Efficacy of SMS to Improve Early Retention in HIV Care for PLWH in Lima

HIV Clinical Trial

Official title:

Efficacy of an Intervention With Text Messaging to Improve Early Retention in HIV Care for People With HIV Who Receive Treatment at VIA LIBRE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03862196
• Other study ID #: NGOViaLibre
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2018
• Est. completion date: August 7, 2019

Study information

• Verified date: March 2019
• Source: NGO Via Libre
• Contact: Robinson Cabello, MD
• Phone: 512039900
• Email: rcabello[@]vialibre.org.pe
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled study that will evaluate the effect of a text message-based strategy to improve retention in HIV care.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: August 7, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Tailored text messages to improve retention in HIV 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.

Locations

Country	Name	City	State
Peru	Via Libre	Lima

Sponsors (1)

Lead Sponsor	Collaborator
NGO Via Libre

Country where clinical trial is conducted

Peru, 

References & Publications (15)

AIDS by the numbers. UNAIDS, 2016. Retrieved from: http://www.unaids.org/sites/default/files/media_asset/AIDS-by-the-numbers2016_en.pdf

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. — View Citation

Chow JY, Konda KA, Borquez A, Caballero P, Silva-Santisteban A, Klausner JD, Cáceres 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. Epub 2016 Apr 20. Review. — View Citation

Consolidated guidelines on the use of antiretroviral drugs for treating and preventing hiv infection recommendations for a public health approach, second edition 2016. World Health Organisation.

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. — View Citation

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. Epub 2002 Mar 11. — View Citation

Menacho L, Garcia PJ, Blas MM, Díaz 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. — View Citation

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. — View Citation

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. Review. — View Citation

Prevention gap report. UNAIDS, 2016. Retrieved from: http://www.unaids.org/sites/default/files/media_asset/2016-prevention-gapreport_en.pdf

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. — View Citation

UNAIDS country Peru report, 2016. Retrieved from: http://www.unaids.org/en/regionscountries/countries/peru

Wolff MJ, Cortes CP, Mejìa FA, Padgett D, Belaunzarán-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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Retention in HIV care	Rate of participants who attended the 2nd and 3rd appointments for HIV care at the study clinic, verified using medical records	3 months
Primary	Retention in timely monitoring of viral load (VL)	Rate of participants with a second lab result of VL available 6 months after initiation of ART, verified using lab records	6 months