Evidence map›Paper›PMID 29950284›Full record

ArticleThe lancet. HIV2018

Development and implementation of participant safety plans for international research with stigmatised populations.

Jeremy Sugarman, Mark Barnes, Scott Rose, Kostyantyn Dumchev, Riza Sarasvita, Ha Tran Viet, Oleksandr Zeziulin, Hepa Susami, Vivian Go, Irving Hoffman and 1 more

Abstract read
In one paragraph

Article in The lancet. HIV, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jeremy SugarmanBerman Institute of Bioethics, School of Medicine, and Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA. Electronic address: jsugarman@jhu.edu.
Mark BarnesRopes & Gray, Boston, MA, USA; Yale Law School, New Haven, CT, USA.
Scott RoseFHI 360, Durham, NC, USA.
Kostyantyn DumchevUkrainian Institute on Public Health Policy, Kiev, Ukraine.
Riza SarasvitaNational Narcotics Board, Jakarta, Indonesia.
Ha Tran VietVietnam Authority of HIV/AIDS Control, Pho Yen Health Center of Thai Nguyen, Vietnam.
Oleksandr ZeziulinUkrainian Institute on Public Health Policy, Kiev, Ukraine.
Hepa SusamiAbhipraya Foundation and Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
Vivian GoDepartment of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Irving HoffmanDivision of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
William C MillerDivision of Epidemiology, College of Public Health, Ohio State University, Columbus, OH, USA.

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
NIAID NIH HHS P30 AI050410NIAID NIH HHS UM1 AI068619
6 · The paper itself

Abstract

People who inject drugs with high-risk sharing practices have high rates of HIV transmission and face barriers to HIV care. Interventions to overcome these barriers are needed; however, stigmatisation of drug use and HIV infection leads to safety concerns during the planning and conduct of research on such interventions. In preparing to address concerns about safety and wellbeing of participants in an international research study, HIV Prevention Trials Network 074, we developed participant safety plans (PSPs) at each site to supplement local research ethics committee oversight, community engagement, and usual clinical trial procedures. The PSPs were informed by systematic local legal and policy assessments, and interviews with key stakeholders. After PSP refinement and implementation, we assessed social impacts at each study visit to ensure continued safety. Throughout the study, five participants reported a negative social impact, with three resulting from study participation. Future research with stigmatised populations should consider using and assessing this approach to enhance safety and welfare.

Indexed as

Patient SafetyStereotypingClinical Trials as TopicDrug UsersEthics CommitteesHIV InfectionsHumansIndonesiaResearchResearch DesignSubstance Abuse, IntravenousUkraineVietnam

Identifiers

PMID29950284
PMCPMC6889082

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.