Trial Outcomes & Findings for Tambua Mapema Plus - to Discover HIV Infection Early and Prevent Onward Transmission (NCT NCT03508908)
NCT ID: NCT03508908
Last Updated: 2023-11-13
Results Overview
Primary endpoints for the HIV-1 RNA testing intervention include the proportion of participants with newly diagnosed prevalent or AHI at care seeking.
COMPLETED
NA
2887 participants
24 months
2023-11-13
Participant Flow
We identified the participating health facilities (three in Kilifi county; three in Mombasa county) due to their size, location (within 20 km of our KEMRI Research Clinic), patient volume (\> 500 patients aged 18-39 years seen over 3 months) and willingness to collaborate with the research team. All clinics served general population patients; the four public facilities included offered limited programming for key populations. Some sites had minor delays in starting an intervention period.
We used a modified stepped-wedge design to evaluate outcomes before and after intervention delivery. Six clinics each had two phases (observation and intervention), for 12 clinic periods. Each clinic period lasted 6 months or until 250 participants were recruited, except first clinic period (3 months of observation, 125 participants). The order in which clinics were active was randomized such that only 2 clinics provided the intervention at a given time (due to limited testing platforms).
Unit of analysis: Clinic periods
Participant milestones
| Measure |
Observation Period
During the observation period, clinics provided standard care, and participants were enrolled, completed a standardized tablet-based survey, and followed up to determine whether the clinic staff provided HIV testing at the index visit.
|
Intervention Period
During the intervention period, all participants enrolled were offered opt-out HIV testing using the HIV-1 NAAT intervention. In addition, participants completed the same standard tablet-based survey as in the observation period.
|
Observation Period Partners
Partners identified in the observation period who had not been tested by 6 weeks were offered testing as part of the research study.
|
Intervention Period Partners
Partners identified in the intervention period were offered enhanced HIV testing as part of the intervention.
|
|---|---|---|---|---|
|
Month 0-3
STARTED
|
249 2
|
0 0
|
0 0
|
0 0
|
|
Month 0-3
COMPLETED
|
249 2
|
0 0
|
0 0
|
0 0
|
|
Month 0-3
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Month 4-6
STARTED
|
250 2
|
125 1
|
1 1
|
1 1
|
|
Month 4-6
COMPLETED
|
250 2
|
125 1
|
1 1
|
1 1
|
|
Month 4-6
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Month 7-9
STARTED
|
250 2
|
250 2
|
1 1
|
1 1
|
|
Month 7-9
COMPLETED
|
250 2
|
250 2
|
1 1
|
1 1
|
|
Month 7-9
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Month 10-12
STARTED
|
250 2
|
250 2
|
0 0
|
2 2
|
|
Month 10-12
COMPLETED
|
250 2
|
250 2
|
0 0
|
2 2
|
|
Month 10-12
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Month 13-15
STARTED
|
250 2
|
250 2
|
0 0
|
2 2
|
|
Month 13-15
COMPLETED
|
250 2
|
250 2
|
0 0
|
2 2
|
|
Month 13-15
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Month 16-18
STARTED
|
125 1
|
250 2
|
1 1
|
1 1
|
|
Month 16-18
COMPLETED
|
125 1
|
250 2
|
1 1
|
1 1
|
|
Month 16-18
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Month 19-21
STARTED
|
0 0
|
250 2
|
0 0
|
3 2
|
|
Month 19-21
COMPLETED
|
0 0
|
250 2
|
0 0
|
3 2
|
|
Month 19-21
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Month 22-24
STARTED
|
0 0
|
125 1
|
0 0
|
0 0
|
|
Month 22-24
COMPLETED
|
0 0
|
125 1
|
0 0
|
0 0
|
|
Month 22-24
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was missing for 6 partners in the intervention period.
Baseline characteristics by cohort
| Measure |
Observation Period
n=1374 Participants
HIV testing will only be done if ordered by the primary care clinician. Individuals diagnosed with HIV who have not yet notified partners will be offered assisted partner notification at a 6-week visit.
|
Intervention Period
n=1500 Participants
Combination intervention with HIV-1 RNA testing followed by rapid tests if positive for HIV diagnosis, immediate ART if diagnosed, assisted partner notification with HIV-1 RNA testing of partners, and PrEP for uninfected partners in discordant relationships.
HIV-1 RNA testing: During the intervention period, a blood sample will be obtained and tested for AHI using point-of-care Xpert® HIV Qual assay (Cepheid, Sunnyvale, California, USA). Individuals who test positive will undergo rapid tests to differentiate acute from prevalent HIV infection. Newly diagnosed individuals will be offered immediate ART and assisted partner notification with the HIV-1 RNA testing intervention delivered to partners following the same approach.
|
Observation Period Partners
n=3 Participants
Consented for testing at week 6
|
Intervention Period Partners
n=10 Participants
Consented for testing and follow-up as soon as possible after diagnosis of the index patient
|
Total
n=2887 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants • Age was missing for 6 partners in the intervention period.
|
26 years
n=7 Participants • Age was missing for 6 partners in the intervention period.
|
32.6 years
n=5 Participants • Age was missing for 6 partners in the intervention period.
|
32.4 years
n=4 Participants • Age was missing for 6 partners in the intervention period.
|
25 years
n=21 Participants • Age was missing for 6 partners in the intervention period.
|
|
Sex: Female, Male
Female
|
886 Participants
n=5 Participants
|
887 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1778 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
488 Participants
n=5 Participants
|
613 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1109 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1374 Participants
n=5 Participants
|
1500 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
2887 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Kenya
|
1374 participants
n=5 Participants
|
1500 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
2887 participants
n=21 Participants
|
|
HIV testing history
Never tested for HIV
|
147 Participants
n=5 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
153 Participants
n=7 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
1 Participants
n=5 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
2 Participants
n=4 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
303 Participants
n=21 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
|
HIV testing history
Tested for HIV in past 12 months
|
499 Participants
n=5 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
563 Participants
n=7 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
1 Participants
n=5 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
1 Participants
n=4 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
1064 Participants
n=21 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
|
HIV testing history
Tested for HIV over 12 months ago
|
728 Participants
n=5 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
784 Participants
n=7 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
1 Participants
n=5 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
0 Participants
n=4 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
1513 Participants
n=21 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
|
HIV testing history
Missing
|
0 Participants
n=5 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
0 Participants
n=7 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
0 Participants
n=5 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
7 Participants
n=4 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
7 Participants
n=21 Participants • HIV testing history was missing for 7 partners in the intervention period.
|
PRIMARY outcome
Timeframe: 24 monthsPrimary endpoints for the HIV-1 RNA testing intervention include the proportion of participants with newly diagnosed prevalent or AHI at care seeking.
Outcome measures
| Measure |
Adult Outpatients With Symptoms of Acute HIV Infection
n=2874 Participants
Adult symptomatic outpatients aged 18-39 years were evaluated by a consensus AHI risk score. Patients with a risk score ≥2 and no previous HIV diagnosis were enrolled in a stepped-wedge trial of opt-out delivery of point-of-care (POC) HIV-1 nucleic acid testing (NAAT), compared to standard provider-initiated HIV testing using rapid tests in the observation period.
|
Observation Phase
n=1374 Participants
adult participants aged 18-39 years
|
Intervention Phase
n=1500 Participants
Adult participants aged 18-39 years
|
|---|---|---|---|
|
Proportion of Patients With Newly Diagnosed HIV Infection at Care Seeking
HIV-positive
|
50 Participants
|
13 Participants
|
37 Participants
|
|
Proportion of Patients With Newly Diagnosed HIV Infection at Care Seeking
Acute HIV infection
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Proportion of Patients With Newly Diagnosed HIV Infection at Care Seeking
HIV-negative
|
2822 Participants
|
1361 Participants
|
1461 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: newly diagnosed participants
Secondary endpoints for the linkage to care intervention include the proportion of newly diagnosed patients captured in the HIV care cascade.
Outcome measures
| Measure |
Adult Outpatients With Symptoms of Acute HIV Infection
n=13 Participants
Adult symptomatic outpatients aged 18-39 years were evaluated by a consensus AHI risk score. Patients with a risk score ≥2 and no previous HIV diagnosis were enrolled in a stepped-wedge trial of opt-out delivery of point-of-care (POC) HIV-1 nucleic acid testing (NAAT), compared to standard provider-initiated HIV testing using rapid tests in the observation period.
|
Observation Phase
n=37 Participants
adult participants aged 18-39 years
|
Intervention Phase
Adult participants aged 18-39 years
|
|---|---|---|---|
|
Proportion of Newly Diagnosed Patients Linked to Care
|
9 Participants
|
33 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: In each period, trial participants who were newly diagnosed with HIV infection were offered assisted partner notification services and asked to report partners. Named partners who were successfully contacted were offered HIV testing and, if willing, provided informed consent for testing and documentation of the test result as part of this trial. Not all named partners were consented. Tested partners were referred to an observational HIV or PrEP cohort according to their status.
Proportion of named partners tested for HIV in each period
Outcome measures
| Measure |
Adult Outpatients With Symptoms of Acute HIV Infection
n=15 Participants
Adult symptomatic outpatients aged 18-39 years were evaluated by a consensus AHI risk score. Patients with a risk score ≥2 and no previous HIV diagnosis were enrolled in a stepped-wedge trial of opt-out delivery of point-of-care (POC) HIV-1 nucleic acid testing (NAAT), compared to standard provider-initiated HIV testing using rapid tests in the observation period.
|
Observation Phase
n=66 Participants
adult participants aged 18-39 years
|
Intervention Phase
Adult participants aged 18-39 years
|
|---|---|---|---|
|
Proportion of Named Partners Tested for HIV
|
3 Participants
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Data collected over 2 years, data is a predicted time point extrapolated to 10 yearsPopulation: The total cost (including both testing and HIV-positive patient management) per participant(base case patient modeled) is derived from the model where a measure of dispersion was not an output of the model.
Model outputs will include an analysis of the cost effectiveness of the novel testing intervention assessing several parameters of the HIV prevention and care cascade using stochastic, agent-based mathematical modelling. The population of interest modeled was 18- to 39-year-old heterosexuals in Kenya. The age range coincides with the sampled population in this study (NCT03508908) which provided the majority of the parameters for the networks and behavioral modules in the simulation. The observations from this study were weighted to match the sex and age composition reported in the Kenya Fact and Figures 2015 published by the Kenya National Bureau of Statistics. Additional model parameters were drawn from the literature on HIV infection, prevention, and treatment in Kenya.The analysis was conducted over a time horizon of 10 years, consistent with the mathematical model. 10,000 base-case patients (simulations) were run.
Outcome measures
| Measure |
Adult Outpatients With Symptoms of Acute HIV Infection
n=10000 case simulations
Adult symptomatic outpatients aged 18-39 years were evaluated by a consensus AHI risk score. Patients with a risk score ≥2 and no previous HIV diagnosis were enrolled in a stepped-wedge trial of opt-out delivery of point-of-care (POC) HIV-1 nucleic acid testing (NAAT), compared to standard provider-initiated HIV testing using rapid tests in the observation period.
|
Observation Phase
n=10000 case simulations
adult participants aged 18-39 years
|
Intervention Phase
Adult participants aged 18-39 years
|
|---|---|---|---|
|
Cost Effectiveness of Novel RNA Testing Intervention: Total Cost (Including Both Testing and HIV-positive Patient Management) Per Participant (Base Case Patient Modeled)
|
47.24 US dollars
|
214.91 US dollars
|
—
|
SECONDARY outcome
Timeframe: Data collected over 2 years, data is a predicted time point extrapolated to 10yearsDisability-adjusted Life Year (DALY) is an index calculated as the sum of years of life lost (YLL) plus the years lost due to disability (YLD), where 1 DALY represents one lost year of healthy life. The higher the DALY index value, the worse the outcome, where there is no theoretical minimum ore maximum index value. the sampled population in this study (NCT03508908) which provided the majority of the parameters for the networks and behavioral modules in the simulation. The observations from this study were weighted to match the sex and age composition reported in the Kenya Fact and Figures 2015 published by the Kenya National Bureau of Statistics. Additional model parameters were drawn from the literature on HIV infection, prevention, and treatment in Kenya. The analysis was conducted over a time horizon of 10 years, consistent with the mathematical model. 10,000 base-case patients (simulations) were run.
Outcome measures
| Measure |
Adult Outpatients With Symptoms of Acute HIV Infection
n=10000 case simulations
Adult symptomatic outpatients aged 18-39 years were evaluated by a consensus AHI risk score. Patients with a risk score ≥2 and no previous HIV diagnosis were enrolled in a stepped-wedge trial of opt-out delivery of point-of-care (POC) HIV-1 nucleic acid testing (NAAT), compared to standard provider-initiated HIV testing using rapid tests in the observation period.
|
Observation Phase
n=10000 case simulations
adult participants aged 18-39 years
|
Intervention Phase
Adult participants aged 18-39 years
|
|---|---|---|---|
|
Cost Effectiveness of Novel RNA Testing Intervention: Disability-Adjusted Life Years (Base Case Patient Modeled)
|
0.2140 index
|
0.1598 index
|
—
|
Adverse Events
Observation Period
Intervention Period
Observation Period Partners
Intervention Period Partners
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place