Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring
© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com..
BACKGROUND: Confounding introduced by individuals' sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use.
METHODS: We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18-45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use.
RESULTS: Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8-3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9-4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%-80%) per-sex-act HIV-1 risk reduction.
CONCLUSIONS: These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use.
CLINICAL TRIALS REGISTRATION: NCT01617096.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:229 |
|---|---|
| Enthalten in: |
The Journal of infectious diseases - 229(2024), 4 vom: 12. Apr., Seite 1158-1165 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Stalter, Randy M [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Anti-HIV Agents |
|---|
| Anmerkungen: |
Date Completed 15.04.2024 Date Revised 29.04.2024 published: Print ClinicalTrials.gov: NCT01617096 Citation Status MEDLINE |
|---|
| doi: |
10.1093/infdis/jiad550 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM365901989 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM365901989 | ||
| 003 | DE-627 | ||
| 005 | 20240429231935.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231227s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1093/infdis/jiad550 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1392.xml |
| 035 | |a (DE-627)NLM365901989 | ||
| 035 | |a (NLM)38099506 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Stalter, Randy M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 15.04.2024 | ||
| 500 | |a Date Revised 29.04.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT01617096 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com. | ||
| 520 | |a BACKGROUND: Confounding introduced by individuals' sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use | ||
| 520 | |a METHODS: We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18-45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use | ||
| 520 | |a RESULTS: Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8-3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9-4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%-80%) per-sex-act HIV-1 risk reduction | ||
| 520 | |a CONCLUSIONS: These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use | ||
| 520 | |a CLINICAL TRIALS REGISTRATION: NCT01617096 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a HIV-1 | |
| 650 | 4 | |a dapivirine | |
| 650 | 4 | |a per sex act | |
| 650 | 4 | |a preexposure prophylaxis | |
| 650 | 4 | |a vaginal ring | |
| 650 | 7 | |a Anti-HIV Agents |2 NLM | |
| 650 | 7 | |a Dapivirine |2 NLM | |
| 650 | 7 | |a TCN4MG2VXS |2 NLM | |
| 650 | 7 | |a Pyrimidines |2 NLM | |
| 700 | 1 | |a Dong, Tracy Q |e verfasserin |4 aut | |
| 700 | 1 | |a Hendrix, Craig W |e verfasserin |4 aut | |
| 700 | 1 | |a Palanee-Phillips, Thesla |e verfasserin |4 aut | |
| 700 | 1 | |a van der Straten, Ariane |e verfasserin |4 aut | |
| 700 | 1 | |a Hillier, Sharon L |e verfasserin |4 aut | |
| 700 | 1 | |a Kiweewa, Flavia M |e verfasserin |4 aut | |
| 700 | 1 | |a Mgodi, Nyaradzo M |e verfasserin |4 aut | |
| 700 | 1 | |a Marzinke, Mark A |e verfasserin |4 aut | |
| 700 | 1 | |a Bekker, Linda-Gail |e verfasserin |4 aut | |
| 700 | 1 | |a Soto-Torres, Lydia |e verfasserin |4 aut | |
| 700 | 1 | |a Baeten, Jared M |e verfasserin |4 aut | |
| 700 | 1 | |a Brown, Elizabeth R |e verfasserin |4 aut | |
| 700 | 0 | |a MTN-020/ASPIRE Study Team |e verfasserin |4 aut | |
| 700 | 1 | |a Baeten, Jared |e investigator |4 oth | |
| 700 | 1 | |a Palanee-Phillips, Thesla |e investigator |4 oth | |
| 700 | 1 | |a Brown, Elizabeth |e investigator |4 oth | |
| 700 | 1 | |a Soto-Torres, Lydia |e investigator |4 oth | |
| 700 | 1 | |a Schwartz, Katie |e investigator |4 oth | |
| 700 | 1 | |a Makanani, Bonus |e investigator |4 oth | |
| 700 | 1 | |a Martinson, Francis |e investigator |4 oth | |
| 700 | 1 | |a Bekker, Linda-Gail |e investigator |4 oth | |
| 700 | 1 | |a Govender, Vaneshree |e investigator |4 oth | |
| 700 | 1 | |a Siva, Samantha |e investigator |4 oth | |
| 700 | 1 | |a Gaffoor, Zakir |e investigator |4 oth | |
| 700 | 1 | |a Naidoo, Logashvari |e investigator |4 oth | |
| 700 | 1 | |a Pather, Arendevi |e investigator |4 oth | |
| 700 | 1 | |a Jeenarain, Nitesha |e investigator |4 oth | |
| 700 | 1 | |a Nair, Gonasagrie |e investigator |4 oth | |
| 700 | 1 | |a Palanee-Phillips, Thesla |e investigator |4 oth | |
| 700 | 1 | |a Kiweewa, Flavia Matovu |e investigator |4 oth | |
| 700 | 1 | |a Mgodi, Nyaradzo |e investigator |4 oth | |
| 700 | 1 | |a Mhlanga, Felix |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t The Journal of infectious diseases |d 1945 |g 229(2024), 4 vom: 12. Apr., Seite 1158-1165 |w (DE-627)NLM000005819 |x 1537-6613 |7 nnns |
| 773 | 1 | 8 | |g volume:229 |g year:2024 |g number:4 |g day:12 |g month:04 |g pages:1158-1165 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1093/infdis/jiad550 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 229 |j 2024 |e 4 |b 12 |c 04 |h 1158-1165 | ||