Evidence map›Paper›PMID 17631387›Full record

Trial reportLancet (London, England)2007

Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial.

Nancy S Padian, Ariane van der Straten, Gita Ramjee, Tsungai Chipato, Guy de Bruyn, Kelly Blanchard, Stephen Shiboski, Elizabeth T Montgomery, Heidi Fancher, Helen Cheng and 5 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00121459 (The Latex Diaphragm to Prevent HIV Acquisition Among Women), which is not on this map. Cited by 141 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
141citing papers in PubMed, 17 pooled it
96.6field-weighted citation impact, top 1% 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.

NCT00121459 phase3withdrawnnot on this map

The Latex Diaphragm to Prevent HIV Acquisition Among Women: A Female-Controlled, Physical Barrier of the Cervix

TypeinterventionalSponsorUniversity of California, San FranciscoRan2003Enrolled0ConditionsHIV InfectionArmsOrtho All-Flex diaphragm and Replens lubricant gel
3 · Its place in the literature

Who cites it

141 citing papers in PubMed, 17 syntheses or guidelines pooled it, 339 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Interventions for preventing unintended pregnancies among adolescents.The Cochrane database of systematic reviews · 2016
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Trial
  19. Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 6 institutions in 4 countries.

Nancy S PadianUniversity of California, San Francisco, CA, USA. Electronic address: npadian@globalhealth.ucsf.edu.
Ariane van der StratenUniversity of California, San Francisco, CA, USA.
Gita RamjeeHIV Prevention Research Unit, Medical Research Council, Durban, South Africa.
Tsungai ChipatoUniversity of Zimbabwe, Harare, Zimbabwe.
Guy de BruynPerinatal HIV Research Unit, University of the Witswatersrand, Johannesburg, South Africa.
Kelly BlanchardIbis Reproductive Health, Cambridge, MA, USA.
Stephen ShiboskiUniversity of California, San Francisco, CA, USA.
Elizabeth T MontgomeryUniversity of California, San Francisco, CA, USA.
Heidi FancherUniversity of California, San Francisco, CA, USA.
Helen ChengUniversity of California, San Francisco, CA, USA.
Michael RosenblumUniversity of California, Berkeley, CA, USA.
Mark van der LaanUniversity of California, Berkeley, CA, USA.
Nicholas JewellUniversity of California, Berkeley, CA, USA.
James McIntyrePerinatal HIV Research Unit, University of the Witswatersrand, Johannesburg, South Africa.
MIRA Team
University of California, San Francisco · USUniversity of California, Berkeley · USPerinatal HIV Research Unit · ZAIbis Reproductive Health · USMedical Research Council · GBUniversity of Zimbabwe · ZW

Funding

Targeted Learning using adaptive designs for HIV Epidemic control in East AfricaR01AI074345 · NIAID · UNIVERSITY OF CALIFORNIA BERKELEY · PI PETERSEN, MAYA LIV, VANDERLAAN, MARK J · 2007 to 2023
$6.6M
Statistical Methods to Study the Epidemiology of HIV & Other DiseaseR01AI070043 · NIAID · UNIVERSITY OF CALIFORNIA BERKELEY · PI JEWELL, NICHOLAS P · 2007 to 2010
$1.3M
NIAID NIH HHS R01 AI070043NIAID NIH HHS R01 AI074345
6 · The paper itself

Abstract

backgroundFemale-controlled methods of HIV prevention are urgently needed. We assessed the effect of provision of latex diaphragm, lubricant gel, and condoms (intervention), compared with condoms alone (control) on HIV seroincidence in women in South Africa and Zimbabwe.

methodsWe did an open-label, randomised controlled trial in HIV-negative, sexually active women recruited from clinics and community-based organisations, who were followed up quarterly for 12-24 months (median 21 months). All participants received an HIV prevention package consisting of pre-test and post-test counselling about HIV and sexually transmitted infections, testing, treatment of curable sexually transmitted infections, and intensive risk-reduction counselling. The primary outcome was incident HIV infection. This study is registered with ClinicalTrials.gov, number NCT00121459.

findingsOverall HIV incidence was 4.0% per 100 woman-years: 4.1% in the intervention group (n=2472) and 3.9% in the control group (n=2476), corresponding to a relative hazard of 1.05 (95% CI 0.84-1.32, intention-to-treat analysis). The proportion of women using condoms was significantly lower in the intervention than in the control group (54%vs 85% of visits, p<0.0001). The proportions of participants who reported adverse events (60% [1523] vs 61% [1529]) and serious adverse events (5% [130] vs 4% [101]) were similar between the two groups.

interpretationWe observed no added protective benefit against HIV infection when the diaphragm and lubricant gel were provided in addition to condoms and a comprehensive HIV prevention package. Our observation that lower condom use in women provided with diaphragms did not result in increased infection merits further research. Although the intervention seemed safe, our findings do not support addition of the diaphragm to current HIV prevention strategies.

Indexed as

Contraceptive Devices, FemaleVaginal Creams, Foams, and JelliesAdolescentAdultCondomsFemaleHIV InfectionsHumansIncidenceMiddle AgedSouth AfricaZimbabweVaginal Creams, Foams, and Jellies

Identifiers

PMID17631387
PMCPMC2442038
OpenAlexW2099331224

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.