Optimizing adherence in HIV prevention product trials: Development and psychometric evaluation of simple tools for screening and adherence counseling

Tolley, Elizabeth E.; Guthrie, Kate M.; Zissette, Seth; Fava, Joseph L.; Gill, Katherine; Louw, Cheryl; Kotze, Philip; Reddy, Krishnaveni; MacQueen, Kathleen M.

doi:10.1371/journal.pone.0195499

Cited by 4 publications

(10 citation statements)

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“…Further research could be beneficial to refine item content. Nevertheless, the correlations between all of the subscales were consistent with our original assumptions based on the literature [ 9 ], providing evidence for their construct validity. An additional limitation is that our tools (both the original vaginal ring and oral PrEP scales) were developed and validated among young adult African women from South Africa and Kenya.…”

Section: Discussionsupporting

confidence: 85%

“…As PrEP and other HIV prevention products become more widely available, product adherence poses a serious challenge to their successful use, particularly among young African women [ 6 , 8 , 9 ]. In trials of PrEP effectiveness, sub-analyses indicated that poor adherence to the prescribed dosing regimen reduced effectiveness [ 10 , 11 ].…”

Section: Introductionmentioning

confidence: 99%

“…In response to the measurement challenges cited above, we previously conducted a study in four South African sites [ 9 ] to develop and provide preliminary validation for two different tools to screen for and monitor product-related adherence within the context of clinical trial participation. The screening tool comprised six subscales measuring potential participants’ attitudes about, and social and structural challenges towards trial participation.…”

Section: Introductionmentioning

confidence: 99%

“…The overall goal of this project was to adapt and provide further psychometric validation for the screening tool and initial psychometric validation for the oral pill monitoring tool. Starting with the tools developed in the aforementioned study (from here forward referred to as the “original” study) [ 9 ], we used scale development processes to adapt the screening and monitoring tool items for local context in two sites in South Africa and Kenya, including rounds of cognitive interviewing to improve item framing, comprehensibility and salience, followed by administration of a survey to facilitate both confirmatory and exploratory factor analyses and psychometric evaluation of resulting constructs.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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Introduction Oral, 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 methods We 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. Results The 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. Conclusions Accurate 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.

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Section: Discussionsupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

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“…Second, parents’ behaviours of adherence were self-reported. Although self-reported adherence has demonstrated adequate validity [34], reported levels are the respondents’ perception of their adherence, and are not necessarily a true reflection of actual events. It is therefore possible that our results represent an overly optimistic view of the extent of adherence to HEP.…”

Section: Discussionmentioning

confidence: 99%

Factors Associated with Parents’ Adherence to Different Types of Exercises in Home Programs for Children with Disabilities

Lillo-Navarro

Montilla-Herrador

Escolar-Reina

et al. 2019

JCM

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There is a lack of knowledge with regard to the adherence to different types of exercises prescribed for children with disabilities. The aim was to examine parents’ adherence to prescriptions of different types of home exercises; to identify associated factors related to the parents, the children and the environment, and to assess the relative influence of the behaviour of health professionals. Parents (393) were recruited from 18 early intervention centres. A cross-sectional survey using a self-reported questionnaire was used to examine whether three types of exercises (“flexibility exercises”, “neuromotor development training” and “body mechanics and postural stabilisation”) were prescribed in their home programs; if the child had received exercises according to a prescription; and items related to the parents, child, environment, and health professionals. The adherence rates were different among the types of exercises. Parents with low perception of barriers and high self-efficacy had a higher adherence to neuromotor development training and postural stabilization, whereas parents with a high level of knowledge increased their odds of adherence to flexibility exercises. Health professionals’ behaviour had a distinct influence on the adherence to different exercises. This study suggests the need to specifically consider the types of exercises prescribed in the management of adherence to home programs.

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The use of objective adherence measures targeting four placebo microbicide delivery forms in the Quatro Clinical Crossover Study

Jacot

Adedipe

Godbout

et al. 2021

Clinical and Translational Dis

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Background: Adherence to topical microbicides for HIV prevention has been a challenge for women using them and those developing novel products. The Quatro Clinical Crossover Study investigated user preference and acceptability of four different placebo-based vaginal delivery forms among young African women. The objective of this sub-study was to test the ability of objective adherence measures in assessing placebo product usage. Methods: A total of two hundred women from Zimbabwe and South Africa used placebo vaginal gel, insert, and film once per week, with or without sex, for 1 month and an intravaginal ring continuously for one month (Months 1-4).Women then chose their preferred product and used it with sex each week during Month 5. Women self-collected vaginal swabs after using the gel, insert and film. Collected vaginal swabs and used intravaginal rings were analysed for placebobased adherence measures using spectroscopy and excipient-based analyses to determine product use. Vaginal insertion and semen exposure was determined using previously developed and published adherence biomarkers. Intravaginal rings were extracted for residual excipient (glycerin) and penetrated bioanalytes.Results: Both methodologies showed that women used gel the most during Months 1-4 (75% by excipient methods, 85% by spectroscopy). The methodologies This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

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Optimizing adherence in HIV prevention product trials: Development and psychometric evaluation of simple tools for screening and adherence counseling

Cited by 4 publications

References 69 publications

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

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

Factors Associated with Parents’ Adherence to Different Types of Exercises in Home Programs for Children with Disabilities

The use of objective adherence measures targeting four placebo microbicide delivery forms in the Quatro Clinical Crossover Study

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