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

Summary Background Female-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. Methods We did an o... Full description

Journal Title: The Lancet (British edition) 2007, Vol.370 (9583), p.251-261
Main Author: Padian, Nancy S, Dr
Other Authors: van der Straten, Ariane, PhD , Ramjee, Gita, PhD , Chipato, Tsungai, MBChB , de Bruyn, Guy, MBChB , Blanchard, Kelly, MS , Shiboski, Stephen, PhD , Montgomery, Elizabeth T, MHS , Fancher, Heidi, MPH , Cheng, Helen, MPH , Rosenblum, Michael, PhD , van der Laan, Mark, PhD , Jewell, Nicholas, PhD , McIntyre, James, MBChB
Format: Electronic Article Electronic Article
Language: English
Subjects:
HIV
STD
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/17631387
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2442038
title: Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial
format: Article
creator:
  • Padian, Nancy S, Dr
  • van der Straten, Ariane, PhD
  • Ramjee, Gita, PhD
  • Chipato, Tsungai, MBChB
  • de Bruyn, Guy, MBChB
  • Blanchard, Kelly, MS
  • Shiboski, Stephen, PhD
  • Montgomery, Elizabeth T, MHS
  • Fancher, Heidi, MPH
  • Cheng, Helen, MPH
  • Rosenblum, Michael, PhD
  • van der Laan, Mark, PhD
  • Jewell, Nicholas, PhD
  • McIntyre, James, MBChB
subjects:
  • Abridged Index Medicus
  • Acquired immune deficiency syndrome
  • Adolescent
  • Adult
  • AIDS
  • Article
  • Biomedical research
  • Birth control
  • Chlamydia
  • Clinics
  • Condoms
  • Condoms - statistics & numerical data
  • Contraceptive Devices, Female
  • Control methods
  • Counseling
  • Developing countries
  • Diaphragm
  • Diaphragms
  • Disease control
  • Disease prevention
  • Drug stores
  • Ethics
  • Evidence-based medicine
  • Family planning
  • Female
  • Health risks
  • HIV
  • HIV Infections - epidemiology
  • HIV Infections - prevention & control
  • Human immunodeficiency virus
  • Human papillomavirus
  • Humans
  • Incidence
  • Infections
  • Internal Medicine
  • Intervention
  • Latex
  • LDCs
  • Lubricants
  • Medical research
  • Methods
  • Middle Aged
  • Motivation
  • Pregnancy
  • Prevention
  • Randomization
  • Reproductive health
  • Risk reduction
  • Sexual behavior
  • Sexually transmitted diseases
  • South Africa - epidemiology
  • STD
  • Urban areas
  • Vaginal Creams, Foams, and Jellies
  • Womens health
  • Zimbabwe - epidemiology
ispartof: The Lancet (British edition), 2007, Vol.370 (9583), p.251-261
description: Summary Background Female-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. Methods We 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. Findings Overall 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
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleDiaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial
sourceAlma/SFX Local Collection
creatorPadian, Nancy S, Dr ; van der Straten, Ariane, PhD ; Ramjee, Gita, PhD ; Chipato, Tsungai, MBChB ; de Bruyn, Guy, MBChB ; Blanchard, Kelly, MS ; Shiboski, Stephen, PhD ; Montgomery, Elizabeth T, MHS ; Fancher, Heidi, MPH ; Cheng, Helen, MPH ; Rosenblum, Michael, PhD ; van der Laan, Mark, PhD ; Jewell, Nicholas, PhD ; McIntyre, James, MBChB
creatorcontribPadian, Nancy S, Dr ; van der Straten, Ariane, PhD ; Ramjee, Gita, PhD ; Chipato, Tsungai, MBChB ; de Bruyn, Guy, MBChB ; Blanchard, Kelly, MS ; Shiboski, Stephen, PhD ; Montgomery, Elizabeth T, MHS ; Fancher, Heidi, MPH ; Cheng, Helen, MPH ; Rosenblum, Michael, PhD ; van der Laan, Mark, PhD ; Jewell, Nicholas, PhD ; McIntyre, James, MBChB ; the MIRA Team ; MIRA Team
descriptionSummary Background Female-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. Methods We 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. Findings Overall 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. Interpretation We 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.
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languageeng
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subjectAbridged Index Medicus ; Acquired immune deficiency syndrome ; Adolescent ; Adult ; AIDS ; Article ; Biomedical research ; Birth control ; Chlamydia ; Clinics ; Condoms ; Condoms - statistics & numerical data ; Contraceptive Devices, Female ; Control methods ; Counseling ; Developing countries ; Diaphragm ; Diaphragms ; Disease control ; Disease prevention ; Drug stores ; Ethics ; Evidence-based medicine ; Family planning ; Female ; Health risks ; HIV ; HIV Infections - epidemiology ; HIV Infections - prevention & control ; Human immunodeficiency virus ; Human papillomavirus ; Humans ; Incidence ; Infections ; Internal Medicine ; Intervention ; Latex ; LDCs ; Lubricants ; Medical research ; Methods ; Middle Aged ; Motivation ; Pregnancy ; Prevention ; Randomization ; Reproductive health ; Risk reduction ; Sexual behavior ; Sexually transmitted diseases ; South Africa - epidemiology ; STD ; Urban areas ; Vaginal Creams, Foams, and Jellies ; Womens health ; Zimbabwe - epidemiology
ispartofThe Lancet (British edition), 2007, Vol.370 (9583), p.251-261
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1van der Straten, Ariane, PhD
2Ramjee, Gita, PhD
3Chipato, Tsungai, MBChB
4de Bruyn, Guy, MBChB
5Blanchard, Kelly, MS
6Shiboski, Stephen, PhD
7Montgomery, Elizabeth T, MHS
8Fancher, Heidi, MPH
9Cheng, Helen, MPH
10Rosenblum, Michael, PhD
11van der Laan, Mark, PhD
12Jewell, Nicholas, PhD
13McIntyre, James, MBChB
14the MIRA Team
15MIRA Team
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0Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial
1The Lancet (British edition)
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descriptionSummary Background Female-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. Methods We 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. Findings Overall 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. Interpretation We 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.
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0Abridged Index Medicus
1Acquired immune deficiency syndrome
2Adolescent
3Adult
4AIDS
5Article
6Biomedical research
7Birth control
8Chlamydia
9Clinics
10Condoms
11Condoms - statistics & numerical data
12Contraceptive Devices, Female
13Control methods
14Counseling
15Developing countries
16Diaphragm
17Diaphragms
18Disease control
19Disease prevention
20Drug stores
21Ethics
22Evidence-based medicine
23Family planning
24Female
25Health risks
26HIV
27HIV Infections - epidemiology
28HIV Infections - prevention & control
29Human immunodeficiency virus
30Human papillomavirus
31Humans
32Incidence
33Infections
34Internal Medicine
35Intervention
36Latex
37LDCs
38Lubricants
39Medical research
40Methods
41Middle Aged
42Motivation
43Pregnancy
44Prevention
45Randomization
46Reproductive health
47Risk reduction
48Sexual behavior
49Sexually transmitted diseases
50South Africa - epidemiology
51STD
52Urban areas
53Vaginal Creams, Foams, and Jellies
54Womens health
55Zimbabwe - epidemiology
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titleDiaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial
authorPadian, Nancy S, Dr ; van der Straten, Ariane, PhD ; Ramjee, Gita, PhD ; Chipato, Tsungai, MBChB ; de Bruyn, Guy, MBChB ; Blanchard, Kelly, MS ; Shiboski, Stephen, PhD ; Montgomery, Elizabeth T, MHS ; Fancher, Heidi, MPH ; Cheng, Helen, MPH ; Rosenblum, Michael, PhD ; van der Laan, Mark, PhD ; Jewell, Nicholas, PhD ; McIntyre, James, MBChB
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1Acquired immune deficiency syndrome
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3Adult
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8Chlamydia
9Clinics
10Condoms
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12Contraceptive Devices, Female
13Control methods
14Counseling
15Developing countries
16Diaphragm
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18Disease control
19Disease prevention
20Drug stores
21Ethics
22Evidence-based medicine
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47Risk reduction
48Sexual behavior
49Sexually transmitted diseases
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52Urban areas
53Vaginal Creams, Foams, and Jellies
54Womens health
55Zimbabwe - epidemiology
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6Shiboski, Stephen, PhD
7Montgomery, Elizabeth T, MHS
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abstractSummary Background Female-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. Methods We 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. Findings Overall 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. Interpretation We 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.
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pmid17631387
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