N/A
N=756
Engagement to Care South Africa
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02417233 ↗Enrolled (actual)
756
Serious AEs
—
Results posted
Aug 2018
Primary outcome: 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 Participants — p=0.848
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SMS text message (Behavioral); SMS text message + Peer Navigation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2016
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 | — |
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.
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.