Evidence map›Paper›PMID 23065145›Full record

Trial reportAIDS and behavior2013

Adherence and acceptability in MTN 001: a randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women.

Alexandra M Minnis, Sharavi Gandham, Barbra A Richardson, Vijayanand Guddera, Beatrice A Chen, Robert Salata, Clemensia Nakabiito, Craig Hoesley, Jessica Justman, Lydia Soto-Torres and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS and behavior, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02995005 (Prevention of Mother-to-child Transmission of Hepatitis B Virus), which is not on this map. Cited by 54 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 4 pooled it
6.6field-weighted citation impact, top 2% of its field
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.

NCT02995005 phase1 / phase2completednot on this mapstarted 2018, after this paper: background citation

Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy

TypeinterventionalSponsorJohns Hopkins Bloomberg School of Public HealthRan2018 to 2023Enrolled98ConditionsHepatitis BArmsTenofovir Disoproxil Fumarate
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 4 syntheses or guidelines pooled it, 74 citations in OpenAlex.

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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

13 authors at 11 institutions in 3 countries.

Alexandra M MinnisWomen's Global Health Imperative, RTI International, San Francisco, CA 94104, USA. aminnis@rti.org
Sharavi Gandham
Barbra A Richardson
Vijayanand Guddera
Beatrice A Chen
Robert Salata
Clemensia Nakabiito
Craig Hoesley
Jessica Justman
Lydia Soto-Torres
Karen Patterson
Kailazarid Gomez
Craig W Hendrix
University of Washington · USCase Western Reserve University · USColumbia University · USFamily Health International 360 · USJohns Hopkins University · USMUJHU Research Collaboration · UGNational Institute of Allergy and Infectious Diseases · USRTI International · USSouth African Medical Research Council · ZAUniversity of Alabama at Birmingham · USUniversity of Pittsburgh · US

Funding

Microbicide Trials NetworkU01AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2006 to 2010
$77.0M
UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
NCATS NIH HHS UL1 TR000005NCRR NIH HHS UL1 RR024153NIAID NIH HHS U01 AI068633NIAID NIH HHS U01AI068633NIAID NIH HHS UM1 AI068615
6 · The paper itself

Abstract

We compared adherence to and acceptability of daily topical and oral formulations of tenofovir (TFV) used as pre-exposure prophylaxis (PrEP) for HIV prevention among women in South Africa, Uganda and the United States. 144 sexually active, HIV-uninfected women participated in a cross-over study of three regimens: oral tablet, vaginal gel, or both. We tested for differences in adherence and evaluated product acceptability. Self-reported adherence for all regimens was high (94 %), but serum TFV concentrations indicated only 64 % of participants used tablets consistently. Most women in the U.S. (72 %) favored tablets over gel; while preferences varied at the African sites (42 % preferred gel and 40 % tablets). Findings indicate a role for oral and vaginal PrEP formulations and highlight the importance of integrating pharmacokinetics-based adherence assessment in future trials. Biomedical HIV prevention interventions should consider geographic and cultural experience with product formulations, partner involvement, and sexual health benefits that ultimately influence use.

Indexed as

Drug MonitoringAdenineAdministration, OralAdministration, TopicalAdolescentAdultAnti-HIV AgentsCross-Over StudiesFemaleHIV InfectionsHumansMedication AdherenceMiddle AgedOrganophosphonatesPatient Acceptance of Health CarePatient PreferenceAdenineAnti-HIV AgentsOrganophosphonatesTenofovirVaginal Creams, Foams, and Jellies

Identifiers

PMID23065145
PMCPMC3562423
OpenAlexW2101717892

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.