Universal Testing, Expanded Treatment, and Incidence of HIV Infection in Botswana.
Adolescent
Adult
Anti-Retroviral Agents
/ therapeutic use
Botswana
/ epidemiology
Circumcision, Male
/ statistics & numerical data
Female
HIV Infections
/ diagnosis
Humans
Incidence
Male
Mass Drug Administration
Mass Screening
Middle Aged
Proportional Hazards Models
Rural Population
Socioeconomic Factors
Viral Load
Young Adult
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
18 07 2019
18 07 2019
Historique:
entrez:
18
7
2019
pubmed:
18
7
2019
medline:
28
7
2019
Statut:
ppublish
Résumé
The feasibility of reducing the population-level incidence of human immunodeficiency virus (HIV) infection by increasing community coverage of antiretroviral therapy (ART) and male circumcision is unknown. We conducted a pair-matched, community-randomized trial in 30 rural or periurban communities in Botswana from 2013 to 2018. Participants in 15 villages in the intervention group received HIV testing and counseling, linkage to care, ART (started at a higher CD4 count than in standard care), and increased access to male circumcision services. The standard-care group also consisted of 15 villages. Universal ART became available in both groups in mid-2016. We enrolled a random sample of participants from approximately 20% of households in each community and measured the incidence of HIV infection through testing performed approximately once per year. The prespecified primary analysis was a permutation test of HIV incidence ratios. Pair-stratified Cox models were used to calculate 95% confidence intervals. Of 12,610 enrollees (81% of eligible household members), 29% were HIV-positive. Of the 8974 HIV-negative persons (4487 per group), 95% were retested for HIV infection over a median of 29 months. A total of 57 participants in the intervention group and 90 participants in the standard-care group acquired HIV infection (annualized HIV incidence, 0.59% and 0.92%, respectively). The unadjusted HIV incidence ratio in the intervention group as compared with the standard-care group was 0.69 (P = 0.09) by permutation test (95% confidence interval [CI], 0.46 to 0.90 by pair-stratified Cox model). An end-of-trial survey in six communities (three per group) showed a significantly greater increase in the percentage of HIV-positive participants with an HIV-1 RNA level of 400 copies per milliliter or less in the intervention group (18 percentage points, from 70% to 88%) than in the standard-care group (8 percentage points, from 75% to 83%) (relative risk, 1.12; 95% CI, 1.09 to 1.16). The percentage of men who underwent circumcision increased by 10 percentage points in the intervention group and 2 percentage points in the standard-care group (relative risk, 1.26; 95% CI, 1.17 to 1.35). Expanded HIV testing, linkage to care, and ART coverage were associated with increased population viral suppression. (Funded by the President's Emergency Plan for AIDS Relief and others; Ya Tsie ClinicalTrials.gov number, NCT01965470.).
Sections du résumé
BACKGROUND
The feasibility of reducing the population-level incidence of human immunodeficiency virus (HIV) infection by increasing community coverage of antiretroviral therapy (ART) and male circumcision is unknown.
METHODS
We conducted a pair-matched, community-randomized trial in 30 rural or periurban communities in Botswana from 2013 to 2018. Participants in 15 villages in the intervention group received HIV testing and counseling, linkage to care, ART (started at a higher CD4 count than in standard care), and increased access to male circumcision services. The standard-care group also consisted of 15 villages. Universal ART became available in both groups in mid-2016. We enrolled a random sample of participants from approximately 20% of households in each community and measured the incidence of HIV infection through testing performed approximately once per year. The prespecified primary analysis was a permutation test of HIV incidence ratios. Pair-stratified Cox models were used to calculate 95% confidence intervals.
RESULTS
Of 12,610 enrollees (81% of eligible household members), 29% were HIV-positive. Of the 8974 HIV-negative persons (4487 per group), 95% were retested for HIV infection over a median of 29 months. A total of 57 participants in the intervention group and 90 participants in the standard-care group acquired HIV infection (annualized HIV incidence, 0.59% and 0.92%, respectively). The unadjusted HIV incidence ratio in the intervention group as compared with the standard-care group was 0.69 (P = 0.09) by permutation test (95% confidence interval [CI], 0.46 to 0.90 by pair-stratified Cox model). An end-of-trial survey in six communities (three per group) showed a significantly greater increase in the percentage of HIV-positive participants with an HIV-1 RNA level of 400 copies per milliliter or less in the intervention group (18 percentage points, from 70% to 88%) than in the standard-care group (8 percentage points, from 75% to 83%) (relative risk, 1.12; 95% CI, 1.09 to 1.16). The percentage of men who underwent circumcision increased by 10 percentage points in the intervention group and 2 percentage points in the standard-care group (relative risk, 1.26; 95% CI, 1.17 to 1.35).
CONCLUSIONS
Expanded HIV testing, linkage to care, and ART coverage were associated with increased population viral suppression. (Funded by the President's Emergency Plan for AIDS Relief and others; Ya Tsie ClinicalTrials.gov number, NCT01965470.).
Identifiants
pubmed: 31314967
doi: 10.1056/NEJMoa1812281
pmc: PMC6800102
mid: NIHMS1536859
doi:
Substances chimiques
Anti-Retroviral Agents
0
Banques de données
ClinicalTrials.gov
['NCT01965470']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
230-242Subventions
Organisme : NIAID NIH HHS
ID : K23 AI091434
Pays : United States
Organisme : NIAID NIH HHS
ID : R01 AI127271
Pays : United States
Organisme : ACL HHS
ID : U2GGH001911
Pays : United States
Organisme : CGH CDC HHS
ID : U01 GH000447
Pays : United States
Organisme : Wellcome Trust
ID : 107752/Z/15/Z
Pays : United Kingdom
Organisme : FIC NIH HHS
ID : D43 TW009610
Pays : United States
Organisme : NIAID NIH HHS
ID : R37 AI051164
Pays : United States
Organisme : NICHD NIH HHS
ID : K23 HD070774
Pays : United States
Organisme : FIC NIH HHS
ID : D43 TW000004
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA236546
Pays : United States
Organisme : NIAID NIH HHS
ID : R01 AI104459
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA222147
Pays : United States
Organisme : NIAID NIH HHS
ID : K24 AI131928
Pays : United States
Organisme : CGH CDC HHS
ID : U2G GH001911
Pays : United States
Organisme : Wellcome Trust
Pays : United Kingdom
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2019 Massachusetts Medical Society.
Références
Lancet. 2016 Mar 5;387(10022):943-944
pubmed: 26972244
N Engl J Med. 2019 Jul 18;381(3):207-218
pubmed: 31314965
Lancet HIV. 2018 Mar;5(3):e116-e125
pubmed: 29199100
Lancet HIV. 2018 Aug;5(8):e438-e447
pubmed: 30025681
N Engl J Med. 2015 Aug 27;373(9):795-807
pubmed: 26192873
Lancet HIV. 2016 May;3(5):e221-30
pubmed: 27126489
N Engl J Med. 2016 Sep 1;375(9):830-9
pubmed: 27424812
Lancet. 2017 Jul 22;390(10092):357
pubmed: 28745597
Clin Trials. 2014 Jun;11(3):309-318
pubmed: 24651566
N Engl J Med. 2019 Jul 18;381(3):219-229
pubmed: 31314966
Lancet. 2009 Jan 3;373(9657):48-57
pubmed: 19038438
J Int AIDS Soc. 2018 Jan;21(1):
pubmed: 29314658
JAMA. 2016 Jul 12;316(2):171-81
pubmed: 27404185