HIVSAPPHIRE PhANCT04810650
SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
A study testing Mobility Dynamic Treatment Intervention, Health Living Intervention for Heavy Alcohol Users and Hypertension Linkage in people with HIV and Hypertension, run by University of California, San Francisco at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Hypertension, Alcohol Drinking
- What is being tested?
- Mobility Dynamic Treatment Intervention, Health Living Intervention for Heavy Alcohol Users and Hypertension Linkage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,233 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Apr 2021to 16 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
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
- HIV, Hypertension, Alcohol Drinking, Maternal Child Health, Cost Effectiveness
- Being tested
- Mobility Dynamic Treatment Intervention, Health Living Intervention for Heavy Alcohol Users, Hypertension Linkage, PrEP/PEP at Outpatient Clinics, PrEP/PEP at Antenatal Clinics
- Keywords
- PrEP, PEP, HIV Treatment and Prevention, Community Health, Mobile Populations, Youth and Adolescents
- Medical subject headings
- Hypertension, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility Dynamic Treatment InterventionOther
- 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 UsersOther
- Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls
Hypertension LinkageOther
- Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits
PrEP/PEP at Outpatient ClinicsOther
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 ClinicsOther
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 HouseholdsOther
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 CareOther
Local country standard of care protocols
Hypertension CommunityOther
Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications
| Study group | Role | What they receive |
|---|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | Experimental | Not described Receives: Other: PrEP/PEP at Outpatient Clinics |
| PREP/PEP at Outpatient Clinics Control | Active comparator | Not described Receives: Other: Standard of Care |
| PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention | Experimental | Not described Receives: Other: PrEP/PEP at Antenatal Clinics |
| PREP/PEP at Antenatal Clinics Control | Active comparator | Not described Receives: Other: Standard of Care |
| PREP/PEP at Community Households Dynamic Prevention Intervention | Experimental | Not described Receives: Other: PrEP/PEP at Community Households |
| PREP/PEP at Community Households Control | Active comparator | Not described Receives: Other: Standard of Care |
| Mobility Dynamic Treatment Intervention | Experimental | Not described Receives: Other: Mobility Dynamic Treatment Intervention |
| Mobility Control | Active comparator | Not described Receives: Other: Standard of Care |
| Healthy Living for Heavy Alcohol Users Intervention | Experimental | Not described Receives: Other: Health Living Intervention for Heavy Alcohol Users |
| Heavy Alcohol Users Control | Active comparator | Not described Receives: Other: Standard of Care |
| Hypertension Linkage Intervention | Experimental | Not described Receives: Other: Hypertension Linkage |
| Hypertension Linkage Control | Active comparator | Not described Receives: Other: Standard of Care |
| Hypertension Community Intervention | Experimental | Not described Receives: Other: Hypertension Community |
| Hypertension Community Control | Active comparator | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start15 Apr 2021
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions.
- Masking
- None (open label)
- Enrolment
- 2,233 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Diane Havlir, MD, Principal investigator, University of California, San FranciscoMoses Kamya, MBChB, PhD, Principal investigator, Makerere UniversityMaya Petersen, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810650
- Sponsor's protocol ID
- SEARCH SAPPHIRE Phase A
- Other IDs
- U01AI150510
- Acronym
- SAPPHIRE PhA
- Status last verified
- Feb 2025
- First submitted
- 18 Mar 2021
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37861683Kabami 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 38489493Kakande 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 38054535Ayieko 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 38054932Puryear 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 38054564Hickey 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 36342940Johnson-Peretz J, Mutabazi A, Byamukama A, Owino L, Akatukwasa C, Onyango A, Atwine F, Arunga TO, Ogachi S, Owaraganise A, Sang N, Wafula EM, Sutter N, Aoko C, Kabami J, Kakande E, Chamie G, Balzer LB, Petersen ML, Kamya MR, Havlir DV, Camlin CS, Hickey MD, Ayieko J. Patient perceptions and preferences during a community-based telehealth care model for moderate-to-severe hypertension in rural communities in Kenya and Uganda. PLoS One. 2026 Jul 28;21(7):e0350915. doi: 10.1371/journal.pone.0350915. eCollection 2026.
PubMed 42520052Balzer 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.
PubMed 41762058Kabami 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.
PubMed 37408473
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
- ClinicalTrials.gov ID
- NCT04810650
- Acronym / sponsor ID
- SAPPHIRE PhA / SEARCH SAPPHIRE Phase A
- Conditions
- HIV, Hypertension, Alcohol Drinking, Maternal Child Health, Cost Effectiveness
- Keywords
- PrEP, PEP, HIV Treatment and Prevention, Community Health, Mobile Populations, Youth and Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,233 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- 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)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 14
- Model description
- Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions.
| Arm | Type | Receives |
|---|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | Experimental | Other: PrEP/PEP at Outpatient Clinics |
| PREP/PEP at Outpatient Clinics Control | Active comparator | Other: Standard of Care |
| PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention | Experimental | Other: PrEP/PEP at Antenatal Clinics |
| PREP/PEP at Antenatal Clinics Control | Active comparator | Other: Standard of Care |
| PREP/PEP at Community Households Dynamic Prevention Intervention | Experimental | Other: PrEP/PEP at Community Households |
| PREP/PEP at Community Households Control | Active comparator | Other: Standard of Care |
| Mobility Dynamic Treatment Intervention | Experimental | Other: Mobility Dynamic Treatment Intervention |
| Mobility Control | Active comparator | Other: Standard of Care |
| Healthy Living for Heavy Alcohol Users Intervention | Experimental | Other: Health Living Intervention for Heavy Alcohol Users |
| Heavy Alcohol Users Control | Active comparator | Other: Standard of Care |
| Hypertension Linkage Intervention | Experimental | Other: Hypertension Linkage |
| Hypertension Linkage Control | Active comparator | Other: Standard of Care |
| Hypertension Community Intervention | Experimental | Other: Hypertension Community |
| Hypertension Community Control | Active comparator | Other: Standard of Care |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobility Dynamic Treatment Intervention1) 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 | Other | Mobility Dynamic Treatment Intervention |
| Health Living Intervention for Heavy Alcohol Users1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls | Other | Healthy Living for Heavy Alcohol Users Intervention |
| Hypertension Linkage1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits | Other | Hypertension Linkage Intervention |
| PrEP/PEP at Outpatient ClinicsIntervention 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 | Other | PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention |
| PrEP/PEP at Antenatal ClinicsIntervention 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 | Other | PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention |
| PrEP/PEP at Community HouseholdsIntervention 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 | Other | PREP/PEP at Community Households Dynamic Prevention Intervention |
| Standard of CareLocal country standard of care protocols | Other | Heavy Alcohol Users Control, Hypertension Community Control, Hypertension Linkage Control, Mobility Control, PREP/PEP at Antenatal Clinics Control, PREP/PEP at Community Households Control, PREP/PEP at Outpatient Clinics Control |
| Hypertension CommunityHypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications | Other | Hypertension Community Intervention |
Primary outcome
Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used 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 Percentage of Follow-up Months 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 Months 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.
Percentage 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 Who 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.
Percentage 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37861683Koss 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.
- Results publication: PubMed 38489493Kabami 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.
- Results publication: PubMed 38054535Kakande 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.
- Results publication: PubMed 38054932Ayieko 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.
- Results publication: PubMed 38054564Puryear 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.
- Results publication: PubMed 36342940Hickey 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.
- Derived from this study: PubMed 42520052Johnson-Peretz J, Mutabazi A, Byamukama A, Owino L, Akatukwasa C, Onyango A, Atwine F, Arunga TO, Ogachi S, Owaraganise A, Sang N, Wafula EM, Sutter N, Aoko C, Kabami J, Kakande E, Chamie G, Balzer LB, Petersen ML, Kamya MR, Havlir DV, Camlin CS, Hickey MD, Ayieko J. Patient perceptions and preferences during a community-based telehealth care model for moderate-to-severe hypertension in rural communities in Kenya and Uganda. PLoS One. 2026 Jul 28;21(7):e0350915. doi: 10.1371/journal.pone.0350915. eCollection 2026.
- Derived from this study: PubMed 41762058Balzer 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.
- Derived from this study: PubMed 37408473Kabami 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.
- SEARCHLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility Dynamic Treatment Intervention, Health Living Intervention for Heavy Alcohol Users and Hypertension Linkage in people with HIV and Hypertension, run by University of California, San Francisco at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP (time frame: 48 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810650, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.