Engagement to Care South Africa

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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: short message service (SMS) text messaging and peer navigation services.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Activating Treatment as Prevention Through Community Mobilization in South Africa

NCT02197793

HIV

COMPLETED NA

Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa

NCT03483857

Hiv

COMPLETED NA

Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

NCT01751620

HIV Positive Youth That Are Newly Engaged in Care

COMPLETED NA

Effect of U=U Messaging on HIV in South Africa

NCT04364165

HIV/AIDS

COMPLETED NA

Behavioural Text Messages to Improve Retention in Care in South Africa

NCT05010291

HIV/AIDS

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 antiretroviral therapy (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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

SMS text message

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.

Group Type ACTIVE_COMPARATOR

SMS text message

Intervention Type BEHAVIORAL

bi-weekly behavioral messages and bi-weekly check-in messages

SMS text message + Peer Navigation

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.

Group Type ACTIVE_COMPARATOR

SMS text message + Peer Navigation

Intervention Type BEHAVIORAL

bi-weekly behavioral messages plus personalized peer navigation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SMS text message

bi-weekly behavioral messages and bi-weekly check-in messages

Intervention Type BEHAVIORAL

SMS text message + Peer Navigation

bi-weekly behavioral messages plus personalized peer navigation

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No