Literature DB >> 25761233

The science of being a study participant: FEM-PrEP participants' explanations for overreporting adherence to the study pills and for the whereabouts of unused pills.

Amy L Corneli1, Kevin McKenna, Brian Perry, Khatija Ahmed, Kawango Agot, Fulufhelo Malamatsho, Joseph Skhosana, Jacob Odhiambo, Lut Van Damme.   

Abstract

BACKGROUND: FEM-PrEP was unable to determine whether once-daily, oral emtricitabine/tenofovir disoproxil fumarate reduces the risk of HIV acquisition among women because of low adherence. Self-reported adherence was high, and pill-count data suggested good adherence. Yet, drug concentrations revealed limited pill use. We conducted a follow-up study with former participants in Bondo, Kenya, and Pretoria, South Africa, to understand factors that had influenced overreporting of adherence and to learn the whereabouts of unused pills.
METHODS: Qualitative, semistructured interviews were conducted with 88 participants, and quantitative, audio computer-assisted self-interviews were conducted with 224 participants. We used thematic analysis and descriptive statistics to analyze the qualitative and quantitative data, respectively.
RESULTS: In audio computer-assisted self-interviews, 31% (n = 70) said they had overreported adherence; the main reason was the belief that nonadherence would result in trial termination (69%, n = 48). A considerable percentage (35%, n = 78) acknowledged discarding unused pills. Few acknowledged giving their pills to someone else (4%, n = 10), and even fewer acknowledged giving them to someone with HIV (2%, n = 5). Many participants in the semistructured interviews said other participants had counted and removed pills from their bottles to appear adherent.
CONCLUSIONS: Despite repeated messages that nonadherence would not upset staff, participants acknowledged several perceived negative consequences of reporting nonadherence, which made it difficult to report accurately. Uneasiness continued in the follow-up study, as many said they had not overreported during the trial. Efforts to improve self-reported measures should include identifying alternative methods for creating supportive environments that allow participants to feel comfortable reporting actual adherence.

Entities:  

Mesh:

Substances:

Year:  2015        PMID: 25761233     DOI: 10.1097/QAI.0000000000000525

Source DB:  PubMed          Journal:  J Acquir Immune Defic Syndr        ISSN: 1525-4135            Impact factor:   3.731


  36 in total

1.  Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

Authors:  Barbara S Mensch; Elizabeth R Brown; Karen Liu; Jeanne Marrazzo; Zvavahera Mike Chirenje; Kailazarid Gomez; Jeanna Piper; Karen Patterson; Ariane van der Straten
Journal:  AIDS Behav       Date:  2016-11

Review 2.  Deception in clinical trials and its impact on recruitment and adherence of study participants.

Authors:  Chuen Peng Lee; Tyson Holmes; Eric Neri; Clete A Kushida
Journal:  Contemp Clin Trials       Date:  2018-08-21       Impact factor: 2.226

Review 3.  Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions.

Authors:  Matthew A Spinelli; Jessica E Haberer; Peter R Chai; Jose Castillo-Mancilla; Peter L Anderson; Monica Gandhi
Journal:  Curr HIV/AIDS Rep       Date:  2020-08       Impact factor: 5.071

4.  Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants' Explanations for Dishonesty.

Authors:  Elizabeth T Montgomery; B Mensch; P Musara; M Hartmann; K Woeber; J Etima; A van der Straten
Journal:  AIDS Behav       Date:  2017-02

5.  Brief Report: Medication Sharing Is Rare Among African HIV-1 Serodiscordant Couples Enrolled in an Efficacy Trial of Oral Pre-exposure Prophylaxis (PrEP) for HIV-1 Prevention.

Authors:  Kerry A Thomson; Jessica E Haberer; Mark A Marzinke; Andrew Mujugira; Craig W Hendrix; Connie Celum; Patrick Ndase; Allan Ronald; David R Bangsberg; Jared M Baeten
Journal:  J Acquir Immune Defic Syndr       Date:  2017-06-01       Impact factor: 3.731

6.  Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers Through Evidence-Based Ethics.

Authors:  Celia B Fisher; Miriam R Arbeit; Melissa S Dumont; Kathryn Macapagal; Brian Mustanski
Journal:  J Empir Res Hum Res Ethics       Date:  2016-03-07       Impact factor: 1.742

7.  Shifting the HIV Training and Research Paradigm to Address Disparities in HIV Outcomes.

Authors:  Julie H Levison; Margarita Alegría
Journal:  AIDS Behav       Date:  2016-09

Review 8.  Tenofovir-based oral preexposure prophylaxis prevents HIV infection among women.

Authors:  Kerry A Thomson; Jared M Baeten; Nelly R Mugo; Linda-Gail Bekker; Connie L Celum; Renee Heffron
Journal:  Curr Opin HIV AIDS       Date:  2016-01       Impact factor: 4.283

9.  Sharing of Investigational Drug Among Participants in the Voice Trial.

Authors:  Jeeva Moodley; Sarita Naidoo; Jayajothi Moodley; Gita Ramjee
Journal:  AIDS Behav       Date:  2016-11

Review 10.  Current concepts for PrEP adherence in the PrEP revolution: from clinical trials to routine practice.

Authors:  Jessica E Haberer
Journal:  Curr Opin HIV AIDS       Date:  2016-01       Impact factor: 4.283

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.