N/A
Completed N=756
Engagement to Care South Africa
Source: ClinicalTrials.gov NCT02417233 ↗Enrolled (actual)
756
Serious AEs
—
Results posted
Aug 2018
Primary outcomePrimary: Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) — 80; 121; 119 Participants — p=0.848
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) |
80; 121; 119 | 0.848 |
| PRIMARY Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) |
55; 79; 94 | 0.636 |
| PRIMARY Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) |
77; 153; 178 | 0.16 |
| PRIMARY Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) |
3; 2; 11 | 0.24 |
| PRIMARY Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) |
67; 141; 132 | 0.093 |
| PRIMARY Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) |
92; 130; 162 | — |
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)
Data sourced from ClinicalTrials.gov (NCT02417233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.