Evidence map›Paper›PMID 38783534›Full record

ArticleJournal of the International AIDS Society2024

HPTN 083-02: factors influencing adherence to injectable PrEP and retention in an injectable PrEP study.

Christina Psaros, Georgia R Goodman, Jasper S Lee, Whitney Rice, Colleen F Kelley, Temitope Oyedele, Lara E Coelho, Nittaya Phanuphak, Yashna Singh, Keren Middelkoop and 13 more

Abstract read
In one paragraph

Article in Journal of the International AIDS Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
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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

23 authors.

Christina PsarosDepartment of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-0705-2239
Georgia R GoodmanDepartment of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-9404-4455
Jasper S LeeDepartment of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.
Whitney RiceDepartment of Behavioral, Social and Health Education Sciences, Emory University Rollins School of Public Health, Atlanta, Georgia, USA.ORCID 0000-0003-1749-023X
Colleen F KelleyDivision of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.ORCID 0000-0001-5611-0119
Temitope OyedeleAstraZeneca Pharmaceuticals, Chicago, Illinois, USA.
Lara E CoelhoInstituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.ORCID 0000-0001-7154-8151
Nittaya PhanuphakInstitute of HIV Research and Innovation, Bangkok, Thailand.ORCID 0000-0002-0036-3165
Yashna SinghDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Keren MiddelkoopDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Sam GriffithFamily Health International 360, Washington, DC, USA.
Marybeth McCauleyFamily Health International 360, Washington, DC, USA.
James RooneyGilead Sciences, Foster City, California, USA.
Alex R RinehartViiV Healthcare, Durham, North Carolina, USA.
Jesse ClarkDivision of Infectious Diseases, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.ORCID 0000-0001-5862-6530
Vivian GoDepartment of Health Behavior, University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, USA.
Jeremy SugarmanBerman Institute of Bioethics and School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.ORCID 0000-0001-7022-8332
Sheldon D FieldsRoss and Carol Nese College of Nursing, The Pennsylvania State University, University Park, Pennsylvania, USA.
Adeola AdeyeyeNigeria Country Office, US Centers for Disease Control and Prevention, Abuja, Nigeria.
Beatriz GrinsztejnInstituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
Raphael J LandovitzCenter for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles, California, USA.
Steven A SafrenDepartment of Psychology, University of Miami, Miami, Florida, USA.ORCID 0000-0002-0121-0806
HPTN 083‐02 Study Team

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI MYRON Scott COHEN, Sinead Delany-Moretlwe · 2011 to 2026
$779.5M
SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
Training Program for Scientists Conducting Research to Reduce HIV Health DisparitR25MH067127 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Emily A Arnold, Torsten Brian Neilands · 2003 to 2026
$5.4M
Eunice Kennedy Shriver Institute for Child Health and Human Development UM1AI068619HIV Prevention Trials Network UM1AI068617HPTN Statistical and Data Management Center UM1AI068613National Institute of Allergy and Infectious DiseasesNIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069476NIDA NIH HHSNIH HHSNIMH NIH HHS R25 MH067127
6 · The paper itself

Abstract

introductionHPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial.

methodsParticipants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (N = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (n = 27), non-adherent (n = 12) and early discontinuers (n = 1). Data were organized using NVivo software and analysed using content analysis.

resultsParticipants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules).

conclusionsRespondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility and affirming clinic environments, inclusive of non-judgemental counselling, were key facilitators of adherence. To support injection persistence, interventions that address structural barriers and promote flexible means of injection delivery may be most effective.

Indexed as

Anti-HIV AgentsDrug MonitoringHIV InfectionsPre-Exposure ProphylaxisAdultBrazilDiketopiperazinesEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationFemaleHomosexuality, MaleHumansInjectionsInterviews as TopicMaleMiddle AgedPyridinesAnti-HIV AgentscabotegravirDiketopiperazinesEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationPyridinesPyridonesTenofovirHIV preventioninjectable PrEPmen who have sex with menpre‐exposure prophylaxisqualitativetransgender women

Identifiers

PMID38783534
PMCPMC11116478

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Registered trials

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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.