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Completed

NCT Number: NCT02417233

Engagement to Care South Africa

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.

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Key information

Conditions

HIV Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moses Kotane Sub-district clinics, Mabeskraal, Northwest, South Africa

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SMS text message

Behavioral

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

SMS text message + Peer Navigation

Behavioral

bi-weekly behavioral messages plus personalized peer navigation

Primary outcomes

  1. Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary)

    Time frame: 3 months

    Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)

  2. Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis)

    Time frame: 3 months

    Participants eligible for ART who initiate treatment within 3 months of diagnosis

  3. Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment)

    Time frame: 12 months

    Participants eligible for ART who initiated ART and who remain on treatment 12 months from enrollment. Retention in care at 12 months is defined as at least 4 clinical care visits with less than 4 months between each visit.

  4. Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis)

    Time frame: 12 months

    Participants who return for repeat CD4 testing within 12 months of diagnosis

  5. Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL)

    Time frame: 12 months

    Viral load test results <400 copies/mL (consistent with current and correct adherence to ART)

  6. Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month)

    Time frame: 12 months

    Self-reported ability to take ART as prescribed in last month, assessed at 12 months from enrollment. Considered compliant if reported "very good" or "excellent" adherence.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • University of Washington

Registry information

Official study title

Improving Engagement to HIV Prevention and Care in North West, South Africa

Acronym: ICARE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2015
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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