Trial · NCT01864603
Sustainable East Africa Research in Community Health
NCT01864603, Not applicable, Completed, University of California, San Francisco; results first posted 2022-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sustainable East Africa Research in Community Health. Trials, record NCT01864603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01864603
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sustainable East Africa Research in Community Health
- NCT number
- NCT01864603
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 150,395 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- HIV, Tuberculosis, Hypertension, Diabetes, Maternal Child Health, Cost Effectiveness
- Interventions
- 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
- First posted
- 2013-05-29
- Last updated
- 2022-03-02
- Results first posted
- 2022-03-02
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative HIV Incidence | 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. |
| Primary | HIV Incidence | 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). |
| Secondary | Incident TB Associated With HIV | 3 years follow up | 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. |
| Secondary | Overall Mortality | 3 years follow up | Mortality risk among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. |
| Secondary | HIV-free Infant Survival | 3 years follow up | 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. |
| Secondary | Percent of HIV+ Adults With HIV RNA <=500 c/mL | 3 years follow up | Percent of HIV+ adults with HIV RNA \<=500 c/mL. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. |
| Secondary | Time in Care for HIV+ Adults With Baseline Viremia | 3 years follow up | Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia |
| Secondary | Cumulative Incidence of ART-initiation | 3 years follow up | Proportion of baseline HIV+ ART-naive persons who initiate ART Mean was calculated as the average across clusters of the cluster-level cumulative incidence. |
| Secondary | Hypertension Control | 3 years follow up | 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. |
| Secondary | Adherence to PrEP Treatment | 3 years follow up | Number of patients with adherence to PrEP treatment (self reported adherence at \>=1 visit) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative HIV Incidence | 3 years follow up | Baseline HIV- stable adult (15+years) residents | cumulative events per 100 persons | MEAN |
| PRIMARY | HIV Incidence | 3 years follow up | 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. | Incident HIV per 100 person-year | NUMBER |
| SECONDARY | Incident TB Associated With HIV | 3 years follow up | Adults without active TB and with HIV at baseline | cumulative events per 100 persons | MEAN |
| SECONDARY | Overall Mortality | 3 years follow up | Known HIV+ at baseline | cumulative events per 100 persons | MEAN |
| SECONDARY | HIV-free Infant Survival | 3 years follow up | Infants born in study period to women with HIV | cumulative events per 100 persons | MEAN |
| SECONDARY | Percent of HIV+ Adults With HIV RNA <=500 c/mL | 3 years follow up | HIV+ adults at year 3, including those out of care or without a prior HIV diagnosis | cumulative events per 100 persons | MEAN |
| SECONDARY | Time in Care for HIV+ Adults With Baseline Viremia | 3 years follow up | HIV+ adults linked to care with baseline HIV RNA \>=500 c/mL | percentage of days | MEAN |
| SECONDARY | Cumulative Incidence of ART-initiation | 3 years follow up | Baseline HIV+ without previous or current ART | cumulative events per 100 persons | MEAN |
| SECONDARY | Hypertension Control | 3 years follow up | Hypertensive adults (aged 30+) at year 3 | cumulative events per 100 persons | MEAN |
| SECONDARY | Adherence to PrEP Treatment | 3 years follow up | Persons who initiated PrEP eligible for a follow-up visit. No data were collected for the second stage in the control arm due to DSMB approved design modification. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative HIV Incidence | Intervention | 0.77 | 95% Confidence Interval 0.60 to 0.93 | cumulative events per 100 persons | |
| Cumulative HIV Incidence | Control | 0.81 | 95% Confidence Interval 0.68 to 0.94 | cumulative events per 100 persons | |
| HIV Incidence | Intervention | 0.35 | 95% Confidence Interval 0.22 to 0.49 | Incident HIV per 100 person-year | |
| HIV Incidence | Control | 0.92 | 95% Confidence Interval 0.49 to 1.41 | Incident HIV per 100 person-year | |
| Incident TB Associated With HIV | Intervention | 3.7 | 95% Confidence Interval 3.2 to 4.1 | cumulative events per 100 persons | |
| Incident TB Associated With HIV | Control | 4.6 | 95% Confidence Interval 4.1 to 5.2 | cumulative events per 100 persons | |
| Overall Mortality | Intervention | 3.0 | 95% Confidence Interval 2.6 to 3.4 | cumulative events per 100 persons | |
| Overall Mortality | Control | 3.9 | 95% Confidence Interval 3.4 to 4.4 | cumulative events per 100 persons | |
| HIV-free Infant Survival | Intervention | 96.7 | 95% Confidence Interval 94.4 to 99.0 | cumulative events per 100 persons | |
| HIV-free Infant Survival | Control | 93.6 | 95% Confidence Interval 92.0 to 95.3 | cumulative events per 100 persons |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage 1 | STARTED | Intervention | 79,818 | 16 |
| Stage 1 | STARTED | Control | 70,577 | 16 |
| Stage 1 | COMPLETED | Intervention | 71,028 | 16 |
| Stage 1 | COMPLETED | Control | 62,912 | 16 |
| Stage 1 | NOT COMPLETED | Intervention | 8,790 | 0 |
| Stage 1 | NOT COMPLETED | Control | 7,665 | 0 |
| Stage 2 | STARTED | Intervention | 91,533 | 16 |
| Stage 2 | STARTED | Control | 92,558 | 16 |
| Stage 2 | COMPLETED | Intervention | 5,477 | 16 |
| Stage 2 | COMPLETED | Control | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Intervention Arm Stage 1 | 2 | 1,671 | 2 |
| other | Abdominal Pain | Gastrointestinal disorders | Intervention Arm Stage II | 0 | 5,447 | 0 |
| other | Altered Mental Status | Psychiatric disorders | Intervention Arm Stage 1 | 4 | 1,671 | 4 |
| other | Altered Mental Status | Psychiatric disorders | Intervention Arm Stage II | 0 | 5,447 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Intervention Arm Stage 1 | 18 | 1,671 | 18 |
| other | Anemia | Blood and lymphatic system disorders | Intervention Arm Stage II | 1 | 5,447 | 1 |
| other | Dehydration | General disorders | Intervention Arm Stage 1 | 1 | 1,671 | 1 |
| other | Dehydration | General disorders | Intervention Arm Stage II | 0 | 5,447 | 0 |
| other | Dizziness | Ear and labyrinth disorders | Intervention Arm Stage 1 | 3 | 1,671 | 3 |
| other | Dizziness | Ear and labyrinth disorders | Intervention Arm Stage II | 0 | 5,447 | 0 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Arm Stage 1 | 1,217 | 79,818 |
| Total, all-cause mortality | Intervention Arm Stage II | 18 | 5,447 |
| Total, other adverse events | Intervention Arm Stage 1 | 80 | 1,671 |
| Total, other adverse events | Intervention Arm Stage II | 17 | 5,447 |
| Total, serious adverse events | Intervention Arm Stage 1 | 89 | 1,671 |
| Total, serious adverse events | Intervention Arm Stage II | 50 | 5,447 |
Source ClinicalTrials.gov
Papers82
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention vs Control: Prevalence of Chronic Kidney Disease (CKD) | Trial comparisons |
| Intervention vs Control: Prevalence of Transmitted HIV Drug-resistance Mutations | Trial comparisons |
| Intervention Arm Stage 1 vs Intervention Arm Stage II: deaths from any cause | Trial comparisons |
| Intervention Arm Stage 1 vs Intervention Arm Stage II: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01864603
GET https://conductscience.org/api/trials/v1/NCT01864603/results?page=2