Evidence map›Paper›PMID 36162740›Full record

Trial reportContemporary clinical trials2022

Acceptability of an intravaginal ring for simultaneously preventing HIV infection and pregnancy: Qualitative findings of the Kisumu Combined Ring Study, 2019.

Eleanor McLellan-Lemal, Stacie R Deaton, Joshua E Betts, Ken Ondenge, Victor Mudhune, Siobhan M O'Connor, Beatrice Nyagol, Andrea R Thurman, Gustavo F Doncel, Shannon A Allen and 3 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03762382 (Phase IIa, 90-Day Safety, Adherence, and Acceptability Study of Intravaginal Rings Releasing Tenofovir With and Without Levonorgestrel Among Women in Western Kenya), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 30% 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.

NCT03762382 phase2unknown statusnot on this map

Phase IIa, 90-Day Safety, Adherence, and Acceptability Study of Intravaginal Rings Releasing Tenofovir With and Without Levonorgestrel Among Women in Western Kenya

TypeinterventionalSponsorCONRADRan2018 to 2020Enrolled50ConditionsHIV, Contraception, Prevention, Anti-Retroviral AgentArmsTFV/LNG IVR, TFV IVR, Placebo IVR
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
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

13 authors at 6 institutions in 2 countries.

Eleanor McLellan-LemalCenters for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of HIV/AIDS Prevention, Atlanta, GA, USA.
Stacie R DeatonICF, Atlanta, GA, USA. Electronic address: snd0@cdc.gov.
Joshua E BettsICF, Atlanta, GA, USA.
Ken OndengeKenya Medical Research Institute, Center for Global Health Research, Kisumu, Kenya.
Victor MudhuneKenya Medical Research Institute, Center for Global Health Research, Kisumu, Kenya.
Siobhan M O'ConnorCenters for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of HIV/AIDS Prevention, Atlanta, GA, USA.
Beatrice NyagolKenya Medical Research Institute, Center for Global Health Research, Kisumu, Kenya.
Andrea R ThurmanCONRAD, Eastern Virginia Medical School, Norfolk, VA, USA.
Gustavo F DoncelCONRAD, Eastern Virginia Medical School, Norfolk, VA, USA.
Shannon A AllenUnited States Agency for International Development, Washington, DC, USA.
Renee HeffronUniversity of Washington, Department of Global Health, International Clinical Research Center, Seattle, WA, USA.
Nelly R MugoUniversity of Washington, Department of Global Health, International Clinical Research Center, Seattle, WA, USA; Kenya Medical Research Institute, Center for Clinical Research, Nairobi, Kenya.
Kisumu Combined Ring Study (KCRS) Team
Kenya Medical Research Institute · KEEastern Virginia Medical School · USICF International (United States) · USNational Center for HIV/AIDS Viral Hepatitis STD and TB Prevention · USNational Clinical Research · USUnited States Agency for International Development · US

Funding

Evaluation of an intravaginal ring for HIV and pregnancy prevention with scientific partnerships and robust systems to strengthen HIV research in Western KenyaU01PS005183 · PS · UNIVERSITY OF WASHINGTON · PI MUGO, NELLY RWAMBA · 2017 to 2019
$1.8M
Intramural CDC HHS CC999999NCHHSTP CDC HHS U01 PS005183PEPFAR
6 · The paper itself

Abstract

Multipurpose prevention technology intravaginal rings (MPT IVRs) may offer a promising solution for addressing women's multiple sexual and reproductive health needs. We describe MPT IVR acceptability perspectives and examine user experiences of 25 cisgender women aged 18-34 years enrolled in a phase IIa randomized, partially blinded, placebo-controlled evaluation of tenofovir-based IVRs with and without contraceptive co-formulation. All took part in an individual, audio-recorded, semi-structured qualitative interview. A thematic analysis of transcribed interviews was completed in MaxQDA. Participants shared little to no knowledge of or experience with IVRs prior to joining the study. Four MPT IVR themes were identified: physical well-being, method reliability, personal management, and societal endorsement. Commonly cited of concern, but less described as being experienced, were physical discomforts (e.g., painful insertion/removal; inability to carry out daily activities/chores; foreign body sensation; expulsion; sexual interference, or debilitating side effects). Uncertainty regarding efficacy influenced perspectives about intended prevention benefits. Personal choices in managing reproduction and sexual behaviors had to be congruent with sociocultural values and norms for acceptance beyond the individual user level. Participants viewed broader community acceptance as likely to be mixed given community opposition to the use of modern family planning methods. They also shared concerns that IVR use could lead to infertility, especially among nulliparous women, or that it would encourage premarital sex or high-risk sexual behaviors among adolescent and young women. While a MPT IVR may not be suitable for all women, first-hand testimonials could help influence collective receptivity. Additional community acceptability research is needed. Clinical Trial Registration The study is registered at http://ClinicalTrials.gov under the identifier NCT03762382.

Indexed as

Contraceptive Devices, FemaleHIV InfectionsAdolescentFemaleHumansPregnancyReproducibility of ResultsSexual BehaviorTenofovirTenofovirAcceptabilityHIV preventionKenyaMultipurpose intravaginal ringsUser experienceWomen

Identifiers

PMID36162740
PMCPMC11265295
OpenAlexW4296817346

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.