HIVICARENCT02417233

Engagement to Care South Africa

A study testing SMS text message and SMS text message + Peer Navigation in people with HIV, run by University of California, San Francisco at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV
What is being tested?: SMS text message and SMS text message + Peer Navigation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 756 participants
Where: 2 sitesSouth Africa
Study dates: Oct 2014to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

Moses Kotane Sub-district clinics
Mabeskraal, Northwest
Rustenburg Sub-district clinics
Rustenburg, Northwest

Other trials in South Africa

About this study

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

Read the 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.

Conditions: HIV
Being tested: SMS text message, SMS text message + Peer Navigation
Keywords: HIV-positive, adherence, engagement to care, mobile Health (mHealth), SMS, peer navigation, retention
Medical subject headings: HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SMS text messageBehavioural
bi-weekly behavioral messages and bi-weekly check-in messages
SMS text message + Peer NavigationBehavioural
bi-weekly behavioral messages plus personalized peer navigation

Study groups in NCT02417233
Study group	Role	What they receive
Standard of Care	No intervention	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	Active comparator	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. Receives: Behavioral: SMS text message
SMS text message + Peer Navigation	Active comparator	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. Receives: Behavioral: SMS text message + Peer Navigation

What is being measured

The primary outcome is the main question the study is designed to answer.

Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary)
Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)
Measured: 3 months
Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis)
Participants eligible for ART who initiate treatment within 3 months of diagnosis
Measured: 3 months
Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment)
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.
Measured: 12 months
Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis)
Participants who return for repeat CD4 testing within 12 months of diagnosis
Measured: 12 months
Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL)
Viral load test results <400 copies/mL (consistent with current and correct adherence to ART)
Measured: 12 months
Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month)
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Jun 2016

First posted15 Apr 2015 (estimated)
Study startOct 2014
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 756 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02417233
Sponsor's protocol ID: 12-10482
Other IDs: P0054377
Acronym: ICARE
Status last verified: Nov 2017
First submitted: 12 Dec 2014
Last updated: 20 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Leslie HH, Mooney AC, Gilmore HJ, Agnew E, Grignon JS, deKadt J, Shade SB, Ratlhagana MJ, Sumitani J, Barnhart S, Steward WT, Lippman SA. Prevalence, motivation, and outcomes of clinic transfer in a clinical cohort of people living with HIV in North West Province, South Africa. BMC Health Serv Res. 2022 Dec 26;22(1):1584. doi: 10.1186/s12913-022-08962-8.
PubMed 36572869
Lippman SA, de Kadt J, Ratlhagana MJ, Agnew E, Gilmore H, Sumitani J, Grignon J, Gutin SA, Shade SB, Gilvydis JM, Tumbo J, Barnhart S, Steward WT. Impact of short message service and peer navigation on linkage to care and antiretroviral therapy initiation in South Africa. AIDS. 2023 Mar 15;37(4):647-657. doi: 10.1097/QAD.0000000000003453. Epub 2022 Dec 5.
PubMed 36468499
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.
PubMed 34435440
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.
PubMed 32779730
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.
PubMed 26852237

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Engagement to HIV Prevention and Care in North West, South Africa
ClinicalTrials.gov ID: NCT02417233
Acronym / sponsor ID: ICARE / 12-10482
Conditions: HIV
Keywords: HIV-positive, adherence, engagement to care, mobile Health (mHealth), SMS, peer navigation, retention
Study type: Interventional
Recruitment status: Completed
Enrolment: 756 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: University of Washington
Study start: Oct 2014
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 15 Apr 2015 (estimated)
Results: Posted 20 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Standard of Care	No intervention	–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	Active comparator	Behavioral: SMS text messageParticipants 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 + Peer Navigation	Active comparator	Behavioral: SMS text message + Peer NavigationParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SMS text messagebi-weekly behavioral messages and bi-weekly check-in messages	Behavioural	SMS text message
SMS text message + Peer Navigationbi-weekly behavioral messages plus personalized peer navigation	Behavioural	SMS text message + Peer Navigation

Primary outcome

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)
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
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.
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
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)
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.

Results and safety

Results posted to the registry on 20 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	169	133
Short Message Service (SMS) Text Message	289	238
Short Message Service (SMS) Text Message + Peer Navigation	298	239

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Standard of Care n = 87	Short Message Service (SMS) Text Message n = 132	SMS Text Message + Peer Navigation n = 133
Value	80	121	119

Standard of Care vs Short Message Service (SMS) Text Message: Odds Ratio (OR): 0.958 (95% CI 0.62 to 1.49), p = 0.848, Regression, Logistic
Standard of Care vs SMS Text Message + Peer Navigation: Odds Ratio (OR): 1.492 (95% CI 0.90 to 2.49), p = 0.125, Regression, Logistic

Population analysed: Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment

Primary outcome: Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis)

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Standard of Care n = 87	SMS Text Message n = 132	SMS Text Message + Peer Navigation n = 133
Value	55	79	94

Standard of Care vs SMS Text Message: Odds Ratio (OR): 0.866 (96% CI 0.48 to 1.57), p = 0.636, Regression, Logistic
Standard of Care vs SMS Text Message + Peer Navigation: Odds Ratio (OR): 1.401 (95% CI 0.87 to 2.26), p = 0.165, Regression, Logistic

Population analysed: Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment

Primary outcome: Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment)

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Standard of Care n = 139	SMS Text Message n = 234	SMS Text Message + Peer Navigation n = 255
Value	77	153	178

Standard of Care vs SMS Text Message: Odds Ratio (OR): 1.48 (95% CI 0.86 to 2.55), p = 0.16, Regression, Logistic
Standard of Care vs SMS Text Message + Peer Navigation: Odds Ratio (OR): 1.82 (95% CI 1.06 to 3.14), p = 0.03, Regression, Logistic

Population analysed: Analysis population is all enrolled participants who were prescribed ART.

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

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Standard of Care n = 28	SMS Text Message n = 55	SMS Text Message + Peer Navigation n = 41
Value	3	2	11

Standard of Care vs SMS Text Message: Odds Ratio (OR): 0.27 (95% CI 0.03 to 2.45), p = 0.24, Regression, Logistic
Standard of Care vs SMS Text Message + Peer Navigation: Odds Ratio (OR): 2.68 (95% CI 0.59 to 12.16), p = 0.20, Regression, Logistic

Population analysed: Analysis population is all enrolled participants who were not prescribed ART

Adverse events

Time frame: "0 participants at risk" included because: Serious and Other Adverse Events were not monitored/assessed in this study because it was not a clinical trial of a new drug or device, but rather, a behavioral intervention. Study staff were not clinicians - only data monitoring assistants and peer health navigators. The study was based in a public clinic system, but the only clinical data abstracted for the study was for the study outcomes described. Other medical data was not recorded.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	0 of 0	0 of 0	4 of 169
SMS Text Message	0 of 0	0 of 0	10 of 289
SMS Text Message + Peer Navigation	0 of 0	0 of 0	14 of 298

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36572869Leslie HH, Mooney AC, Gilmore HJ, Agnew E, Grignon JS, deKadt J, Shade SB, Ratlhagana MJ, Sumitani J, Barnhart S, Steward WT, Lippman SA. Prevalence, motivation, and outcomes of clinic transfer in a clinical cohort of people living with HIV in North West Province, South Africa. BMC Health Serv Res. 2022 Dec 26;22(1):1584. doi: 10.1186/s12913-022-08962-8.
Derived from this study: PubMed 36468499Lippman SA, de Kadt J, Ratlhagana MJ, Agnew E, Gilmore H, Sumitani J, Grignon J, Gutin SA, Shade SB, Gilvydis JM, Tumbo J, Barnhart S, Steward WT. Impact of short message service and peer navigation on linkage to care and antiretroviral therapy initiation in South Africa. AIDS. 2023 Mar 15;37(4):647-657. doi: 10.1097/QAD.0000000000003453. Epub 2022 Dec 5.
Derived from this study: PubMed 34435440Steward 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.
Derived from this study: PubMed 32779730Palmer 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.
Derived from this study: PubMed 26852237Lippman 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sheri Lippman, PhD principal investigator

University of California, San Francisco

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SMS text message and SMS text message + Peer Navigation in people with HIV, run by University of California, San Francisco at 2 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02417233, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.