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

NCT04810650 | Completed Results DMC

• 2 other identifiers: SEARCH SAPPHIRE Phase AU01AI150510
• Study Type: interventional
• Target: 2,233
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

HIV; Hypertension; Alcohol Drinking; Maternal Child Health; Cost Effectiveness

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  48 weeks

• Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml

  Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records.

  48 weeks

• 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.

  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.

  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.

  24 weeks

Study Arms (14)

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

Interventions

Mobility Dynamic Treatment Intervention OTHER

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

Mobility Dynamic Treatment Intervention

Health Living Intervention for Heavy Alcohol Users OTHER

1\) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls

Healthy Living for Heavy Alcohol Users Intervention

Hypertension Linkage OTHER

1\) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits

Hypertension Linkage Intervention

PrEP/PEP at Outpatient Clinics OTHER

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 Outpatient Clinics Dynamic Prevention Intervention

PrEP/PEP at Antenatal Clinics OTHER

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 Antenatal Clinics Dynamic Prevention Intervention

PrEP/PEP at Community Households OTHER

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

PREP/PEP at Community Households Dynamic Prevention Intervention

Standard of Care OTHER

Local country standard of care protocols

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 Community OTHER

Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications

Hypertension Community Intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

GPRT / SEARCH Office

Kisumu, Kenya

Location

IDRC Southwest Uganda

Mbarara, Uganda

Location

Related Publications (7)

• 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.

  PMID: 37861683 RESULT

• 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.

  PMID: 38489493 RESULT

• 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.

  PMID: 38054535 RESULT

• 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.

  PMID: 38054932 RESULT

• 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.

  PMID: 38054564 RESULT

• 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.

  PMID: 36342940 RESULT

• Kabami 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.

  PMID: 37408473 DERIVED

Related Links

• SEARCH

MeSH Terms

Conditions

Hypertension; Alcohol Drinking

Interventions

Ethanol; Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Douglas Black
• Organization: University of California, San Francisco

douglas.black@ucsf.edu

4158063016

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 23, 2021
• Study Start: April 15, 2021
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1); UG (1)