Overview

This trial has been completed.

Condition hiv
Treatments sms text message, sms text message + peer navigation
Sponsor University of California, San Francisco
Collaborator University of Washington
Start date October 2014
End date June 2016
Trial size 757 participants
Trial identifier NCT02417233, 12-10482, P0054377

Summary

This study will evaluate the efficacy of two strategies for enhancing overall preventive behaviors, retention in HIV care, and adherence to medication for HIV positive individuals in South Africa: SMS text messing and peer navigation services.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime) only. This group will not receive any additional engagement to care intervention.
(Active Comparator)
Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also automated bi-weekly "check-in" text messages that will trigger a phone call from clinic staff if the participant reports not being well.
sms text message
bi-weekly behavioral messages and bi-weekly check-in messages
(Active Comparator)
Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also bi-weekly contact from an HIV-positive peer who provides personalized support and with health or other service systems navigation assistance.
sms text message + peer navigation
bi-weekly behavioral messages plus personalized peer navigation

Primary Outcomes

Measure
Linkage to care (Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)
time frame: 3 months
Timely ART initiation (Participants eligible for ART who initiate treatment within 3 months of CD4 staging)
time frame: 3 months
Retention in Care - ART eligible (Participants eligible for ART who initiated ART and who remain on treatment)
time frame: 12 months
Retention in Care - non-ART (Participants who return for repeat CD4 count testing)
time frame: 12 months
Adherence to ART - objective (pharmacy refill records)
time frame: 12 months
Adherence to ART - subjective (Self-reported pill-taking)
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - HIV positive (diagnosed within the last 12 months prior to study/patient contact) - Has access to a mobile phone - Willing to receive and respond to text messages and calls from clinic and study staff (all arms) - Willing to communicate and meet with PN (PN arm) - Willing to meet with study staff for survey at study start, 6 months, and 12 months (all arms) - regard study clinic area as the regular clinic for accessing healthcare Exclusion Criteria: - First tested positive over 12 months prior to recruitment - Under the age of 18 - Unable to give informed consent - Unable to read basic English and with no one to read study sms to participant - Principally accesses care through a clinic not in the study - Planning to permanently move away from the area served by the clinic within next 6 months (following enrollment)

Additional Information

Official title Improving Engagement to HIV Prevention and Care in North West, South Africa
Principal investigator Sheri Lippman, PhD
Description Treatment-as-prevention represents a game changing potential to stem further HIV transmission by ensuring that infected individuals are tested, linked to care, retained in care, and adherent to their regimens. Little is known, however, about the most feasible and cost-effective means to promote overall engagement in care coupled with behavioral risk reduction for HIV positive individuals in South Africa. For this reason, the study proposes to first assess what engagement in care activities are underway in select clinics in the Bojanala Platinum District, North West Province, South Africa, and will then implement and evaluate the feasibility, acceptability, and potential efficacy of two strategies for enhancing overall preventive behaviors, retention in HIV care and adherence to medication. The first strategy will employ automated text message reminders to encourage patients to return for needed care, adhere to their ART regimens, and practice safer sex and other risk reduction behaviors. This approach also includes designation of a retention, adherence, and prevention monitor to supervise the system. A second strategy builds on the first model, including the automated text message system, but also utilizes peer navigator-provider teams to serve as point people for care engagement. Peer navigators will work with providers to introduce patients to care and help them establish a care and prevention plan. They will also check in with patients to discuss and support resolution of challenges to engaging in care, adhering to drug regimens, and reducing transmission risk behavior.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.