Forventet)
7. august 2019
Datoer for studieregistrering
Først innsendt
28. november 2018
Først innsendt som oppfylte QC-kriteriene
1. mars 2019
Først lagt ut (Faktiske)
5. mars 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- NGOViaLibre
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .