WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS

HIV Clinical Trial

Official title:

WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01630304
• Other study ID #: H12-00563
• Secondary ID: R01MH097558
• Status: Active, not recruiting
• Phase: N/A
• First received: June 25, 2012
• Last updated: December 17, 2015
• Start date: January 2013
• Est. completion date: September 2016

Study information

• Verified date: December 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review CommitteeCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

Description:

Patient retention in care is critical to the success of programs funded by the President's Emergency Relief Plan for HIV/AIDS (PEPFAR). High levels of patient retention after first clinical contact contribute to the timely initiation of antiretroviral therapy (ART) and better health outcomes for patients. With the dramatic proliferation of cell phone use in Africa, telecommunications technology offers new opportunities to improve retention using a low-cost, culturally appropriate format. In Kenya (WelTel Kenya1), a weekly short message service (SMS) text message led to improved ART adherence and viral load suppression. This study, WelTel Retain, will evaluate the effect of WelTel on retaining pre-ART patients in care and determine the cost-effectiveness of the intervention. Specific objectives include: 1) determining if the WelTel SMS intervention improves patient retention in the first stage of HIV care; 2) determining whether the WelTel SMS intervention improves 12-month retention; and 3) evaluating the cost-effectiveness of the WelTel SMS intervention. We will fulfil these objectives by conducting a randomized controlled trial at the Kibera Community Health Centre in Nairobi, Kenya. Over one year, HIV positive individuals newly enrolling at the clinic will be recruited and randomly allocated to an intervention or control arm at a 1:1 ratio. Intervention arm participants will receive a weekly SMS 'check-in' to which they will be required to respond within 48 hours. An HIV clinician will follow-up and triage any problems that are identified. The control arm will receive standard of care. Patients will be followed for one year. The WelTel Retain study will contribute critical information on the effectiveness of an mHealth program to engage patients in care during the first year of HIV care. This research has the potential to demonstrate that the WelTel SMS intervention is an effective, feasible retention strategy, which can contribute significantly to the long-term success of PEPFAR-funded programs and towards a sustainable global HIV/AIDS response.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• individuals will be excluded if they do not meet all of the inclusion criteria.

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• WelTel SMS service
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.

Locations

Country	Name	City	State
Kenya	Kibera Community Health Centre	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient retention in care		12 months	No
Secondary	First ART eligibility assessment	Proportion of patients completing 1st eligibility assessment within 3 weeks	3 weeks	No
Secondary	Enrolment in HIV care and treatment program	Proportion of patients who complete counselling sessions (3) and are eligible to enrol in the HIV care and treatment program	2 months	No