Evidence map›Paper›PMID 34043657›Full record

ArticlePloS one2021

Adaptation and validation of simple tools to screen and monitor for oral PrEP adherence.

Seth Zissette, Elizabeth E Tolley, Andres Martinez, Homaira Hanif, Katherine Gill, Nelly Mugo, Laura Myers, Ednar Casmir, Menna Duyver, Kenneth Ngure and 1 more

Abstract readValidation Study
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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

11 authors.

Seth ZissetteFHI 360, Behavioral, Epidemiological, Clinical Sciences, Durham, North Carolina, United States of America.
Elizabeth E TolleyFHI 360, Behavioral, Epidemiological, Clinical Sciences, Durham, North Carolina, United States of America.ORCID 0000-0002-9823-3675
Andres MartinezFHI 360, Behavioral, Epidemiological, Clinical Sciences, Durham, North Carolina, United States of America.
Homaira HanifCONRAD, Eastern Virginia Medical School, Norfolk, Virginia, United States of America.
Katherine GillDesmond Tutu HIV Foundation, University of Cape Town, Cape Town, South Africa.
Nelly MugoCenter for Clinical Research (CCR), Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Laura MyersDesmond Tutu HIV Foundation, University of Cape Town, Cape Town, South Africa.
Ednar CasmirCenter for Clinical Research (CCR), Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Menna DuyverDesmond Tutu HIV Foundation, University of Cape Town, Cape Town, South Africa.
Kenneth NgureDepartment of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Gustavo F DoncelCONRAD, Eastern Virginia Medical School, Norfolk, Virginia, United States of America.

Funding

PEPFAR
6 · The paper itself

Abstract

introductionOral, vaginal and other pre-exposure prophylaxis (PrEP) products for HIV prevention are in various stages of development. Low adherence poses a serious challenge to successful evaluation in trials. In a previous study, we developed tools to screen for general adherence and specifically monitor intravaginal ring adherence within the context of HIV prevention clinical trials. This study aimed to further validate the screening tool and to adapt and provide initial psychometric validation for an oral pill monitoring tool. MATERIALS AND

methodsWe administered a cross-sectional survey between June and October 2018 at a trial site located near Cape Town, South Africa, and another in Thika, Kenya, with 193 women who had experience using daily oral pills. We fit confirmatory factor analysis models on the screening tool items to assess our previously-hypothesized subscale structure. We conducted an exploratory factor analysis of oral PrEP monitoring items to determine the underlying subscale structure. We then assessed the construct validity of each tool by comparing subscales against each other within the current sample and against our original sample, from a study conducted in four sites in South Africa, including Cape Town.

resultsThe screening tool structure showed moderate evidence of construct validity. As a whole, the tool performed in a similar way to the original sample. The monitoring tool items, which were revised to assess perceptions about and experiences using daily oral PrEP, factored into five subscales that showed moderate to good reliability. Four of the five subscales had a similar structure overall to the vaginal ring monitoring tool from which they were adapted.

conclusionsAccurate measurement of HIV-prevention product adherence is of critical importance to the assessment of product efficacy and safety in clinical trials, and the support of safe and effective product use in non-trial settings. In this study, we provide further validation for these measures, demonstrating the screening tool's utility in additional populations and adapting the monitoring tool's utility for different HIV-prevention products.

Indexed as

Drug MonitoringAdolescentAdultContraceptives, OralCross-Sectional StudiesFemaleHIV InfectionsHumansKenyaMedication AdherenceMonitoring, PhysiologicPre-Exposure ProphylaxisSouth AfricaContraceptives, Oral

Identifiers

PMID34043657
PMCPMC8158999

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.