HIVSEARCHNCT01864603

Sustainable East Africa Research in Community Health

A study testing Universal ART in a streamlined care model, Annual Community Health Campaigns and Targeted PrEP and Targeted testing interventions in people with HIV and Tuberculosis, run by University of California, San Francisco at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: HIV, Tuberculosis, Hypertension
What is being tested?: Universal ART in a streamlined care model, Annual Community Health Campaigns and Targeted PrEP and Targeted testing interventions
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150,395 participants
Where: 3 sitesin 2 countries
Study dates: Apr 2013to Apr 2021
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Community Level Inclusion Criteria:

Non-adjacent geopolitical units in south-western and eastern Uganda and western Kenya.
Most recent census population between 9,000 and 11,000 individuals.
Served by an ART providing health center.
Community leader commitment for study participation and implementation.
Accessibility to health center via a maintained transportation route.
Community location with sufficient distance from other potential study communities to limit contamination of intervention or control conditions (buffer zone)

Individual Level Inclusion Criteria:

Residency of individual in community, defined as present in household for at least 6 months of the calendar year.

Community Level Exclusion Criteria:

Presence of ongoing community-based ART intervention strategies that provide treatment outside of the current in-country treatment guidelines.
An urban setting defined as a city with a population of 100,000 or more inhabitants.
Absence of a health center able to provide ART.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Uganda2 sites

Eastern Uganda
Mbale/Tororo Region
Southwestern Uganda
Mbarara Region

Other trials in Uganda

Kenya1 site

Nyanza Province Kenya
Nyanza Province

Other trials in Kenya

About this study

The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP) in the context of universal treatment and streamlined care. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".

Read the detailed description

Conditions: HIV, Tuberculosis, Hypertension, Diabetes, Maternal Child Health, Cost Effectiveness
Being tested: Universal ART in a streamlined care model, Annual Community Health Campaigns, Targeted PrEP and Targeted testing interventions, Baseline community-based HIV and multi-disease testing
Keywords: HIV treatment and prevention, Tuberculosis, Community health campaign, PrEP
Medical subject headings: Tuberculosis, Hypertension, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Universal ART in a streamlined care modelOther
immediate ART start for all HIV+ in community with streamlined care
Annual Community Health CampaignsOther
HIV and multi-disease testing for all community members
Targeted PrEP and Targeted testing interventionsOther
Baseline community-based HIV and multi-disease testingOther
HIV and multi-disease testing for all community members at baseline only

Study groups in NCT01864603
Study group	Role	What they receive
1st: universal test and treat; 2nd: targeted PrEP and cascade	Experimental	Intervention arm first phase: annual universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery Intervention arm second phase: baseline universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery + targeted PrEP, and targeted HIV testing interventions Receives: Other: Universal ART in a streamlined care model; Other: Annual Community Health Campaigns; Other: Targeted PrEP and Targeted testing interventions
1st: baseline community testing; 2nd: None	Active comparator	Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care Receives: Other: Universal ART in a streamlined care model; Other: Baseline community-based HIV and multi-disease testing

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative HIV Incidence
Cumulative 3 year HIV incidence in men and women ages ≥15 years after the start of Phase I intervention.
Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Measured: 3 years follow up
HIV Incidence
HIV incidence rate in men and women ages ≥15 years after the start of Phase II intervention (started after 3 years of Phase I).
Measured: 3 years follow up

Secondary outcomes (15)

Incident TB Associated With HIV
Cumulative incidence of TB or death due to illness among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Measured: 3 years follow up
Overall Mortality
Mortality risk among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Measured: 3 years follow up
HIV-free Infant Survival
Probability of an infant born to an HIV+ mother remaining alive and HIV uninfected.
Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Measured: 3 years follow up
Percent of HIV+ Adults With HIV RNA <=500 c/mL
Percent of HIV+ adults with HIV RNA <=500 c/mL. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Measured: 3 years follow up
Time in Care for HIV+ Adults With Baseline Viremia
Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia
Measured: 3 years follow up
Cumulative Incidence of ART-initiation
Proportion of baseline HIV+ ART-naive persons who initiate ART Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Measured: 3 years follow up
Hypertension Control
hypertension control (greater than or equal to 140 mg Hg systolic or 90 mg Hg diastolic after 3 repeated readings) at year 3 among adults aged >= 30 years with hypertension.
Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Measured: 3 years follow up
Adherence to PrEP Treatment
Number of patients with adherence to PrEP treatment (self reported adherence at >=1 visit)
Measured: 3 years follow up
Average Adults' on- and Off-farm Employment
HIV+ adults with on- and off-farm employment
Measured: 3 years follow up
Year 3 Viremia Among ART-experienced Persons With Baseline Viremia
Plasma HIV RNA <400 cps/ml Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Measured: 3 years follow up
Linkage to Care
Proportion of Persons Attending an HIV Clinic Visit by 30 Days After HIV Test Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Measured: 30 days after HIV test
HIV Incidence Rate
HIV incidence rates during the first and third year of follow up; Results from the Control arm are not provided because annual HIV incidence was not measured in the control arm (annual HIV testing was only conducted in the intervention arm).
Measured: 3 years follow up
Prevalence of Transmitted HIV Drug-resistance Mutations
HIV NNRTI drug-resistance mutations found at baseline
Measured: Baseline
Prevalence of Chronic Kidney Disease (CKD)
Percentage of participants with chronic kidney disease (CKD)
Measured: 3 years follow up
Total Costs of Programming (ART)
Cost of ART streamlined care delivery amount HIV+ persons
Measured: Follow up year 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Apr 2021

First posted29 May 2013 (estimated)
Study startApr 2013
Primary completionApr 2021
Study completionApr 2021

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 (82)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
Masking: None (open label)
Enrolment: 150,395 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01864603
Sponsor's protocol ID: SEARCH
Acronym: SEARCH
Status last verified: Feb 2022
First submitted: 26 Apr 2013
Last updated: 2 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Balzer LB, Petersen ML, van der Laan MJ; SEARCH Consortium. Adaptive pair-matching in randomized trials with unbiased and efficient effect estimation. Stat Med. 2015 Mar 15;34(6):999-1011. doi: 10.1002/sim.6380. Epub 2014 Nov 25.
PubMed 25421503
Camlin CS, Seeley J, Viljoen L, Vernooij E, Simwinga M, Reynolds L, Reis R, Plank R, Orne-Gliemann J, McGrath N, Larmarange J, Hoddinott G, Getahun M, Charlebois ED, Bond V. Strengthening universal HIV 'test-and-treat' approaches with social science research. AIDS. 2016 Mar 27;30(6):969-70. doi: 10.1097/QAD.0000000000001008. No abstract available.
PubMed 26959355
SEARCH Collaboration. Evaluating the feasibility and uptake of a community-led HIV testing and multi-disease health campaign in rural Uganda. J Int AIDS Soc. 2017 Mar 30;20(1):21514. doi: 10.7448/IAS.20.1.21514.
PubMed 28406269
Balzer LB, van der Laan MJ, Petersen ML; SEARCH Collaboration. Adaptive pre-specification in randomized trials with and without pair-matching. Stat Med. 2016 Nov 10;35(25):4528-4545. doi: 10.1002/sim.7023. Epub 2016 Jul 19.
PubMed 27436797
Balzer L, Staples P, Onnela JP, DeGruttola V. Using a network-based approach and targeted maximum likelihood estimation to evaluate the effect of adding pre-exposure prophylaxis to an ongoing test-and-treat trial. Clin Trials. 2017 Apr;14(2):201-210. doi: 10.1177/1740774516679666. Epub 2017 Jan 26.
PubMed 28124579
Tram KH, Mwangwa F, Atukunda M, Owaraganise A, Ayieko J, Plenty A, Kwariisima D, Clark TD, Petersen ML, Charlebois ED, Kamya MR, Chamie G, Havlir DV, Marquez C; SEARCH Collaboration. Isoniazid Preventive Therapy Completion in the Era of Differentiated HIV Care. J Acquir Immune Defic Syndr. 2017 Dec 15;76(5):e115-e117. doi: 10.1097/QAI.0000000000001540. No abstract available.
PubMed 28885271
Puryear SB, Balzer LB, Ayieko J, Kwarisiima D, Hahn JA, Charlebois ED, Clark TD, Cohen CR, Bukusi EA, Kamya MR, Petersen ML, Havlir DV, Chamie G. Associations between alcohol use and HIV care cascade outcomes among adults undergoing population-based HIV testing in East Africa. AIDS. 2020 Mar 1;34(3):405-413. doi: 10.1097/QAD.0000000000002427.
PubMed 31725431
Balzer LB, Havlir DV, Kamya MR, Chamie G, Charlebois ED, Clark TD, Koss CA, Kwarisiima D, Ayieko J, Sang N, Kabami J, Atukunda M, Jain V, Camlin CS, Cohen CR, Bukusi EA, Van Der Laan M, Petersen ML. Machine Learning to Identify Persons at High-Risk of Human Immunodeficiency Virus Acquisition in Rural Kenya and Uganda. Clin Infect Dis. 2020 Dec 3;71(9):2326-2333. doi: 10.1093/cid/ciz1096.
PubMed 31697383
Marcus JL, Sewell WC, Balzer LB, Krakower DS. Artificial Intelligence and Machine Learning for HIV Prevention: Emerging Approaches to Ending the Epidemic. Curr HIV/AIDS Rep. 2020 Jun;17(3):171-179. doi: 10.1007/s11904-020-00490-6.
PubMed 32347446
Balzer LB, Ayieko J, Kwarisiima D, Chamie G, Charlebois ED, Schwab J, van der Laan MJ, Kamya MR, Havlir DV, Petersen ML. Far from MCAR: Obtaining Population-level Estimates of HIV Viral Suppression. Epidemiology. 2020 Sep;31(5):620-627. doi: 10.1097/EDE.0000000000001215.
PubMed 32452912
Jewell BL, Balzer LB, Clark TD, Charlebois ED, Kwarisiima D, Kamya MR, Havlir DV, Petersen ML, Bershteyn A. Predicting HIV Incidence in the SEARCH Trial: A Mathematical Modeling Study. J Acquir Immune Defic Syndr. 2021 Aug 1;87(4):1024-1031. doi: 10.1097/QAI.0000000000002684.
PubMed 33770065
Chamie G, Kwarisiima D, Clark TD, Kabami J, Jain V, Geng E, Petersen ML, Thirumurthy H, Kamya MR, Havlir DV, Charlebois ED; SEARCH Collaboration. Leveraging rapid community-based HIV testing campaigns for non-communicable diseases in rural Uganda. PLoS One. 2012;7(8):e43400. doi: 10.1371/journal.pone.0043400. Epub 2012 Aug 20.
PubMed 22916256
Thirumurthy H, Chamie G, Jain V, Kabami J, Kwarisiima D, Clark TD, Geng E, Petersen ML, Charlebois ED, Kamya MR, Havlir DV; SEARCH Collaboration. Improved employment and education outcomes in households of HIV-infected adults with high CD4 cell counts: evidence from a community health campaign in Uganda. AIDS. 2013 Feb 20;27(4):627-34. doi: 10.1097/QAD.0b013e32835c54d8.
PubMed 23169332
Jain V, Liegler T, Kabami J, Chamie G, Clark TD, Black D, Geng EH, Kwarisiima D, Wong JK, Abdel-Mohsen M, Sonawane N, Aweeka FT, Thirumurthy H, Petersen ML, Charlebois ED, Kamya MR, Havlir DV; SEARCH Collaboration. Assessment of population-based HIV RNA levels in a rural east African setting using a fingerprick-based blood collection method. Clin Infect Dis. 2013 Feb;56(4):598-605. doi: 10.1093/cid/cis881. Epub 2012 Dec 12.
PubMed 23243180
Namusobya J, Semitala FC, Amanyire G, Kabami J, Chamie G, Bogere J, Jain V, Clark TD, Charlebois E, Havlir DV, Kamya M, Geng EH. High retention in care among HIV-infected patients entering care with CD4 levels >350 cells/muL under routine program conditions in Uganda. Clin Infect Dis. 2013 Nov;57(9):1343-50. doi: 10.1093/cid/cit490. Epub 2013 Jul 29.
PubMed 23899683

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sustainable East Africa Research in Community Health
ClinicalTrials.gov ID: NCT01864603
Acronym / sponsor ID: SEARCH / SEARCH
Conditions: HIV, Tuberculosis, Hypertension, Diabetes, Maternal Child Health, Cost Effectiveness
Keywords: HIV treatment and prevention, Tuberculosis, Community health campaign, PrEP
Study type: Interventional
Recruitment status: Completed
Enrolment: 150,395 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Infectious Diseases Research Collaboration, Uganda, Makerere University, Kenya Medical Research Institute, Gilead Sciences, World Bank, National Institute of Allergy and Infectious Diseases (NIAID), United States President's Emergency Plan for AIDS Relief, Bill and Melinda Gates Foundation
Study start: Apr 2013
Primary completion: Apr 2021 (actual)
Study completion: Apr 2021 (actual)
First posted: 29 May 2013 (estimated)
Results: Posted 2 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1st: universal test and treat; 2nd: targeted PrEP and cascade	Experimental	Other: Universal ART in a streamlined care model, Other: Annual Community Health Campaigns, Other: Targeted PrEP and Targeted testing interventionsIntervention arm first phase: annual universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery Intervention arm second phase: baseline universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery + targeted PrEP, and targeted HIV testing interventions
1st: baseline community testing; 2nd: None	Active comparator	Other: Universal ART in a streamlined care model, Other: Baseline community-based HIV and multi-disease testingComparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care

Who may qualify

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
Universal ART in a streamlined care modelimmediate ART start for all HIV+ in community with streamlined care	Other	1st: baseline community testing; 2nd: None, 1st: universal test and treat; 2nd: targeted PrEP and cascade
Annual Community Health CampaignsHIV and multi-disease testing for all community members	Other	1st: universal test and treat; 2nd: targeted PrEP and cascade
Targeted PrEP and Targeted testing interventions	Other	1st: universal test and treat; 2nd: targeted PrEP and cascade
Baseline community-based HIV and multi-disease testingHIV and multi-disease testing for all community members at baseline only	Other	1st: baseline community testing; 2nd: None

Primary outcome

Cumulative HIV Incidence
Time frame: 3 years follow up
Cumulative 3 year HIV incidence in men and women ages ≥15 years after the start of Phase I intervention. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
HIV Incidence
Time frame: 3 years follow up
HIV incidence rate in men and women ages ≥15 years after the start of Phase II intervention (started after 3 years of Phase I).

15 secondary outcomes

Incident TB Associated With HIV
Time frame: 3 years follow up
Overall Mortality
Time frame: 3 years follow up
HIV-free Infant Survival
Time frame: 3 years follow up
Percent of HIV+ Adults With HIV RNA <=500 c/mL
Time frame: 3 years follow up
Time in Care for HIV+ Adults With Baseline Viremia
Time frame: 3 years follow up
Cumulative Incidence of ART-initiation
Time frame: 3 years follow up
Hypertension Control
Time frame: 3 years follow up
Adherence to PrEP Treatment
Time frame: 3 years follow up
Average Adults' on- and Off-farm Employment
Time frame: 3 years follow up
Year 3 Viremia Among ART-experienced Persons With Baseline Viremia
Time frame: 3 years follow up
Linkage to Care
Time frame: 30 days after HIV test
HIV Incidence Rate
Time frame: 3 years follow up
Prevalence of Transmitted HIV Drug-resistance Mutations
Time frame: Baseline
Prevalence of Chronic Kidney Disease (CKD)
Time frame: 3 years follow up
Total Costs of Programming (ART)
Time frame: Follow up year 3

Results and safety

Results posted to the registry on 2 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	79,818	71,028
Control	70,577	62,912

Primary outcome: Cumulative HIV Incidence

Time frame: 3 years follow up. Mean (95% Confidence Interval). Unit: cumulative events per 100 persons

Measure	Intervention n = 61676	Control n = 55438
Value	0.77 (0.60 to 0.93)	0.81 (0.68 to 0.94)

Intervention vs Control: Risk Ratio (RR): 0.95 (95% CI 0.77 to 1.17)

Population analysed: Baseline HIV- stable adult (15+years) residents

Primary outcome: HIV Incidence

Time frame: 3 years follow up. Number (95% Confidence Interval). Unit: Incident HIV per 100 person-year

Measure	Intervention n = 5477	Control n = 2061
Value	0.35 (0.22 to 0.49)	0.92 (0.49 to 1.41)

Intervention vs Control: Rate ratio: 0.26 (95% CI 0.09 to 0.75)

Population analysed: Intervention population consists of persons aged 15+ years who initiated PrEP in Phase II intervention communities. The comparator population consists of propensity score matched historical controls from Phase I intervention communities. HIV testing was not comprehensively conducted during Phase 2.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Phase I: 3 years Phase II: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Arm Stage 1	89 of 1,671 (5.3%)	80 of 1,671 (4.8%)	1,217 of 79,818
Intervention Arm Stage II	50 of 5,447 (0.9%)	17 of 5,447 (0.3%)	18 of 5,447

Limitations and caveats (from the sponsor): In the second stage, following re-randomization, there was a DSMB approved study modification due to policy changes in standard of care. As a result, outcomes were only assessed among participants in the intervention arm who were offered PrEP. No data were collected in the control arm.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25421503Balzer LB, Petersen ML, van der Laan MJ; SEARCH Consortium. Adaptive pair-matching in randomized trials with unbiased and efficient effect estimation. Stat Med. 2015 Mar 15;34(6):999-1011. doi: 10.1002/sim.6380. Epub 2014 Nov 25.
Background: PubMed 26959355Camlin CS, Seeley J, Viljoen L, Vernooij E, Simwinga M, Reynolds L, Reis R, Plank R, Orne-Gliemann J, McGrath N, Larmarange J, Hoddinott G, Getahun M, Charlebois ED, Bond V. Strengthening universal HIV 'test-and-treat' approaches with social science research. AIDS. 2016 Mar 27;30(6):969-70. doi: 10.1097/QAD.0000000000001008. No abstract available.
Background: PubMed 28406269SEARCH Collaboration. Evaluating the feasibility and uptake of a community-led HIV testing and multi-disease health campaign in rural Uganda. J Int AIDS Soc. 2017 Mar 30;20(1):21514. doi: 10.7448/IAS.20.1.21514.
Background: PubMed 27436797Balzer LB, van der Laan MJ, Petersen ML; SEARCH Collaboration. Adaptive pre-specification in randomized trials with and without pair-matching. Stat Med. 2016 Nov 10;35(25):4528-4545. doi: 10.1002/sim.7023. Epub 2016 Jul 19.
Background: PubMed 28124579Balzer L, Staples P, Onnela JP, DeGruttola V. Using a network-based approach and targeted maximum likelihood estimation to evaluate the effect of adding pre-exposure prophylaxis to an ongoing test-and-treat trial. Clin Trials. 2017 Apr;14(2):201-210. doi: 10.1177/1740774516679666. Epub 2017 Jan 26.
Background: PubMed 28885271Tram KH, Mwangwa F, Atukunda M, Owaraganise A, Ayieko J, Plenty A, Kwariisima D, Clark TD, Petersen ML, Charlebois ED, Kamya MR, Chamie G, Havlir DV, Marquez C; SEARCH Collaboration. Isoniazid Preventive Therapy Completion in the Era of Differentiated HIV Care. J Acquir Immune Defic Syndr. 2017 Dec 15;76(5):e115-e117. doi: 10.1097/QAI.0000000000001540. No abstract available.
Background: PubMed 31725431Puryear SB, Balzer LB, Ayieko J, Kwarisiima D, Hahn JA, Charlebois ED, Clark TD, Cohen CR, Bukusi EA, Kamya MR, Petersen ML, Havlir DV, Chamie G. Associations between alcohol use and HIV care cascade outcomes among adults undergoing population-based HIV testing in East Africa. AIDS. 2020 Mar 1;34(3):405-413. doi: 10.1097/QAD.0000000000002427.
Background: PubMed 31697383Balzer LB, Havlir DV, Kamya MR, Chamie G, Charlebois ED, Clark TD, Koss CA, Kwarisiima D, Ayieko J, Sang N, Kabami J, Atukunda M, Jain V, Camlin CS, Cohen CR, Bukusi EA, Van Der Laan M, Petersen ML. Machine Learning to Identify Persons at High-Risk of Human Immunodeficiency Virus Acquisition in Rural Kenya and Uganda. Clin Infect Dis. 2020 Dec 3;71(9):2326-2333. doi: 10.1093/cid/ciz1096.
Background: PubMed 32347446Marcus JL, Sewell WC, Balzer LB, Krakower DS. Artificial Intelligence and Machine Learning for HIV Prevention: Emerging Approaches to Ending the Epidemic. Curr HIV/AIDS Rep. 2020 Jun;17(3):171-179. doi: 10.1007/s11904-020-00490-6.
Background: PubMed 32452912Balzer LB, Ayieko J, Kwarisiima D, Chamie G, Charlebois ED, Schwab J, van der Laan MJ, Kamya MR, Havlir DV, Petersen ML. Far from MCAR: Obtaining Population-level Estimates of HIV Viral Suppression. Epidemiology. 2020 Sep;31(5):620-627. doi: 10.1097/EDE.0000000000001215.
Background: PubMed 33770065Jewell BL, Balzer LB, Clark TD, Charlebois ED, Kwarisiima D, Kamya MR, Havlir DV, Petersen ML, Bershteyn A. Predicting HIV Incidence in the SEARCH Trial: A Mathematical Modeling Study. J Acquir Immune Defic Syndr. 2021 Aug 1;87(4):1024-1031. doi: 10.1097/QAI.0000000000002684.
Results publication: PubMed 22916256Chamie G, Kwarisiima D, Clark TD, Kabami J, Jain V, Geng E, Petersen ML, Thirumurthy H, Kamya MR, Havlir DV, Charlebois ED; SEARCH Collaboration. Leveraging rapid community-based HIV testing campaigns for non-communicable diseases in rural Uganda. PLoS One. 2012;7(8):e43400. doi: 10.1371/journal.pone.0043400. Epub 2012 Aug 20.
SEARCH Collaboration websiteLink 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 study chair

University of California, San Francisco

Moses Kamya, MBChB, PhD principal investigator

Makerere University

Maya Petersen, PhD principal investigator

University of California, Berkeley

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Uganda, Kenya. 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 2 Mar 2022). 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?

Cumulative HIV Incidence (time frame: 3 years follow up). The study lists 2 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 NCT01864603, which also lists 82 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 2 Mar 2022.