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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI150510 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Infectious Diseases Research Collaboration, Uganda | OTHER |
| Makerere University | OTHER |
| Kenya Medical Research Institute | OTHER |
| University of California, Berkeley |
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The randomized trials in this record will assess effectiveness, fidelity and cost of prevention and treatment interventions for HIV and hypertension with the objective of informing a population-based study of multi-sectored, multi-disease interventions for HIV.
The study will conduct randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions. The study will conduct two randomization trials to evaluate dynamic treatment interventions tailored to the needs of heavy alcohol users and mobile populations. The study will conduct three randomized trials to evaluate dynamic choice prevention interventions delivered in the context of antenatal clinics, the outpatient department, and in the community delivered by village health teams. The trial will conduct a randomized trial to evaluate a linkage intervention for patients with hypertension and a randomized trial to evaluate a clinic vs. community based intervention for hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | Experimental |
| |
| PREP/PEP at Outpatient Clinics Control | Active Comparator |
| |
| PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention | Experimental |
| |
| PREP/PEP at Antenatal Clinics Control | Active Comparator |
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| PREP/PEP at Community Households Dynamic Prevention Intervention | Experimental |
| |
| PREP/PEP at Community Households Control | Active Comparator |
| |
| Mobility Dynamic Treatment Intervention | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobility Dynamic Treatment Intervention | Other | 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at outpatient clinics vs. PrEP/PEP standard of care at outpatient clinics (not applicable to other arms). Primary definition of coverage will rely on self report. | 48 weeks |
| Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at antenatal clinics vs. PrEP/PEP standard of care at antenatal clinics (not applicable to other arms). Primary definition of coverage will rely on self report. | 48 weeks |
| Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at community households vs. PrEP/PEP standard of care at community households (not applicable to other arms). Primary definition of coverage will rely on self report. | 48 weeks |
| Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml | Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records. | 48 weeks |
| Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml | Primary outcome for comparison of Healthy Living Intervention for Heavy Alcohol Users vs. standard of care control (not applicable to other arms). Data collected from medical records. |
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INDIVIDUAL LEVEL INCLUSION CRITERIA FOR COMPONENT INTERVENTIONS
PrEP/PEP at Outpatient Clinics
PrEP/PEP at Antenatal Clinics
PrEP/PEP at Community Households
Mobility Dynamic Treatment Intervention
Healthy Living Intervention for Heavy Alcohol Users
Hypertension Linkage Intervention
Community Hypertension Intervention
INDIVIDUAL LEVEL EXCLUSION CRITERIA FOR COMPONENT INTERVENTIONS
PrEP/PEP at Outpatient Clinics
PrEP/PEP at Antenatal Clinics
PrEP/PEP at Community Households
Mobility Dynamic Treatment intervention
Healthy Living Intervention for Heavy Alcohol Users
Hypertension Linkage Intervention
Community Hypertension Intervention
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| Name | Affiliation | Role |
|---|---|---|
| Diane Havlir, MD | University of California, San Francisco | Principal Investigator |
| Moses Kamya, MBChB, PhD | Makerere University | Principal Investigator |
| Maya Petersen, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GPRT / SEARCH Office | Kisumu | Kenya | ||||
| IDRC Southwest Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37861683 | Result | Koss CA, Ayieko J, Kabami J, Balzer LB, Kakande E, Sunday H, Nyabuti M, Wafula E, Shade SB, Biira E, Opel F, Atuhaire HN, Okochi H, Ogachi S, Gandhi M, Bacon MC, Bukusi EA, Chamie G, Petersen ML, Kamya MR, Havlir DV; SEARCH study team. Dynamic choice HIV prevention intervention at outpatient departments in rural Kenya and Uganda. AIDS. 2024 Mar 1;38(3):339-349. doi: 10.1097/QAD.0000000000003763. Epub 2023 Oct 19. | |
| 38489493 | Result | Kabami J, Koss CA, Sunday H, Biira E, Nyabuti M, Balzer LB, Gupta S, Chamie G, Ayieko J, Kakande E, Bacon MC, Havlir D, Kamya MR, Petersen M; SEARCH Study Team. Randomized Trial of Dynamic Choice HIV Prevention at Antenatal and Postnatal Care Clinics in Rural Uganda and Kenya. J Acquir Immune Defic Syndr. 2024 Apr 15;95(5):447-455. doi: 10.1097/QAI.0000000000003383. Epub 2024 Mar 11. |
| Label | URL |
|---|---|
| SEARCH | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2023 | Nov 6, 2024 |
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| OTHER |
| University College, London | OTHER |
| University of Pennsylvania | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions.
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| Mobility Control | Active Comparator |
|
| Healthy Living for Heavy Alcohol Users Intervention | Experimental |
|
| Heavy Alcohol Users Control | Active Comparator |
|
| Hypertension Linkage Intervention | Experimental |
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| Hypertension Linkage Control | Active Comparator |
|
| Hypertension Community Intervention | Experimental |
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| Hypertension Community Control | Active Comparator |
|
|
| Health Living Intervention for Heavy Alcohol Users | Other | 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls |
|
| Hypertension Linkage | Other | 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits |
|
| PrEP/PEP at Outpatient Clinics | Other | Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services |
|
| PrEP/PEP at Antenatal Clinics | Other | Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services |
|
| PrEP/PEP at Community Households | Other | Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services |
|
| Standard of Care | Other | Local country standard of care protocols |
|
| Hypertension Community | Other | Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications |
|
| 24 weeks |
| Number of Participants Who Linked to Hypertension Care | Primary outcome for comparison of Hypertension linkage intervention vs. hypertension linkage control (not applicable for other arms). Linkage to hypertension care at the local government clinic within 30 days of screening positive for high blood pressure during community screening. The primary definition will rely on clinical records. | 30 days |
| Percentage of Participants With Hypertension Control <140/90 mmHg | Primary outcome for hypertension community treatment intervention vs. hypertension community treatment control (not applicable for other arms). Blood pressure will be measured three times using standardized procedures in all trial participants at the 24-week study visit. Hypertension is considered controlled if the average of the 2nd and 3rd measures <140 mmHg systolic and <90 mmHg diastolic. | 24 weeks |
| Mbarara |
| Uganda |
| 38054535 | Result | Kakande ER, Ayieko J, Sunday H, Biira E, Nyabuti M, Agengo G, Kabami J, Aoko C, Atuhaire HN, Sang N, Owaranganise A, Litunya J, Mugoma EW, Chamie G, Peng J, Schrom J, Bacon MC, Kamya MR, Havlir DV, Petersen ML, Balzer LB; SEARCH Study Team. A community-based dynamic choice model for HIV prevention improves PrEP and PEP coverage in rural Uganda and Kenya: a cluster randomized trial. J Int AIDS Soc. 2023 Dec;26(12):e26195. doi: 10.1002/jia2.26195. |
| 38054932 | Result | Ayieko J, Balzer LB, Inviolata C, Kakande E, Opel F, Wafula EM, Kabami J, Owaraganise A, Mwangwa F, Nakato H, Bukusi EA, Camlin CS, Charlebois ED, Bacon MC, Petersen ML, Kamya MR, Havlir DV, Chamie G; SEARCH Study Team. Randomized Trial of a "Dynamic Choice" Patient-Centered Care Intervention for Mobile Persons With HIV in East Africa. J Acquir Immune Defic Syndr. 2024 Jan 1;95(1):74-81. doi: 10.1097/QAI.0000000000003311. Epub 2023 Dec 1. |
| 38054564 | Result | Puryear SB, Mwangwa F, Opel F, Chamie G, Balzer LB, Kabami J, Ayieko J, Owaraganise A, Kakande E, Agengo G, Bukusi E, Kabageni S, Omoding D, Bacon M, Schrom J, Woolf-King S, Petersen ML, Havlir DV, Kamya M, Hahn JA. Effect of a brief alcohol counselling intervention on HIV viral suppression and alcohol use among persons with HIV and unhealthy alcohol use in Uganda and Kenya: a randomized controlled trial. J Int AIDS Soc. 2023 Dec;26(12):e26187. doi: 10.1002/jia2.26187. |
| 36342940 | Result | Hickey MD, Owaraganise A, Sang N, Opel FJ, Mugoma EW, Ayieko J, Kabami J, Chamie G, Kakande E, Petersen ML, Balzer LB, Kamya MR, Havlir DV. Effect of a one-time financial incentive on linkage to chronic hypertension care in Kenya and Uganda: A randomized controlled trial. PLoS One. 2022 Nov 7;17(11):e0277312. doi: 10.1371/journal.pone.0277312. eCollection 2022. |
| 41762058 | Derived | Balzer LB, van der Laan MJ, Petersen ML. Machine learning to optimize precision in the analysis of randomized trials: A journey in pre-specified, yet data-adaptive learning. Clin Trials. 2026 Jun;23(3):289-296. doi: 10.1177/17407745261417227. Epub 2026 Feb 28. |
| 37408473 | Derived | Kabami J, Kakande E, Chamie G, Balzer LB, Petersen ML, Camlin CS, Nyabuti M, Koss CA, Bukusi EA, Kamya MR, Havlir DV, Ayieko J. Uptake of a patient-centred dynamic choice model for HIV prevention in rural Kenya and Uganda: SEARCH SAPPHIRE study. J Int AIDS Soc. 2023 Jul;26 Suppl 1(Suppl 1):e26121. doi: 10.1002/jia2.26121. |
| FG001 | PREP/PEP at Outpatient Clinics Control | Standard of Care: Local country standard of care protocols |
| FG002 | PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention | PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services |
| FG003 | PREP/PEP at Antenatal Clinics Control | Standard of Care: Local country standard of care protocols |
| FG004 | PREP/PEP at Community Households Dynamic Prevention Intervention | PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services |
| FG005 | PREP/PEP at Community Households Control | Standard of Care: Local country standard of care protocols |
| FG006 | Mobility Dynamic Treatment Intervention | Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel |
| FG007 | Mobility Control | Standard of Care: Local country standard of care protocols |
| FG008 | Healthy Living for Heavy Alcohol Users Intervention | Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls |
| FG009 | Heavy Alcohol Users Control | Standard of Care: Local country standard of care protocols |
| FG010 | Hypertension Linkage Intervention | Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits |
| FG011 | Hypertension Linkage Control | Standard of Care: Local country standard of care protocols |
| FG012 | Hypertension Community Intervention | Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications |
| FG013 | Hypertension Community Control | Standard of Care: Local country standard of care protocols |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services |
| BG001 | PREP/PEP at Outpatient Clinics Control | Standard of Care: Local country standard of care protocols |
| BG002 | PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention | PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services |
| BG003 | PREP/PEP at Antenatal Clinics Control | Standard of Care: Local country standard of care protocols |
| BG004 | PREP/PEP at Community Households Dynamic Prevention Intervention | PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services |
| BG005 | PREP/PEP at Community Households Control | Standard of Care: Local country standard of care protocols |
| BG006 | Mobility Dynamic Treatment Intervention | Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel |
| BG007 | Mobility Control | Standard of Care: Local country standard of care protocols |
| BG008 | Healthy Living for Heavy Alcohol Users Intervention | Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls |
| BG009 | Heavy Alcohol Users Control | Standard of Care: Local country standard of care protocols |
| BG010 | Hypertension Linkage Intervention | Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits |
| BG011 | Hypertension Linkage Control | Standard of Care: Local country standard of care protocols |
| BG012 | Hypertension Community Intervention | Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications |
| BG013 | Hypertension Community Control | Standard of Care: Local country standard of care protocols |
| BG014 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Region of Enrollment | 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error. | Number | 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 | Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at outpatient clinics vs. PrEP/PEP standard of care at outpatient clinics (not applicable to other arms). Primary definition of coverage will rely on self report. | Participants who completed the Week 48 visit. | Posted | Mean | 95% Confidence Interval | Percentage of months | 48 weeks |
|
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| Primary | Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at antenatal clinics vs. PrEP/PEP standard of care at antenatal clinics (not applicable to other arms). Primary definition of coverage will rely on self report. | Posted | Mean | 95% Confidence Interval | Percentage of months | 48 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at community households vs. PrEP/PEP standard of care at community households (not applicable to other arms). Primary definition of coverage will rely on self report. | Posted | Mean | 95% Confidence Interval | Percentage of months | 48 weeks |
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| Primary | Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml | Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records. | Posted | Count of Participants | Participants | 48 weeks |
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| Primary | Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml | Primary outcome for comparison of Healthy Living Intervention for Heavy Alcohol Users vs. standard of care control (not applicable to other arms). Data collected from medical records. | Posted | Number | 95% Confidence Interval | Percentage of participants with VL <400 | 24 weeks |
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| Primary | Number of Participants Who Linked to Hypertension Care | Primary outcome for comparison of Hypertension linkage intervention vs. hypertension linkage control (not applicable for other arms). Linkage to hypertension care at the local government clinic within 30 days of screening positive for high blood pressure during community screening. The primary definition will rely on clinical records. | Posted | Count of Participants | Participants | 30 days |
|
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| Primary | Percentage of Participants With Hypertension Control <140/90 mmHg | Primary outcome for hypertension community treatment intervention vs. hypertension community treatment control (not applicable for other arms). Blood pressure will be measured three times using standardized procedures in all trial participants at the 24-week study visit. Hypertension is considered controlled if the average of the 2nd and 3rd measures <140 mmHg systolic and <90 mmHg diastolic. | Participants who completed the 24-week follow-up visit | Posted | Number | 95% Confidence Interval | Percentage of persons with HTN control | 24 weeks |
|
|
Between 30 days and 48 weeks depending on the primary outcome measure.
Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other [Not Including Serious] Adverse Events were not monitored/assessed in both intervention and control arms.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services | 0 | 197 | 7 | 197 | 0 | 0 |
| EG001 | PREP/PEP at Outpatient Clinics Control | Standard of Care: Local country standard of care protocols | 0 | 206 | 0 | 206 | 0 | 0 |
| EG002 | PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention | PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services | 0 | 203 | 17 | 203 | 0 | 0 |
| EG003 | PREP/PEP at Antenatal Clinics Control | Standard of Care: Local country standard of care protocols | 0 | 197 | 2 | 197 | 0 | 0 |
| EG004 | PREP/PEP at Community Households Dynamic Prevention Intervention | PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services | 0 | 212 | 4 | 212 | 0 | 0 |
| EG005 | PREP/PEP at Community Households Control | Standard of Care: Local country standard of care protocols | 0 | 217 | 1 | 217 | 0 | 0 |
| EG006 | Mobility Dynamic Treatment Intervention | Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel | 2 | 102 | 3 | 102 | 0 | 0 |
| EG007 | Mobility Control | Standard of Care: Local country standard of care protocols | 2 | 99 | 2 | 99 | 0 | 0 |
| EG008 | Healthy Living for Heavy Alcohol Users Intervention | Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls | 0 | 197 | 3 | 197 | 0 | 0 |
| EG009 | Heavy Alcohol Users Control | Standard of Care: Local country standard of care protocols | 1 | 203 | 1 | 203 | 0 | 0 |
| EG010 | Hypertension Linkage Intervention | Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits | 0 | 100 | 5 | 100 | 0 | 0 |
| EG011 | Hypertension Linkage Control | Standard of Care: Local country standard of care protocols | 0 | 99 | 0 | 99 | 0 | 0 |
| EG012 | Hypertension Community Intervention | Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications | 2 | 98 | 5 | 98 | 0 | 0 |
| EG013 | Hypertension Community Control | Standard of Care: Local country standard of care protocols | 1 | 102 | 1 | 102 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death of premature infant | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Emergency caesarian section | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Incarcerated inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Intimate partner violence | Social circumstances | Non-systematic Assessment |
| ||
| Pre-term delivery | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Diabetes Type 2 | Endocrine disorders | Non-systematic Assessment |
| ||
| Uterine fibroids | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Death due to unknown illness | General disorders | Non-systematic Assessment |
| ||
| Hydatidiform mole | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Lumbar spondylosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Incomplete abortion | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Cryptococcal meningitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pulmonary tuberculosis | Infections and infestations | Non-systematic Assessment |
| ||
| Homicide | Social circumstances | Non-systematic Assessment |
| ||
| Urine retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Severe hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Chronic renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Right inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Black | University of California, San Francisco | 4158063016 | douglas.black@ucsf.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2021 | Nov 6, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2022 | Nov 6, 2024 | ICF_002.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000431 | Ethanol |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
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