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AzTrials

HIVNCT03862196

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

A study testing Tailored text messages to improve retention in HIV care in people with HIV, run by NGO Via Libre at 1 site in Peru.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Tailored text messages to improve retention in HIV care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 sitePeru
Study dates
21 Dec 2018to 7 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Robinson Cabello, MD contact

512039900 ext. 110

rcabello@vialibre.org.pe

Luis Menacho, MD, MPH contact

51991671979

luchomenacho@gmail.com

Peru1 site, 1 recruiting

  • Via Libre

    Lima, Lima1

    Robinson Cabello, MD, 012039900, rcabello@vialibre.org.pe

    Maria Romero, BSN, 012039900, mromero.vialibre@gmail.com

    Recruiting

Other trials in Peru

About this study

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

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

Read the detailed 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.

Conditions
HIV
Being tested
Tailored text messages to improve retention in HIV care
Keywords
prevention, retention, mHealth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tailored text messages to improve retention in HIV careBehavioural

    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.

Study groups in NCT03862196
Study groupRoleWhat they receive
InterventionExperimentalParticipants will receive 2 tailored text messages weekly from a trained counselor during 3 months.
Receives: Behavioral: Tailored text messages to improve retention in HIV care
ControlNo interventionParticipants will receive standard of care: pre and post counseling after being diagnosed with HIV

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study start21 Dec 2018
  3. Primary completion11 Apr 2019 (estimated)
  4. Study completion7 Aug 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Care provider
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03862196
Sponsor's protocol ID
NGOViaLibre
Status last verified
Mar 2019
First submitted
28 Nov 2018
Last updated
5 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28820663

  • 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.

    PubMed 27099168

  • 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.

    PubMed 28618980

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

  • 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/

    PubMed 27466667

  • 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.

    PubMed 28639990

  • 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.

    PubMed 27028183

  • 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.

    PubMed 21071074

  • 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.

    PubMed 28622034

  • 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.

    PubMed 29973167

  • 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.

    PubMed 11915001

  • 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.

    PubMed 23802032

  • 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.

    PubMed 26236767

Questions about this trial

What is this clinical trial studying?

A study testing Tailored text messages to improve retention in HIV care in people with HIV, run by NGO Via Libre at 1 site in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Robinson Cabello, MD (512039900 ext. 110, rcabello@vialibre.org.pe), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention in timely monitoring of viral load (VL) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03862196, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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