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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04810650
Other study ID # SAPPHIRE
Secondary ID U01AI150510
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 15, 2021
Est. completion date September 2024

Study information

Verified date May 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3000
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility INDIVIDUAL LEVEL INCLUSION CRITERIA FOR COMPONENT INTERVENTIONS PrEP/PEP at Outpatient Clinics 1. Age =15 years 2. HIV-negative 3. Current or anticipated risk for HIV-infection PrEP/PEP at Antenatal Clinics 1. Age =15 years 2. HIV-negative 3. Current or anticipated risk for HIV-infection PrEP/PEP at Community Households 1. Age > 15 years 2. HIV-negative 3. Current or anticipated risk for HIV-infection Mobility Dynamic Treatment Intervention 1. Age =15 years 2. HIV-positive 3. 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 4. Travel outside the community =2 times in past 12 months 5. Enrolled or new to care in a study clinic Healthy Living Intervention for Heavy Alcohol Users 1. Age =18 years 2. HIV-positive 3. 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 4. Heavy alcohol use per AUDIT-C tool (scores of =4 for men, and =3 for women) 5. Enrolled or new to care in a study clinic Hypertension Linkage Intervention 1. Age =25 years 2. Blood pressure =140/90 mmHg on three repeated measurements during community-based hypertension screening 3. Resident (by self-report) within catchment area of referral health center Community Hypertension Intervention 1. Age >=40 2. Blood pressure =160/100 on average of 2nd and 3rd measurements at initial screening 3. Sustained blood pressure elevation to =140/90 at initial clinic enrollment visit INDIVIDUAL LEVEL EXCLUSION CRITERIA FOR COMPONENT INTERVENTIONS PrEP/PEP at Outpatient Clinics 1. <15 years of age 2. Unable to provide consent or parental co-consent as per country guidelines 3. Participation in another Phase A RCT intervention component PrEP/PEP at Antenatal Clinics 1. <15 years of age 2. unable to provide consent or parental co-consent as per country guidelines 3. Participation in another Phase A RCT intervention component PrEP/PEP at Community Households 1. <15 years of age 2. unable to provide consent or parental co-consent as per country guidelines 3. Participation in another Phase A RCT intervention component Mobility Dynamic Treatment intervention 1. <15 years of age 2. Participation in another Phase A RCT intervention component Healthy Living Intervention for Heavy Alcohol Users 1. <18 years of age 2. Participation in another Phase A RCT intervention component 3. No access to mobile phone Hypertension Linkage Intervention 1. <25 years of age 2. Plan to out-migrate from the catchment area of referral health center within 30 days of screening visit 3. Already engaged in hypertensive care (by self-report) 4. Blood pressure measure of =180/110 mmHg during screening symptoms of hypertensive emergency Community Hypertension Intervention 1. Pregnancy 2. Co-morbidities that preclude home monitoring

Study Design


Intervention

Other:
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
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
Hypertension Linkage
1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits
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
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
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
Standard of Care
Local country standard of care protocols
Hypertension Community
Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications

Locations

Country Name City State
Kenya GPRT / SEARCH Office Kisumu
Uganda IDRC Southwest Uganda Mbarara

Sponsors (11)

Lead Sponsor Collaborator
University of California, San Francisco Infectious Diseases Research Collaboration, Uganda, Kenya Medical Research Institute, Makerere University, National Heart, Lung, and Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), University College, London, University of California, Berkeley, University of Pennsylvania

Countries where clinical trial is conducted

Kenya,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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. 48 weeks
Primary 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
Primary 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
Primary 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
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