Trial Outcomes & Findings for Engagement to Care South Africa (NCT NCT02417233)
NCT ID: NCT02417233
Last Updated: 2018-08-20
Results Overview
Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
756 participants
Primary outcome timeframe
3 months
Results posted on
2018-08-20
Participant Flow
Participant milestones
| Measure |
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.
|
Short Message Service (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.
SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages
|
Short Message Service (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.
SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation
|
|---|---|---|---|
|
Overall Study
STARTED
|
169
|
289
|
298
|
|
Overall Study
COMPLETED
|
133
|
238
|
239
|
|
Overall Study
NOT COMPLETED
|
36
|
51
|
59
|
Reasons for withdrawal
| Measure |
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.
|
Short Message Service (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.
SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages
|
Short Message Service (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.
SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation
|
|---|---|---|---|
|
Overall Study
Death
|
4
|
10
|
14
|
|
Overall Study
Lost to Follow-up
|
27
|
39
|
34
|
|
Overall Study
Protocol Violation
|
2
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
8
|
|
Overall Study
Relocation out of study area
|
1
|
0
|
1
|
|
Overall Study
Mentally unstable
|
0
|
1
|
0
|
Baseline Characteristics
Engagement to Care South Africa
Baseline characteristics by cohort
| Measure |
Standard of Care
n=167 Participants
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.
|
SMS Text Message
n=289 Participants
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.
SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages
|
SMS Text Message + Peer Navigation
n=296 Participants
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.
SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation
|
Total
n=752 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
167 Participants
n=5 Participants
|
289 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
750 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
292 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
460 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
166 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
749 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Colored
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment
Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)
Outcome measures
| Measure |
Standard of Care
n=87 Participants
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.
|
Short Message Service (SMS) Text Message
n=132 Participants
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.
SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages
|
SMS Text Message + Peer Navigation
n=133 Participants
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.
SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation
|
|---|---|---|---|
|
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 Participants
|
121 Participants
|
119 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment
Participants eligible for ART who initiate treatment within 3 months of diagnosis
Outcome measures
| Measure |
Standard of Care
n=87 Participants
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.
|
Short Message Service (SMS) Text Message
n=132 Participants
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.
SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages
|
SMS Text Message + Peer Navigation
n=133 Participants
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.
SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation
|
|---|---|---|---|
|
Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis)
|
55 Participants
|
79 Participants
|
94 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis population is all enrolled participants who were prescribed ART.
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.
Outcome measures
| Measure |
Standard of Care
n=139 Participants
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.
|
Short Message Service (SMS) Text Message
n=234 Participants
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.
SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages
|
SMS Text Message + Peer Navigation
n=255 Participants
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.
SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation
|
|---|---|---|---|
|
Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment)
|
77 Participants
|
153 Participants
|
178 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis population is all enrolled participants who were not prescribed ART
Participants who return for repeat CD4 testing within 12 months of diagnosis
Outcome measures
| Measure |
Standard of Care
n=28 Participants
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.
|
Short Message Service (SMS) Text Message
n=55 Participants
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.
SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages
|
SMS Text Message + Peer Navigation
n=41 Participants
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.
SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation
|
|---|---|---|---|
|
Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis)
|
3 Participants
|
2 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis population is all enrolled participants who were prescribed ART and had received viral load testing by 12 months of study enrollment
Viral load test results \<400 copies/mL (consistent with current and correct adherence to ART)
Outcome measures
| Measure |
Standard of Care
n=76 Participants
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.
|
Short Message Service (SMS) Text Message
n=157 Participants
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.
SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages
|
SMS Text Message + Peer Navigation
n=160 Participants
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.
SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation
|
|---|---|---|---|
|
Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL)
|
67 Participants
|
141 Participants
|
132 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis population is all enrolled participants prescribed ART who returned to answer the 12 month survey.
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.
Outcome measures
| Measure |
Standard of Care
n=115 Participants
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.
|
Short Message Service (SMS) Text Message
n=201 Participants
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.
SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages
|
SMS Text Message + Peer Navigation
n=214 Participants
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.
SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation
|
|---|---|---|---|
|
Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month)
|
92 Participants
|
130 Participants
|
162 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
SMS Text Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
SMS Text Message + Peer Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sheri Lippman
University of California San Francisco
Phone: 415-476-6319
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place