Evidence map›Paper›PMID 22511916›Full record

Trial reportPloS one2012

Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers.

Gaudensia Mutua, Eduard Sanders, Peter Mugo, Omu Anzala, Jessica E Haberer, David Bangsberg, Burc Barin, James F Rooney, David Mark, Paramesh Chetty and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00971230 (A Pilot Study of Pre-Exposure Prophylaxis), which is not on this map. Cited by 97 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
97citing papers in PubMed, 12 pooled it
–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.

NCT00971230 phase1 / phase2completednot on this map

A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Kenya, Africa

TypeinterventionalSponsorInternational AIDS Vaccine InitiativeRan2009 to 2010Enrolled72ConditionsHIV InfectionsArmsFTC/TDF, Placebo
3 · Its place in the literature

Who cites it

97 citing papers in PubMed, 12 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Substance Use and HIV Risk Among Men Who Have Sex With Men in Africa: A Systematic Review.Journal of acquired immune deficiency syndromes (1999) · 2017
    Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

37 more citing papers are in PubMed but not listed here.

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

12 authors.

Gaudensia MutuaKenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya.
Eduard Sanders
Peter Mugo
Omu Anzala
Jessica E Haberer
David Bangsberg
Burc Barin
James F Rooney
David Mark
Paramesh Chetty
Patricia Fast
Frances H Priddy

Funding

Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in UgandaK23MH087228 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI HABERER, JESSICA ELIZABETH · 2009 to 2013
$916k
Mentoring Patient Oriented Adherence Research in UgandaK24MH087227 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI BANGSBERG, DAVID ROY · 2009 to 2013
$776k
NIMH NIH HHS K23 MH087228NIMH NIH HHS K24 MH087227
6 · The paper itself

Abstract

backgroundLittle is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM) and female sex workers (FSW). METHODS/PRINCIPAL

findingsMSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral FTC/TDF or placebo in a 2:1:2:1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS). Sexual activity data were collected via daily text message (SMS) queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63-92] for daily dosing and 55% [IQR:28-78] for fixed intermittent dosing (p = 0.003), while adherence to any post-coital doses was 26% [IQR:14-50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen. CONCLUSIONS/SIGNIFICANCE: Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens.

trial registrationClinicalTrials.gov NCT00971230.

Indexed as

Patient ComplianceAdenineAdolescentAdultAnti-HIV AgentsDeoxycytidineEmtricitabineFemaleHIV-1HIV InfectionsHomosexuality, MaleHumansKenyaMaleMiddle AgedOrganophosphonatesAdenineAnti-HIV AgentsDeoxycytidineEmtricitabineOrganophosphonatesTenofovir

Identifiers

PMID22511916
PMCPMC3325227

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.