To elucidate the clinical questions that remain unresolved or understudied regarding the universal test and treat strategy (TNT).

To determine what health services or implementation research remains to be done in order to support implementation of TNT.

To identify the ethical concerns that need to be addressed in order to proceed with TNT.

Data were gathered from electronic databases. Searches were limited to articles with English-language abstracts available. Searches were limited by publication date between January 2009 and May 2012. Searches applied to the following databases: PubMed, SCOPUS, Global Health, Web of Science, BIOSIS, Cochrane Central Register of Controlled Trials (CENTRAL), EBSCO Africa-Wide Information, EBSCO CINAHL Plus.

The following search term structure was used: ("test and treat" OR "universal testing" OR “universal treatment” OR “treatment as prevention”) AND ("HIV"[Mesh] OR HIV OR AIDS OR "acquired immunodeficiency syndrome"[MeSH Terms]). The MESH terms were only included in the search in the Pubmed database.

Articles were excluded if they were book chapters, conference abstracts, had no listed author, or if they were not available in English.

Test and Treat in the context of HIV/AIDS.

All populations.

Must be peer reviewed. For inclusion, must meet at least meet one of the following two criteria:

• The subject of the article pertained specifically to HIV infection and directly mentioned one of the following terms: "Test-and-treat," "seek, test, and treat," "treatment as prevention," "Universal testing and treatment," or "universal access to treatment."

• The subject of the article was related to the strategy of universal testing and treatment as defined by author mention of either:

o How the particular study's findings have implications for the widespread implementation of HIV testing and immediate initiation of antiretroviral treatment or the widespread use of antiretroviral treatment as prevention.

o Concerns or gaps in the evidence based surrounding the widespread implementation of HIV testing and immediate initiation of antiretroviral treatment or the widespread use of antiretroviral treatment as prevention.

Article abstracts were each independently reviewed by two reviewers and recommended for full-length article review if the abstract subject pertained to HIV infection and met one of the following conditions:

1) made mention of "Test-and-treat," "seek, test, and treat," "treatment as prevention," "Universal testing and treatment," or "universal access to treatment"; or

2) mentioned how the particular study's findings have implications for the widespread implementation of HIV testing and immediate initiation of antiretroviral treatment or the widespread use of antiretroviral treatment as prevention; or

3) mentioned concerns or gaps in the evidence based surrounding the widespread implementation of HIV testing and immediate initiation of antiretroviral treatment or the widespread use of antiretroviral treatment as prevention.

Articles were excluded if they were book chapters, conference abstracts, had no listed author, or if they were not available in English. Articles solely focusing on the use of antiretroviral medications for pre-exposure prophylaxis, post-exposure prophylaxis, or mother to child transmission to reduce HIV transmission or incidence as well as articles whose main outcome was something other than HIV transmission and incidence, such as tuberculosis incidence, were excluded. When abstracts were not available or reviewers disagreed about whether the article met inclusion criteria, the article was referred for full article review.

Not applicable.

Primary outcomes

Effectiveness of Test and Treat.

Problems with the Test and Treat strategy.

Unanswered questions about the Test and Treat strategy.

Secondary outcomes

Ethics of Test and Treat.

Full length articles will be reviewed to determine whether they meet the criteria described above. Differences between reviewers regarding whether an article met criteria will be resolved by consensus after reference to the original article. The inter-observer agreement for article inclusion will be measured using Cohen’s kappa statistic.

A data extraction template was created. Full articles that meet criteria will again be read independently by two reviewers and categorized by study design into the following categories: empiric results from either an experimental design, observational study, or mathematical modeling analysis; narrative or systematic review article; or commentary, including correspondences. Review articles include both systematic reviews and narrative reviews. Narrative reviews will be distinguished from commentaries by the identification of substantial literature citation and evidence review that identifies critical points of the current knowledge on particular topics related to test and treat. Commentaries, which include short pieces and correspondences, include substantial argumentative points, but do not attempt to summarize the literature on the topic of interest.

Study design category, includes themes, key quotes

Not applicable.

Narrative synthesis.

Clinical, Health systems, Ethics.

Karthik Sarma

945 Weyburn Terrace Apt C16

Los Angeles, CA 90024

ksarma@ksarma.com

UCLA

Mr Karthik Sarma,
Dr Kavita Shah,
Dr Anish Mahajan,
Dr Sonali Kulkarni,

01 May 2012

03 September 2012

NIH, UCLA AI, UCLA CFAR

None known

English

United States of America

Subject indexing assigned by CRD

Antiretroviral Therapy, Highly Active; Ethics; Health Services; HIV; HIV Seropositivity; Humans

31 August 2012

31 August 2012