CompletedNCT04810650SAPPHIRE PhAUpdated Feb 6, 2025Results posted

SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

An interventional study of Mobility Dynamic Treatment Intervention and Health Living Intervention for Heavy Alcohol Users in HIV, Hypertension and Alcohol Drinking, sponsored by University of California, San Francisco. Completed at 2 sites in 2 countries. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 2,233
Allocation: Randomized
Ages: 15 Years and older
Sex: All

Study 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.

Read the detailed 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.

Conditions studied

HIV
Hypertension
Alcohol Drinking
Maternal Child Health
Cost Effectiveness

Browse trials for

Alcohol Drinking 925

Keywords

PrEP
PEP
HIV Treatment and Prevention
Community Health
Mobile Populations
Youth and Adolescents

In context

Alcohol Drinking

925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.

This study's enrollment of 2,233 is above the median of 108 across 802 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 15 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

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

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 2,233 participants (actual)

Study arms

Experimental
PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention
Other: PrEP/PEP at Outpatient Clinics
Active comparator
PREP/PEP at Outpatient Clinics Control
Other: Standard of Care
Experimental
PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention
Other: PrEP/PEP at Antenatal Clinics
Active comparator
PREP/PEP at Antenatal Clinics Control
Other: Standard of Care
Experimental
PREP/PEP at Community Households Dynamic Prevention Intervention
Other: PrEP/PEP at Community Households
Active comparator
PREP/PEP at Community Households Control
Other: Standard of Care
Experimental
Mobility Dynamic Treatment Intervention
Other: Mobility Dynamic Treatment Intervention
Active comparator
Mobility Control
Other: Standard of Care
Experimental
Healthy Living for Heavy Alcohol Users Intervention
Other: Health Living Intervention for Heavy Alcohol Users
Active comparator
Heavy Alcohol Users Control
Other: Standard of Care
Experimental
Hypertension Linkage Intervention
Other: Hypertension Linkage
Active comparator
Hypertension Linkage Control
Other: Standard of Care
Experimental
Hypertension Community Intervention
Other: Hypertension Community
Active comparator
Hypertension Community Control
Other: Standard of Care

Interventions

OtherMobility 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
OtherHealth Living Intervention for Heavy Alcohol Users
1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls
OtherHypertension Linkage
1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits
OtherPrEP/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
OtherPrEP/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
OtherPrEP/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
OtherStandard of Care
Local country standard of care protocols
OtherHypertension Community
Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks

Results

Posted Feb 6, 2025

Participant flow

Participant flow — Overall Study
Milestone	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention	PREP/PEP at Outpatient Clinics Control	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention	PREP/PEP at Antenatal Clinics Control	PREP/PEP at Community Households Dynamic Prevention Intervention	PREP/PEP at Community Households Control	Mobility Dynamic Treatment Intervention	Mobility Control	Healthy Living for Heavy Alcohol Users Intervention	Heavy Alcohol Users Control	Hypertension Linkage Intervention	Hypertension Linkage Control	Hypertension Community Intervention	Hypertension Community Control
Started	197	206	203	197	212	217	102	99	198	203	100	99	98	102
Completed	182	194	196	188	202	211	100	96	185	192	97	99	93	92
Not completed	15	12	7	9	10	6	2	3	13	11	3	0	5	10
Withdrew: Disenrolled in error	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Withdrew: Death	0	0	0	0	0	0	2	2	0	1	0	0	2	1
Withdrew: Moved/transferred care	0	0	0	0	0	0	0	1	12	10	0	0	0	0
Withdrew: Lost to follow-up	15	12	7	9	10	6	0	0	0	0	1	0	3	9
Withdrew: Participant declined	0	0	0	0	0	0	0	0	0	0	2	0	0	0

Outcome measures

PrimaryPrevention 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.

Time frame:: 48 weeks
Reported as:: Mean · Percentage of months

Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP
Percentage of months	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention	PREP/PEP at Outpatient Clinics Control
Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP	47.5 (42.3 to 52.7)	18.3 (14.4 to 22.1)

PrimaryPrevention 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.

Time frame:: 48 weeks
Reported as:: Mean · Percentage of months

Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP
Percentage of months	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention	PREP/PEP at Antenatal Clinics Control
Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP	70 (65 to 74)	29 (25 to 34)

PrimaryPrevention 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.

Time frame:: 48 weeks
Reported as:: Mean · Percentage of months

Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP
Percentage of months	PREP/PEP at Community Households Dynamic Prevention Intervention	PREP/PEP at Community Households Control
Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP	28.0 (23.5 to 32.4)	0.5 (0 to 1.0)

PrimaryNumber 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.

Time frame:: 48 weeks
Reported as:: Count of participants · Participants

Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml
Participants	Mobility Dynamic Treatment Intervention	Mobility Control
Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml	85	83

PrimaryPercentage 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.

Time frame:: 24 weeks
Reported as:: Number · Percentage of participants with VL <400

Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml
Percentage of participants with VL <400	Healthy Living for Heavy Alcohol Users Intervention	Heavy Alcohol Users Control
Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml	83 (78 to 89)	82 (77 to 87)

PrimaryNumber 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.

Time frame:: 30 days
Reported as:: Count of participants · Participants

Number of Participants Who Linked to Hypertension Care
Participants	Hypertension Linkage Intervention	Hypertension Linkage Control
Number of Participants Who Linked to Hypertension Care	96	65

PrimaryPercentage 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.

Time frame:: 24 weeks
Reported as:: Number · Percentage of persons with HTN control

Percentage of Participants With Hypertension Control <140/90 mmHg
Percentage of persons with HTN control	Hypertension Community Intervention	Hypertension Community Control
Percentage of Participants With Hypertension Control <140/90 mmHg	77 (69 to 85)	51 (42 to 60)

Adverse events

Collected over Between 30 days and 48 weeks depending on the primary outcome measure.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention	0/197 (0%)	7/197 (3.6%)	—
PREP/PEP at Outpatient Clinics Control	0/206 (0%)	0/206 (0%)	—
PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention	0/203 (0%)	17/203 (8.4%)	—
PREP/PEP at Antenatal Clinics Control	0/197 (0%)	2/197 (1%)	—
PREP/PEP at Community Households Dynamic Prevention Intervention	0/212 (0%)	4/212 (1.9%)	—
PREP/PEP at Community Households Control	0/217 (0%)	1/217 (0.5%)	—
Mobility Dynamic Treatment Intervention	2/102 (2%)	3/102 (2.9%)	—
Mobility Control	2/99 (2%)	2/99 (2%)	—
Healthy Living for Heavy Alcohol Users Intervention	0/197 (0%)	3/197 (1.5%)	—
Heavy Alcohol Users Control	1/203 (0.5%)	1/203 (0.5%)	—
Hypertension Linkage Intervention	0/100 (0%)	5/100 (5%)	—
Hypertension Linkage Control	0/99 (0%)	0/99 (0%)	—
Hypertension Community Intervention	2/98 (2%)	5/98 (5.1%)	—
Hypertension Community Control	1/102 (1%)	1/102 (1%)	—

Most frequent serious events

Showing 10 of 22

Most frequent serious events
Event	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention	PREP/PEP at Outpatient Clinics Control	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention	PREP/PEP at Antenatal Clinics Control	PREP/PEP at Community Households Dynamic Prevention Intervention	PREP/PEP at Community Households Control	Mobility Dynamic Treatment Intervention	Mobility Control	Healthy Living for Heavy Alcohol Users Intervention	Heavy Alcohol Users Control	Hypertension Linkage Intervention	Hypertension Linkage Control	Hypertension Community Intervention	Hypertension Community Control
MiscarriagePregnancy, puerperium and perinatal conditions	0/197	0/206	5/203	2/197	0/212	0/217	0/102	0/99	0/197	0/203	0/100	0/99	0/98	0/102
Chronic renal failureRenal and urinary disorders	0/197	0/206	0/203	0/197	0/212	0/217	0/102	0/99	0/197	0/203	0/100	0/99	2/98	0/102
Severe hypertensionCardiac disorders	0/197	0/206	0/203	0/197	0/212	0/217	0/102	0/99	0/197	0/203	2/100	0/99	1/98	0/102
Emergency caesarian sectionPregnancy, puerperium and perinatal conditions	0/197	0/206	4/203	0/197	0/212	0/217	0/102	0/99	0/197	0/203	0/100	0/99	0/98	0/102
HomicideSocial circumstances	0/197	0/206	0/203	0/197	0/212	0/217	2/102	1/99	0/197	0/203	0/100	0/99	0/98	0/102
Death of premature infantPregnancy, puerperium and perinatal conditions	1/197	0/206	3/203	0/197	0/212	0/217	0/102	0/99	0/197	0/203	0/100	0/99	0/98	0/102
Intimate partner violenceSocial circumstances	2/197	0/206	3/203	0/197	2/212	0/217	0/102	0/99	0/197	0/203	0/100	0/99	0/98	0/102
Death due to unknown illnessGeneral disorders	0/197	0/206	0/203	0/197	0/212	0/217	0/102	0/99	0/197	0/203	0/100	0/99	1/98	1/102
Right inguinal herniaGastrointestinal disorders	0/197	0/206	0/203	0/197	0/212	0/217	0/102	0/99	0/197	0/203	0/100	0/99	1/98	0/102
Cryptococcal meningitisInfections and infestations	0/197	0/206	0/203	0/197	0/212	0/217	0/102	1/99	1/197	0/203	0/100	0/99	0/98	0/102

Baseline characteristics

Age, Continuous
Age, Continuous(years)	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention	PREP/PEP at Outpatient Clinics Control	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention	PREP/PEP at Antenatal Clinics Control	PREP/PEP at Community Households Dynamic Prevention Intervention	PREP/PEP at Community Households Control	Mobility Dynamic Treatment Intervention	Mobility Control	Healthy Living for Heavy Alcohol Users Intervention	Heavy Alcohol Users Control	Hypertension Linkage Intervention	Hypertension Linkage Control	Hypertension Community Intervention	Hypertension Community Control	Total
Median	27 (22 to 36)	29 (22 to 37)	24 (20 to 29)	24 (20 to 29)	29 (22 to 38)	30 (22 to 40)	38 (31 to 42)	36 (29 to 45)	37 (31 to 45)	37 (30 to 42)	57 (47 to 69)	56 (47 to 68)	60 (50 to 70)	63 (53 to 73)	34 (25 to 45)

Sex: Female, Male
Sex: Female, Male(Participants)	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention	PREP/PEP at Outpatient Clinics Control	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention	PREP/PEP at Antenatal Clinics Control	PREP/PEP at Community Households Dynamic Prevention Intervention	PREP/PEP at Community Households Control	Mobility Dynamic Treatment Intervention	Mobility Control	Healthy Living for Heavy Alcohol Users Intervention	Heavy Alcohol Users Control	Hypertension Linkage Intervention	Hypertension Linkage Control	Hypertension Community Intervention	Hypertension Community Control	Total
Female	120	125	203	197	124	119	56	53	60	71	60	59	69	70	1386
Male	77	81	0	0	88	98	46	46	137	132	40	40	29	32	846

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention	PREP/PEP at Outpatient Clinics Control	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention	PREP/PEP at Antenatal Clinics Control	PREP/PEP at Community Households Dynamic Prevention Intervention	PREP/PEP at Community Households Control	Mobility Dynamic Treatment Intervention	Mobility Control	Healthy Living for Heavy Alcohol Users Intervention	Heavy Alcohol Users Control	Hypertension Linkage Intervention	Hypertension Linkage Control	Hypertension Community Intervention	Hypertension Community Control	Total
African	197	206	203	197	212	217	102	99	197	203	100	99	98	102	2232

Region of Enrollment
Region of Enrollment(participants)	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention	PREP/PEP at Outpatient Clinics Control	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention	PREP/PEP at Antenatal Clinics Control	PREP/PEP at Community Households Dynamic Prevention Intervention	PREP/PEP at Community Households Control	Mobility Dynamic Treatment Intervention	Mobility Control	Healthy Living for Heavy Alcohol Users Intervention	Heavy Alcohol Users Control	Hypertension Linkage Intervention	Hypertension Linkage Control	Hypertension Community Intervention	Hypertension Community Control	Total
Uganda	100	102	100	99	102	117	51	49	113	117	50	50	48	52	1150
Kenya	97	104	103	98	110	100	51	50	84	86	50	49	50	50	1082

Study locations

2 sites

GPRT / SEARCH Office
Kisumu, Kenya
IDRC Southwest Uganda
Mbarara, Uganda

References and documents

Publications

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. PubMed 37861683 ↗
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. PubMed 38489493 ↗
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. PubMed 38054535 ↗
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. PubMed 38054932 ↗
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. PubMed 38054564 ↗
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. PubMed 36342940 ↗

Study documents

Study protocol · Jul 26, 2023
Statistical analysis plan · Dec 21, 2021
Informed consent form · Aug 10, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04810650
Lead sponsor: University of California, San Francisco
Collaborators: Infectious Diseases Research Collaboration, Uganda, Makerere University, Kenya Medical Research Institute, University of California, Berkeley, University College, London, University of Pennsylvania, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI)
Responsible party: Sponsor
First posted: Mar 23, 2021
Start date: Apr 15, 2021
Primary completion: Oct 16, 2023
Completion: Oct 16, 2023
Results posted: Feb 6, 2025
Last update: Feb 6, 2025

Study contacts

Diane Havlir, MD

principal investigator · University of California, San Francisco

Moses Kamya, MBChB, PhD

principal investigator · Makerere University

Maya Petersen, PhD

principal investigator · University of California, Berkeley

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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