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The Ya Tsie balloon (also alleged the Botswana Combination Prevention Project) was a pair-matched, community-randomized balloon that activated whether a action of assay and interventions to anticipate HIV infection would abate the population-level accumulative accident of HIV infection over 29 months.10,11 The balloon was conducted from 2013 to 2018 in 30 rural or periurban communities with an boilerplate citizenry of 6000 (Figure 1). Fifteen association pairs were akin according to citizenry admeasurement and age structure, bloom services, and geographic location. The association pairs were again assigned, by accidental draw witnessed by bodies who were detached with the trial, to the action accumulation or the standard-care group. Afterwards association mobilization (e.g., accouterment of advice about the balloon to association leaders, accessible discussions and question-and-answer sessions about the balloon with association in accessible meetings, and announcements over a loudspeaker throughout the apple afore admission of balloon activities), we enrolled association from a accidental sample of about 20% of households in anniversary association in a -to-be accomplice to appraise the accident of HIV infection and the action uptake. The interventions were scaled up in the 15 communities in the action accumulation anon afterwards acceptance of the cohort. The planned aftereffect was beneath from 36 months to 29 months because of bread-and-butter constraints.
The action action included community-wide, standardized, home-based and adaptable HIV testing campaigns, accessory of accepted testing in bloom accessories (e.g., with adjustment of added agents associates for HIV testing and an accent on the accent of accepted testing), and targeted beat testing of all men (regardless of age) and adolescent bodies (men and women ≤25 years of age), as able-bodied as alive bond to affliction at bounded clinics for HIV-positive bodies who were not accepting ART (with an arrangement appointed aural 1 week, a argument bulletin admonition afore the appointment, and alive archetype if the arrangement was missed). In addition, until August 2015, broadcast ART was provided for participants with an HIV blazon 1 (HIV-1) RNA akin of 10,000 copies per milliliter or added (if the CD4 calculation was >350 beef per cubic millimeter); from August 2015 through May 2016, ART was provided for participants with a CD4 calculation of 500 beef per cubic millimeter or beneath or an HIV-1 RNA akin of 10,000 copies per milliliter or added (if the CD4 calculation was >500 beef per cubic millimeter). Starting in June 2016, accepted ART (treatment accommodation for all bodies with a assay of HIV infection, behindhand of the CD4 calculation or HIV-1 RNA level) was accomplished at the aboriginal dispensary visit. Increased admission to macho circumcision casework (mobilization campaigns, adaptable clinics, and associate bond with appointed appointments, reminders, and transportation) was additionally provided.
In all 30 communities, from the admission of the balloon until June 2016, HIV-positive bodies who had a CD4 calculation of 350 beef per cubic millimeter or beneath or World Bloom Organization (WHO) date III or IV disease, as able-bodied as those who were abundant or breast-feeding, were acceptable to accept ART. Afterwards June 2016, accepted ART was offered in both the action and standard-care groups.
All the communities implemented the accordant changes in the ART accommodation belief simultaneously. In the communities in the action group, participants who were acceptable to accept ART according to the revised belief were contacted and referred. Beginning in June 2016, the first-line ART dieting provided by the government to all balloon communities was switched from efavirenz–tenofovir disoproxil fumarate (TDF)–emtricitabine (FTC) to dolutegravir–TDF-FTC. Bodies who confused into communities in the action accumulation were acceptable for all interventions. Noncitizens were acceptable alone for chargeless HIV testing. Interventions were provided by cadres of agents who were about active in the region, and ART was provided in accessible clinics by government staff.
Prospective accomplice participants were articular with the use of a household-based probabilistic sampling action at the association level. Aural all 30 communities, every artifice of acreage with a houselike anatomy was geocoded with accessory adumbration (Google Earth). A simple accidental sample of about 20% of households in anniversary association was called from the account of geocoded plots. Association of houses on called plots were enumerated, and assay agents approached all potentially acceptable association for participation. Plots were visited up to three times for enumeration; up to three added visits were fabricated to accept anniversary potentially acceptable resident. Accommodation belief included the following: age of 16 to 64 years, an boilerplate of 3 or added nights per ages spent in the association over the above-mentioned 12 months, added nights spent in this domiciliary than any added domiciliary in the aforementioned community, accurate Botswana citizenship or alliance to a aborigine of Botswana, and the adeptness to accommodate abreast consent. Both HIV-positive and HIV-negative association were enrolled; HIV-negative association constituted the HIV-incidence cohort.
The domiciliary assay included questions about sociodemographic information, health, and HIV-risk behavior. Participants after accurate HIV-positive cachet were offered counseling and alongside HIV accelerated tests (KHB, Shanghai Kehua Bio-Engineering; Uni-Gold, Trinity Biotech). HIV-1 RNA was activated (Abbott RealTime HIV-1 assay) in all HIV-positive participants at baseline and at the final surveys, irrespective of ART use. An ephemeral HIV-1 RNA akin was authentic as 400 copies per milliliter or less. If they were not accepting ART, bodies with an ephemeral HIV-1 RNA akin underwent testing with bifold agitator immunoassay. A point-of-care CD4 calculation (Alere Pima) was acquired for HIV-positive participants who were not accepting ART at enrollment. Documentation of assay with ART was appropriate in adjustment to allocate a actor as accepting ART. During aftereffect visits at 12 months and about 29 months, we administered questionnaires and (in HIV-negative participants) echo HIV testing.
Three association pairs (six communities), one per geographic region, were called to participate in an end-of-trial assay to appraise advantage of action apparatus (including HIV testing, ART initiation, viral suppression, and macho circumcision) according to group. Alternative of these communities was fabricated after ability of the action uptake. End-of-trial assay participants in these six communities were acknowledging associates of the absolute 80% of the association association who did not booty allotment in the longitudinal cohort. The aforementioned assay procedures as declared aloft were followed. Bodies who confused into communities during the balloon were acceptable to participate in the end-of-trial survey.
In both groups, after-effects of testing to actuate HIV, HIV-1 RNA, and CD4 cachet were aggregate with the participants, and HIV-infected participants who were not yet accepting ART were referred to their bounded clinic. According to the protocol, adverse contest that were both abrupt and possibly accompanying to balloon accord were to be reported.
The balloon was accustomed by the Botswana Bloom Assay and Development Committee and the institutional assay lath of the Centers for Ache Control and Prevention and was monitored by a abstracts and assurance ecology lath and Westat. All accomplice participants provided accounting abreast consent. Participants who were 16 or 17 years of age provided accounting acceptance (with accounting permission from their parents or guardians).
All analyses were prespecified and performed in accordance with the agreement and statistical assay plan, accessible with the abounding argument of this commodity at NEJM.org. Statistical analyses were performed with the use of SAS software, adaptation 9.4 (SAS Institute).
An agent-based arrangement catching archetypal was acclimated to appraisal balloon power.12 We estimated that 15 clusters per accumulation and an boilerplate of 300 participants in the HIV-incidence accomplice per association would accommodate at atomic 85% ability to ascertain a 40% lower accident of HIV infection in the action accumulation than in the standard-care accumulation (between-cluster accessory of variation, 0.26). In 2017, on the base of codicillary ability calculations absorption aerial baseline ART coverage, a alteration accepted of ART, and beneath follow-up, we estimated greater than 60% ability to ascertain a 34% lower accident of HIV infection in the action accumulation than in the standard-care group.
The primary end point was the accident of HIV infection, abstinent as the time to HIV infection from acceptance in the HIV-incidence cohort. Person-time for adventure cases was breach censored amid the best contempo abrogating HIV assay and the aboriginal absolute test; a time breach in which the infection occurred was bent back the absolute time of infection was not observable. Abstracts for participants after a absolute HIV assay were appropriate censored at the time of the aftermost accessible abrogating test. Abstracts for participants who died were censored at the time of death.
For the prespecified unadjusted primary analysis, we acclimated a about-face assay with the accomplishment authentic as the inverse-variance abounding boilerplate of pair-specific accident ratios estimated beneath a Cox proportional-hazards archetypal for the akin pair, accounting for breach censoring. This about-face assay is absolutely able-bodied to absorption but does not crop a aplomb interval. To admission a 95% aplomb breach for the action effect, we fit a pair-stratified interval-censored Cox proportional-hazards archetypal that accounted for between-pair airheadedness in baseline incidence. To appraise acuteness to within-pair clustering, we fit an incomparable Cox proportional-hazards alloyed archetypal with accidental aftereffect for community. P ethics were two-sided. We generated Kaplan–Meier adaptation curves and pointwise aplomb intervals application interval-midpoint allegation of accident times.13 To appraise the collective aftereffect of abstention and abased censoring due to death, we implemented changed anticipation weighting.14
Covariate-adjusted versions of these analyses were additionally performed, as prespecified, with astern capricious alternative with a pair-stratified interval-censored Cox proportional-hazards archetypal with an admittance P amount blow of 0.20; the action accumulation was bare from the archetypal in this alternative action and was added alone to the final model. In column hoc analyses, we advised the alternation amid the action and the participants’ sex, age, and geographic region.
Comparison of advantage of action apparatus according to accumulation was a prespecified end point, analyzed with the use of baseline abstracts from the accomplice of about 20% of association and postintervention abstracts from the absolute 80% of the citizenry involving six communities that alternate in the end-of-trial survey. Citizenry viral abolishment was authentic as the cardinal of HIV-positive bodies accepting ART who had an HIV-1 RNA akin of 400 copies per milliliter or beneath disconnected by the cardinal of all HIV-positive bodies who had an HIV-1 RNA result, behindhand of ART cachet (overall 90-90-90 cascade). We acclimated Poisson corruption with log-link, anchored furnishings for matched-pair, time, and their alternation (accounting for community-level clustering) to appraise the aftereffect of randomized accumulation on advantage of action components.
Secondary, exploratory, and subgroup analyses were not adapted for assorted comparisons. After-effects are appear with point estimates and 95% aplomb intervals, after P values. The aplomb intervals were not adapted for assorted comparisons, and inferences fatigued from them may not be reproducible.
All the authors vouch for the accurateness and abyss of the abstracts and for the allegiance of the balloon to the protocol. The balloon board had admission to the data, but the sponsors did not.
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