A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

Conditions
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HIV, Hypertension, Alcohol Drinking, Maternal Child Health, Cost Effectiveness

Intervention / Treatment
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* Other: PrEP/PEP at Community Households
* Other: Standard of Care
* Other: Hypertension Community
* Other: Mobility Dynamic Treatment Intervention
* Other: Health Living Intervention for Heavy Alcohol Users
* Other: Hypertension Linkage
* Other: PrEP/PEP at Outpatient Clinics
* Other: PrEP/PEP at Antenatal Clinics


Participation Criteria
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Eligibility Criteria
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INDIVIDUAL LEVEL INCLUSION CRITERIA FOR COMPONENT INTERVENTIONS PrEP/PEP at Outpatient Clinics Age ≥15 years HIV-negative Current or anticipated risk for HIV-infection PrEP/PEP at Antenatal Clinics Age ≥15 years HIV-negative Current or anticipated risk for HIV-infection PrEP/PEP at Community Households Age > 15 years HIV-negative Current or anticipated risk for HIV-infection Mobility Dynamic Treatment Intervention Age ≥15 years HIV-positive HIV RNA non-suppression (>400 c/mL in the prior 12 months) or missed 2 visits in past 12 months or missed 2 visits in past 12 months or no VL measured in past 12 months Travel outside the community ≥2 times in past 12 months Enrolled or new to care in a study clinic Healthy Living Intervention for Heavy Alcohol Users Age ≥18 years HIV-positive HIV RNA non-suppression (>400 c/mL in the prior 12 months) or missed clinic visits (>2 weeks or <=90 days from last scheduled clinic visit) within past 6 months, or out of care without return to care (>90 days from last scheduled clinic visit) within past 6 months Heavy alcohol use per AUDIT-C tool (scores of ≥4 for men, and ≥3 for women) Enrolled or new to care in a study clinic Hypertension Linkage Intervention Age ≥25 years Blood pressure ≥140/90 mmHg on three repeated measurements during community-based hypertension screening Resident (by self-report) within catchment area of referral health center Community Hypertension Intervention Age >=40 Blood pressure ≥160/100 on average of 2nd and 3rd measurements at initial screening Sustained blood pressure elevation to ≥140/90 at initial clinic enrollment visit INDIVIDUAL LEVEL EXCLUSION CRITERIA FOR COMPONENT INTERVENTIONS PrEP/PEP at Outpatient Clinics <15 years of age Unable to provide consent or parental co-consent as per country guidelines Participation in another Phase A RCT intervention component PrEP/PEP at Antenatal Clinics <15 years of age unable to provide consent or parental co-consent as per country guidelines Participation in another Phase A RCT intervention component PrEP/PEP at Community Households <15 years of age unable to provide consent or parental co-consent as per country guidelines Participation in another Phase A RCT intervention component Mobility Dynamic Treatment intervention <15 years of age Participation in another Phase A RCT intervention component Healthy Living Intervention for Heavy Alcohol Users <18 years of age Participation in another Phase A RCT intervention component No access to mobile phone Hypertension Linkage Intervention <25 years of age Plan to out-migrate from the catchment area of referral health center within 30 days of screening visit Already engaged in hypertensive care (by self-report) Blood pressure measure of ≥180/110 mmHg during screening symptoms of hypertensive emergency Community Hypertension Intervention Pregnancy Co-morbidities that preclude home monitoring

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention<br> | Other: PrEP/PEP at Outpatient Clinics<br>* 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<br>|
| Active Comparator: PREP/PEP at Outpatient Clinics Control<br> | Other: Standard of Care<br>* Local country standard of care protocols<br>|
| Experimental: PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention<br> | Other: PrEP/PEP at Antenatal Clinics<br>* 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<br>|
| Active Comparator: PREP/PEP at Antenatal Clinics Control<br> | Other: Standard of Care<br>* Local country standard of care protocols<br>|
| Experimental: PREP/PEP at Community Households Dynamic Prevention Intervention<br> | Other: PrEP/PEP at Community Households<br>* 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<br>|
| Active Comparator: PREP/PEP at Community Households Control<br> | Other: Standard of Care<br>* Local country standard of care protocols<br>|
| Experimental: Mobility Dynamic Treatment Intervention<br> | Other: Mobility Dynamic Treatment Intervention<br>* 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<br>|
| Active Comparator: Mobility Control<br> | Other: Standard of Care<br>* Local country standard of care protocols<br>|
| Experimental: Healthy Living for Heavy Alcohol Users Intervention<br> | Other: Health Living Intervention for Heavy Alcohol Users<br>* 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls<br>|
| Active Comparator: Heavy Alcohol Users Control<br> | Other: Standard of Care<br>* Local country standard of care protocols<br>|
| Experimental: Hypertension Linkage Intervention<br> | Other: Hypertension Linkage<br>* 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits<br>|
| Active Comparator: Hypertension Linkage Control<br> | Other: Standard of Care<br>* Local country standard of care protocols<br>|
| Experimental: Hypertension Community Intervention<br> | Other: Hypertension Community<br>* Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications<br>|
| Active Comparator: Hypertension Community Control<br> | Other: Standard of Care<br>* Local country standard of care protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention coverage defined as proportion of follow-up weeks 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 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 proportion of follow-up weeks 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 weeks 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 | 
| Number 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. | 24 weeks | 
| Number of participants to 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 | 
| Proportion 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community Health, Mobile Populations, Youth and Adolescents, PrEP, PEP, HIV Treatment and Prevention