Evidence map›Paper›PMID 33411782›Full record

ArticlePloS one2021

Women design their own vaginal microbicide trial: Suggestions on how to improve adherence from former participants of HIV prevention trials.

Lori Miller, Neetha Morar, Saidi Kapiga, Gita Ramjee, Richard Hayes

Abstract read
In one paragraph

Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
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

5 authors.

Lori MillerLondon School of Hygiene and Tropical Medicine, London, United Kingdom.ORCID 0000-0001-6338-9349
Neetha MorarHIV Prevention Research Unit, Medical Research Council, Durban, South Africa.
Saidi KapigaLondon School of Hygiene and Tropical Medicine, London, United Kingdom.
Gita RamjeeAurum Institute, Durban, South Africa.
Richard HayesLondon School of Hygiene and Tropical Medicine, London, United Kingdom.

Funding

Global HIV Implementation Science Research Training Grant RenewalT32AI114398 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Yael R Hirsch-Moverman · 2014 to 2026
$4.1M
Medical Research Council G0901756Medical Research Council MR/R00255X/1Medical Research Council MR/R010161/1NIAID NIH HHS T32 AI114398
6 · The paper itself

Abstract

Low adherence in vaginal microbicide clinical trials for HIV prevention has impeded interpretation of trial results and hindered evaluation of potentially efficacious HIV prevention gels. Understanding the underlying reasons why women join trials and their barriers to product use can support identification of ways to improve adherence and its reporting. Eight focus group discussion workshops were conducted with 46 former microbicide trial participants in Durban, South Africa and Mwanza, Tanzania. Participants provided feedback on why women join trials, the barriers to using study gel and reporting adherence accurately, and how clinical trial design can be improved to support better adherence and its reporting. Women join microbicide trials for a number of important reasons such as healthcare and financial reimbursement. Fear of adverse effects from the investigational product was the most important reason why participants reported not using the gel. The key reason for inaccurate reporting of gel use was fear of removal from the trial. Participants made concrete suggestions for improving microbicide trial design such as applicator use testing and real time feedback, improving education to participants about how trials answer their research questions, and improving transparency and clarity about study procedures. Participants also gave feedback on an innovative trial design with a non-randomised arm. Identifying HIV prevention products for women requires better understanding of the lives of women asked to join these trials, and application of that understanding to microbicide trial design. This study has demonstrated that participants and research teams can work collaboratively to design clinical trials that meet needs of both the research and of participants.

Indexed as

Patient Acceptance of Health CareRandomized Controlled Trials as TopicAdministration, IntravaginalAdultAgedAnti-HIV AgentsAnti-Infective AgentsFearFemaleHIV InfectionsHumansMiddle AgedPatient ComplianceResearch DesignSouth AfricaTanzaniaAnti-HIV AgentsAnti-Infective Agents

Identifiers

PMID33411782
PMCPMC7790400

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.