NCT01630304

Brief Summary

The purpose of this study is to determine whether weekly text-messages improve retention in care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

3.7 years

First QC Date

June 25, 2012

Last Update Submit

December 17, 2015

Conditions

HIV

Keywords

telecommunicationsAfricarandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Patient retention in care

    12 months

Secondary Outcomes (2)

  • First ART eligibility assessment

    3 weeks

  • Enrolment in HIV care and treatment program

    2 months

Study Arms (2)

WelTel SMS service

EXPERIMENTAL

In addition to standard care, weekly text messages will be delivered to participants randomized to this arm for a one year period. Participants will be requested to respond to the outgoing message "Mambo?" within 48 hours; they may respond that they are doing well (sawa) or that they have a problem (shida). A clinician will call to follow-up with all participants who respond indicating a problem or who do not respond within 48 hours.

Behavioral: WelTel SMS service

Standard care

NO INTERVENTION

This arm will receive standard clinical care.

Interventions

WelTel SMS serviceBEHAVIORAL

Weekly text message "Mambo?" ("How are you?") to which participants are required to respond either "Shida" (problem) or "Sawa" (OK) within 48 hours. Shida responses and participants who do not respond are called by a clinician.

WelTel SMS service

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • evidence of HIV infection
  • newly enrolling at the Kibera Community Health Centre
  • own or have sufficient access to a cell phone; able to operate a cell phone using simple text-messaging\*
  • able and willing to provide informed assent/consent to participate \*If a participant does not own a phone but has sufficient access to a cell phone (through a partner, relative, etc.), the participant would be able to either 1) use the accessed phone to respond to the text messages themselves; or, if they are unable to text themselves 2) have their partner, relative etc. respond on their behalf.

You may not qualify if:

  • individuals transferring from other clinics who are already taking ART will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kibera Community Health Centre

Nairobi, Kenya

Location

Related Publications (3)

  • Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

    PMID: 32779730DERIVED

  • van der Kop ML, Muhula S, Nagide PI, Thabane L, Gelmon L, Awiti PO, Abunah B, Kyomuhangi LB, Budd MA, Marra C, Patel A, Karanja S, Ojakaa DI, Mills EJ, Ekstrom AM, Lester RT. Effect of an interactive text-messaging service on patient retention during the first year of HIV care in Kenya (WelTel Retain): an open-label, randomised parallel-group study. Lancet Public Health. 2018 Mar;3(3):e143-e152. doi: 10.1016/S2468-2667(17)30239-6. Epub 2018 Jan 30.

    PMID: 29361433DERIVED

  • van der Kop ML, Ojakaa DI, Patel A, Thabane L, Kinagwi K, Ekstrom AM, Smillie K, Karanja S, Awiti P, Mills E, Marra C, Kyomuhangi LB, Lester RT. The effect of weekly short message service communication on patient retention in care in the first year after HIV diagnosis: study protocol for a randomised controlled trial (WelTel Retain). BMJ Open. 2013 Jun 20;3(6):e003155. doi: 10.1136/bmjopen-2013-003155.

    PMID: 23794578DERIVED

Study Officials

  • Richard T Lester, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 28, 2012

Study Start

January 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

KE(1)