Evidence map›Paper›PMID 27146827›Full record

Trial reportAIDS and behavior2016

Sharing of Investigational Drug Among Participants in the Voice Trial.

Jeeva Moodley, Sarita Naidoo, Jayajothi Moodley, Gita Ramjee

Erratum issued Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in AIDS and behavior, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00705679 (Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT00705679 phase2completednot on this map

Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2012Enrolled5,029ConditionsHIV InfectionsArmsEmtricitabine/tenofovir disoproxil fumarate, Emtricitabine/tenofovir disoproxil fumarate placebo, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate placebo, Tenofovir 1% vaginal gel
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Jeeva MoodleyHIV Prevention Research Unit, South African Medical Research Council, 123 Jan Hofmeyr Road, Westville, Durban, 3630, South Africa. jeeva.moodley@mrc.ac.za.
Sarita NaidooHIV Prevention Research Unit, South African Medical Research Council, 123 Jan Hofmeyr Road, Westville, Durban, 3630, South Africa.
Jayajothi MoodleyHIV Prevention Research Unit, South African Medical Research Council, 123 Jan Hofmeyr Road, Westville, Durban, 3630, South Africa.
Gita RamjeeHIV Prevention Research Unit, South African Medical Research Council, 123 Jan Hofmeyr Road, Westville, Durban, 3630, South Africa.

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Microbicide Trials NetworkU01AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2006 to 2010
$77.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
South African Medical Research Council Clinical Trials Unit (MRC CTU)UM1AI069422 · NIAID · MEDICAL RESEARCH COUNCIL OF SOUTH AFRICA · PI ABDULLAH, MAHOMED FAREED ABOOBAKER, GOGA, AMEENA · 2012 to 2020
$37.4M
Laboratory Center (LC): Microbicide Trials NetworkUM1AI106707 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MELLORS, JOHN W, ROHAN, LISA CENCIA · 2014 to 2021
$27.1M
NIAID NIH HHS U01 AI068633NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069422NIAID NIH HHS UM1 AI106707
6 · The paper itself

Abstract

Product sharing among participants can impact on adherence and compromise the outcome in clinical trials. We describe incidents of product sharing at the Durban clinical research sites conducting the VOICE trial. The Durban sites enrolled 2750 women with 1103 and 1647 participants randomized to the vaginal gel and oral tablet arms respectively. Monthly pill and applicator counts including product assessments were conducted by pharmacists. Discrepancies with product counts prompted discussions with participants. Thirty-two cases of product sharing were identified. Vaginal gels were more commonly shared than oral tablets. Product sharing between study participants and their female friends or relatives living in the same household was identified as the most common source of product sharing in this analysis. Study product counts and pharmacist-driven discussions with participants may help to identify reasons for product sharing and inform the development of strategies for PrEP implementation outside of the research setting. ClinicalTrials.gov number: NCT00705679.

Indexed as

Pre-Exposure ProphylaxisAdministration, OralAdultAnti-HIV AgentsDouble-Blind MethodDrugs, InvestigationalEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationFemaleHIV InfectionsHumansMedication AdherenceSouth AfricaSubstance-Related DisordersTenofovirVaginal Creams, Foams, and JelliesYoung AdultAnti-HIV AgentsDrugs, InvestigationalEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationTenofovirVaginal Creams, Foams, and JelliesHIV preventionPill countPre-exposure prophylaxisProduct sharingVOICE

Identifiers

PMID27146827
PMCPMC5071120

What OpenQuestion holds

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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.