Evidence map›Paper›PMID 33892693›Full record

Trial reportBMC women's health2021

Experiences with simultaneous use of contraception and the vaginal ring for HIV prevention in sub-Saharan Africa.

Jonah Leslie, Flavia Kiweewa, Thesla Palanee-Phillips, Katherine Bunge, Felix Mhlanga, Betty Kamira, Jared Baeten, Ariana Katz, Sharon Hillier, Elizabeth Montgomery and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in BMC women's health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01617096 (A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 52% 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.

NCT01617096 phase3completednot on this map

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women

TypeinterventionalSponsorInternational Partnership for Microbicides, Inc.Ran2012 to 2015Enrolled2,629ConditionsHIV InfectionsArmsDapivirine Vaginal Ring, Placebo Ring
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
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

11 authors at 7 institutions in 4 countries.

Jonah LeslieWomen's Global Health Imperative, RTI International, San Francisco, CA, USA. jleslie.anthro@gmail.com.ORCID 0000-0003-2208-4658
Flavia KiweewaMakerere University-Johns Hopkins University Research Unit, Kampala, Uganda.
Thesla Palanee-PhillipsWits Reproductive Health and HIV Institute (Wits RHI), Hillbrow, South Africa.
Katherine BungeDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
Felix MhlangaUZ-UCSF Collaborative Research Programme, Harare, Zimbabwe.
Betty KamiraMakerere University-Johns Hopkins University Research Unit, Kampala, Uganda.
Jared BaetenDepartments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA, USA.
Ariana KatzWomen's Global Health Imperative, RTI International, San Francisco, CA, USA.
Sharon HillierMagee-Womens Research Institute, Pittsburgh, PA, USA.
Elizabeth MontgomeryWomen's Global Health Imperative, RTI International, San Francisco, CA, USA.
MTN-020/ASPIRE Study Team
RTI International · USMUJHU Research Collaboration · UGUniversity of Washington · USUniversity of Zimbabwe-University of California San Francisco · ZWPerinatal HIV Research Unit · ZAMagee-Womens Research Institute · USUniversity of Pittsburgh · US

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Alan David Levine · 1994 to 2026
$50.0M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
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 P30 AI036219NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI106707
6 · The paper itself

Abstract

backgroundClinical trials have found that a monthly dapivirine vaginal ring was well-tolerated and reduced HIV-1 risk among women in sub-Saharan Africa. However, in order for the ring or other novel prevention methods to have optimal impact, it is necessary to understand and address women's challenges to uptake and adherence. This paper provides insight into a few key challenges noted by women using the ring and contraceptives simultaneously.

methodsThe qualitative portion of the MTN-020/ASPIRE study consisted of data collection using single in-depth interviews, serial in-depth interviews, and focus group discussions, conducted with 214 participants across 15 sites in Malawi, South Africa, Uganda and Zimbabwe. A coding team used qualitative analysis software to identify themes within the interviews.

resultsThe primary qualitative themes among participant data pertained to side effects. Participants reported negative side effects related to menses, in some cases attributing these effects to their contraceptives and in others to the vaginal ring. Participants also expressed concern over the long-term impact of contraception and ring use on fertility, including the reversibility of the contraceptive, especially among nulliparous women.

conclusionsWomen's attitudes toward contraceptives can impact their willingness to concurrently use and adhere to a novel HIV prevention product. To optimize the potential of both prevention products, researchers should pre-emptively address concerns about contraceptive impact on fertility and counsel women about the expected side effects of contraceptives versus the ring. Clinical trials identifier NCT01617096. Registered on 6-12-2012 at clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01617096.

Indexed as

Anti-HIV AgentsContraceptive Devices, FemaleHIV InfectionsContraceptionFemaleHumansMalawiSouth AfricaUgandaZimbabweAnti-HIV AgentsAfrica South of the SaharaClinical trialContraceptionHIVQualitative researchVaginal ring

Identifiers

PMID33892693
PMCPMC8067655
OpenAlexW3155795118

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.