Clinical trial NCT02417233: Engagement to Care South Africa
Official title: Improving Engagement to HIV Prevention and Care in North West, South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV-positive
adherence
engagement to care
mobile Health (mHealth)
SMS
peer navigation
retention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2015-04-15
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary)
timeFrame: 3 months
measure: Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis)
timeFrame: 3 months
measure: Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment)
timeFrame: 12 months
measure: Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis)
timeFrame: 12 months
measure: Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL)
timeFrame: 12 months
measure: Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mabeskraal
country: South Africa
facility: Moses Kotane Sub-district clinics
state: Northwest
city: Rustenburg
country: South Africa
facility: Rustenburg Sub-district clinics
state: Northwest
Study officials:
affiliation: University of California, San Francisco
name: Sheri Lippman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steward WT, Agnew E, de Kadt J, Ratlhagana MJ, Sumitani J, Gilmore HJ, Grignon J, Shade SB, Tumbo J, Barnhart S, Lippman SA. Impact of SMS and peer navigation on retention in HIV care among adults in South Africa: results of a three-arm cluster randomized controlled trial. J Int AIDS Soc. 2021 Aug;24(8):e25774. doi: 10.1002/jia2.25774.
citation: 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.
citation: Lippman SA, Shade SB, Sumitani J, DeKadt J, Gilvydis JM, Ratlhagana MJ, Grignon J, Tumbo J, Gilmore H, Agnew E, Saberi P, Barnhart S, Steward WT. Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial. Trials. 2016 Feb 6;17:68. doi: 10.1186/s13063-016-1190-y.