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| ID | Type | Description | Link |
|---|---|---|---|
| P0054377 | Other Grant/Funding Number | PHS Health Resources & Services Admin. |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS text message | Behavioral | bi-weekly behavioral messages and bi-weekly check-in messages |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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. | 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 | 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) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheri Lippman, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moses Kotane Sub-district clinics | Mabeskraal | Northwest | South Africa | |||
| Rustenburg Sub-district clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36572869 | Derived | 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. | |
| 36468499 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 duplicate participants and 2 participants who were later found not to be HIV+ (not eligible) were removed from analysis. The first participant who was not HIV+ was dishonest about their status; the second person who was not HIV+ had a reactive rapid test but the confirmatory Western Blot was negative.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | SMS Text Message |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Participants who received CD4 count test result within 3 months of testing HIV-positive (binary) | Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment | Posted | Count of Participants | Participants | 3 months |
|
"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.
"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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sheri Lippman | University of California San Francisco | 415-476-6319 | sheri.lippman@ucsf.edu |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| SMS text message + Peer Navigation | Behavioral | bi-weekly behavioral messages plus personalized peer navigation |
|
| 12 months |
| Rustenburg |
| Northwest |
| South Africa |
| 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. |
| 34435440 | Derived | 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. |
| 32779730 | Derived | 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. |
| 26852237 | Derived | 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. |
| Protocol Violation |
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| Withdrawal by Subject |
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| Relocation out of study area |
|
| Mentally unstable |
|
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | 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 |
| OG002 | 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 |
|
|
|
| Primary | 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 | Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment | Posted | Count of Participants | Participants | 3 months |
|
|
|
|
| Primary | 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. | Analysis population is all enrolled participants who were prescribed ART. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Primary | 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 | Analysis population is all enrolled participants who were not prescribed ART | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Primary | 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) | Analysis population is all enrolled participants who were prescribed ART and had received viral load testing by 12 months of study enrollment | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Primary | 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. | Analysis population is all enrolled participants prescribed ART who returned to answer the 12 month survey. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 4 |
| 169 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 10 | 289 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 14 | 298 | 0 | 0 | 0 | 0 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Odds Ratio (OR) |
| 1.401 |
| 2-Sided |
| 95 |
| 0.87 |
| 2.26 |
| Other |
| Odds Ratio (OR) |
| 1.82 |
| 2-Sided |
| 95 |
| 1.06 |
| 3.14 |
| Other |
| Odds Ratio (OR) |
| 2.68 |
| 2-Sided |
| 95 |
| 0.59 |
| 12.16 |
| Other |
| Odds Ratio (OR) |
| 1.764 |
| 2-Sided |
| 95 |
| 0.81 |
| 3.83 |
| Other |