A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa (SAPPHIRE)
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ClinicalTrials.gov Identifier: NCT04810650 |
Recruitment Status :
Recruiting
First Posted : March 23, 2021
Last Update Posted : May 5, 2022
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Condition or disease | Intervention/treatment | Phase |
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HIV Hypertension Alcohol Drinking Maternal Child Health Cost Effectiveness | 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 Other: PrEP/PEP at Community Households Other: Standard of Care Other: Hypertension Community | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 3000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions. |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa |
Actual Study Start Date : | April 15, 2021 |
Estimated Primary Completion Date : | September 2024 |
Estimated Study Completion Date : | September 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention |
Other: 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 |
Active Comparator: PREP/PEP at Outpatient Clinics Control |
Other: Standard of Care
Local country standard of care protocols |
Experimental: PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention |
Other: 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 |
Active Comparator: PREP/PEP at Antenatal Clinics Control |
Other: Standard of Care
Local country standard of care protocols |
Experimental: PREP/PEP at Community Households Dynamic Prevention Intervention |
Other: 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 |
Active Comparator: PREP/PEP at Community Households Control |
Other: Standard of Care
Local country standard of care protocols |
Experimental: Mobility Dynamic Treatment 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 |
Active Comparator: Mobility Control |
Other: Standard of Care
Local country standard of care protocols |
Experimental: Healthy Living for Heavy Alcohol Users Intervention |
Other: 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 |
Active Comparator: Heavy Alcohol Users Control |
Other: Standard of Care
Local country standard of care protocols |
Experimental: Hypertension Linkage Intervention |
Other: Hypertension Linkage
1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits |
Active Comparator: Hypertension Linkage Control |
Other: Standard of Care
Local country standard of care protocols |
Experimental: Hypertension Community Intervention |
Other: Hypertension Community
Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications |
Active Comparator: Hypertension Community Control |
Other: Standard of Care
Local country standard of care protocols |
- Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP [ Time Frame: 48 weeks ]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.
- Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP [ Time Frame: 48 weeks ]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.
- Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP [ Time Frame: 48 weeks ]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.
- Number of participants with viral suppression defined by HIV RNA<400 cps/ml [ Time Frame: 48 weeks ]Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records.
- Number of participants with viral suppression defined by HIV RNA<400 cps/ml [ Time Frame: 24 weeks ]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.
- Number of participants to linked to hypertension care [ Time Frame: 30 days ]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.
- Proportion of participants with hypertension control <140/90 mmHg [ Time Frame: 24 weeks ]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.

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810650
Contact: Tamara Clark, MHS | 628-206-8790 | Tamara.Clark@ucsf.edu |
Kenya | |
GPRT / SEARCH Office | Recruiting |
Kisumu, Kenya | |
Contact: James Ayeiko, MBChB, MPH, PhD +254-720-925262 jimayieko@gmail.com | |
Principal Investigator: Elizabeth Bukusi, MBChB, PhD | |
Uganda | |
IDRC Southwest Uganda | Recruiting |
Mbarara, Uganda | |
Contact: Jane Kabami, MPH +256-706-315810 jkabami@idrc-uganda.org | |
Principal Investigator: Moses R Kamya, MBChB, PhD |
Principal Investigator: | 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 |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT04810650 |
Other Study ID Numbers: |
SAPPHIRE U01AI150510 ( U.S. NIH Grant/Contract ) |
First Posted: | March 23, 2021 Key Record Dates |
Last Update Posted: | May 5, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
PrEP PEP HIV Treatment and Prevention |
Community Health Mobile Populations Youth and Adolescents |
Alcohol Drinking Drinking Behavior |