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

NCT03862196 | Unknown DMC

• 1 other identifier: NGOViaLibre
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV

Keywords

prevention; retention; mHealth

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Retention in HIV care

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive 2 tailored text messages weekly from a trained counselor during 3 months.

Behavioral: Tailored text messages to improve retention in HIV care

Control

NO INTERVENTION

Participants will receive standard of care: pre and post counseling after being diagnosed with HIV

Interventions

Tailored text messages to improve retention in HIV care BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Enrolled in other HIV study using text messages.
• Have started ART.
• Enrolled in a clinical trial.

Sponsors & Collaborators

• NGO Via Libre: lead

Study Sites (1)

Via Libre

Lima, Lima1, Peru

RECRUITING

Related Publications (15)

• 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.

  PMID: 28820663 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 27099168 BACKGROUND

• 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.

  PMID: 28618980 BACKGROUND

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

  BACKGROUND

• 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/

  PMID: 27466667 BACKGROUND

• 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.

  PMID: 28639990 BACKGROUND

• 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.

  PMID: 27028183 BACKGROUND

• 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.

  PMID: 21071074 BACKGROUND

• 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.

  PMID: 28622034 BACKGROUND

• 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.

  PMID: 29973167 BACKGROUND

• 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.

  PMID: 11915001 BACKGROUND

• 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.

  PMID: 23802032 BACKGROUND

• 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.

  PMID: 26236767 BACKGROUND

Central Study Contacts

Robinson Cabello, MD

CONTACT

512039900; rcabello@vialibre.org.pe

Luis Menacho, MD, MPH

CONTACT

51991671979; luchomenacho@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: After consenting, participants will be randomly assigned to the intervention or control with a 1:1 ratio and random block sizes of 2 and 4 using computer generated random numbers. Block sizes will not be disclosed. Allocations will be sealed in individual, sequentially numbered opaque envelopes. The RECRUITER, who will be masked to the group assignment, will give instructions to all participants on how they should interact if they start receiving SMS. After completing the baseline survey, one of the principal investigators will assign the participant to a group by opening the corresponding envelope. The PI will report to one of trained providers in charge of delivering the intervention (different from recruiters) when a new participant of the intervention arm is enrolled. Because of the nature of the participation, providers and participants will not be masked to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Model Details: Randomized controlled pilot study with a parallel 2-arm design.The intervention arm will receive 2 tailored text messages weekly from a trained counselor during 3 months. The control arm will receive the standard of care, which consists of pre and post counseling after the HIV diagnosis and referral to a health facility to start antiretroviral treatment.

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: March 5, 2019
• Study Start: December 21, 2018
• Primary Completion: April 11, 2019
• Study Completion: August 7, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)